Diphtheria, Tetanus Toxoids, Acellular Pertussis, Hepatitis B (Recombinant), and Poliovirus (Inactivated) Vaccine

• Pediarix

Primary immunization: Infants and Children 6 weeks to <7 years: IM: 0.5 mL/dose; administer as a 3-dose series at 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.

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. The minimum age and minimum intervals during the first 6 months of life should only be used 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[30] 2009).

Use in infants and children previously vaccinated with one or more component, and who are also scheduled to receive all vaccine components:

Infants previously vaccinated with hepatitis B vaccine: Infants 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 born to HBsAg-positive women should begin dosing with DTaP-HepB-IPV by age 6-8 weeks after receiving the single antigen hepatitis B vaccine at birth (ACIP [Robinson 2016]).

Infants previously vaccinated with diphtheria and tetanus toxoids, and acellular pertussis vaccine (DTaP): Infants 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.

Infants previously vaccinated with inactivated polio vaccine (IPV): Infants 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 adjustment provided in the manufacturer’s labeling.

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 (NCIRD/ACIP 2011).

• Arthus-type hypersensitivity: Patients with a history of severe local reaction (Arthus-type) following a previous tetanus toxoid 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 (NCIRD/ACIP 2011).

• 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 (NCIRD/ACIP 2011). 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.

• 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 (NCIRD/ACIP 2011).

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. Consider deferring 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) (NCIRD/ACIP 2011).

• Bleeding disorders: Use with caution in patients with bleeding disorders (including thrombocytopenia) and patients on anticoagulant therapy; bleeding/hematoma may occur from IM administration; if the patient receives antihemophilia or other similar therapy, I.M. injection can be scheduled shortly after such therapy is administered (NCIRD/ACIP 2011).

• Guillain-Barré syndrome: Use with caution if Guillain-Barré syndrome occurred within 6 weeks of prior tetanus toxoid-containing vaccine (NCIRD/ACIP 2011).

• Neurologic disorders: Use with caution in patients with history of seizure disorder, progressive neurologic disease, or conditions predisposing to seizures; ACIP guidelines recommend deferring immunization until health status can be assessed and condition stabilized (NCIRD/ACIP 2011).

Concurrent drug therapy issues:

• 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 (NCIRD/ACIP 2011).

Special populations:

• Altered immunocompetence: Use with caution in severely immunocompromised patients (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 (IDSA [Rubin 2014]; NCIRD/ACIP 2011); inactivated vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible (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 combination product in these patients to complete the hepatitis B vaccination series is limited but is considered acceptable by the ACIP. Apnea has been reported following IM vaccine administration in premature infants; consider clinical status implications. In general, preterm infants should be vaccinated at the same chronological age as full-term infants (NCIRD/ACIP 2011).

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.

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. Vaccines may not be effective if administered during periods of altered immune competence (NCIRD/ACIP 2011).

Reproduction studies have not been conducted; not indicated for women of childbearing 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 or irritation. Have caregiver report immediately to prescriber severe dizziness, passing out, vision changes, burning or numbness feeling, abnormal movements, or abnormal crying (children) (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 healthcare 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.