Version May 2024
(For additional information see "Diphtheria, tetanus toxoids, acellular pertussis, recombinant hepatitis B, and inactivated poliovirus vaccine (DTaP-HepB-IPV): Pediatric drug information")
Note: Consult CDC/ACIP annual immunization schedules for additional information including specific detailed recommendations for catch-up scenarios and/or care of patients with high-risk conditions. According to ACIP, doses administered ≤4 days before minimum interval or age are considered valid; however, local or state mandates may supersede this timeframe (Ref).
Primary immunization: Infants ≥6 weeks and Children <7 years: IM: 0.5 mL per dose for a total of three doses administered as follows: 2, 4, and 6 months of age in 6- to 8-week intervals (preferably 8-week intervals). Vaccination usually begins at 2 months, but may be started as early as 6 weeks of age. Preterm infants should be vaccinated according to their chronological age from birth.
Note: Pediarix is approved for the first 3 doses of polio vaccine. Per the ACIP, polio vaccine is given at 2, 4, and 6 to 18 months of age. Use of the minimum age and minimum intervals during the first 6 months of life should only be done when the vaccine recipient is at risk for imminent exposure to circulating poliovirus (shorter intervals and earlier start dates may lead to lower seroconversion) (Ref).
Previous vaccination with one or more components and scheduled to receive all vaccine components: Infants and Children <7 years:
Hepatitis B vaccine: If previously vaccinated with 1 or 2 doses of another hepatitis B vaccine may use Pediarix to complete the 3-dose series. Not for use as birth dose of hepatitis B vaccine; infants who received a birth dose of hepatitis B vaccine may receive a 3-dose series of Pediarix (total of 4 hepatitis B vaccine doses). Infants born to HBsAg-positive women should begin dosing with DTaP-HepB-IPV by age 6 to 8 weeks after receiving the single antigen hepatitis B vaccine at birth (Ref).
Diphtheria, tetanus toxoids, and acellular pertussis vaccine (DTaP): If previously vaccinated with 1 or 2 doses of Infanrix may use Pediarix to complete the first 3 doses of the series; use of Pediarix to complete DTaP vaccination started with products other than Infanrix has not been studied.
Inactivated polio vaccine (IPV): If previously vaccinated with 1 or 2 doses of IPV may use Pediarix to complete the first 3 doses of the series.
There are no dosage adjustments provided in the manufacturer’s labeling.
There are no dosage adjustments provided in the manufacturer’s labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
Adverse events reported within 4 days of vaccination at 2-, 4-, and 6 months of age in patients given Pediarix concomitantly with Hib conjugate vaccine and PCV7 vaccine.
>10%:
Central nervous system: Irritability (≤61% to 65%; grade 3: ≤3% to 4%), drowsiness (41% to 57%)
Gastrointestinal: Anorexia (26% to 31%; grade 3: <1%)
Local: Erythema at injection site (25% to 40%; >20 mm: 1% to 3%), pain at injection site (31% to 36%; grade 3: 2% to 3%), swelling at injection site (17% to 29%; >20 mm: 2% to 3%)
Miscellaneous: Fussiness (≤61% to 65%; grade 3: ≤3% to 4%), fever (≥100.4°F: 28% to 39%; >103.1°F: ≤1%)
<1%, postmarketing, and/or case reports: Abnormal hepatic function tests, anaphylactoid reaction, anaphylaxis, angioedema, apnea, arthus phenomenon, bulging fontanel, cough, cranial nerve dysfunction (cranial mononeuropathy), crying, cyanosis, demyelinating disease, diarrhea, dyspnea, encephalitis, erythema, fatigue, febrile seizures, Guillain-Barré syndrome, hypersensitivity reaction, hypotonia, hypotonic/hyporesponsive episode, impaired consciousness, injection site reaction (cellulitis at injection site, induration at injection site, injection site nodule, injection site pruritus, injection site vesicle, warm sensation at injection site), insomnia, lethargy, limb pain, nervousness, neuritis (brachial), pallor, peripheral neuropathy (mononeuropathy), petechiae, restlessness, screaming, seizure, skin rash, sudden infant death syndrome, swelling of extremities, upper respiratory tract infection, urticaria, vomiting
Hypersensitivity to diphtheria and tetanus toxoids, pertussis, hepatitis B, poliovirus vaccine, or any component of the vaccine; encephalopathy occurring within 7 days of a previous pertussis vaccine (not attributable to another identifiable cause); progressive neurologic disorders (including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy)
Concerns related to adverse effects:
• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (ACIP [Kroger 2023]).
