Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine, DTaP; Hepatitis B Vaccine, Recombinant; Inactivated Poliovirus Vaccine, IPV (Pediarix(TM)), is a combination of five of the seven vaccines that are currently recommended for all children before the first birthday. The vaccines combined in Pediarix(TM), along with the Haemophilus influenzae type b (Hib) Vaccine and the Pneumococcal Conjugate Vaccine (PCV) are recommended to be given at 2, 4, and 6 months of age. The administration of combination vaccines such as Pediarix(TM) is believed to reduce cost and improve compliance to the vaccination schedule by reducing the number of injections received per physician visit. The DTP component of the Pediarix(TM) vaccine is the same as that found in Infanrix(R) and contains an acellular pertussis vaccine (DTaP). Acellular pertussis vaccine has a significantly lower incidence of local and systemic adverse reactions and better efficacy when compared to whole cell pertussis vaccine (DTwP). The hepatitis B vaccine component is the same as that found in Engerix-B(R). The inactivated poliovirus vaccine in this product is a new formulation containing an enhanced potency IPV (eIPV), meaning that it has an increased amount of poliovirus antigen per dose compared to formulations that were available before 1987. In 2000, the CDC recommended the inactivated poliovirus vaccine (IPV) over oral poliovirus vaccine (OPV) for routine childhood polio vaccination in the US. This recommendation was prompted in part by the the rare but serious side-effect of OPV-associated paralytic poliomyelitis as well as the eradication of wild-type poliovirus from the Western hemisphere. In general, OPV-only immunization regimens will remain the preferred regimens to control outbreaks associated with wild-type poliovirus, for imminent travel to polio endemic areas, or for special circumstances related to individual patients. The Pediarix(TM) vaccine was FDA-approved on December 13, 2002.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
NOTE: Health care professionals administering this vaccine should take appropriate precautions to prevent allergic reactions (see Precautions).
NOTE: According to U.S. federal laws, the health care provider must record in the patient's permanent record: the manufacturer, lot number, date of administration, and the name and address of the person administering the vaccine.
Route-Specific Administration
Injectable Administration
-Pediarix is administered intramuscularly; do not give intravenously or subcutaneously.
-Fractional doses (doses < 0.5 mL) should not be given.
-Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit
Intramuscular Administration
Preparation:
-Shake vial vigorously just before withdrawing dose (use aseptic technique) to ensure a uniform, cloudy suspension. If the vaccine cannot be resuspended or if a gel-like substance is present, discard it.
-A separate syringe and needle should be used for each person receiving Pediarix.
-Do not mix with any other vaccine.
-Storage of unopened vials:-Manufacturer recommendations: Store refrigerated at 2 to 8 degrees C (36 to 46 degrees F); do not freeze.
-Off-label storage information: According to a 2007 published article, storage of Pediarix (GlaxoSmithKline) at room temperature for up to 24 hours is acceptable. NOTE: Because changes in vaccine formulation may affect stability and effectiveness, confirmation of acceptable duration of storage at room temperature directly from the manufacturer for the specific vaccine being administered is recommended.
Intramuscular injection:
-Before administration, clean skin over the injection site with a suitable cleansing agent.
-The preferred injection sites are the anterolateral aspect of the thigh (particularly for infants) and the deltoid muscle of the upper arm (usually suitable for older children). Do NOT inject into the gluteal area or other areas where there may be a major nerve trunk.
-When concomitant administration of other vaccines or immunoglobulin is required they should be given with different syringes and at different injection sites. In clinical trials, Pediarix and Hib conjugate vaccine were routinely concomitantly administered at separate sites. Data are also available from 2 clinical studies in which Pediarix, Hib, and 7-valent pneumococcal conjugate vaccines were concomitantly administered at separate sites.
