Peanut (Arachis hypogaea) allergen powder is an oral immunotherapy approved for the mitigation of allergic reactions, including anaphylaxis, due to accidental exposure to peanut in patients 4 years of age and older with a confirmed peanut allergy. It cannot be used for the emergency treatment of allergic reactions, including anaphylaxis. Peanut allergy affects approximately 1 million pediatric patients in the United States, and only 1 out of 5 patients will outgrow their allergy. Allergic reactions to peanut are unpredictable; some patients experience severe reactions from even trace amounts. Physical symptoms can develop within seconds of exposure and may include skin reactions (e.g., hives, redness, or swelling), digestive discomfort, or anaphylaxis. Antihistamines and epinephrine can be used to treat allergic reactions, but severe reactions can be fatal, even with appropriate and prompt treatment. Treatment with peanut (Arachis hypogaea) allergen powder is administered in 3 sequential phases: Initial Dose Escalation, Up-Dosing, and Maintenance. The Initial Dose Escalation phase is administered in sequential order on a single day. The Up-Dosing phase consists of 11 increasing dose levels and occurs over several months. Patients that complete all Up-Dosing levels may begin the daily maintenance dose. Anaphylaxis may occur at any time during peanut (Arachis hypogaea) allergen powder therapy; however, patients are at the highest risk during and after the Initial Dose Escalation and the first dose of each Up-Dosing level. Therefore, Initial Dose Escalation and the first dose of each Up-Dosing level must be given in a health care provider's office where the patient can be observed for potential adverse reactions. If the patient tolerates the first dose of each Up-Dosing level, that dose level may be continued daily at home. Auto-injectable epinephrine should be available, and patients and caregivers should be properly educated about the signs and symptoms of severe allergic reactions, the proper use of auto-injectable epinephrine, and the need to seek immediate medical attention upon epinephrine use.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Oral Administration
Oral Solid Formulations
-Auto-injectable epinephrine should be available to all patients receiving oral allergen extract outside the healthcare setting; educate on proper use.
-Do NOT swallow capsule(s). Do NOT inhale powder.
-Initial Dose Escalation phase
-Administer under the supervision of a health care professional in a health care setting, with the ability to manage potentially severe allergic reactions, including anaphylaxis.
-Administer in sequential order on a single day. Separate each dose by an observation period of 20 to 30 minutes.
-After completion of Initial Dose Escalation, observe patients for at least 60 minutes prior to discharge.
-Up-Dosing phase
-Patients tolerating at least the 3 mg single dose during Initial Dose Escalation must return to the health care setting for initiation of Up-Dosing, preferably the next day. If the patient is unable to return within 4 days, repeat Initial Dose Escalation.
-The first dose of each new Up-Dosing level is administered under the supervision of a health care professional in a health care setting; observe the patient for at least 60 minutes until suitable for discharge. If the patient tolerates the first dose of the increased dose level, the patient may continue that dose level at home.
-Instruct the patient to consume each dose daily with a meal at approximately the same time each day, preferably in the evening.
-Daily Maintenance phase
--May be given daily at home.
-To administer dose, open capsule(s) or sachet and empty the entire dose of peanut (Arachis hypogaea) allergen powder onto a few spoonfuls of refrigerated or room temperature semisolid food (e.g., applesauce, yogurt, pudding). Do NOT use liquid (e.g., milk, water, juice) to prepare.
-Mix well and consume the entire volume of the prepared mixture promptly.
-Dispose of the opened capsule(s) or sachet.
-Wash hands immediately after handling peanut (Arachis hypogaea) allergen powder capsule(s) or sachets.
-Dispose of all unused peanut (Arachis hypogaea) allergen powder.
-Missed doses: After 1 to 2 consecutive days of missed doses, patients may resume peanut (Arachis hypogaea) allergen powder at the same dose level. Data are insufficient to inform resumption of peanut (Arachis hypogaea) allergen powder after 3 or more consecutive days of missed doses. After missing 3 or more consecutive days, patients should consult their healthcare providers; resumption of peanut (Arachis hypogaea) allergen powder should be done under medical supervision.
