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    Vaccine Combinations with a Tetanus Component

    DEA CLASS

    Rx

    DESCRIPTION

    Pediarix™ is a combination of 5 of the 7 vaccines that are currently recommended for all children in the first 6 months of life; the DTaP component of this vaccine is the same as that found in Infanrix®; the hepatitis B vaccine component is the same as that found in Engerix-B®; the inactivated poliovirus vaccine in this product is a new formulation.

    COMMON BRAND NAMES

    Pediarix

    HOW SUPPLIED

    Pediarix Intramuscular Inj Susp

    DOSAGE & INDICATIONS

    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

    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.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

    Renal Impairment

    Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

    ADMINISTRATION

     
    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.

    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.[48514]
    Off-label storage information: According to a 2007 published article, storage of Pediarix (GlaxoSmithKline) at room temperature for up to 24 hours is acceptable.[58514] 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.

    STORAGE

    Pediarix:
    - Discard if product has been frozen
    - Do not freeze
    - Refrigerate (between 36 and 46 degrees F)

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    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.

    Hepatitis

    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.

    Anticoagulant therapy, coagulopathy, hemophilia, intraarterial administration, intravenous administration, subcutaneous administration, thrombocytopenia, vitamin K deficiency

    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.

    Children, geriatric, infants, neonates, premature neonates

    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.

    Neomycin hypersensitivity, polymyxin hypersensitivity, yeast hypersensitivity

    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.

    Latex 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.

    Fever, shock

    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.

    Coma, encephalopathy, neurological disease, seizure disorder, seizures

    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.

    Guillain-Barre syndrome

    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.

    Chemotherapy, immunosuppression, radiation therapy

    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.

    Pregnancy

    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.

    Breast-feeding

    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.

    ADVERSE REACTIONS

    Severe

    intussusception / Delayed / 0-1.0
    apnea / Delayed / Incidence not known
    seizures / Delayed / Incidence not known
    myelitis / Delayed / Incidence not known
    Guillain-Barre syndrome / Delayed / Incidence not known
    aluminum toxicity / Delayed / Incidence not known
    muscle paralysis / Delayed / Incidence not known
    erythema multiforme / Delayed / Incidence not known
    bronchospasm / Rapid / Incidence not known
    anaphylactoid reactions / Rapid / Incidence not known
    Stevens-Johnson syndrome / Delayed / Incidence not known
    angioedema / Rapid / Incidence not known
    anaphylactic shock / Rapid / Incidence not known
    cyanosis / Early / Incidence not known

    Moderate

    erythema / Early / 10.0
    hypotonia / Delayed / Incidence not known
    neuritis / Delayed / Incidence not known
    encephalopathy / Delayed / Incidence not known
    peripheral neuropathy / Delayed / Incidence not known
    lymphadenopathy / Delayed / Incidence not known
    dyspnea / Early / Incidence not known
    hypotension / Rapid / Incidence not known
    elevated hepatic enzymes / Delayed / Incidence not known

    Mild

    injection site reaction / Rapid / 10.0
    anorexia / Delayed / 10.0
    irritability / Delayed / Incidence not known
    inconsolable crying / Delayed / Incidence not known
    fever / Early / Incidence not known
    weakness / Early / Incidence not known
    hypoesthesia / Delayed / Incidence not known
    paresthesias / Delayed / Incidence not known
    arthralgia / Delayed / Incidence not known
    pallor / Early / Incidence not known
    insomnia / Early / Incidence not known
    asthenia / Delayed / Incidence not known
    malaise / Early / Incidence not known
    headache / Early / Incidence not known
    chills / Rapid / Incidence not known
    pruritus / Rapid / Incidence not known
    urticaria / Rapid / Incidence not known
    maculopapular rash / Early / Incidence not known
    lethargy / Early / Incidence not known
    fatigue / Early / Incidence not known
    drowsiness / Early / Incidence not known
    petechiae / Delayed / Incidence not known
    alopecia / Delayed / Incidence not known
    rash / Early / Incidence not known
    restlessness / Early / Incidence not known
    diarrhea / Early / Incidence not known
    vomiting / Early / Incidence not known
    syncope / Early / Incidence not known

    DRUG INTERACTIONS

    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.
    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.
    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 4 weeks before siponimod initiation, whenever possible. Vaccines may be less effective if given during siponimod treatment and for 1 month after discontinuation of siponimod treatment.

    PREGNANCY AND LACTATION

    Pregnancy

    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.

    MECHANISM OF ACTION

    Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine, DTaP; Hepatitis B Vaccine, Recombinant; Inactivated Poliovirus Vaccine, IPV (Pediarix™) 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®).
     
    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®). 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.