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Raptiva

Drug Side Effects: Types

Side effects fall into several categories. Allergic reactions can happen with any drug and can range from itching and rash all the way up to a life-threatening anaphylactic reaction.

Other side effects simply –come with the territory.” Some drugs can't help but trigger side effects because of their chemical structure. One example is the common allergy drug diphenhydramine (also known by the brand name Benadryl). Though it eases allergy symptoms, it also suppresses the activity of the body chemical acetylcholine, and that leads to drowsiness and a host of other side effects, including dry mouth.

Some drugs have barely noticeable side effects when dosed properly. For example, Warfarin (Jantoven, Coumadin) used to prevent blood clots, is usually well tolerated, but serious internal bleeding can occur.

Side effects may only pop up when certain drugs are mixed with certain other things. These might also be...

Raptiva

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Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

RAPTIVA®
(efalizumab)

For injection, Subcutaneous

WARNING

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.

DRUG DESCRIPTION

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...

Read All Potential Side Effects and See Pictures of Raptiva »

What are the precautions when taking efalizumab (Raptiva)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: current infections (e.g., PML), blood problems (e.g., thrombocytopenia), history of cancer, immune system problems, currently on phototherapy.

Do not have immunizations/vaccinations without the consent of your doctor while using this medication. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

This medication should be used only when clearly...

Read All Potential Precautions of Raptiva »

Last reviewed on RxList: 4/16/2009
This monograph has been modified to include the generic and brand name in many instances.

Raptiva - User Reviews

Raptiva User Reviews

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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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