The most common adverse reactions to the diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV include injection site reaction (usually erythema, swelling, and tenderness). Among recipients of Pediarix administered concomitantly with Hib conjugate vaccine and 7-valent pneumococcal conjugate vaccine, 24.9-40.1% had redness, 31.2-36.1% had pain, and 17.3-28.7% had swelling at the injection site. Injection site reactions (including cellulitis, induration, itching, nodule/lump, pain, redness, swelling, and warmth at the site of injection) have been reported during the post-marketing surveillance program. Local reactions are usually self-limiting and do not require therapy. As with other vaccines that use aluminum as an adjuvant, a small nodule may be palpable at the vaccination site for several weeks. Persistent nodules have been reported after the use of adsorbed products. These nodules are likely due to poor IM administration technique. The nodule is usually not associated with pain, is self limited, and does not require therapy.
After intramuscular vaccination with the diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV, apnea has been observed in some infants born prematurely. For infants born prematurely, consider the infant's medical status and the potential benefits and possible risks of vaccination when deciding when to administer an intramuscular vaccine.
Among recipients of diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV (Pediarix) administered concomitantly with Hib conjugate vaccine and 7-valent pneumococcal conjugate vaccine, 61.1-64.9% had irritability and 27.9-38.8% had fever of at least 100.4 degrees F. In clinical trials, administration of Pediarix in infants was associated with higher rates of fever, relative to separately administered vaccines. The prevalence of fever appears to be highest on the day of vaccination and the following day. The majority of episodes of fever (> 96%) resolved within the 4-day period after vaccination. The following possible adverse reactions are related to the pertussis component of Pediarix: collapse or shock-like state (hypotonic-hyporesponsive episode (HHE)) within 48 hours; seizures with or without fever within 3 days; persistent, inconsolable crying for >= 3 hours (or high-pitched unusual screaming) occurring within 48 hours; or fever of 40.5 degrees C (105 degrees F) or higher not attributable to other causes and occurring within 48 hours of immunization. Worldwide voluntary reports of adverse events received for Pediarix since market introduction include convulsions, depressed level of consciousness, febrile convulsion, hypotonia, hypotonic-hyporesponsive episode, and screaming. This list includes serious adverse events or events that have a suspected causal connection to components of Pediarix or other vaccines or drugs. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Instruct patients to report any signs and symptoms of a fever or a systemic reaction. Children experiencing any of these reactions following Pediarix administration should be evaluated for the appropriateness of continuing Pediarix immunization versus completing immunization with DT toxoids and separately administered hepatitis B vaccine and poliovirus vaccine. Seizures are more likely to occur in children with a history of seizures or a family history of seizures. Studies indicate that such seizures, occurring in otherwise normal children, do not induce permanent brain damage.
A causal relationship between tetanus toxoid receipt and both brachial neuritis and Guillain-Barre syndrome appears to exist. If Guillain-Barre syndrome occurs within 6 weeks of receipt of a prior vaccine that contained tetanus toxoid, base the decision to give any vaccine containing tetanus toxoid such as the diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV on careful consideration of the potential benefits and possible risks, as the risk for Guillain-Barre syndrome may be increased. When a decision is made to withhold tetanus toxoid, administer other available vaccines, as indicated. Postmarketing, encephalopathy, neuritis, myelitis, hypoesthesia, paresthesias, peripheral neuropathy, muscle paralysis, and muscular weakness have been reported with DTP, DT, or the hepatitis B vaccine. Demyelinating diseases of the central nervous system, cranial mononeuropathies, and EEG disturbances with encephalopathy (with or without permanent intellectual and/or motor function impairment) have also been reported, but data are insufficient to accept or reject causality. Tetanus toxoid could be a possible etiology for these events. Whole cell DTP (DTwP) has been associated with acute encephalopathy in children. There are insufficient data at this time to determine if there is a causal association of encephalopathy with vaccines such as Pediarix that contain acellular DTP vaccines, or if the incidence is