efalizumab

This medication is used to treat adults with moderate to severe plaque psoriasis. Discuss risks and benefits of treatment and other possible medication options with your doctor. This drug is a man-made protein (monoclonal antibody) that decreases the actions of certain immune system cells (T lymphocytes). This action decreases the skin changes that are seen with plaque psoriasis. This drug has been withdrawn from the US and Canadian markets due to problems with safety (see Warning section - PML). Talk with your doctor about alternative treatments for psoriasis.

If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule. Do not double the dose to catch up.

Read the Medication Guide provided by your pharmacist before you start using efalizumab and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist. Give this medication by injecting under the skin (subcutaneously-SC) of the thigh, abdomen, buttock, or upper arm, once a week; or use as directed by your doctor. Your dose of efalizumab is based on your weight. Tell your doctor if your weight changes. Do not change your dose or stop taking this medication without talking to your doctor. Follow all instructions for preparing this drug for injection. Gently swirl the vial to mix the drug. Do not shake. If you have questions regarding the use of this medication, consult your pharmacist. Before injecting each dose, clean the injection site with rubbing alcohol. It is important to change the location of the injection site weekly. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Use this medication regularly in order to get the most benefit from it. Remember to use it on the same day each week. It may take up to four weeks before the full benefits of this drug take effect. If your condition does not improve or worsens, contact your doctor. Learn how to store and discard needles and medical supplies safely. Consult your pharmacist.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: live vaccines, drugs that suppress immune system (e.g., prednisone, cyclosporine). This product can affect the results of certain lab tests. Make sure laboratory personnel and your doctors know you use this drug. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Do not share this medication with others. Laboratory and/or medical tests (e.g., platelet counts, alkaline phosphatase, white blood cell counts) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include severe vomiting.

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 needed during pregnancy. Discuss the risks and benefits with your doctor. Tell your doctor immediately if you become pregnant or think you may be pregnant while using this medication, or if you become pregnant within 6 weeks of stopping treatment. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Refrigerate between 36 and 46 degrees F (2-8 degrees C) away from light. Do not freeze. This medication must be used immediately after mixing. The mixed drug may be stored up to 8 hours at room temperature. If not used within this time, discard the medicine and mix a brand new dose. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

See also Warning section. Headache, chills, fever, nausea, vomiting, or muscle aches may occur during the first weeks, but then subside as your body adjusts to this medication. Pain, acne, backache, weakness, or flu-like symptoms may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these serious side effects occur: joint pain or swelling, swelling of hands or feet. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: unusual bleeding or bruising, unusual lumps, swollen glands, changes in skin appearance other than psoriasis-affected areas, yellowing of eyes/skin, dark urine, dizziness upon standing, sudden numbness/tingling/weakness, mental/mood changes (e.g., changes in thinking). A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Efalizumab decreases immune system function (immunosuppression), which can result in very serious (possibly fatal) infections (e.g., tuberculosis, meningitis, PML), or a worsening of an existing infection. Seek immediate medical attention if you develop signs of serious infection such as persistent fever/cough, difficulty breathing, confusion, loss of balance, sudden vision/speech problems.