when initiating therapy (e.g., monthly) and may decrease in frequency with continued treatment (e.g., every 3 months). Severe thrombocytopenia has been observed (see WARNINGS, Immune-Mediated Thrombocytopenia).

Drug Interactions

No formal drug interaction studies have been performed with RAPTIVA. RAPTIVA should not be used with other immunosuppressive drugs (see PRECAUTIONS, Immunosuppression). Live (including live-attenuated) vaccines should not be administered during RAPTIVA treatment (see PRECAUTIONS, Immunizations).

Drug/Laboratory Test Interactions

Increases in lymphocyte counts related to the pharmacologic mechanism of action are frequently observed during RAPTIVA treatment (see CLINICAL PHARMACOLOGY, Pharmacodynamics).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been conducted to evaluate the carcinogenic potential of RAPTIVA.

Subcutaneous injections of male and female mice with an anti-mouse CD11a antibody, a murine surrogate for efalizumab, at up to 30 times the equivalent of the 1 mg/kg clinical dose of RAPTIVA had no adverse effects on mating, fertility, or reproduction parameters. The clinical significance of this observation is uncertain. Genotoxicity studies were not conducted.

Pregnancy (Category C)

Animal reproduction studies have not been conducted with RAPTIVA. It is also not known whether RAPTIVA can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. RAPTIVA should be given to a pregnant woman only if clearly needed.

See Raptiva Page 12