different from that of DTwP. Encephalopathy such as coma, decreased level of consciousness, or prolonged seizures within 7 days of a previous dose of a pertussis containing vaccine that is not attributable to another identifiable cause is a contraindication to administration of any pertussis-containing vaccine. The results of the National Childhood Encephalopathy Study (NCES) in England concluded that children 2 to 35 months of age who had histories of acute neurologic disorders were more likely to have received DTwP immunization within 7 days of the onset of the neurologic illness than controls. The incidence of these events is estimated at 1 per every 140,000 children vaccinated with DTwP. A follow up study of the NCES 10 years later concluded that these affected cases were also more likely to have experienced chronic neurologic sequelae. The ACIP has evaluated the follow up study and has concluded that the data are insufficient to determine if DTwP administration before the acute neurologic event influenced the potential for chronic neurologic dysfunction 10 years later. Subsequent studies have not been able to prove a causal relationship. The overall risk in children for chronic nervous system dysfunction may not be increased. Formaldehyde is considered to be neurotoxic, but information on the safety of the trace concentrations of formaldehyde in DTP vaccines is limited. In general, most people will not experience symptoms with a low-level exposure to formaldehyde (up to 0.1 ppm). Formulations of DTP also contain trace amounts of aluminum as an adjuvant. A link between exposure to aluminum or aluminum compounds and Alzheimer's disease or other neurological diseases has been suggested. Also, aluminum toxicity has been associated with osteomalacia or aplastic bone disease, myopathy, increased risk of infection, microcytic anemia, and with very high levels, sudden death. Limited data are available on the impact (negative or otherwise) of aluminum in patients receiving vaccines.
Drowsiness was among the most common adverse reactions to the diphtheria vaccine, tetanus toxoid vaccine, acellular pertussis vaccine, DTaP; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV (Pediarix). Among recipients of Pediarix administered concomitantly with Hib conjugate vaccine and 7-valent pneumococcal conjugate vaccine, 40.9-57.2% had drowsiness. Limb pain, limb swelling, anaphylactic shock, anaphylactoid reactions, hypersensitivity, dyspnea, cyanosis, angioedema, rash (unspecified), urticaria, lethargy, fatigue, pallor, petechiae, insomnia, nervousness, and restlessness have been reported postmarketing. Other adverse reactions noted with DTaP or hepatitis B vaccines and, thus, could occur with Pediarix include asthenia, malaise, lymphadenopathy, chills, arthralgia, headache, erythema multiforme, Stevens-Johnson syndrome, pruritus, bronchospasm, maculopapular rash, hypotension, myocarditis, myositis, and alopecia. As is the case with all voluntary reporting systems, such reports of adverse events do not necessarily indicate causality of the event. Instruct patients to report any signs and symptoms of a systemic reaction. Also, have immediate availability of epinephrine (1:1000) injection and other agents used in the treatment of severe anaphylaxis such as anaphylactic shock.
Anorexia may be noted after the diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV (Pediarix). Among children who received Pediarix concomitantly with Hib conjugate vaccine and 7-valent pneumococcal conjugate vaccine, 26.2-30.6% had anorexia. Post-marketing, diarrhea, vomiting, and elevated hepatic enzymes were reported. Other adverse reactions noted with DTaP or hepatitis B vaccines and, thus, could occur with Pediarix include abdominal pain, nausea, intussusception, and jaundice. As is the case with all voluntary reporting systems, such reports of adverse events do not necessarily indicate causality of the event.
Syncope has been reported post-marketing with the diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV (Pediarix). Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. Have procedures in place to avoid falling injury and to restore cerebral perfusion after syncope.
Prior to administration of Pediarix, health care personnel should inform the patient, parent, guardian, or responsible adult of the vaccine's benefits and risks. This should include the provision of the vaccine information statement from the manufacturer. The responsible adult should report any adverse reaction following vaccine administration to the health care provider. The U.S. Department of Health and Human Services has established a Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine. This includes, but is not limited to, the reporting of events required by the National Childhood Vaccine Injury Act of 1986. The toll-free number for VAERS is 800-822-7967.