Clinical trials were conducted in 709 peanut-allergic patients enrolled in 2 phase 3, double-blind, placebo-controlled studies evaluating peanut (Arachis hypogaea) allergen powder, and in long-term, open-label, follow-on studies. A total of 155 (21.9%) patients receiving peanut (Arachis hypogaea) allergen powder and 19 (6.5%) placebo-treated patients discontinued treatment for any reason. Adverse reactions led to study discontinuation in 9.2% of patients receiving peanut (Arachis hypogaea) allergen powder and 1.7% of placebo-treated patients during Initial Dose Escalation and Up-Dosing and 1% of patients receiving peanut (Arachis hypogaea) allergen powder during Maintenance dosing. Symptoms occurring in the clinic following any dose of peanut (Arachis hypogaea) allergen powder had a median time to onset of 4 minutes for 502 (70.8%) patients. The median time to resolution of the last symptom was 37 minutes.
As with all immunotherapy, peanut (Arachis hypogaea) allergen powder can cause life-threatening serious hypersensitivity reactions or anaphylaxis, including anaphylactoid reactions. Anaphylaxis has occurred during all phases of peanut (Arachis hypogaea) allergen powder dosing, including Maintenance and in patients who have undergone recommended Up-Dosing and dose modifications procedures. During clinical trials, anaphylaxis was reported in 9.4% of peanut (Arachis hypogaea) allergen powder treated patients compared with 3.8% of placebo-treated patients during Initial Dose Escalation and Up-Dosing combined, and in 8.7% of peanut (Arachis hypogaea) allergen powder treated patients compared with 1.7% of placebo-treated patients during Maintenance. Epinephrine use for any reason was reported in 10.4% of peanut (Arachis hypogaea) allergen powder treated patients compared with 4.8% of placebo-treated patients during Initial Dose Escalation and Up-Dosing combined, and in 7.7% of peanut (Arachis hypogaea) allergen powder treated patients compared with 3.4% of placebo-treated patients during Maintenance. Anaphylaxis occurred within 2 hours after dosing in 70% of reactions, greater than 2 hours and up to 10 hours in 18% of reactions, and greater than 10 hours in 12% of reactions among patients receiving peanut (Arachis hypogaea) allergen powder. In clinical trials, throat irritation (9.3% to 40.3%), cough (2.5% to 31.9%), pruritus (7.9% to 32.5%), urticaria (3.9% to 28.4%), rhinorrhea (1.3% to 20.9%), sneezing (3.4% to 20.2%), throat tightness (2.5% to 14.1%), wheezing (0.6% to 12.3%), anaphylactic reaction (0.7% to 9.1%), dyspnea (0.3% to 7.6%), and ear pruritus (0.7% to 5.9%) were reported. Severe anaphylaxis was reported in 0.6% of patients during Up-Dosing and 0.3% of patients during Maintenance. Oral pruritus, which also includes tongue pruritus and lip pruritus, was reported in 8.7% to 31.2% of patients. Respiratory disorders were the second most common reason for discontinuation of therapy during Initial Dose Escalation and Up-Dosing combined (2.3% in patients receiving peanut (Arachis hypogaea) allergen powder vs. 1% placebo). Temporary dose modification of peanut (Arachis hypogaea) allergen powder may be required for patients who experience allergic reactions during Up-Dosing or Maintenance. Administration of Initial Dose Escalation and the first dose of each new Up-Dosing level should take place in a healthcare setting where acute allergic reactions can be recognized and treated by an experienced clinician. Observe patients for at least 60 minutes after completion of Initial Dose Escalation and after the first dose of each new Up-Dosing level has been administered to monitor for signs and symptoms of a severe allergic reaction. Auto-injectable epinephrine should be available to all patients. Educate patients and their caregivers about the signs and symptoms of severe allergic reactions, the proper use of auto-injectable epinephrine, and the need to seek immediate medical attention upon epinephrine use.
Abdominal pain (26.1% to 67.1%), including upper abdominal pain and abdominal discomfort, was the most common gastrointestinal (GI) adverse reaction reported during clinical trials of peanut (Arachis hypogaea) allergen powder. Vomiting (3.1% to 36.5%), nausea (8.5% to 32.3%), and oral paresthesias (1.8% to 13.6%) were also reported. Consider dose modifications for patients who report these reactions. GI reactions were the most common reason for discontinuation of therapy during Initial Dose Escalation and Up-Dosing combined (6.5% in patients receiving peanut (Arachis hypogaea) allergen powder vs. 1% placebo). In clinical trials, 28 of 1,050 (2.7%) patients were referred for a gastroenterology evaluation, and 17 of these 28 patients reported undergoing an esophagogastroduodenoscopy (EGD). Of the patients who underwent EGD, 12 were diagnosed with biopsy-confirmed eosinophilic esophagitis while receiving of peanut (Arachis hypogaea) allergen powder compared to 0 of 292 patients receiving placebo. After peanut (Arachis hypogaea) allergen powder discontinuation, symptomatic improvement was reported in all 12 patients. In 8 patients with follow-up biopsy results, eosinophilic esophagitis was resolved in 6 patients and improved in 2 patients. Discontinue therapy in patients who experience severe or persistent gastroesophageal symptoms, including dysphagia, vomiting, nausea, gastroesophageal reflux, chest pain, or abdominal pain.
