efalizumab, Raptiva (cont.)

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.

Efalizumab increases the riskfor progressive multifocal leukoencephalopathy (PML), a rare, serious, progressive disease of the nervous system caused by a virus. PML usually occurs in people with severely weakened immune systems resulting in an irreversible decline in function of the nervous system and death. There is no known effective treatment for PML. Patients receiving efalizumab therapy should be monitored for symptoms that suggest PML. If PML is suspected, efalizumab should be discontinued.

Reference: FDA Prescribing Information

Last Editorial Review: 10/16/2005

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