For known exposures to hepatitis B virus (HBV), the hepatitis B immune globulin (HBIG) should be given in combination with the appropriate vaccine in accordance with the ACIP recommendations. Diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV may not prevent HBV infection in those with an unrecognized illness at the time of vaccination. Additionally, it may not prevent HBV infection if adequate antibody titers are not achieved.
Do not give Diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; Hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV via intravenous administration, intraarterial administration, subcutaneous administration, or intradermal administration. Patients with thrombocytopenia, vitamin K deficiency, a coagulopathy (e.g., hemophilia), or those receiving anticoagulant therapy should be monitored closely when given Pediarix because bleeding can occur at the IM injection site.
Pediarix vaccine is not recommended for use in geriatric patients or in any other adult populations. This vaccine is not recommended for any adolescents or children >= 7 years of age. Tetanus and Diphtheria Toxoids Adsorbed (Td) for adult use, IPV, and Hepatitis B vaccine (recombinant) should be used in individuals 7 years of age or older. Safety and efficacy of Pediarix in neonates or infants < 6 weeks of age have not been established. In some premature neonates, apnea after intramuscular vaccination has been observed. Consider the infant's medical status and the vaccine's potential benefits and possible risks when deciding when to administer an intramuscular vaccine such as Pediarix to infants born prematurely.
Pediarix is contraindicated in patients who have had an immediate anaphylactic reaction, temporally associated with a previous dose of this vaccine or any of its components. This includes patients with yeast hypersensitivity, neomycin hypersensitivity, and polymyxin hypersensitivity.
The tip caps on the prefilled syringes of Pediarix may contain dry natural latex rubber; thus, health care professionals should administer this vaccine with caution to patients with a history of latex hypersensitivity or a condition with the potential for latex hypersensitivity (e.g., spina bifida). The plungers do NOT contain latex. With any biologic product, the prescriber or health care professional should take precautions to prevent allergic reactions. The health care professional should have immediate availability of epinephrine (1:1000) injection and other agents used in the treatment of severe anaphylaxis in the event of a serious allergic reaction.
If any of the following occur in temporal relation to administration of a vaccine containing pertussis (whole cell or acellular), the potential benefits and possible risks should be carefully considered when deciding to administer subsequent doses of Pediarix or other pertussis-containing vaccine: fever of >=40.5 degrees C (105 degrees F) within 48 hours not due to another identifiable cause; collapse or shock like state (hypotonic-hyporesponsive episode) within 48 hours; persistent, inconsolable crying lasting >=3 hours, occurring within 48 hours; and convulsions with or without fever occurring within 3 days.
Pediarix is contraindicated in patients who have experienced encephalopathy (coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous dose of a pertussis-containing vaccine that is not attributable to another cause. Pediarix is also contraindicated in patients with a progressive neurological disease including infantile spasms, an uncontrolled seizure disorder, or progressive encephalopathy; do not administer the pertussis vaccine to patients with these conditions until a treatment regimen has been established and the condition has stabilized. The ACIP recognizes that children with a personal or family history of seizure disorder may have an increased seizure risk following immunization with a vaccine containing DTP (e.g. Pediarix) versus children without such histories. The ACIP recognizes that vaccination of infants or children with stable neurological disease, including well-controlled seizures, may not contraindicate immunization with a vaccine containing DTP. Consideration of deferral of vaccination is recommended in unstable, deteriorating, or progressive neurologic disorders, and ACIP and AAP guidelines should be reviewed. If the decision to administer Pediarix is made, the parent or guardian should be informed of the potential risks. For children at higher risk of seizures than the general population, the ACIP recommends that acetaminophen or ibuprofen be administered at the time of vaccination and for 24 hours after to reduce the possibility of postvaccination fever.
If Guillain-Barre syndrome occurs within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give subsequent doses of Pediarix or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks.
