Hibtiter (Haemophilus b Conjugate Vaccine (Diphtheria CRM 197 Protein Conjugate)) - Drug Interactions, Contraindications, Overdosage

DRUG INTERACTIONS

Children receiving therapy with immunosuppressive agents (large amounts of corticosteroids, antimetabolites, alkylating agents, cytotoxic agents) may not respond optimally to active immunization.^37,38,39(See PRECAUTIONS, GENERAL.)

As with other intramuscular injections, HibTITER should be given with caution to children on anticoagulant therapy.

No impairment of the antibody response to the individual antigens was demonstrated when HibTITER was given at the same time but at separate sites as DTP plus OPV to children 2 to 20 months of age or MMR to children 15 ± 1 month of age. ^20,43,44

There are no clinical studies where a direct comparison of the immune responses to HibTITER was compared with the concurrent administration of diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP), hepatitis B vaccine (Hep B), inactivated poliovirus vaccine (IPV), 7-valent Conjugate Vaccine-Diphtheria CRM₁₉₇ Protein (Prevnar), or Varicella vaccine. However, in clinical trials where HibTITER and DTaP or HibTITER, DTaP, IPV, and Hep B vaccines were administered concurrently with or without Prevnar in children at 2, 4, and 6 months of age, the percentage of children achieving Hib antibody levels of >/=0.15 or >/=1.0 µg/mL were similar. ^45,46 In one study where children 12-15 months of age were administered a booster dose of HibTITER concurrently with DTaP and Prevnar, some suppression of the Hib antibody response was observed, but over 97% of children achieved titers of >/=1.0 µg/mL. ^47,48 However, in another study where a booster dose of HibTITER was administered to children at 12-15 months of age concurrently with or without Prevnar the percentage of children achieving Hib antibody levels of >/=0.15 or >/=1.0 µg/mL was found to be similar. ^49,50

HibTITER and DTaP administered concurrently with and without Prevnar at 2, 4, and 6, and 12-15 months of age did not impair immune responses to the seven Pneumococcal vaccine serotypes in Prevnar. ^47,48,51,52

There are no clinical trials where the local and systemic reactogenicity of HibTITER was directly compared with the concurrent administration of DTaP, Hep B, IPV, Prevnar, or Varicella vaccines.

The American Academy of Pediatrics (AAP), the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP) encourage routine simultaneous administration of DTaP, IPV, Haemophilus influenzae type b vaccine, pneumococcal conjugate vaccine, measles-mumps-rubella (MMR), varicella vaccine and hepatitis B vaccine for children who are the recommended age to receive these vaccines and for whom no specific contraindications exist at the time of the visit, unless, in the judgment of the provider, complete vaccination of the child will not be compromised by administering different vaccines at different visits. Simultaneous administration is particularly important if the child might not return for subsequent vaccinations. ^32,33,34,35

OVERDOSAGE

There have been reports of overdose with HibTITER. Many cases were due to inadvertent coadministration with another Haemophilus b conjugate-containing vaccine. Most individuals were asymptomatic. In general, adverse events reported with overdosage have also been reported with recommended single doses of HibTITER.

CONTRAINDICATIONS

Hypersensitivity to any component of the vaccine, including diphtheria toxoid, is a contraindication to the use of HibTITER.

The occurrence of an allergic or anaphylactic reaction following a prior dose of HibTITER is a contraindication to the use of HibTITER.

The decision to administer or delay vaccination because of a current or recent febrile illness depends largely on the severity of the symptoms and their etiology. Although a severe or even moderate febrile illness is sufficient reason to postpone vaccinations, minor illnesses, such as a mild respiratory infection with or without low-grade fever, are not generally contraindications.