Prevnar (Pneumococcal 7-Valent Conjugate Vaccine (Diphtheria CRM 197 Protein)) - Drug Interactions, Contraindications, Overdosage

DRUG INTERACTIONS

DRUG INTERACTIONS

Children receiving therapy with immunosuppressive agents (large amounts of corticosteroids, antimetabolites, alkylating agents, cytotoxic agents) may not respond optimally to active immunization. 33,34 (See PRECAUTIONS, General .)

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

Simultaneous Administration with Other Vaccines

During clinical studies, Prevnar^® was administered simultaneously with DTaP and HbOC, IPV, Hep B vaccines, MMR, and Varicella vaccine. Thus, the safety experience with Prevnar^® reflects the use of this product as part of the routine immunization schedule. 20,21, 25,27, 28,30

The immune response to routine vaccines when administered with Prevnar^® (at separate sites) was assessed in 3 clinical studies in which there was a control group for comparison. Higher antibody levels (GMC) to Hib were observed after 3 doses of HbOC given with Prevnar in the infant series, compared to HbOC without Prevnar. After the 4^th dose, Hib GMCs were lower when HbOC was given with Prevnar compared to control; however, over 97% of children receiving HbOC with Prevnar achieved a serum antibody concentration of ≥1 Î¼g/mL. Although some inconsistent differences in response to pertussis antigens were observed, the clinical relevance is unknown. The response to 2 doses of IPV given concomitantly with Prevnar^®, assessed 3 months after the second dose, was equivalent to controls for poliovirus Types 2 and 3, but lower for Type 1. In another study, over 98% of subjects achieved neutralizing antibody titers ≥1:8 for all polio types, following a third dose of IPV given concomitantly with Prevnar at 12 months of age. 35 Seroresponse rates to measles, mumps and rubella were similar after MMR was given concomitantly with Prevnar at 12 months of age compared to seroresponse rates after MMR was given without Prevnar at 12 months of age. 36 A clinical study demonstrated no interference with the immune response to varicella vaccine when administered concurrently with a 4th dose of Prevnar^®. 37

OVERDOSAGE

There have been reports of overdose with Prevnar^®, including cases of administration of a higher than recommended dose and cases of subsequent doses administered closer than recommended to the previous dose. Most individuals were asymptomatic. In general, adverse events reported with overdose have also been reported with recommended single doses of Prevnar^®.

CONTRAINDICATIONS

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