Immunosuppression can cause a decreased response to tetanus toxoid. Patients on immunosuppressive therapy including chemotherapy, who are receiving radiation therapy, or who have other immunodeficiency may need to delay therapy with Pediarix because of decreased response. Patients with HIV infection should receive immunization.
Pediarix is classified as FDA pregnancy risk category C. No adequate and well-controlled studies have been conducted in pregnant women and the ability of the vaccine to cause fetal harm or to affect reproduction capacity is unknown. According to the Advisory Committee on Immunization Practices (ACIP), administration of inactivated virus or bacterial vaccines to pregnant women have not resulted in adverse effects in the fetus. The ACIP recommends vaccination during pregnancy when the likelihood of disease exposure is high, potential infection would cause harm to mother or fetus, and when the vaccine is unlikely to cause harm. According to the manufacturer, use of this vaccine is not recommended in women of childbearing age. Pregnant patients who require immunization or boosters, should refer to the individual vaccine component monographs for more information.
According to the Advisory Committee on Immunization Practices, inactivated, recombinant, subunit, polysaccharide, conjugate vaccines and toxoids, such as Pediarix, pose no risk for nursing mothers or their infants. Additionally, breast-feeding does not adversely affect immunization; limited data suggest breast-feeding may enhance the immune response to certain vaccine antigens. Pediarix is not approved for use in women of childbearing age; however, the individual vaccine components are and may be potential alternatives to consider during breast-feeding (see the individual monographs for more information). 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 administered drug, health care providers are encouraged to report the adverse effect to the FDA.
The following recommendations for Pediarix apply to use for primary immunization. Children previously vaccinated with one or more of the separate components found in the Pediarix vaccine should consult the package insert and the Advisory Committee on Immunization Practices (ACIP) for specific guidelines on the use of Pediarix to complete the immunization series.
-Pediarix is not recommended for completion of the first 3 doses of the DTaP vaccination series if the series was initiated with a DTaP vaccine from a different manufacturer. Data are not available regarding the safety or efficacy of using acellular pertussis vaccines from different manufacturers for successive doses.
-Infants born to Hepatitis B surface antigen (HBsAg)-positive mothers or to mothers whose HBsAg status is unknown should receive Hepatitis B vaccine within 12 hours of birth and should complete the Hepatitis B vaccine series according to the schedule recommended by the ACIP.
-Infants born to HBsAg-negative mothers who received a dose of hepatitis B vaccine shortly after birth may be administered Pediarix according to the 3-dose schedule, regardless of the manufacturer used for the initial hepatitis B vaccine.
-Pediarix may be used to complete the first 3 doses of the IPV series in infants who have received 1 or 2 doses of IPV and are also scheduled to receive the other vaccine components found in Pediarix, even if the initial IPV was from a different manufacturer. The safety and efficacy of Pediarix in such infants, however, has not been evaluated.
-Pediarix may also be used to complete the first 3 doses of the DTaP series in infants who have received 1 or 2 doses of Infanrix and are also scheduled to receive the other vaccine components of Pediarix, although the safety and efficacy of Pediarix in this situation has not been studied.
-Interruption of the recommended schedule should not interfere with the final immunity achieved with Pediarix. Regardless of the time elapsed between doses, there is no need to start the series over again.
-The use of reduced volume or fractional doses is not recommended as protection against disease.
For simultaneous diphtheria prophylaxis, tetanus prophylaxis, pertussis prophylaxis, hepatitis B prophylaxis, and poliovirus prophylaxis for primary immunization:
Intramuscular dosage:
Adults, Adolescents, and Children >= 7 years: Pertussis vaccine is not recommended in this age group. Therefore, Pediarix is not recommended. Use tetanus and diphtheria toxoid (Td) in adults for tetanus and diphtheria prophylaxis.