Peanut (Arachis hypogaea) allergen powder can cause life-threatening allergic reactions, including a risk of serious hypersensitivity reactions or anaphylaxis. Anaphylaxis has occurred during all phases of peanut (Arachis hypogaea) allergen powder dosing, including Maintenance and in patients who have undergone recommended Up-Dosing and dose modification procedures. Do not initiate peanut (Arachis hypogaea) allergen powder therapy in a patient who has had severe or life-threatening anaphylaxis within the previous 60 days. Patients may be at a higher risk of experiencing an allergic reaction when taking a hot bath or shower or when exercising up to 3 hours after peanut (Arachis hypogaea) allergen powder administration. Other risk factors include intercurrent illness (e.g., viral infection), fasting, menstruation, sleep deprivation, and nonsteroidal anti-inflammatory drug use. If possible, adjust the time of dosing to avoid these risk factors. If it is not possible, consider temporarily withholding therapy. Temporary dose modification of peanut (Arachis hypogaea) allergen powder may be required for patients who experience allergic reactions during the Up-Dosing or Maintenance phases. For temporary dose modification, use clinical judgment to determine the best course of action, which can include maintaining the dose level for longer than 2 weeks, reducing, withholding, or discontinuing peanut (Arachis hypogaea) allergen powder doses. Discontinue treatment in patients who are unable to tolerate doses up to and including the 3 mg dose during the Initial Dose Escalation phase. The Initial Dose Escalation phase and the first dose of each new Up-Dosing level requires a specialized care setting and requires an experienced clinician due to the risk of severe allergic reactions; give these doses in a healthcare setting where acute allergic reactions can be recognized and treated by an experienced clinician. Observe the patient for at least 60 minutes after completion of the Initial Dose Escalation phase and after the first dose of each new Up-Dosing level has been administered to monitor for signs and symptoms of a severe allergic reaction. If the first dose of the new Up-Dosing level is tolerated, subsequent doses may be administered at home. Auto-injectable epinephrine should be available to all patients. Educate patients and their caregivers on the signs and symptoms of severe allergic reactions, the proper use of auto-injectable epinephrine, and the need to seek immediate medical attention upon epinephrine use.
Peanut (Arachis hypogaea) allergen powder is contraindicated in patients with uncontrolled asthma (e.g., status asthmaticus or acute bronchospasm); ensure patients have their asthma under control prior to the initiation of therapy. Patients may be at a higher risk of experiencing an allergic reaction when asthma is uncontrolled. Temporarily withhold therapy if the patient is experiencing an acute asthma exacerbation and cautiously restart therapy after the resolution of the exacerbation. Reevaluate patients with recurrent asthma exacerbations for appropriateness of therapy and consider discontinuation. Peanut (Arachis hypogaea) allergen powder may not be suitable for patients who have acute or chronic markedly compromised lung function (e.g., asthma, chronic lung disease (CLD), chronic obstructive pulmonary disease (COPD), or emphysema) that may reduce the patient's ability to survive a serious allergic reaction or increase the risk of adverse reactions after epinephrine administration. Peanut (Arachis hypogaea) allergen powder has not been studied in patients with severe asthma, persistently uncontrolled asthma, or patients on long-term systemic corticosteroid therapy.
Peanut (Arachis hypogaea) allergen powder is contraindicated in patients with a history of eosinophilic esophagitis or other eosinophilic GI disease. Discontinue treatment in patients who experience severe or persistent gastroesophageal symptoms, including dysphagia, vomiting, nausea, gastroesophageal reflux, chest pain, or abdominal pain, and consider a diagnosis of eosinophilic esophagitis.
Peanut (Arachis hypogaea) allergen powder may not be suitable for patients with medical conditions that may decrease the patient's ability to survive a serious allergic reaction or increase the risk of adverse reactions after epinephrine administration. These conditions may include, but are not limited to, compromised lung function, severe mast cell disorder, and cardiovascular disease (i.e., unstable angina, recent myocardial infarction, significant cardiac arrhythmias, and uncontrolled hypertension). Further, the therapy may not be suitable for patients taking medications that can potentiate or inhibit the effects of epinephrine.
