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]
Mechanism of Action
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.
Use: Labeled Indications
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 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.
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)
Dosage and Administration
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 (ACIP [Kroger 2017]).
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) (CDC 58 2009).
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 (CDC/ACIP [Schillie 2018]).
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.
Store under refrigeration at 2°C to 8°C (36°F to 46°F); do not freeze. Discard if frozen. Extended storage information at room temperature may be available; contact product manufacturer to obtain current recommendations.
Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated). 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. Consider therapy modification
Immunosuppressants: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Exceptions: Cytarabine (Liposomal). Consider therapy modification
Meningococcal Polysaccharide (Groups A / C / Y and W-135) Tetanus Toxoid Conjugate Vaccine: May diminish the therapeutic effect of Tetanus Toxoids Vaccines. Management: When possible, administer the meningococcal polysaccharide (groups A / C / Y and W-135) tetanus toxoid conjugate vaccine either together with or at least one month before a tetanus toxoids-containing vaccine. Consider therapy modification
Siponimod: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Avoid administration of vaccines (inactivated) during treatment with siponimod and for 1 month after discontinuation due to potential decreased vaccine efficacy. Consider therapy modification
Venetoclax: May diminish the therapeutic effect of Vaccines (Inactivated). Monitor therapy
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.
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
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 2017]).
- 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 2017]). 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]).
- 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 2017]).
- 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. Defer 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 2017]).
- 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 2017]).
- 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 2017]).
- 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 inactivated) for which a person is eligible at a single clinic 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 2017]).
- Altered immunocompetence: Consider deferring immunization during periods of severe immunosuppression (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroids]); may have a reduced response to vaccination. In general, household and close contacts of persons with altered immunocompetence may receive all age appropriate vaccines. Inactivated vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible; inactivated vaccines administered during chemotherapy should be readministered after immune competence is regained (ACIP [Kroger 2017]; (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.
- Latex: Packaging may contain natural latex rubber.
- 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.
- 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. Vaccines may not be effective if administered during periods of altered immune competence (ACIP [Kroger 2017]).
Monitor for syncope for 15 minutes following administration (ACIP [Kroger 2017]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.
Pediarix is not approved for use in patients >5 years of age.
- Discuss specific use of vaccine and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience fatigue, irritability, lack of appetite, or injection site pain, redness, or edema. Have caregiver report immediately to prescriber severe dizziness, passing out, high fever, vision changes, seizures, burning or numbness feeling, abnormal movements, change in balance, abnormal gait, or persistent crying (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.