Infants >= 6 weeks and Children up to 7 years: Give 0.5 ml IM at intervals of 6-8 weeks (preferably 8 weeks) for 3 doses. The first dose is recommended at 2 months of age, but may be given as early as 6 weeks and up to the seventh birthday. Administer 0.5 ml IM beginning at 8 weeks of age then at 4-8 week intervals to complete a total of 3 doses. Vaccination may be initiated up to the seventh birthday. NOTE: The recommended immunization schedule from the Centers for Disease Control calls for 4 doses of an inactivated poliovirus vaccine (IPV) at 2 months of age, 4 months of age, between 6 and 18 months of age, and 4-6 years of age. The final dose of a poliovirus vaccine series must be administered at age 4 to 6 years regardless of the number of previous doses; therefore, a child who received 3 doses of Pediarix at 2, 4, and 6 months of age will need an additional IPV dose at age 4-6 years (see Poliovirus Vaccine, Inactivated, IPV monograph).
Pre-term infants >= 6 weeks: See infant dosage; pre-term infants should be vaccinated according to their chronological age from birth.
Maximum Dosage Limits:
-Adults
Do not use.
-Geriatric
Do not use.
-Adolescents
Do not use.
-Children
>= 7 years: Do not use.
12 months up to 7 years: 0.5 mL/dose IM.
-Infants
>= 6 weeks: 0.5 mL/dose IM.
-Neonates
Do not use.
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
Albuterol; Budesonide: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Betamethasone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Bimekizumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to vaccines. When feasible, administer indicated vaccines at least two 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.
Budesonide: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Budesonide; Formoterol: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Budesonide; Glycopyrrolate; Formoterol: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Corticosteroids (systemic): (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Corticotropin, ACTH: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Cortisone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Deflazacort: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Deucravacitinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished vaccine response. When feasible, administer indicated vaccines at least two 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.
Dexamethasone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Elivaldogene Autotemcel: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to non-live vaccines. When feasible, administer indicated vaccines at least six 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.
Hepatitis B Immune Globulin, HBIG: (Minor) Administration of hepatitis B virus vaccines (e.g., hepatitis B vaccine, recombinant) at the same site or in the same syringe as hepatitis B immune globulin, HBIG can result in neutralization. Hepatitis B Immune Globulin (human) may be administered at the same time (but at a different site) or up to one month preceding hepatitis B vaccination without impairing the active immune response to hepatitis B vaccine.
Hydrocortisone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Methylprednisolone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Ocrelizumab: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Ofatumumab: (Major) Administer all needed non-live vaccines according to immunization guidelines at least 2 weeks before initiation of ofatumumab. Ofatumumab may interfere with the effectiveness of inactivated vaccines due to its actions, which cause B-cell depletion.
Prednisolone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Prednisone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Satralizumab: (Major) Administer all non-live vaccines according to immunization guidelines at least 2 weeks before initiation of satralizumab.
Siponimod: (Moderate) Administer all non-live vaccines at least 2 weeks before siponimod initiation, whenever possible. Vaccines may be less effective if given during siponimod treatment. Patients should be considered unimmunized if vaccinated within a 14-day period before starting immunosuppresive therapy or during immunosuppressive therapy, and should they be revaccinated at least 3 months after therapy is discontinued if immune competence is restored.
Triamcinolone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Ublituximab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to non-live vaccines. When feasible, administer indicated vaccines at least two 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.
Vamorolone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine, DTaP; Hepatitis B Vaccine, Recombinant; Inactivated Poliovirus Vaccine, IPV (Pediarix(TM)) confers immunity against the bacteria that cause diphtheria, tetanus, pertussis (whooping cough), as well as the viruses that cause hepatitis B and polio.
-Diptheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine, DTaP: The diphtheria toxoid, tetanus toxoid, and pertussis antigens in this product are the same as those in diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix(R)).