There is no human or animal data on peanut (Arachis hypogaea) allergen powder administered to pregnant women to establish the presence or absence of the risks in pregnancy. Anaphylaxis may occur after accidental exposure to peanut in peanut-allergic pregnant women resulting in compromised placental perfusion and significant risk to the fetus. Additionally, peanut (Arachis hypogaea) allergen powder can cause anaphylaxis. A pregnancy registry has been established to monitor maternal and fetal outcomes; women or health care providers are encouraged to register pregnant women exposed to peanut (Arachis hypogaea) allergen powder by calling 1-833-246-2566.
There are no data available on the presence of peanut (Arachis hypogaea) allergen powder in human milk, the effects on the breastfed infant, or the effects on milk production. The lack of clinical data during lactation precludes clear determination of the risk of peanut (Arachis hypogaea) allergen powder in breast-feeding women. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.
General Dosing Guidelines
-Peanut (Arachis hypogaea) allergen powder is approved for use in patients with a confirmed diagnosis of peanut allergy.
-Use peanut (Arachis hypogaea) allergen powder in conjunction with a peanut-avoidant diet.
-It is not indicated for the emergency treatment of allergic reactions, including anaphylaxis.
-Treatment is administered in 3 sequential phases: Initial Dose Escalation, Up-Dosing, and Maintenance.
-Temporary dose modification of peanut (Arachis hypogaea) allergen powder may be required for patients who experience allergic reactions during Up-Dosing or Maintenance phases, for patients who miss doses, or for practical reasons of patient management. Dose modifications are not appropriate during the Initial Dose Escalation phase. Allergic reactions, including gastrointestinal reactions, that are severe, recurrent, bothersome, or last longer than 90 minutes during Up-Dosing or Maintenance phases should be actively managed with dose modifications.
-For temporary dose modification, use clinical judgment to determine the best course of action, which can include maintaining the dose level for longer than 2 weeks, reducing, withholding, or discontinuing peanut (Arachis hypogaea) allergen powder doses.
-Discontinue treatment in patients who are unable to tolerate doses up to and including the 3 mg dose during the Initial Dose Escalation phase, patients with suspected eosinophilic esophagitis, patients unable to comply with the daily dosing requirements, and patients with recurrent asthma exacerbations or persistent loss of asthma control.
For mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut in persons with peanut allergy:
Oral dosage (Initial Dose Escalation):
Children and Adolescents 4 to 17 years: 0.5 mg, 1 mg, 1.5 mg, 3 mg, and 6 mg PO in sequential order on a single day, separating each dose by an observation period of 20 to 30 minutes; do not omit any dose. Begin up-dosing the following day, if possible, in persons tolerating at least the 3 mg single dose during initial dose escalation. Repeat initial dose escalation if unable to begin up-dosing within 4 days.
Oral dosage (Up-Dosing):
Children and Adolescents 4 to 17 years: 3 mg, 6 mg, 12 mg, 20 mg, 40 mg, 80 mg, 120 mg, 160 mg, 200 mg, 240 mg, and 300 mg PO in sequential order at 2-week intervals if tolerated; do not omit any dose. Complete all dose levels of up-dosing before starting maintenance dosing.
Oral dosage (Maintenance Dosing):
Adults: 300 mg PO once daily. Daily maintenance is required to maintain the effect of peanut (Arachis hypogaea) allergen powder.
Children and Adolescents 4 to 17 years: 300 mg PO once daily. Daily maintenance is required to maintain the effect of peanut (Arachis hypogaea) allergen powder.
Maximum Dosage Limits:
-Adults
300 mg/day PO.
-Geriatric
300 mg/day PO.
-Adolescents
300 mg/day PO.
-Children
4 to 12 years: 300 mg/day PO.
1 to 3 years: Safety and efficacy have not been established.
-Infants
Safety and efficacy have not been established.
-Neonates
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
There are no drug interactions associated with Peanut (Arachis hypogaea) Allergen Powder products.
The exact mechanism of action of peanut (Arachis hypogaea) allergen powder has not been established. Peanut (Arachis hypogaea) allergen powder is manufactured from defatted peanut flour to be used as oral immunotherapy.
Oral immunotherapy (OIT) is a treatment that allows an allergic individual to ingest an increasing amount of an allergen with the goal of increasing the threshold that triggers a reaction. For peanut allergic patients, a very small amount of peanut protein that would not trigger a reaction is initially given to a patient. The amount is then gradually increased over a period of months. OIT is not curative therapy, but protection against accidental ingestion of the allergen.
Peanut (Arachis hypogaea) allergen powder is administered orally.