Generic Name: efalizumab (EF a LIZ oo mab)Brand Names: Raptiva
Efalizumab is a man-made form of a protein similar to human antibodies. Efalizumab is made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage.
Efalizumab is used to treat plaque psoriasis (raised, silvery flaking of the skin) in adults.
Efalizumab may also be used for other purposes not listed in this medication guide.
Before using efalizumab, tell your doctor about all other medications you are using, especially other psoriasis medications or phototherapy, or drugs that weaken your immune system such as cancer medicine, steroids, and medicines to prevent rejection of a transplanted organ.
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;
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.
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.
Call your doctor for instructions if you miss a dose of efalizumab.
Overdose may cause severe vomiting.
Avoid being near people who have colds, the flu, or other contagious illnesses.Do not receive a "live" vaccine while you are using efalizumab, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), oral polio, chickenpox (varicella), and nasal flu vaccine.
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, problems with speech or walking, decreased vision (these symptoms may start gradually and get worse quickly);
cough with yellow or green mucus, stabbing chest pain or tightness, wheezing, trouble breathing;
neck stiffness, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions);
numbness or tingly feeling in your feet and spreading upward, muscle weakness in your face; or
problems with vision, speech, swallowing, or bladder and bowel functions.
Less serious side effects may include:
headache, muscle pain, and nausea or vomiting (especially after the first dose);
joint pain, stiffness, or swelling; or
swelling in your hands or feet.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Psoriasis:
Genentech and the FDA notified healthcare professionals of the voluntary, phased withdrawal of efalizumab from the U.S. market due to a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML). By June 8, 2009, efalizumab will no longer be available in the United States. Prescribers are being asked not to initiate efalizumab treatment for any new patients. Prescribers should immediately begin discussing with patients currently using efalizumab how to transition to alternative therapies. The FDA strongly recommends that patients work with their health care professional to transition to alternative therapies for psoriasis. The following dosage information applies to when the drug was available in the U.S.Initial Dose: 0.7 mg/kg subcutaneously once.Maintenance Dose: 1 mg/kg subcutaneously weekly.A maximum single dosage has been imposed at 200 mg as recommended by the manufacturer.The safety and efficacy of efalizumab therapy beyond one year have not been established.
Tell your doctor about all other medications you are using, especially:
other psoriasis medications or phototherapy;
drugs that weaken your immune system (such as cancer medicine or steroids);
cyclosporine (Neoral, Sandimmune, Gengraf);
sirolimus (Rapamune), tacrolimus (Prograf);
basiliximab (Simulect), efalizumab (Raptiva), muromonab-CD3 (Orthoclone);
mycophenolate mofetil (CellCept); or
azathioprine (Imuran), leflunomide (Arava), etanercept (Enbrel).
This list is not complete and there may be other drugs that can interact with efalizumab. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.