• Arthus-type hypersensitivity: Patients with a history of severe local reaction (Arthus-type) following a previous diphtheria toxoid or tetanus toxoid-containing vaccine dose should not be given further routine or emergency doses of Td more frequently than every 10 years, even if using for wound management with wounds that are not clean or minor; these patients generally have high serum antitoxin levels (CDC/ACIP [Liang 2018]).
• Fever: The use of Pediarix combination vaccine is associated with higher rates of fever in comparison to the separate administration of individual components. Per the manufacturer, antipyretic prophylaxis may be considered for patients at high risk for seizures. However, antipyretics have not been shown to prevent febrile seizures; antipyretics may be used to treat fever or discomfort following vaccination (ACIP [Kroger 2023]). One study reported that routine prophylactic administration of acetaminophen to prevent fever prior to vaccination decreased the immune response of some vaccines; the clinical significance of this reduction in immune response has not been established (Prymula 2009).
• Reactions from previous pertussis vaccine: Carefully consider use in patients with history of any of the following effects from previous administration of a pertussis-containing vaccine: Fever ≥105°F (40.5°C) within 48 hours of unknown cause; seizures with or without fever occurring within 3 days; persistent, inconsolable crying episodes lasting ≥3 hours and occurring within 48 hours; collapse or shock-like state (hypotonic-hyporesponsive episode) occurring within 48 hours (CDC/ACIP [Liang 2018]).
• Shoulder injury related to vaccine administration: Vaccine administration that is too high on the upper arm may cause shoulder injury (eg, shoulder bursitis or tendinopathy) resulting in shoulder pain and reduced range of motion following injection. Use proper injection technique for vaccines administered in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Cross 2016; Foster 2013).
• Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); typically reported in adolescents and young adults and within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (ACIP [Kroger 2023]).
Disease-related concerns:
• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Postpone administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever) (ACIP [Kroger 2023]).
• Bleeding disorders: Use with caution in patients with bleeding disorders (including thrombocytopenia); bleeding/hematoma may occur from IM administration; if the patient receives antihemophilia or other similar therapy, IM injection can be scheduled shortly after such therapy is administered (ACIP [Kroger 2023]).
• Guillain-Barré syndrome: Use with caution if Guillain-Barré syndrome occurred within 6 weeks of prior tetanus toxoid-containing vaccine (CDC/ACIP [Liang 2018]).
• Neurologic disorders: According to the manufacturer, use is contraindicated in patients with, progressive neurologic disease including infantile spasms, uncontrolled seizure, or a progressive encephalopathy. ACIP guidelines recommend deferring immunization until health status can be assessed and condition stabilized (CDC/ACIP [Liang 2018]).
Concurrent drug therapy issues:
• Anticoagulant therapy: Use with caution in patients receiving anticoagulant therapy; bleeding/hematoma may occur from IM administration (ACIP [Kroger 2023]).
• Vaccines: In order to maximize vaccination rates, the ACIP recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or nonlive) for which a person is eligible at a single visit, unless contraindications exist. The use of combination vaccines is generally preferred over separate injections, taking into consideration provider assessment, patient preference, and adverse events. When using combination vaccines, the minimum age for administration is the oldest minimum age for any individual component; the minimum interval between dosing is the greatest minimum interval between any individual components. The ACIP prefers each dose of a specific vaccine in a series come from the same manufacturer when possible; however, vaccination should not be deferred because a specific brand name is unavailable (ACIP [Kroger 2023]).
