Porfimer is a photoactivated radical generator consisting of oligomers containing porphyrin. Photodynamic therapy (PDT) with porfimer is a 2-stage process involving intravenous administration of porfimer, followed by administration of a 630 nm wavelength laser light. It is indicated for the palliative treatment of patients with partially or completely obstructing esophageal cancer or endobronchial non-small cell lung cancer (NSCLC), for the treatment of inoperable microinvasive endobronchial NSCLC in patients not eligible for radiation therapy, and for the ablation of high-grade dysplasia in Barrett's esophagus patients who do not undergo endoscopy. All patients will develop photosensitivity after treatment and must observe precautions to avoid exposure of skin to direct sunlight or bright indoor light for at least 30 days after treatment. Patients should also wear dark sunglasses for at least 30 days (or until ocular sensitivity resolves) when outdoors.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Injectable Administration
Reconstituted porfimer is an opaque solution, making the detection of particulate matter extremely difficult. However, visually inspect for particulate matter and discoloration prior to administration whenever solution and container permit.
Intravenous Administration
-Photodynamic therapy (PDT) with porfimer and associated light delivery devices should be administered under the supervision of a trained medical provider.
-Administration of PDT with porfimer is a 2-step process requiring the IV administration of porfimer followed in 40 to 50 hours with activation by laser light.
Reconstitution
-Reconstitute each vial with 31.8 mL of either 5% Dextrose Injection or 0.9% Sodium Chloride Injection, resulting in a final concentration of 2.5 mg/mL. Each vial has been formulated with an overage to deliver the 75 mg labeled quantity.
-Shake well until dissolved. Do not mix with other drugs in the same solution.
-Protect the reconstituted product from bright light and use immediately; discard any unused portion.
IV Infusion
-Administer as a slow IV infusion over 3 to 5 minutes.
Other Administration Route(s)
Photoactivation:
-Light is delivered to the tumor by cylindrical Optiguide fiber optic diffusers passed through the operating channel of an endoscope/bronchoscope.
-The laser system must be approved for the delivery of stable power output at a wavelength of 630 +/- 3 nm.
Esophageal Cancer
-The total power output at the fiber tip is set to deliver the appropriate light dose using exposure times of 12 minutes and 30 seconds.
Endobronchial Cancer
-In patients who have recently undergone radiotherapy, allow sufficient time (approximately 4 weeks) for acute radiation-induced inflammation to subside prior to PDT.
-The total power output at the fiber tip is set to deliver the appropriate light dose using exposure times of 8 minutes and 20 seconds.
-For noncircumferential endobronchial tumors that are soft enough to penetrate, interstitial fiber placement is preferred to intraluminal activation.
-Debride 2 to 3 days after each administration to minimize the potential of obstruction caused by necrotic debris.
Barrett's Esophagus, Pretreatment or "Skip" Areas
-Use a short fiber diffuser (2.5 cm or less) without a centering balloon, placed directly against the nodule. Follow with standard balloon application as described below.
-For a 1 cm Fiber Optic Diffuser and a light intensity of 400 mW/cm, the required power output from the diffuser is 400 mW for a treatment time of 2 minutes and 5 seconds (125 seconds).
-For a 1.5 cm Fiber Optic Diffuser and a light intensity of 400 mW/cm, the required power output from the diffuser is 600 mW for a treatment time of 2 minutes and 5 seconds (125 seconds).
-For a 2 cm Fiber Optic Diffuser and a light intensity of 400 mW/cm, the required power output from the diffuser is 800 mW for a treatment time of 2 minutes and 5 seconds (125 seconds).
-For a 2.5 cm Fiber Optic Diffuser and a light intensity of 400 mW/cm, the required power output from the diffuser is 1,000 mW for a treatment time of 2 minutes and 5 seconds (125 seconds).
-No more than 1.5 times the required diffuser power output should be needed from the laser. If more is required, the system should be checked.
Barrett's Esophagus, Treatment
-The choice of diffuser tip length depends on the length of the tumor or Barrett's mucosa to be treated; it should be sized to avoid exposure of nonmalignant tissue to light and to prevent overlapping of previously treated malignant tissue.
-Treated length, 1 to 3 cm: Use a 5 cm Fiber Optic Diffuser with an X-Cell PDT Balloon Window Length of 3 cm. Using a light intensity of 270 mW/cm, the required power output from the diffuser is 1,350 mW for a treatment time of 8 minutes (480 seconds).
-Treated length, 4 to 5 cm: Use a 7 cm Fiber Optic Diffuser with an X-Cell PDT Balloon Window Length of 5 cm. Using a light intensity of 270 mW/cm, the required power output from the diffuser is 1,900 mW for a treatment time of 8 minutes (480 seconds).
-Treated length, 6 to 7 cm: Use a 9 cm Fiber Optic Diffuser with an X-Cell PDT Balloon Window Length of 7 cm. Using a light intensity of 270 mW/cm, the required power output from the diffuser is 2,440 mW for a treatment time of 8 minutes (480 seconds).
-No more than 1.5 times the required diffuser power output should be needed from the laser. If more is required, the system should be checked.
-For lasers with a total capacity of 2.5 W or less, a light intensity of 200 mW/cm may be used: the required power output from the diffuser is 1,800 mW for a treatment time of 10 minutes and 50 seconds. The light dose (Joules/cm) equals [Power output from Diffuser (W) x Treatment Time (seconds)] / [Diffuser Length (cm)].
All patients who receive porfimer will be photosensitive and must observe precautions to avoid sunlight and bright indoor light (e.g., examination lamps, including dental lamps, operating room lamps, and unshaded light bulbs at close proximity) for at least 30 days after treatment; some patients may be photosensitive for 90 days or more. The level of photosensitivity will vary for different areas of the body, depending on the extent of previous exposure to light; the tissue around the eyes may be more sensitive than other areas. Photosensitivity reactions occurred in 9% to 22% of cancer patients and in up to 69% of those with high-grade dysplasia in Barrett's esophagus treated with porfimer; typically these reactions consisted of mild to moderate erythema, but have also included swelling, pruritus, burning sensation, feeling hot, or blisters. In patients with Barrett's esophagus, photosensitivity reactions were more common in patients with high-grade dysplasia (47%) than in patients with Barrett's metaplasia, indefinite dysplasia, low-grade dysplasia, or adenocarcinoma at baseline (16%). Less common skin manifestations in areas where photosensitivity reactions occurred include increased hair growth, skin discoloration, skin nodule, skin wrinkling, and increased skin fragility; these may be attributable to a pseudo-porphyria state (temporary drug-induced cutaneous porphyria). Photophobia has also been reported in patients who received porfimer; patients should wear dark sunglasses with average light transmittance of less than 4% when outdoors for at least 30 days after treatment.
Jaundice and peritonitis have occurred in patients with obstructing esophageal cancer treated with porfimer plus photodynamic therapy (PDT) in a noncomparative trial.
Back pain (11% or less) and generalized pain (1% to 22%) have been reported in clinical trials in patients treated with porfimer plus photodynamic therapy (PDT). Additionally, post-procedural complications were reported in 5% of patients with completely or partially obstructing esophageal cancer (n = 88). Injury and procedural complications occurred in 11% to 19% of patients with high-grade dysplasia in Barrett's esophagus who received PDT plus omeprazole, and post-procedural pain was reported in 6% to 14% of these patients.
Vigorous debridement may cause tumor bleeding. For endobronchial tumors, discontinue debridement of necrotic tissue when the volume of bleeding increases, as this may indicate that debridement has gone beyond the zone of the photodynamic therapy (PDT) effect. Tumor hemorrhage occurred in 8% of patients with obstucting esophageal cancer treated with PDT.
Anemia was reported in 32% of patients with completely or partially obstructing esophageal cancer treated with porfimer plus photodynamic therapy (PDT) (n = 88). In patients with esophageal cancer, treatment-related anemia may occur due to tumor bleeding. Patients who had tumors located in the lower third of the esophagus, the most vascular region, as well as those with large tumors (greater than 10 cm) were more likely to experience anemia.