Corynebacterium diphtheriae infections are mediated by diphtheria exotoxin, an extracellular protein metabolite of toxogenic strains of C. diphtheriae. Diphtheria toxoid induces the production of neutralizing antibodies against the exotoxin. Infection with C. diphtheriae does not necessarily confer immunity, and previously infected individuals should still receive toxoid.
Exotoxin release by C. tetani causes the neuromuscular dysfunction associated with tetanus. The tetanus toxoid contains antigens that induce the production of antibodies against the exotoxin. Natural immunity to C. tetani also does not occur, and patients previously infected with C. tetani should receive the tetanus toxoid.
Pertussis, or whooping cough, is a highly communicable disease of the respiratory tract caused by Bordetella pertussis infection. The acellular pertussis vaccine contains different pertussis antigens (e.g., filamentous hemagglutinin, pertactin, and pertussis toxin) derived from B. pertussis, which confer immunity by inducing the production of antibodies against these cellular components.
-Hepatitis B Vaccine, recombinant: The hepatitis B surface antigen in this product is the same as that in hepatitis B vaccine, recombinant (Engerix-B(R)). Immunization with hepatitis B vaccine stimulates the immune system to produce anti-hepatitis B surface antigen antibodies (anti-HBs) without exposing the patient to the risks of active infection. Many epidemiological studies indicate that patients who develop anti-HBs following infection with hepatitis B are immune to the virus upon reexposure. Infection with hepatitis D can occur only with concurrent hepatitis B infection, therefore, vaccination with recombinant hepatitis B vaccine provides protection against hepatitis D as well. Chronic hepatitis B infection has been linked to the development of hepatocellular carcinoma. Because vaccination with hepatitis B vaccine can prevent this, it is recognized as the first anti-cancer vaccine.
-Inactivated poliovirus vaccine, IPV: The inactivated poliovirus vaccine component in Pediarix is a new formulation that has demonstrated similar efficacy to the currently available inactivated poliovirus vaccines in the US. Immunization with inactivated poliovirus vaccine (IPV) stimulates the immune system to produce anti-poliovirus antibodies against the each of the 3 poliovirus strains.
Pharmacokinetics:
Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine, DTaP; Hepatitis B Vaccine, Recombinant; Inactivated Poliovirus Vaccine, IPV (i.e., Pediarix) is administered intramuscularly. The pharmacokinetics of this vaccine are not well defined. In one study, pre-vaccination and 1 month post-third dose antibody titers were drawn for Pediarix and its separately administered components. When the immunogenicities were compared, no differences in immune response rates were found. There were, however, some quantitative differences in specific antibody titers among groups. The immunity information below is primarily based on administration of each vaccine alone.
-Diphtheria toxoid, tetanus toxoid, pertussis vaccine (DTP): After three doses of DTP, 90% of vaccine recipients develop protective antibodies against diphtheria and tetanus. In patients receiving four doses of DTP, immunity has been shown to persist for 10 years or more. After three doses of DTP, 70-90% of recipients develop protective antibodies against B. pertussis. In patients receiving four doses of DTP, immunity has been shown to persist for 10 years or more. In those receiving four doses of DTP, immunity starts to decline 4-6 years after immunization, and fewer than 50% of recipients have protective antibodies against B. pertussis 10 years after immunization. Lifelong immunity occurs, however, most likely from subsequent B. pertussis infections.
-Hepatitis B vaccine, recombinant: Studies evaluating plasma-derived hepatitis B vaccine reveal that anti-HBs appear in the serum 2 weeks after IM administration, peak within 6 months, and can remain detectable for 3-7 years.
-Inactivated poliovirus vaccine (IPV): Inactivated poliovirus vaccine produces protective levels of antibody to all three serotypes of poliovirus in over 98% of recipients completing the 3 dose series. Circulating antibodies to all three types of poliovirus persist for at least 10 years. The post third dose immune response rates to the IPV component found in Pediarix were found to be not inferior to those induced by the currently licensed IPV and OPV.