"A US Food and Drug Administration (FDA) advisory panel has backed a new biologic for psoriasis, though the panelists recommended strong warnings about the potential for suicide and self-injurious behavior (SIB) with the drug.
(Generic versions may still be available.)
For injection, Subcutaneous
RISK OF PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML)
- RAPTIVA (efalizumab) 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 (efalizumab) exposure. The time dependent threshold when the
risk for PML increases is unknown (see WARNINGS).
- Patients on RAPTIVA (efalizumab) 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 (efalizumab) 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 (efalizumab) . If a patient develops a serious infection, RAPTIVA (efalizumab) should be discontinued and appropriate therapy instituted.
RAPTIVA® (efalizumab) is an immunosuppressive recombinant humanized IgG1 kappa isotype monoclonal antibody that binds to human CD11a. Efalizumab has a molecular weight of approximately 150 kilodaltons and is produced in a Chinese hamster ovary mammalian cell expression system in a nutrient medium containing the antibiotic gentamicin. Gentamicin is not detectable in the final product.
RAPTIVA (efalizumab) is supplied as a sterile, white to off-white, lyophilized powder in single-use glass vials for subcutaneous (SC) injection. Reconstitution of the single-use vial with 1.3 mL of the supplied sterile water for injection (non-USP) yields approximately 1.5 mL of solution to deliver 125 mg per 1.25 mL (100 mg/mL) of RAPTIVA (efalizumab) . The sterile water for injection supplied does not comply with USP requirement for pH. After reconstitution, RAPTIVA (efalizumab) is a clear to pale yellow solution with a pH of approximately 6.2. Each single-use vial of RAPTIVA contains 150 mg of efalizumab, 123.2 mg of sucrose, 6.8 mg of L-histidine hydrochloride monohydrate, 4.3 mg of L-histidine and 3 mg of polysorbate 20 and is designed to deliver 125 mg of efalizumab in 1.25 mL.
What are the possible side effects of efalizumab (Raptiva)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, or mouth sores;
- signs of a skin infection, such as redness, tenderness, and swelling;
- pale or yellowed skin, dark colored urine, confusion or weakness;
- change in your mental state,...
Last reviewed on RxList: 4/16/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Raptiva Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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