Fatal massive hemoptysis (FMH) has occurred in patients treated with porfimer plus photodynamic therapy (PDT). In 2 multicenter, randomized trials of patients with obstructing endobronchial cancer, there was a trend toward a higher rate of FMH occurring in patients treated with PDT compared with those who received Nd:YAG (10% vs. 5%); however, the rate of FMH within 30 days of treatment was the same in each arm (4% total events, 3% treatment-associated events). Of patients who received the currently marketed formulation, hemoptysis within 30 days of treatment occurred in 7% of patients in the PDT arm compared with 6% in the Nd:YAG arm; in the entire follow-up period, the incidence was 16% versus 8% of patients, respectively. Patients who received prior radiation therapy had a higher incidence of FMH in both arms of this study (21% vs. 10%, respectively), which may be due to associated prognostic factors such as having a centrally located tumor. In patients with no prior radiation therapy, FMH occurred in less than 1% of patients. Patients with cavitating tumors and those with extensive tumors extrinsic to the bronchus are also at increased risk for FMH. One inoperable patient with a superficial endobronchial tumor (microinvasive or carcinoma in situ) out of 3 noncomparative studies had FMH within 30 days of treatment (1%). Hematemesis occurred in 8% of patients with completely or partially obstructing esophageal cancer in a noncomparative trial.
Asthenia was reported in 6% of patients with completely or partially obstructing esophageal cancer (n = 88) treated with porfimer plus photodynamic therapy (PDT) in a noncomparative trial.
Respiratory adverse reactions have occurred in cancer patients after treatment with porfimer with photodynamic therapy (PDT) including bronchitis, bronchospasm, dyspnea, laryngotracheal edema (laryngeal edema), pneumonitis, pulmonary hemorrhage, pulmonary edema, respiratory arrest, and stridor; the temporal relationship to administration of laser light therapy was suggestive of mediastinal inflammation in some patients. In 3 multicenter, randomized trials of patients with obstructive endobronchial cancer, bronchitis and dyspnea occurred more often in patients treated with PDT compared with Nd:YAG. Most cases of bronchitis occurred within 1 week of treatment and were mild to moderate in intensity. Treatment-related worsening of dyspnea was generally transient and self-limiting. Treatment-related, life-threatening respiratory insufficiency occurred in 3% of PDT-treated patients and in 2% of those receiving Nd:YAG. In a noncomparative trial of patients with superficial endobronchial tumors (n = 90), 3 patients experienced life-threatening dyspnea: one had received a double-dose of light, one was concurrently treated in both mainstem bronchi, and the last had a prior pneumonectomy and was treated in the sole remaining airway. In clinical trials, the following respiratory adverse reactions were reported: dyspnea (7% to 30%), pneumonia (6% to 18%), pharyngitis (11%), bronchitis (10%), respiratory insufficiency (6% to 10%), and cough (5% to 15%).
Pleural effusion occurred in 5% of patients with obstructing endobronchial cancer treated with porfimer plus photodynamic therapy (PDT) in 3 multicenter, randomized trials. The incidence of pleural effusion was higher (10% to 15%) in patients with high-grade dysplasia in Barrett's esophagus treated with porfimer plus PDT and omeprazole in another randomized clinical trial.
Fever occurred in 8% to 31% of patients treated with porfimer plus photodynamic therapy (PDT) in clinical trials. In addition to respiratory infection (6% to 18%) which occurred secondary to treatment across clinical trials, patients with completely or partially obstructing esophageal cancer (n = 88) also experienced candidiasis (9%) and urinary tract infection (7%) in a noncomparative trial.
Esophageal stricture was reported in 38% of patients who received porfimer and photodynamic therapy (PDT) to the esophagus in 3 clinical trials. Nodule pretreatment had occurred in 49% of patients who developed a stricture, and 82% of patients who developed a stricture had a mucosal segment more than once. Overall, esophageal strictures occurred within 6 months after therapy. Multiple esophageal dilations may be required: 28% of patients required 1 to 2 dilations, 28% required 3 to 5 dilations, 21% required 6 to 10 dilations, and 23% required more than 10 dilations. Dysphagia occurred in 10% and esophageal stenosis in 6% of patients with completely or partially obstructing esophageal cancer treated with PDT in a noncomparative trial. Bronchostenosis occurred in 11% of patients with superficial endobronchial tumors treated with porfimer plus PDT; stent placement was required in 3% of the patients due to endobronchial stricture. Dysphagia was more common (22% to 26%) in patients with Barrett's esophagus receiving porfimer plus PDT and omeprazole in a randomized clinical trial, but esophageal narrowing (24% to 32%) and esophageal stricture (33 to 37%) occurred with a similar incidence to cancer patients. The majority of cases of esophageal stenosis in patients with Barrett's esophagus including strictures reported with porfimer plus PDT and omeprazole were of mild (57%) or moderate (35%) intensity, and most were reported during the second course of treatment.
Visual impairment including abnormal vision, diplopia, and ocular pain have been reported in patients treated with porfimer plus photodynamic therapy (PDT). One case of cataracts was reported in a patient with high-grade dysplasia in Barrett's esophagus. Within 2 months of treatment with porfimer plus PDT, the patient initially noted difficulty with distance vision; an eye exam revealed a change in the refractive error that later progressed to cataracts in both eyes. Both of his parents had a history of cataracts, and it is unknown whether porfimer directly caused or accelerated a familial underlying condition.
Hypotension (7%) and hypertension (6%) were both reported in patients with obstructing esophageal cancer treated with porfimer plus photodynamic therapy (PDT) in a noncomparative trial.
Substernal chest pain may be reported in patients treated with porfimer plus photodynamic therapy (PDT) due to an inflammatory response in the area of treatment; pain may be of sufficient intensity to warrant the short-term prescription of opioid analgesics. Chest pain (unspecified) (22%), substernal chest pain (5%), atrial fibrillation (10%), heart failure (7%), and sinus tachycardia (6%) were reported in patients with completely or partially obstructing esophageal cancer (n = 88) treated with PDT in a noncomparative trial. Chest pain (29% to 37%) was more common in patients with high-grade dysplasia in Barrett's esophagus; chest discomfort was additionally reported in 6% to 19% of PDT-treated patients. Chest pain occurred in 7% to 8% of patients with obstructing endobronchial cancer treated with PDT. In patients with esophageal cancer, tumors located in the middle third of the esophagus were prognostic for atrial fibrillation. Additional cardiovascular reactions have included angina, bradycardia, myocardial infarction, sick sinus syndrome, and supraventricular tachycardia (SVT).
Thromboembolic events (thromboembolism) can occur after porfimer and photodynamic therapy (PDT). Most cases were reported in patients with other risk factors such as advanced cancer, major surgery, prolonged immobilization, or cardiovascular disease. Specific events that have been reported in less than 5% of patients include pulmonary thrombosis and pulmonary embolism. A possible cerebrovascular accident (stroke) has been reported in one patient.
Insomnia (5% to 14%), confusion (8% or less), and anxiety (3% to 7%) have been reported in patients with esophageal or endobronchial cancer treated with porfimer plus photodynamic therapy (PDT) in clinical trials.
Tracheoesophageal fistula was reported in 6% of patients with completely or partially obstructing esophageal cancer treated with porfimer plus photodynamic therapy (PDT). The use of porfimer plus PDT is contraindicated in patients with a tracheoesophageal or bronchoesophageal fistula; serious and sometimes fatal tissue necrosis (esophageal and gastrointestinal), esophageal perforation, and GI perforation can occur following treatment. Two of 17 patients with complete esophageal obstruction from tumor experienced esophageal perforations that were considered to be possibly treatment-associated; these perforations occurred during subsequent endoscopies. Evaluate all patients with esophageal cancer for the presence of a tracheoesophageal or bronchoesophageal fistula before each course of treatment.
A treatment-related deep esophageal ulceration occurred in one patient with high-grade dysplasia in Barrett's esophagus. Additionally, bronchial ulceration occurred in 9% of patients with superficial endobronchial tumors (microinvasive or carcinoma in situ) in 3 noncomparative trials. (n = 62).