Special populations:
• Altered immunocompetence: Postpone vaccination during periods of severe immunosuppression (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroids]) if appropriate; may have a reduced response to vaccination. In general, household and close contacts of persons with altered immunocompetence may receive all-age appropriate vaccines. Nonlive vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible; nonlive vaccines administered during chemotherapy should be readministered after immune competence is regained (ACIP [Kroger 2023]; IDSA [Rubin 2014]).
• Pediatric: Infants born of HBsAg-positive mothers should receive monovalent hepatitis B vaccine and hepatitis B immune globulin; infants born of HBsAg-unknown mothers should receive monovalent hepatitis B vaccine; use of the combination product to complete a series is acceptable once patient is old enough to receive (ie, >6 weeks old) (CDC/ACIP [Schillie 2018]).
Dosage form specific issues:
• Aluminum: Product may contain aluminum.
• Neomycin: Product may contain neomycin.
• Polymyxin B: Product may contain polymyxin B.
• Polysorbate 80: Product may contain polysorbate 80. Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer’s labeling.
• Yeast protein: Product may contain yeast protein.
Other warnings/precautions:
• Booster dose: Not approved for the fourth dose of the IPV series or the fourth and fifth doses of the DTaP series.
• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval (ACIP [Kroger 2023]).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, suspension [preservative free]:
Pediarix: Diphtheria toxoid 25 Lf, tetanus toxoid 10 Lf, acellular pertussis antigens [inactivated pertussis toxin 25 mcg, filamentous hemagglutinin 25 mcg, pertactin 8 mcg, HBsAg 10 mcg, type 1 poliovirus 40 D antigen units, type 2 poliovirus 8 D antigen units and type 3 poliovirus 32 D antigen units] per 0.5 mL (0.5 mL) [contains aluminum, formaldehyde, neomycin sulfate (trace amounts), polymyxin B (trace amounts), polysorbate 80, and yeast protein ≤5%; may contain natural rubber/natural latex in prefilled syringe]
No
Shake well; administer IM in either the anterolateral aspect of the thigh or in the deltoid muscle of the upper arm; not for IV or SubQ administration. If injecting in the deltoid muscle, use proper injection technique (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Ref). Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection.
US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be recorded.
For patients at risk of hemorrhage following intramuscular injection, the vaccine should be administered intramuscularly if, in the opinion of the physician familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, intramuscular vaccination can be scheduled shortly after such therapy is administered. A fine needle (23-gauge or smaller) should be used for the vaccination and firm pressure on the site (without rubbing) for at least 2 minutes. The patient should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (Ref).
In the United States, the appropriate CDC-approved Vaccine Information Statement (VIS) must be provided to the patient/caregiver before administering each dose of this vaccine; the VIS edition date and date it was provided to the patient/caregiver should be recorded as required by US law; VIS is available at http://www.cdc.gov/vaccines/hcp/vis/vis-statements/multi.html .
Diphtheria, tetanus, pertussis, poliomyelitis, and hepatitis B prevention: Active immunization against diphtheria, tetanus, pertussis, hepatitis B virus (all known subtypes), and poliomyelitis in infants born of HBsAg-negative mothers, beginning as early as 6 weeks of age through 6 years of age (prior to the seventh birthday).
The Advisory Committee on Immunization Practices (ACIP) recommends Pediarix for the following (CDC/ACIP [Liang 2018]; CDC/ACIP [Schillie 2018]; CDC/ACIP 58[30] 2009):
- Primary vaccination for DTaP, Hep B, and IPV in infants at 2, 4, and 6 months of age.
- To complete the primary vaccination series in children who have received DTaP (Infanrix) and who are scheduled to receive the other components of the vaccine. Whenever feasible, the same manufacturer should be used to provide the pertussis component; however, vaccination should not be deferred if a specific brand is not known or is not available. HepB and IPV from different manufacturers are interchangeable.
Pediarix (DTaP-HepB-IPV) may be confused with Pentacel (DTaP-IPV/Hib).
