April 29, 2017
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"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.

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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 Patient Information including How Should I Take

What should I discuss with my healthcare provider before using efalizumab (Raptiva)?

You should not use this medication if you are allergic to efalizumab.

Efalizumab increases the risk of a serious infections, including a viral infection of the brain that can lead to disability or death. This risk is higher if you have a weak immune system or are receiving certain medicines.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using efalizumab, tell your doctor if you have:

  • any active or chronic infection;
  • arthritis; or
  • a weak immune system (caused by disease or by using certain medicines).

You should be current on all immunizations before you start using efalizumab.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Tell your doctor if you become pregnant while using efalizumab, or within 6 weeks after you stop using the medication.

Your name may need to be listed on a pregnancy registry if you become pregnant while using this medication. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether efalizumab had any effect on the baby.

It is not known whether efalizumab passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

Treatment with efalizumab may increase your risk of developing certain types of cancer. Talk with your doctor about your individual risk.

How should I use efalizumab (Raptiva)?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Efalizumab is given as an injection under the skin. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Efalizumab is usually given once per week. Try to use the medicine on the same day each week.

Use a different place on your stomach, thigh, buttocks, or upper arm each time you give yourself an injection. Your care provider will show you the places on your body where you can safely inject the medication. Do not inject into the same place two times in a row.

Efalizumab is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication.

Do not shake the mixed medicine. Vigorous shaking can cause the mixture to foam. Do not draw your efalizumab dose into a syringe until you are ready to give yourself an injection. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.

Each single-use vial (bottle) of this medicine is for one use only. Throw away the vial after one use, even if there is still some medicine left in it after injecting your dose.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

A day or two after using your first dose of efalizumab, you may have nausea, vomiting, muscle pain, and/or a headache. Call your doctor if these effects become severe.

Efalizumab can lower blood cells that help your body fight infections, making it easier for you to bleed from an injury or get sick from being around others who are ill.

During your efalizumab treatment, it is extremely important that your doctor check you every 3 to 6 months to make sure you are not developing any signs of serious infection. Do not miss any scheduled visits to your doctor.

Call your doctor if your symptoms do not improve, or if they get worse while using efalizumab. Your psoriasis may get worse after you stop using efalizumab for any reason. Your doctor may want to keep checking to make sure your psoriasis does not get worse. Do not miss any follow-up visits.

Store efalizumab in its original carton in the refrigerator, protected from light. Do not freeze.

If you have mixed your medicine and cannot use it right away, keep the mixture at room temperature and use it within 8 hours. Check to make sure the mixture is still clear or pale yellow and does not contain any particles.

Side Effects Centers

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.

Women's Health

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