Generalized edema (5% to 18%), peripheral edema (3% to 7%), and esophageal edema (8% or less) occurred in patients with esophageal cancer and endobronchial cancer in clinical trials. Tumors located in the upper third of the esophagus were prognostic for esophageal edema. A few cases of fluid imbalance have been reported in patients treated with porfimer plus photodynamic therapy (PDT) for overtly disseminated intraperitoneal malignancies; fluid imbalance is an expected treatment-related event for patients receiving PDT.
Infusion-related reactions including urticaria, bradycardia, hypotension, dizziness, and hypertension ahve been reported in postmarketing experience with porfimer. In one case, a patient had urticaria, wheezing, spasmodic cough, and periorbital edema within 5 minutes of administration; the patient responded to treatment with diphenhydramine and methylprednisolone. Another patient also experienced urticaria as well as increased blood pressure after treatment with porfimer.
Nausea (24%), vomiting (17%), dyspepsia (6%), and eructation (5%) were reported in patients with completely or partially obstructing esophageal cancer (n = 88) who were treated with porfimer plus photodynamic therapy (PDT) in a noncomparative trial. In patients with high-grade dysplasia in Barrett's esophagus treated with PDT plus omeprazole, nausea (26%), vomiting (29%), hiccups (7%), and dyspepsia (5%) were reported. In this study, nausea (62%) and vomiting (34%) were more common in patients with Barrett's metaplasia, indefinite dysplasia, low-grade dysplasia, and adenocarcinoma at baseline; dyspepsia (4%) and hiccups (1%) were less common. Severe adverse reactions in patients with Barrett's esophagus included noncardiac chest pain, nausea, vomiting, regurgitation, and pyrosis (heartburn); the severity of these symptoms decreased within 4 to 6 weeks following treatment. Dyspepsia occurred in 1% to 2% of PDT-treated patients with obstructing endobronchial tumors.
Constipation (7% to 24%), abdominal pain (5% to 20%), diarrhea (5% or less), and melena (5% or less) were reported in patients with esophageal cancer, endobronchial cancer, or Barrett's esophagus who were treated with porfimer plus photodynamic therapy (PDT) across clinical trials; gastric ulcer (peptic ulcer) and ileus have also occurred.
Esophagitis occurred in 5% of patients with completely or partially obstructing esophageal cancer (n = 88) treated with porfimer plus photodynamic therapy (PDT) in a nonrandomized trial. In patients with superficial endobronchial tumors (microinvasive or carcinoma in situ), mucositis/stomatitis was the most common reaction to therapy (18%), manifested as edema, exudate, and obstruction, and can be minimized by avoiding exposure of normal tissue to excessive light. Exudate was present in 22% of patients and a bronchial mucous plug or bronchial obstruction in 21% of these patients. A mucous plug can be easily removed with suction or forceps. In patients with Barrett's esophagus treated with PDT, esophageal pain was reported in 6% to 9% of patients and odynophagia in 4% to 6%.
Weight loss (9%), anorexia (8%), and dehydration (7%) occurred in patients with completely or partially obstructing esophageal cancer (n = 88) treated with porfimer plus photodynamic therapy (PDT) in a noncomparative trial. Metabolism and nutrition disorders were reported in 13% to 16% of PDT-treated patients with Barrett's esophagus, including dehydration (8% to 11%) and weight loss (2% to 7%).
Dysphonia was reported in 3% to 5% of patients with obstructing endobronchial cancer treated with porfimer plus photodynamic therapy (PDT) in a multicenter, randomized trial.
Porfimer is contraindicated in patients with porphyria. Patients with porphyria can be extremely photosensitive, with skin friability and chronic, blistering lesions when exposed to sunlight. Patients may also be sensitive to indoor sunlight as well as some types of artificial light; high-intensity lights can cause tissue injury. Photosensitivity reactions are common in patients treated with porfimer, which may be attributable to a state of pseudoporphyria (temporary drug-induced cutaneous porphyria). Using porfimer in patients with porphyria may cause severe tissue damage.
Photodynamic therapy (PDT) is contraindicated in patients with an existing tracheoesophageal or bronchoesophageal fistula. Evaluate all patients with esophageal cancer for the presence of a tracheoesophageal or bronchoesophageal fistula before each course of treatment. Do not initiate porfimer with PDT in patients with esophageal tumors eroding into the trachea or bronchial tree or bronchial wall because of the high likelihood of tracheoesophageal or bronchoesophageal fistula. Serious and sometimes fatal gastrointestinal and esophageal necrosis and perforation can occur following treatment.
Due to the high risk of hemorrhage, porfimer is contraindicated in patients with esophageal varices, gastric varices, and patients with esophageal ulcers greater than 1 cm in diameter. Additionally, it is contraindicated in patients with tumors eroding into a major blood vessel. Patients with large, centrally located tumors, cavitating tumors, or extensive tumors extrinsic to the bronchus are also at high risk for fatal massive hemoptysis.
Avoid direct sunlight (UV) exposure to the skin and eyes, or exposure to bright indoor light (e.g., examination lamps, including dental lamps, operating room lamps, and unshaded light bulbs at close proximity) for at least 30 days following porfimer injection; some patients may remain photosensitive for 90 days or more. Photosensitivity is due to residual drug, which is present in all parts of the skin. Exposure of the skin to ambient indoor light, however, is beneficial as it gradually and safely inactivates the remaining drug through a photobleaching reaction; patients should not stay in a darkened room during the period of photosensitivity. Before exposing any area of skin to direct sunlight or bright indoor light, the patient should test it for residual photosensitivity by exposing a small area to sunlight for 10 minutes. If no reaction occurs within 24 hours (e.g., erythema, edema, blistering), the patient can cautiously and gradually resume normal outdoor activities. If photosensitivity occurs with the limited skin test, the patient should continue precautions for another 2 weeks before retesting. If patients travel to a different geographical area with greater sunshine, they should retest their level of photosensitivity. The tissue around the eyes may be more sensitive; patients should not use the face for testing. Conventional ultraviolet sunscreens will only protect against UV light-related photosensitivity and will not protect against photosensitivity reactions caused by visible light. Patients should wear dark sunglasses (average light transmittance of less than 4%) when outdoors for at least 30 days after treatment and until ocular sensitivity resolves; in addition to sunlight, other bright lights including car headlights can cause ocular discomfort.
Porfimer is contraindicated for the emergency treatment of patients with severe acute respiratory insufficiency caused by an obstructing bronchial lesion because 40 to 50 hours are required between the administration of porfimer and photodynamic therapy (PDT). Use porfimer plus PDT with caution in patients with endobronchial tumors in locations where treatment-induced inflammation can obstruct the main airway (e.g., long or circumferential tumors of the trachea, tumors of the carina that involve both mainstream bronchi circumferentially, or circumferential tumors in the mainstem bronchus in patients with prior pneumonectomy). Monitor patients closely between the laser light therapy and the mandatory debridement bronchoscopy for any evidence of respiratory distress. Inflammation, mucositis, and necrotic debris may cause obstruction of the airway. If respiratory distress occurs, the physician should be prepared to carry out immediate bronchoscopy to remove secretions and debris to open the airway.
If porfimer plus photodynamic therapy (PDT) is to be used before or after radiation therapy, allow enough time between the therapies to ensure that the inflammatory response produced by the first treatment has subsided before beginning the second treatment. If radiation is to be given before PDT, allow 4 weeks to pass after completing radiation before beginning PDT. If radiation is to be given after PDT, allow 2 to 4 weeks to pass after completing PDT before starting radiation. The extent of inflammatory response after PDT is dependent on tumor size and the extent of surrounding normal tissue that receives light. In addition to inflammatory responses, patients who have received prior radiation therapy are also at increased risk of fatal massive hemoptysis (FMH), possibly due to associated poor prognostic factors such as having a centrally located tumor.
