Full Prescribing Information
Raptiva Dear Healthcare Provider Letter (122K/PDF)
Raptiva® (efalizumab) is a humanized therapeutic antibody designed to selectively and reversibly block the activation, reactivation and trafficking of T-cells that lead to the development of psoriasis.
Status The U.S. Food and Drug Administration (FDA) approved Raptiva in October 2003.
Raptiva is approved for the treatment of chronic moderate-to-severe plaque psoriasis in adults 18 years or older who are candidates for systemic therapy or phototherapy. Between 5.8 and 7.5 million Americans have psoriasis and of these between 1.5 and 1.9 million are considered to have moderate-to-severe disease. In clinical studies, Raptiva demonstrated a rapid onset of action, in some patients by four weeks, in the reduction of symptoms associated with psoriasis. Raptiva is administered once-weekly via subcutaneous injection and can be self-administered by patients at home.
Raptiva was approved on the basis of efficacy and safety seen in 4 pivotal trials which showed sustained improvement in psoriasis symptoms over 6 months. Genentech presented final results from a long-term study at the American Association of Dermatology Academy 2005 meeting that showed sustained improvement in psoriasis symptoms throughout three years of continuous treatment.
Safety The most serious adverse reactions observed during treatment with Raptiva® (efalizumab) were serious infections, malignancies, thrombocytopenia, hemolytic anemia, arthritis events, and psoriasis worsening and variants.
Raptiva is an immunosuppressive agent. Many immunosuppressive agents have the potential to increase the risk of infection, reactivate latent, chronic infections, or increase the risk of malignancy. Patients receiving other immunosuppressive agents should not receive concurrent therapy with Raptiva.
Serious infections requiring hospitalization occurred in 0.3% of Raptiva patients during clinical trials, and additional serious infections have been reported during postmarketing surveillance. Raptiva should not be administered to patients with clinically important infections. If a patient develops a serious infection, Raptiva should be discontinued.
The role of Raptiva in the development of malignancy is not known. In clinical trials, the overall incidence of malignancies was 1.8 per 100 patient-years for Raptiva-treated patients vs 1.6 per 100 patient-years for placebo-treated patients. Caution should be exercised when considering the use of Raptiva in patients at high risk for malignancy. If a patient develops a malignancy, Raptiva should be discontinued.
Infrequent cases (0.3%) of immune-mediated thrombocytopenia were observed during clinical trials and reports of severe thrombocytopenia have been received postmarketing; therefore, platelet monitoring is recommended. Physicians should follow patients for signs and symptoms of thrombocytopenia, and Raptiva should be discontinued if thrombocytopenia develops.
Reports of immune-mediated hemolytic anemia, some serious, diagnosed 4-6 months after the start of Raptiva treatment have been received. Raptiva should be discontinued if hemolytic anemia occurs.
Worsening of psoriasis can occur during or after treatment with Raptiva. During clinical studies, 19 of 2589 (0.7 %) Raptiva-treated patients had serious worsening of psoriasis during treatment (n = 5, 0.2 %) or after discontinuation of Raptiva (n = 14, 0.5 %). Some patients required hospitalization (n = 17, 0.7%). Patients, including those not responding to Raptiva treatment, should be closely observed following discontinuation of Raptiva and appropriate psoriasis treatment instituted as necessary.
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.
The safety and efficacy of vaccines administered to patients being treated with Raptiva have not been studied. Acellular, live, and live-attenuated vaccines should not be administered during Raptiva treatment.
The most common adverse reactions associated with Raptiva were a symptom complex that included headache, chills, fever, nausea, and myalgia within 48 hours following the first 2 injections. 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.
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) to enroll in the Registry.
Mechanism of Action In psoriasis, special immune cells called T-cells become overactive. This activity sets off a whole series of events that eventually makes skin cells multiply so fast, they simply pile up on the surface of the skin. As cells multiply faster and faster, they form red, scaly patches called plaques.
Raptiva prevents T-cells from becoming activated and entering the skin. This, in turn, inhibits the process that leads to plaque formation. As Raptiva starts working in the body and plaque formation is slowed, psoriasis symptoms start to clear.
For more information, see the Raptiva Proposed Mechanism of Action.
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