Medication Guide (272K/PDF)
Full Prescribing Information

Letters Regarding Voluntary U.S. Market Withdrawal of Raptiva issued April 8, 2009:

• Dear Healthcare Provider
• Dear Patient

Previously Issued Raptiva Dear Healthcare Provider and Patient Letters

As of June 9, 2009, Raptiva® (efalizumab) is no longer available in the United States. On April 8, 2009, Genentech announced a phased voluntary withdrawal of the psoriasis drug Raptiva from the U.S. market. The company's decision was based on the association of Raptiva with an increased risk of progressive multifocal leukoencephalopathy (PML), a rare and usually fatal disease of the central nervous system.

Physicians with questions about Raptiva use may contact Genentech Medical Communications at 1-800-821-8590. Patients with questions about Raptiva should contact their doctor.

For more information, please refer to the press release.

Safety

WARNING: RISK OF PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML) Raptiva increases the risk for PML, a rapidly progressive viral infection of the central nervous system that has no known treatment and that leads to death or severe disability. The risk of PML may markedly increase with longer duration of Raptiva exposure. The time dependent threshold when the risk for PML increases is unknown (see WARNINGS). Patients on Raptiva should be monitored frequently to ensure they are receiving significant clinical benefit, to ensure they understand the significance of the risk of PML, and for any sign or symptom that may be suggestive of PML (see WARNINGS). Raptiva dosing should be withheld immediately at the first sign or symptom suggestive of PML. For diagnosis, brain magnetic resonance imaging (MRI) and, when indicated, cerebrospinal fluid analysis for JC viral DNA are recommended (see WARNINGS). 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.

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 PML, serious infections, malignancies, immunosuppression, thrombocytopenia, hemolytic anemia, arthritis events, psoriasis worsening and variants, and neurologic events. Some infections were fatal. New infections developing during Raptiva treatment should be monitored closely. Raptiva increases the risk for PML. The risk of PML may markedly increase with longer duration of Raptiva exposure. The time dependent threshold when the risk for PML increases is unknown. Physicians treating patients with Raptiva should consider PML in any patient with new-onset neurologic manifestations. Patients should be instructed to report any new neurological signs or symptoms to their physician.

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.

For more information, please refer to the Raptiva full prescribing information including Boxed WARNING and Medication Guide.

Pregnancy Registry
Female patients should also be advised to notify their physicians if they become pregnant while taking Raptiva (or within 6 weeks of discontinuing Raptiva) and be advised of the existence of and encouraged to enroll in the Raptiva Pregnancy Registry by calling 1-877-Raptiva (1-877-727-8482).