Avoid accidental exposure of porfimer to the skin as well as ocular exposure; handle using rubber gloves and eye protection. It is not a primary ocular or dermal irritant; however, due to the potential for photosensitivity reactions it may cause eye and/or skin irritation in the presence of bright light. Wipe up any spills with a damp cloth and dispose of contaminated materials in a polyethylene bag consistent with local regulations. As with therapeutic overdose, any overexposed person must be protected from bright light. If extravasation occurs, the area must also be protected from light; there is no known benefit from injecting the extravasation site with another substance.
Administration of porfimer with photodynamic therapy (PDT) requires an experienced clinician trained in the safe and efficacious treatment use of porfimer and associated light delivery devices. Porfimer with PDT should only be applied in facilities properly equipped for the procedure. Laser systems must be approved for the delivery of a stable power output at a wavelength of 630 +/- 3 nm.
The elimination of porfimer will likely be prolonged in patients with hepatic disease or renal impairment, leading to higher rates of toxicity and a prolonged duration of photosensitivity. In patients with severe renal impairment or mild to severe hepatic impairment, the period requiring precautionary measures for photosensitivity may be longer than 90 days.
Use porfimer with caution in patients with a history of thromboembolic disease, as thromboembolic events can occur following photodynamic therapy with porfimer. Most events occurred in patients with other risk factors for thrombosis, including advanced cancer, following major surgery, prolonged immobilization, or cardiac disease.
Counsel patients about the reproductive risk and contraception requirements during porfimer treatment. Porfimer can adversely affect embryofetal development if taken by the mother during pregnancy. Females of reproductive potential should avoid pregnancy and use effective contraception during and for at least 5 months after treatment with porfimer. Due to the risk of male-mediated teratogenicity, males with female partners of reproductive potential should also use effective contraception during and for at least 5 months after treatment with porfimer. Females of reproductive potential should undergo pregnancy testing prior to initiation of porfimer. Women who become pregnant while receiving porfimer should be apprised of the potential hazard to the fetus.
Pregnancy should be avoided by females of reproductive potential during porfimer treatment and for at least 5 months after the last dose. Although there are no adequately controlled studies in pregnant humans, porfimer can cause fetal harm when administered during pregnancy based on its mechanism of action and animal studies. Women who are pregnant or who become pregnant while receiving porfimer should be apprised of the potential hazard to the fetus. Intravenous administration of porfimer to pregnant rats and rabbits for 10 to 13 days during organogenesis at dose levels approximately 0.65 times the recommended human dose based on BSA resulted in maternal and embryofetal toxicity including increased resorptions, decreased litter size, delayed ossification, and reduced fetal weight; major fetal malformations did not occur. When administered to rats for at least 42 days during late pregnancy (postorganogenesis) through lactation at dose levels 0.32 times the recommended human dose based on BSA, a reversible decrease in the growth of offspring occurred. Parturition was unaffected.
Due to the potential for serious adverse reactions in nursing infants from porfimer, advise women to discontinue breast-feeding during treatment and for 5 months after the final dose. It is not known whether porfimer is present in human milk.
For the treatment of esophageal cancer:
NOTE: Porfimer has been designated by the FDA as an orphan drug for the treatment of esophageal cancer.
-for the palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who are unable to be satisfactorily treated with Nd:YAG laser therapy:
Intravenous dosage:
Adults: 2 mg/kg IV administered slowly over 3 to 5 minutes. Initiate delivery of 630 nm wavelength laser light at a dose of 300 Joules/cm of diffuser length 40 to 50 hours after the porfimer injection. The total power output at the fiber tip is set to deliver the appropriate light dose using exposure times of 12 minutes and 30 seconds. A second laser light application may be given 96 to 120 hours after the initial porfimer injection; a second porfimer injection should not be given if this occurs. Prior to providing a second laser light treatment, the residual tumor may be debrided; this is optional since the residual tumor will be naturally removed by peristaltic action of the esophagus. Vigorous debridement may cause tumor bleeding. Up to 3 courses of photodynamic therapy may be administered, each separated by a minimum of 30 days. In a multicenter, noncomparative study of patients with completely obstructing esophageal cancer (n = 17), photodynamic therapy with porfimer resulted in a clinically important benefit in 65% of patients, defined by complete tumor response (n = 3), achievement of normal swallowing (grade 5 dysphagia improved to grade 1 in 2 patients), or achievement of improved dysphagia by at least 2 grades with minimal adverse reactions (n = 6). The median duration of benefit was 69 days; median survival for the 11 patients with clinically important benefit was 115 days.
For the treatment of resistant or refractory superficial bladder cancer*:
NOTE: Porfimer sodium has been designated by the FDA as an orphan drug for use in transitional cell carcinoma in situ of the urinary bladder
Intravenous dosage:
Adults: 1.5 mg/kg IV given 48 to 72 hours prior to whole bladder photodynamic therapy (PDT) with 20 to 25 joules (J)/cm2 (630 nm) of light has been studied; a higher dose of 2 mg/kg IV has also been studied but caused severe bladder toxicity. The overall response rate (ORR) at 3 months after porfirmer 1.5 mg/kg IV and PDT was 56.5% (CR, 44%) in 32 evaluable patients with transitional cell carcinoma (TCC) in situ of the bladder or extensive small flat papillary stage Ta or T1 lesions who had failed intravesical chemotherapy, immunotherapy, or both (mean of 2.6 prior therapies; range, 1 to 5). Four of 5 patients with extensive small flat papillary lesions had no response to therapy. All patients experienced voiding symptoms, although most symptoms were transient and manageable. In a retrospective analysis of superficial bladder cancer patients who had failed at least 1 intravesical therapy or had a contraindication to intravesical therapy or immunotherapy, the ORRs at 3 months were 84% in 19 patients with residual resistant papillary TCC and 75% in 20 patients with refractory carcinoma in situ of the bladder following treatment with porfimer 1.5 or 2 mg/kg IV given 48 to 72 hours prior to whole bladder PDT with 10 to 60 J/cm2 (630 nm) of light. Severe bladder toxicity occurred in patients who received porfimer 2 mg/kg and 15 to 25 J/cm2 of light. Additionally, mild or moderate cutaneous toxicity occurred in 22% of patients.
For the treatment of non-small cell lung cancer (NSCLC):
-for the treatment of microinvasive endobronchial non-small cell lung cancer (NSCLC) in patients for whom surgery and radiotherapy are not indicated:
Intravenous dosage:
Adults: 2 mg/kg IV administered slowly over 3 to 5 minutes. Initiate delivery of 630 nm wavelength laser light at a dose of 200 Joules/cm of diffuser length 40 to 50 hours after the porfimer injection. The total power output at the fiber tip is set to deliver the appropriate light dose using exposure times of 8 minutes and 20 seconds. For noncircumferential endobronchial tumors that are soft enough to penetrate, interstitial fiber placement is preferred to intraluminal activation as it has better efficacy and results in less exposure of normal bronchial mucosa to light. Perform a debridement 2 to 3 days after light administration to minimize the potential for obstruction caused by necrotic debris; discontinue debridement when the volume of bleeding increases, indicating the debridement has gone beyond the zone of the photodynamic effect. A second laser light application may be given 96 to 120 hours after the initial porfimer injection; a second porfimer injection should not be given if this occurs. Debridement should be performed 2 to 3 days after each light administration. Up to 3 courses of photodynamic therapy may be administered, each separated by a minimum of 30 days. In patients who have recently undergone radiotherapy, allow sufficient time between therapies (approximately 4 weeks) to ensure the acute inflammation produced by radiotherapy has subsided prior to photodynamic therapy (PDT). In 3 noncomparative studies of patients with inoperable microinvasive endobronchial tumors (n = 62), 50% of patients treated with PDT had a complete tumor response rate at 3 months; in patients for whom both surgery and radiation were not indicated (n = 11), the complete tumor response rate at 3 months was 27%. The median time to tumor recurrence was more than 2.7 years and the median overall survival was 2.9 years.
