Diphtheria, tetanus toxoids, acellular pertussis, inactivated poliovirus, Haemophilus influenzae type B, hepatitis B conjugate vaccine (DTaP-IPV-Hib-HepB): Drug information

Warnings/Precautions

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]).

• Reactions from previous pertussis vaccination: Carefully consider use and weigh risks/benefits in patients with history of any of the following effects from previous administration of a pertussis-containing vaccine: Fever ≥40.5°C (105°F) 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. Vaccine should not be administered in patients with a history of severe allergic reaction after a previous dose or encephalopathy not attributable to another cause within 7 days following a previous dose of pertussis-containing vaccine (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 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 a history of 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]).

• Brachial neuritis: Has occurred following tetanus toxoid-containing vaccines; use with caution (CDC/ACIP [Liang 2018]).

• 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: Use pertussis-containing vaccines with caution in patients with progressive neurologic disease including infantile spasms, uncontrolled seizure, or a progressive encephalopathy, or conditions predisposing to seizures; the Advisory Committee on Immunization Practices (ACIP) guidelines recommend deferring immunization until health status can be assessed and condition stabilized (CDC/ACIP [Liang 2018]). Per the manufacturer, it is contraindicated to administer vaccine until a treatment regimen is established and the condition is stabilized.

• Poliomyelitis: Infanrix hexa [Canadian product]: Defer elective immunization of individuals ≥6 months of age during outbreaks of poliomyelitis.

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]). An increased incidence of febrile reactions, convulsions (with or without fever) and hypotonic hyporesponsive episode have been observed with concomitant use of Infanrix hexa [Canadian product] and pneumococcal conjugate vaccine.

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. May be used in patients with HIV infection. In general, household and close contacts of persons with altered immunocompetence may receive all age-appropriate vaccines. Non-live vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible; non-live vaccines administered during chemotherapy should be readministered after immune competence is regained (ACIP [Kroger 2023]; IDSA [Rubin 2014]).

• Pediatric: 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 (AAP [Saari 2003]; ACIP [Kroger 2023]).

Dosage form specific issues:

• Aluminum: Formulation may contain aluminum.

• Neomycin: Formulation contains trace amounts of neomycin; use caution in patients with prior hypersensitivity to neomycin.

• Polymyxin B: Formulation contains trace amounts of polymyxin B; use caution in patients with prior hypersensitivity to polymyxin B.

• 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.

Other warnings/precautions:

• Antipyretics: 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).

• 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 2021]).