PRECAUTIONS
Arthritis Events
Infrequent new onset or recurrent severe arthritis events, including psoriatic arthritis events, have been reported in clinical trials and postmarketing. These arthritis events began while on treatment or following discontinuation of RAPTIVA and were uncommonly associated with flare of psoriasis. Patients improved after discontinuation of RAPTIVA with or without anti-arthritis therapy.
Immunosuppression
The safety and efficacy of RAPTIVA in combination with other immunosuppressive agents or phototherapy have not been evaluated. Patients receiving other immunosuppressive agents should not receive concurrent therapy with RAPTIVA because of the possibility of increased risk of infections and malignancies.
Immunizations
Prior to initiating therapy with RAPTIVA, psoriatic patients should receive all immunizations appropriate for age as recommended by current immunization guidelines. Patients on treatment with RAPTIVA should not receive live (including live-attenuated) vaccines. Vaccinations that are not live, which are received during a course of RAPTIVA, may not elicit an immune response sufficient to prevent disease. Patients receiving RAPTIVA should be cautioned if household contacts receive live vaccines, because of the potential risk for shedding and transmission.
In a small clinical study with IV administered RAPTIVA, a single-dose of 0.3 mg/kg given before primary immunization with a neoantigen decreased the secondary immune response, and a dose of 1 mg/kg almost completely ablated it. A dose of 0.3 mg/kg IV has comparable pharmacodynamic effects to the recommended dose of 1 mg/kg SC. In chimpanzees exposed to RAPTIVA at > 10 times the clinical exposure level (based on mean peak plasma levels) antibody responses were decreased following immunization with tetanus toxoid compared with untreated control animals.
First Dose Reactions
First dose reactions including headache, fever, nausea, and vomiting are associated with RAPTIVA treatment and are dose-level related in incidence and severity (see ADVERSE REACTIONS). Therefore, a conditioning dose of 0.7 mg/kg is recommended to reduce
U.S. BL 125075/96 Amendment: Raptiva® (efalizumab)?Genentech, Inc. 9 of 33/Regional (PAS) (Safety Updates): Final Raptiva label-clean (3).doc June 2005; Rev. Date Oct. 16, 2008
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