-for the reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial non-small cell lung cancer (NSCLC):
Intravenous dosage:
Adults: 2 mg/kg IV administered slowly over 3 to 5 minutes. Initiate delivery of 630 nm wavelength laser light at a dose of 200 Joules/cm of diffuser length 40 to 50 hours after the porfimer injection. The total power output at the fiber tip is set to deliver the appropriate light dose using exposure times of 8 minutes and 20 seconds. For noncircumferential endobronchial tumors that are soft enough to penetrate, interstitial fiber placement is preferred to intraluminal activation as it has better efficacy and results in less exposure of normal bronchial mucosa to light. Perform a debridement 2 to 3 days after light administration to minimize the potential for obstruction caused by necrotic debris; discontinue debridement when the volume of bleeding increases, indicating the debridement has gone beyond the zone of the photodynamic effect. A second laser light application may be given 96 to 120 hours after the initial porfimer injection; a second porfimer injection should not be given if this occurs. Debridement should be performed 2 to 3 days after each light administration. Up to 3 courses of photodynamic therapy may be administered, each separated by a minimum of 30 days. In patients who have recently undergone radiotherapy, allow sufficient time between therapies (approximately 4 weeks) to ensure the acute inflammation produced by radiotherapy has subsided prior to photodynamic therapy (PDT). In 2 multicenter, randomized trials, 59% of patients with partially or completely obstructing endobronchial NSCLC treated with PDT (n = 102) had an objective response at week 1 compared with 58% of patients treated with Nd:YAG (n = 109); the response rate at 1 month or later was 60% versus 41%, respectively. In a separate retrospective analysis, 36% of PDT-treated patients received a clinically important benefit with minimal or moderate toxicities of short duration, compared with 23% of those who received Nd:YAG. The median duration of benefit was 63 days; median survival for patients with late-stage obstructing lung cancer was 714 days in PDT-treated patients compared with 161 days in patients who received Nd:YAG.
For the treatment of Barrett's esophagus:
-for the ablation of high-grade dysplasia in Barrett's esophagus in patients who do not undergo esophagectomy:
NOTE: Porfimer has been designated by the FDA as an orphan drug for the ablation of high-grade dysplasia in Barrett's esophagus in patients who are not candidates for esophagectomy.
NOTE: Prior to initiating therapy, the diagnosis of high-grade dysplasia in Barrett's esophagus should be confirmed by an expert GI pathologist.
Intravenous dosage:
Adults: 2 mg/kg IV administered slowly over 3 to 5 minutes. Initiate delivery of 630 nm wavelength laser light at a dose of 130 Joules/cm of diffuser length using a centering balloon, 40 to 50 hours after the porfimer injection. Nodules may be pretreated with 50 Joules/cm of diffuser length without a centering balloon prior to regular balloon treatment in the first laser light session. Take care to minimize exposure of normal tissue as it is also sensitized. A second laser light application may be given on day 5 to a previously treated segment that shows a "skip" area (an area that does not show sufficient mucosal response), using a short (2.5 cm or less) fiber optic diffuser without centering balloon at a light dose of 50 Joules/cm of the diffuser length; again, take care to minimize exposure of normal tissue. Treat a maximum of 7 cm of esophageal mucosa at the first light session, containing all areas of high-grade dysplasia whenever possible; allow a normal tissue margin of a few millimeters at the proximal and distal ends of light application if possible. For the ablation of Barrett's esophagus, patients may receive up to 3 courses of photodynamic therapy (PDT; porfimer plus light therapy) to a previously treated segment which still shows high-grade dysplasia, low-grade dysplasia, or Barrett's metaplasia, or to a new segment if the initial Barrett's segment was greater than 7 cm in length; each injection should be separated by a minimum of 90 days. Both residual and additional segments may be treated in the same light session provided that the total length of the segment treated with the balloon/diffuser combination is not greater than 7 cm. If a previously treated segment has not sufficiently healed and/or histology is unclear, the subsequent course of PDT may be delayed for an additional 1 to 2 months. Treatment with PDT plus omeprazole (n = 138) significantly improved the response rate of patients with Barrett's esophagus compared to patients receiving omeprazole alone (n = 70) in a multicenter, randomized, pathology-blinded clinical trial (76.8% vs. 38.6%); a complete replacement of all Barrett's metaplasia and dysplasia with normal squamous cell epithelium occurred in 52% versus 7% of patients, respectively. The median duration of response was 44.6 months in the PDT plus omeprazole arm compared with 3.2 months in patients receiving omeprazole alone. Fewer patients treated with PDT plus omeprazole progressed to cancer after 2 years (13% vs. 28%); the time to progression to cancer was also significantly longer in the PDT arm (HR 0.36). The long-term effect of PDT on high-grade dysplasia in Barrett's esophagus is unknown.
Maximum Dosage Limits:
-Adults
2 mg/kg IV.
-Elderly
2 mg/kg IV.
-Adolescents
Safety and efficacy have not been established.
-Children
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
The effect of hepatic impairment on porfimer dosing has not been studied.
Patients with Renal Impairment Dosing
The effect of renal impairment on porfimer dosing has not been studied. Porfimer is not dialyzable.
*non-FDA-approved indication
Acitretin: (Major) Avoid coadministration of porfimer with retinoids due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like retinoids may increase the risk of a photosensitivity reaction.
Adapalene: (Major) Avoid coadministration of porfimer with adapalene due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like adapalene may increase the risk of a photosensitivity reaction.
Adapalene; Benzoyl Peroxide: (Major) Avoid coadministration of porfimer with adapalene due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like adapalene may increase the risk of a photosensitivity reaction. (Major) Avoid coadministration of porfimer with benzoyl peroxide due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like benzoyl peroxide may increase the risk of a photosensitivity reaction.
Alectinib: (Major) Avoid coadministration of porfimer with alectinib due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like alectinib may increase the risk of a photosensitivity reaction.
Aliskiren; Hydrochlorothiazide, HCTZ: (Major) Avoid coadministration of porfimer with thiazide diuretics due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like thiazide diuretics may increase the risk of a photosensitivity reaction.
Amiloride; Hydrochlorothiazide, HCTZ: (Major) Avoid coadministration of porfimer with thiazide diuretics due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like thiazide diuretics may increase the risk of a photosensitivity reaction.
Aminolevulinic Acid: (Major) Avoid coadministration of porfimer with topical photosensitizing agents due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents may increase the risk of a photosensitivity reaction.
Amiodarone: (Major) Avoid coadministration of porfimer with amiodarone due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like amiodarone may increase the risk of a photosensitivity reaction.
Amitriptyline: (Major) Avoid coadministration of porfimer with tricyclic antidepressants due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like tricyclic antidepressants may increase the risk of a photosensitivity reaction.
Amlodipine; Valsartan; Hydrochlorothiazide, HCTZ: (Major) Avoid coadministration of porfimer with thiazide diuretics due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like thiazide diuretics may increase the risk of a photosensitivity reaction.
Atenolol; Chlorthalidone: (Major) Avoid coadministration of porfimer with thiazide diuretics due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like thiazide diuretics may increase the risk of a photosensitivity reaction.
Azilsartan; Chlorthalidone: (Major) Avoid coadministration of porfimer with thiazide diuretics due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like thiazide diuretics may increase the risk of a photosensitivity reaction.
Benazepril; Hydrochlorothiazide, HCTZ: (Major) Avoid coadministration of porfimer with thiazide diuretics due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like thiazide diuretics may increase the risk of a photosensitivity reaction.
Benzoic Acid; Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate: (Major) Avoid coadministration of porfimer with methylene blue due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like methylene blue may increase the risk of a photosensitivity reaction.
Benzoyl Peroxide: (Major) Avoid coadministration of porfimer with benzoyl peroxide due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like benzoyl peroxide may increase the risk of a photosensitivity reaction.
Benzoyl Peroxide; Clindamycin: (Major) Avoid coadministration of porfimer with benzoyl peroxide due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like benzoyl peroxide may increase the risk of a photosensitivity reaction.
Benzoyl Peroxide; Erythromycin: (Major) Avoid coadministration of porfimer with benzoyl peroxide due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like benzoyl peroxide may increase the risk of a photosensitivity reaction.
