Raptiva® (efalizumab)

Important Safety Information

WARNING: RISK OF SERIOUS INFECTIONS Infections, including serious infections leading to hospitalizations or death, have been observed in patients treated with Raptiva (see WARNINGS and ADVERSE REACTIONS). These infections have included bacterial sepsis, viral meningitis, invasive fungal disease and other opportunistic infections. Patients should be educated about the symptoms of infection and be closely monitored for signs and symptoms of infection during and after treatment with Raptiva. If a patient develops a serious infection, Raptiva should be discontinued and appropriate therapy instituted. Progressive Multifocal Leukoencephalopathy (PML) resulting from JC virus infection has occurred during therapy with Raptiva (see WARNINGS).

Raptiva is an immunosuppressive agent and has the potential to increase the risk of infection and reactivate latent, chronic infections. The most serious adverse reactions observed during treatment with Raptiva are serious infections including PML, malignancies, thrombocytopenia, hemolytic anemia, psoriasis worsening and variants, and neurologic events. Some infections were fatal. New infections developing during Raptiva treatment should be monitored closely. Raptiva likely increases the risk for PML. Based on the clinical characteristics of reported cases of PML in Raptiva patients, prolonged exposure to Raptiva and older age may further increase this risk. Patients should be instructed to report any new neurological signs or symptoms to their physician. Physicians treating patients with Raptiva should consider PML in any patient with new-onset neurologic manifestations.

Patients on treatment with Raptiva should not receive live (including live-attenuated) vaccines. Raptiva should not be prescribed in pediatric patients.

The most common adverse reactions associated with Raptiva are a symptom complex that includes headache, chills, fever, nausea, and myalgia within 48 hours following the first 2 injections. In clinical trials, these events were largely mild to moderate when a first dose of 0.7 mg/kg was given. Less than 1% of patients discontinued Raptiva treatment because of these adverse events.

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