efalizumab, Raptiva

DRUG INTERACTIONS: The safety and efficacy of efalizumab in combination with other immune-suppressing medicines have not been evaluated. It is recommended that patients receiving other immune-suppressing medicines should not receive efalizumab because of the possibility of increasing the risks of infections and tumors. The safety and efficacy of vaccines administered to patients being treated with efalizumab also have not been studied. Some vaccines consisting of live viruses which have been rendered inactive (attenuated) should not be used in patients taking efalizumab

PREGNANCY: Reproduction studies in animals have not been conducted with efalizumab. It also is not known whether efalizumab can cause harm to the fetus in humans. Therefore, efalizumab should be given to a pregnant woman only if the physician feels that its benefits clearly warrant the theoretical risks and with the patient's consent. Female patients also should notify their physicians if they become pregnant while taking efalizumab (or within 6 weeks of discontinuing efalizumab) and be encouraged to enroll in the RAPTIVA Pregnancy Registry.

NURSING MOTHERS: It is not known whether efalizumab passes into breast milk. Since animal data suggest a potential for side effects in nursing infants from similar (but not commercially available) drugs, a decision must be carefully made whether to discontinue nursing while taking efalizumab or to discontinue efalizumab, taking into account the importance of the drug to the mother.

SIDE EFFECTS: Reactions to the first dose of efalizumab include headache, fever, nausea, and vomiting and are dose-level related, that is, the higher the dose the more likely are reactions. With the currently recommended first dose (0.7 mg/kg), one in three patients will have a reaction.

Efalizumab suppresses the immune system and there have been reports ofinfections including serious infections and infections that worsen despite treatment with antibiotics. It also is possible that this immune-suppressing effect may increase the riskfor tumors. Low platelet counts may occur increasing the risk of bleeding. An immune-mediated anemia due to the destruction of red blood cells also has been reported.

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