Benzoyl Peroxide; Sulfur: (Major) Avoid coadministration of porfimer with benzoyl peroxide due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like benzoyl peroxide may increase the risk of a photosensitivity reaction.
Bexarotene: (Major) Avoid coadministration of porfimer with retinoids due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like retinoids may increase the risk of a photosensitivity reaction.
Bismuth Subcitrate Potassium; Metronidazole; Tetracycline: (Major) Avoid coadministration of porfimer with tetracyclines due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like tetracyclines may increase the risk of a photosensitivity reaction.
Bismuth Subsalicylate; Metronidazole; Tetracycline: (Major) Avoid coadministration of porfimer with tetracyclines due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like tetracyclines may increase the risk of a photosensitivity reaction.
Bisoprolol; Hydrochlorothiazide, HCTZ: (Major) Avoid coadministration of porfimer with thiazide diuretics due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like thiazide diuretics may increase the risk of a photosensitivity reaction.
Calcipotriene: (Major) Avoid the concomitant use of porfimer with calcipotriene. Calcipotriene may enhance the ability of ultraviolet radiation to induce skin tumors. Coadministration of photosensitizing agents such as porfimer may increase this risk.
Calcipotriene; Betamethasone: (Major) Avoid the concomitant use of porfimer with calcipotriene. Calcipotriene may enhance the ability of ultraviolet radiation to induce skin tumors. Coadministration of photosensitizing agents such as porfimer may increase this risk.
Calcitriol: (Major) Avoid the concomitant use of porfimer with calcitriol ointment. The vehicle of the ointment may enhance the ability of ultraviolet radiation to induce skin tumors. Coadministration of photosensitizing agents such as porfimer may increase this risk.
Candesartan; Hydrochlorothiazide, HCTZ: (Major) Avoid coadministration of porfimer with thiazide diuretics due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like thiazide diuretics may increase the risk of a photosensitivity reaction.
Captopril; Hydrochlorothiazide, HCTZ: (Major) Avoid coadministration of porfimer with thiazide diuretics due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like thiazide diuretics may increase the risk of a photosensitivity reaction.
Carbamazepine: (Major) Avoid coadministration of porfimer with carbamazepine due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like carbamazepine may increase the risk of a photosensitivity reaction.
Chlordiazepoxide; Amitriptyline: (Major) Avoid coadministration of porfimer with tricyclic antidepressants due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like tricyclic antidepressants may increase the risk of a photosensitivity reaction.
Chlorothiazide: (Major) Avoid coadministration of porfimer with thiazide diuretics due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like thiazide diuretics may increase the risk of a photosensitivity reaction.
Chlorpromazine: (Major) Avoid coadministration of porfimer with phenothiazines due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like phenothiazines may increase the risk of a photosensitivity reaction.
Chlorthalidone: (Major) Avoid coadministration of porfimer with thiazide diuretics due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like thiazide diuretics may increase the risk of a photosensitivity reaction.
Cholera Vaccine: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the live cholera vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to cholera bacteria after receiving the vaccine.
Ciprofloxacin: (Major) Avoid the concomitant use of porfimer with other drugs known to cause photosensitivity, such as ciprofloxacin. Concomitant use with other photosensitizing agents may increase the risk of a photosensitivity reaction.
Clindamycin; Adapalene; Benzoyl Peroxide: (Major) Avoid coadministration of porfimer with adapalene due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like adapalene may increase the risk of a photosensitivity reaction. (Major) Avoid coadministration of porfimer with benzoyl peroxide due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like benzoyl peroxide may increase the risk of a photosensitivity reaction.
Clomipramine: (Major) Avoid coadministration of porfimer with tricyclic antidepressants due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like tricyclic antidepressants may increase the risk of a photosensitivity reaction.
Cobimetinib: (Major) Avoid coadministration of porfimer with cobimetinib due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like cobimetinib may increase the risk of a photosensitivity reaction.
Cod Liver Oil: (Major) Avoid coadministration of porfimer with retinoids due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like retinoids may increase the risk of a photosensitivity reaction.
Codeine; Phenylephrine; Promethazine: (Major) Avoid coadministration of porfimer with phenothiazines due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like phenothiazines may increase the risk of a photosensitivity reaction.
Codeine; Promethazine: (Major) Avoid coadministration of porfimer with phenothiazines due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like phenothiazines may increase the risk of a photosensitivity reaction.
Dantrolene: (Major) Avoid coadministration of porfimer with dantrolene due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like dantrolene may increase the risk of a photosensitivity reaction.
Demeclocycline: (Major) Avoid coadministration of porfimer with tetracyclines due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like tetracyclines may increase the risk of a photosensitivity reaction.
Dengue Tetravalent Vaccine, Live: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the dengue virus vaccine. When feasible, administer indicated vaccines at least 2 weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Desipramine: (Major) Avoid coadministration of porfimer with tricyclic antidepressants due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like tricyclic antidepressants may increase the risk of a photosensitivity reaction.
Diclofenac: (Minor) Preclinical data suggest agents that inhibit prostaglandin synthesis such as diclofenac could decrease the efficacy of photosensitizing agents used in photodynamic therapy. Avoidance of diclofenac before and during photodynamic therapy may be advisable.
Diclofenac; Misoprostol: (Minor) Preclinical data suggest agents that inhibit prostaglandin synthesis such as diclofenac could decrease the efficacy of photosensitizing agents used in photodynamic therapy. Avoidance of diclofenac before and during photodynamic therapy may be advisable.
Doxepin: (Major) Avoid coadministration of porfimer with tricyclic antidepressants due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like tricyclic antidepressants may increase the risk of a photosensitivity reaction.
Doxycycline: (Major) Avoid coadministration of porfimer with tetracyclines due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like tetracyclines may increase the risk of a photosensitivity reaction.
Enalapril; Hydrochlorothiazide, HCTZ: (Major) Avoid coadministration of porfimer with thiazide diuretics due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like thiazide diuretics may increase the risk of a photosensitivity reaction.
Eprosartan; Hydrochlorothiazide, HCTZ: (Major) Avoid coadministration of porfimer with thiazide diuretics due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like thiazide diuretics may increase the risk of a photosensitivity reaction.
Eravacycline: (Major) Avoid coadministration of porfimer with eravacycline due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like eravacycline may increase the risk of a photosensitivity reaction.
Flucytosine: (Major) Avoid coadministration of porfimer with flucytosine due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like flucytosine may increase the risk of a photosensitivity reaction.
Fluorouracil, 5-FU: (Major) Avoid coadministration of porfimer with topical fluorouracil preparations due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like topical fluorouracil may increase the risk of a photosensitivity reaction.
Fluphenazine: (Major) Avoid coadministration of porfimer with phenothiazines due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like phenothiazines may increase the risk of a photosensitivity reaction.
Fosinopril; Hydrochlorothiazide, HCTZ: (Major) Avoid coadministration of porfimer with thiazide diuretics due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like thiazide diuretics may increase the risk of a photosensitivity reaction.
Furosemide: (Major) Avoid coadministration of porfimer with furosemide due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like furosemide may increase the risk of a photosensitivity reaction.
Gemifloxacin: (Major) Avoid the concomitant use of porfimer with other drugs known to cause photosensitivity, such as gemifloxacin. Concomitant use with other photosensitizing agents may increase the risk of a photosensitivity reaction.
Glimepiride: (Major) Avoid coadministration of porfimer with sulfonylureas due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like sulfonylureas may increase the risk of a photosensitivity reaction.
Glipizide: (Major) Avoid coadministration of porfimer with sulfonylureas due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like sulfonylureas may increase the risk of a photosensitivity reaction.
Glipizide; Metformin: (Major) Avoid coadministration of porfimer with sulfonylureas due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like sulfonylureas may increase the risk of a photosensitivity reaction.
Glyburide: (Major) Avoid coadministration of porfimer with sulfonylureas due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like sulfonylureas may increase the risk of a photosensitivity reaction.
Glyburide; Metformin: (Major) Avoid coadministration of porfimer with sulfonylureas due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like sulfonylureas may increase the risk of a photosensitivity reaction.