DTaP-HepB-IPV (diphtheria and tetanus toxoids, acellular pertussis, hepatitis B, and poliovirus [inactivated] vaccine) may be confused with DTaP-IPV/Hib (diphtheria and tetanus toxoids, acellular pertussis, poliovirus [inactivated], and Haemophilus influenzae type b conjugate vaccine) and DTaP-IPV (diphtheria and tetanus toxoids, acellular pertussis and poliovirus [inactivated] vaccine)
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Acetaminophen: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of acetaminophen before or during vaccine administration when possible. Acetaminophen is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification
Anti-CD20 B-Cell Depleting Therapies: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation or 6 months after anti-CD20 B-cell depleting therapies. If vaccinated prior to B cell recovery, consider assessing immune response to vaccination. Risk D: Consider therapy modification
Cladribine: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of cladribine when possible. Patients vaccinated less than 14 days before initiating or during cladribine should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification
Corticosteroids (Systemic): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Administer vaccines at least 2 weeks prior to immunosuppressive corticosteroids if possible. If patients are vaccinated less than 14 days prior to or during such therapy, repeat vaccination at least 3 months after therapy if immunocompetence restored. Risk D: Consider therapy modification
Elivaldogene Autotemcel: May enhance the adverse/toxic effect of Vaccines. Specifically, there may be a greater risk for contracting an infection from any live vaccine. Elivaldogene Autotemcel may diminish the therapeutic effect of Vaccines. Management: Administration of vaccines is not recommended in the 6 weeks before myeloablative conditioning, and until hematologic recovery after elivaldogene autotemcel treatment. Risk X: Avoid combination
Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting fingolimod. If vaccinated during fingolimod therapy, revaccinate 2 to 3 months after fingolimod discontinuation. Risk D: Consider therapy modification
Immunosuppressants (Cytotoxic Chemotherapy): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of chemotherapy when possible. Patients vaccinated less than 14 days before initiating or during chemotherapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification
Immunosuppressants (Miscellaneous Oncologic Agents): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 3 after therapy is complete. Risk D: Consider therapy modification
Immunosuppressants (Therapeutic Immunosuppressant Agents): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider therapy modification
Meningococcal (Groups A / C / Y and W-135) Conjugate Vaccine: Tetanus Toxoids Vaccines may diminish the therapeutic effect of Meningococcal (Groups A / C / Y and W-135) Conjugate Vaccine. Management: When possible, administer the meningococcal polysaccharide (groups A / C / Y and W-135) conjugate vaccine (Nimenrix brand) either together with, or at least one month before, a tetanus toxoids-containing vaccine. Risk D: Consider therapy modification
Methotrexate: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Administer vaccines at least 2 weeks prior to methotrexate initiation, if possible. If patients are vaccinated less than 14 days prior to or during methotrexate therapy, repeat vaccination at least 3 months after therapy if immunocompetence restored. Risk D: Consider therapy modification
Propacetamol: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of propacetamol before or during vaccine administration when possible. Propacetamol is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification
Siponimod: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Avoid administration of vaccines (inactivated) during treatment with siponimod and for 1 month after discontinuation due to potential decreased vaccine efficacy. Risk D: Consider therapy modification
Teplizumab: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Vaccination with inactivated or non-replicating vaccines is not recommended in the 2 weeks prior to teplizumab therapy, during treatment, or for 6 weeks following completion of therapy. Risk D: Consider therapy modification
Pediarix is not approved for use in patients >5 years of age.
Not indicated for patients of childbearing age. Breastfeeding infants should be vaccinated according to the recommended schedules (ACIP [Kroger 2023]).
Monitor for hypersensitivity and syncope for 15 minutes following administration (ACIP [Kroger 2023]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.
Promotes active immunity to diphtheria, tetanus, pertussis, hepatitis B and poliovirus (types 1, 2 and 3) by inducing production of specific antibodies and antitoxins.
Onset of action: Immune response observed to all components 1 month following the 3-dose series
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