Griseofulvin: (Major) Avoid coadministration of porfimer with griseofulvin due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like griseofulvin may increase the risk of a photosensitivity reaction.
Hydrochlorothiazide, HCTZ: (Major) Avoid coadministration of porfimer with thiazide diuretics due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like thiazide diuretics may increase the risk of a photosensitivity reaction.
Hydrochlorothiazide, HCTZ; Moexipril: (Major) Avoid coadministration of porfimer with thiazide diuretics due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like thiazide diuretics may increase the risk of a photosensitivity reaction.
Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate; Sodium Biphosphate: (Major) Avoid coadministration of porfimer with methylene blue due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like methylene blue may increase the risk of a photosensitivity reaction.
Imatinib: (Major) Avoid coadministration of porfimer with imatinib due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like imatinib may increase the risk of a photosensitivity reaction.
Imipramine: (Major) Avoid coadministration of porfimer with tricyclic antidepressants due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like tricyclic antidepressants may increase the risk of a photosensitivity reaction.
Irbesartan; Hydrochlorothiazide, HCTZ: (Major) Avoid coadministration of porfimer with thiazide diuretics due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like thiazide diuretics may increase the risk of a photosensitivity reaction.
Isotretinoin: (Major) Avoid coadministration of porfimer with retinoids due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like retinoids may increase the risk of a photosensitivity reaction.
Ketoconazole: (Major) Avoid coadministration of porfimer with ketoconazole foam due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like ketoconazole foam may increase the risk of a photosensitivity reaction.
Ketorolac: (Major) Preclinical data suggest agents that inhibit prostaglandin synthesis such as ketorolac could decrease the efficacy of photosensitizing agents used in photodynamic therapy. Avoidance of ketorolac before and during photodynamic therapy may be advisable.
Levofloxacin: (Major) Avoid the concomitant use of porfimer with other drugs known to cause photosensitivity, such as levofloxacin. Concomitant use with other photosensitizing agents may increase the risk of a photosensitivity reaction.
Lisinopril; Hydrochlorothiazide, HCTZ: (Major) Avoid coadministration of porfimer with thiazide diuretics due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like thiazide diuretics may increase the risk of a photosensitivity reaction.
Losartan; Hydrochlorothiazide, HCTZ: (Major) Avoid coadministration of porfimer with thiazide diuretics due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like thiazide diuretics may increase the risk of a photosensitivity reaction.
Mafenide: (Major) Avoid coadministration of porfimer with sulfonamides due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like sulfonamides may increase the risk of a photosensitivity reaction.
Maprotiline: (Major) Avoid coadministration of porfimer with maprotiline due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like maprotiline may increase the risk of a photosensitivity reaction.
Mercaptopurine, 6-MP: (Major) Avoid coadministration of porfimer with mercaptopurine due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like mercaptopurine may increase the risk of a photosensitivity reaction.
Mesalamine, 5-ASA: (Major) Avoid coadministration of porfimer with mesalamine due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like mesalamine may increase the risk of a photosensitivity reaction.
Methenamine; Sodium Acid Phosphate; Methylene Blue; Hyoscyamine: (Major) Avoid coadministration of porfimer with methylene blue due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like methylene blue may increase the risk of a photosensitivity reaction.
Methotrexate: (Major) Avoid coadministration of porfimer with methotrexate due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like methotrexate may increase the risk of a photosensitivity reaction.
Methoxsalen: (Major) Avoid coadministration of porfimer with methoxsalen due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like methoxsalen may increase the risk of a photosensitivity reaction.
Methylene Blue: (Major) Avoid coadministration of porfimer with methylene blue due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like methylene blue may increase the risk of a photosensitivity reaction.
Metolazone: (Major) Avoid coadministration of porfimer with thiazide diuretics due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like thiazide diuretics may increase the risk of a photosensitivity reaction.
Metoprolol; Hydrochlorothiazide, HCTZ: (Major) Avoid coadministration of porfimer with thiazide diuretics due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like thiazide diuretics may increase the risk of a photosensitivity reaction.
Minocycline: (Major) Avoid coadministration of porfimer with tetracyclines due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like tetracyclines may increase the risk of a photosensitivity reaction.
Moxifloxacin: (Major) Avoid the concomitant use of porfimer with other drugs known to cause photosensitivity, such as moxifloxacin. Concomitant use with other photosensitizing agents may increase the risk of a photosensitivity reaction.
Nortriptyline: (Major) Avoid coadministration of porfimer with tricyclic antidepressants due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like tricyclic antidepressants may increase the risk of a photosensitivity reaction.
Ofloxacin: (Major) Avoid the concomitant use of porfimer with other drugs known to cause photosensitivity, such as ofloxacin. Concomitant use with other photosensitizing agents may increase the risk of a photosensitivity reaction.
Olmesartan; Amlodipine; Hydrochlorothiazide, HCTZ: (Major) Avoid coadministration of porfimer with thiazide diuretics due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like thiazide diuretics may increase the risk of a photosensitivity reaction.
Olmesartan; Hydrochlorothiazide, HCTZ: (Major) Avoid coadministration of porfimer with thiazide diuretics due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like thiazide diuretics may increase the risk of a photosensitivity reaction.
Omadacycline: (Major) Avoid coadministration of porfimer with tetracyclines due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like tetracyclines may increase the risk of a photosensitivity reaction.
Oxaprozin: (Major) Avoid coadministration of porfimer with oxaprozin due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like oxaprozin may increase the risk of a photosensitivity reaction.
Perphenazine: (Major) Avoid coadministration of porfimer with phenothiazines due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like phenothiazines may increase the risk of a photosensitivity reaction.
Perphenazine; Amitriptyline: (Major) Avoid coadministration of porfimer with phenothiazines due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like phenothiazines may increase the risk of a photosensitivity reaction. (Major) Avoid coadministration of porfimer with tricyclic antidepressants due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like tricyclic antidepressants may increase the risk of a photosensitivity reaction.
Phenothiazines: (Major) Avoid coadministration of porfimer with phenothiazines due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like phenothiazines may increase the risk of a photosensitivity reaction.
Photosensitizing agents (topical): (Major) Avoid coadministration of porfimer with topical photosensitizing agents due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents may increase the risk of a photosensitivity reaction.
Pioglitazone; Glimepiride: (Major) Avoid coadministration of porfimer with sulfonylureas due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like sulfonylureas may increase the risk of a photosensitivity reaction.
Pirfenidone: (Major) Avoid coadministration of porfimer with pirfenidone due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like pirfenidone may increase the risk of a photosensitivity reaction.
Prochlorperazine: (Major) Avoid coadministration of porfimer with phenothiazines due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like phenothiazines may increase the risk of a photosensitivity reaction.
Promethazine: (Major) Avoid coadministration of porfimer with phenothiazines due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like phenothiazines may increase the risk of a photosensitivity reaction.
Promethazine; Dextromethorphan: (Major) Avoid coadministration of porfimer with phenothiazines due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like phenothiazines may increase the risk of a photosensitivity reaction.
Promethazine; Phenylephrine: (Major) Avoid coadministration of porfimer with phenothiazines due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like phenothiazines may increase the risk of a photosensitivity reaction.
Protriptyline: (Major) Avoid coadministration of porfimer with tricyclic antidepressants due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like tricyclic antidepressants may increase the risk of a photosensitivity reaction.
Quinapril; Hydrochlorothiazide, HCTZ: (Major) Avoid coadministration of porfimer with thiazide diuretics due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like thiazide diuretics may increase the risk of a photosensitivity reaction.
Retinoids: (Major) Avoid coadministration of porfimer with retinoids due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like retinoids may increase the risk of a photosensitivity reaction.
Rucaparib: (Major) Avoid coadministration of porfimer with rucaparib due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like rucaparib may increase the risk of a photosensitivity reaction.
Sarecycline: (Major) Avoid coadministration of porfimer with tetracyclines due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like tetracyclines may increase the risk of a photosensitivity reaction.
SARS-CoV-2 (COVID-19) vaccines: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine.
SARS-CoV-2 Virus (COVID-19) Adenovirus Vector Vaccine: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine.
SARS-CoV-2 Virus (COVID-19) mRNA Vaccine: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine.
SARS-CoV-2 Virus (COVID-19) Recombinant Spike Protein Nanoparticle Vaccine: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine.
Spironolactone; Hydrochlorothiazide, HCTZ: (Major) Avoid coadministration of porfimer with thiazide diuretics due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like thiazide diuretics may increase the risk of a photosensitivity reaction.
St. John's Wort, Hypericum perforatum: (Major) Avoid coadministration of porfimer with St. Johns Wort due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like St. Johns Wort may increase the risk of a photosensitivity reaction.
Sulfadiazine: (Major) Avoid coadministration of porfimer with sulfonamides due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like sulfonamides may increase the risk of a photosensitivity reaction.
Sulfamethoxazole; Trimethoprim, SMX-TMP, Cotrimoxazole: (Major) Avoid coadministration of porfimer with sulfonamides due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like sulfonamides may increase the risk of a photosensitivity reaction.
Sulfasalazine: (Major) Avoid coadministration of porfimer with sulfonamides due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like sulfonamides may increase the risk of a photosensitivity reaction.
Sulfonamides: (Major) Avoid coadministration of porfimer with sulfonamides due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like sulfonamides may increase the risk of a photosensitivity reaction.
Sulfonylureas: (Major) Avoid coadministration of porfimer with sulfonylureas due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like sulfonylureas may increase the risk of a photosensitivity reaction.
Telmisartan; Hydrochlorothiazide, HCTZ: (Major) Avoid coadministration of porfimer with thiazide diuretics due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like thiazide diuretics may increase the risk of a photosensitivity reaction.
Tetracycline: (Major) Avoid coadministration of porfimer with tetracyclines due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like tetracyclines may increase the risk of a photosensitivity reaction.
Tetracyclines: (Major) Avoid coadministration of porfimer with tetracyclines due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like tetracyclines may increase the risk of a photosensitivity reaction.
Thiazide diuretics: (Major) Avoid coadministration of porfimer with thiazide diuretics due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like thiazide diuretics may increase the risk of a photosensitivity reaction.
Thioridazine: (Major) Avoid coadministration of porfimer with phenothiazines due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like phenothiazines may increase the risk of a photosensitivity reaction.
Tretinoin, ATRA: (Major) Avoid coadministration of porfimer with retinoids due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like retinoids may increase the risk of a photosensitivity reaction.
Tretinoin; Benzoyl Peroxide: (Major) Avoid coadministration of porfimer with benzoyl peroxide due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like benzoyl peroxide may increase the risk of a photosensitivity reaction.
Triamterene; Hydrochlorothiazide, HCTZ: (Major) Avoid coadministration of porfimer with thiazide diuretics due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like thiazide diuretics may increase the risk of a photosensitivity reaction.
Tricyclic antidepressants: (Major) Avoid coadministration of porfimer with tricyclic antidepressants due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like tricyclic antidepressants may increase the risk of a photosensitivity reaction.
Trifarotene: (Major) Avoid coadministration of porfimer with trifarotene due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like trifarotene may increase the risk of a photosensitivity reaction.
Trifluoperazine: (Major) Avoid coadministration of porfimer with phenothiazines due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like phenothiazines may increase the risk of a photosensitivity reaction.
Trimipramine: (Major) Avoid coadministration of porfimer with tricyclic antidepressants due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like tricyclic antidepressants may increase the risk of a photosensitivity reaction.
Tuberculin Purified Protein Derivative, PPD: (Moderate) Immunosuppressives may decrease the immunological response to tuberculin purified protein derivative, PPD. This suppressed reactivity can persist for up to 6 weeks after treatment discontinuation. Consider deferring the skin test until completion of the immunosuppressive therapy.
Valsartan; Hydrochlorothiazide, HCTZ: (Major) Avoid coadministration of porfimer with thiazide diuretics due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like thiazide diuretics may increase the risk of a photosensitivity reaction.
Vandetanib: (Major) Avoid coadministration of porfimer with vandetanib due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like vandetanib may increase the risk of a photosensitivity reaction.
Vemurafenib: (Major) Avoid coadministration of porfimer with vemurafenib due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like vemurafenib may increase the risk of a photosensitivity reaction.
Vitamin A: (Major) Avoid coadministration of porfimer with retinoids due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like retinoids may increase the risk of a photosensitivity reaction.
Voriconazole: (Major) Avoid coadministration of porfimer with voriconazole due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like voriconazole may increase the risk of a photosensitivity reaction.
Ziprasidone: (Major) Avoid coadministration of porfimer with ziprasidone due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like ziprasidone may increase the risk of a photosensitivity reaction.
Porfimer sodium is a photoactivated radical generator, consisting of oligomers containing up to 8 porphyrin units. The cytotoxic and antitumor actions of porfimer are both light- and oxygen-dependent. Photodynamic therapy (PDT) with porfimer is a 2-stage process: intravenous administration of porfimer followed by illumination with 630 nm wavelength laser light. This wavelength was chosen due to its increased tissue penetration that yields increased cytotoxic effects. Porfimer has no effect on tissues until it is activated by light. Tumor selectivity in treatment occurs through a combination of selective tissue retention of porfimer and selective delivery of light. Cellular damage caused by porfimer plus PDT occurs due to the propagation of radical reactions; radical initiation may occur after porfimer sodium absorbs light to form a porphyrin excited state. Spin transfer from porfimer sodium to molecular oxygen may then generate singlet oxygen. Subsequent radical reactions can form superoxide and hydroxyl radicals. Cell damage is characterized by cessation of normal cellular movement and formation of multiple blebs (balloon-like protrusions from the cell membrane that indicates severe membrane damage). After bleb formation, the cell no longer divides and dies. Mitochondrial damage after PDT includes inhibition of oxidative phosphorylation and electron transport enzymes, and reduction in cellular adenosine triphosphate (ATP) levels. DNA strand breaks have been noted following PDT therapy, but do not seem to contribute to overall cytotoxic activity. Tumor death also occurs through ischemic necrosis secondary to vascular occlusion that appears to be partly mediated by thromboxane A2 release. As opposed to a thermal effect, the laser treatment with porfimer is a photochemical effect. The necrotic reaction and associated inflammatory responses may evolve over several days.
Porfimer is administered intravenously. It is approximately 90% protein bound in human serum in vitro; this binding was independent of concentration over a range of 20 to 100 mcg/mL. The duration of the photodynamic effect of porfimer is dependent on retention and clearance of porfimer sodium from the tumor tissue and delivery of light. Clearance from a variety of tissues occurs over 40 to 72 hours; tumors, skin, and organs of the reticuloendothelial system (including the liver and spleen) retain porfimer for a longer period. The elimination half-life is 410 hours after the first dose of porfimer and increases to 725 hours after the second dose.
Affected cytochrome P450 isoenzymes and drug transporters: None.
Findings in animals and cell culture suggest that many drugs could influence the effect of photodynamic therapy with porfimer, including compounds that quench active oxygen species or scavenge free radicals, those that decrease clotting, vasoconstriction, or platelet aggregation (e.g., glucocorticoids), allopurinol, calcium channel blockers, and some prostaglandin inhibitors.
-Route-Specific Pharmacokinetics
Intravenous Route
Two doses of porfimer were administered to cancer patients (n = 18), separated by 30 to 45 days. The mean Cmax of both doses were comparable after the first (43.1 +/- 10.5 mcg/mL) and second (41.3 +/- 8.7 mcg/mL) doses. However, the mean AUC was approximately 34% higher after the second dose (3,937 +/- 1,034 mcg x hour/mL) compared to the first dose (2,937 +/- 627 mcg x hour/mL), indicating some degree of accumulation with repeated administration.
-Special Populations
Hepatic Impairment
The effect of hepatic impairment on the pharmacokinetics of porfimer has not been studied.
Renal Impairment
The effect of renal impairment on the pharmacokinetics of porfimer has not been studied.
Gender Differences
Gender does not have a clinically significant effect on the pharmacokinetics of porfimer.