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|Efalizumab

Efalizumab

Efalizumab is used for:

Treating chronic, moderate to severe plaque psoriasis.

Efalizumab is an immunosuppressive monoclonal antibody. It works by increasing the presence of T lymphocytes in areas of inflammation, which reduces the skin problems associated with plaque psoriasis.

Do NOT use Efalizumab if:

• you are allergic to any ingredient in Efalizumab
• you have a tumor, a low blood platelet count, or a severe infection
• you are breast-feeding

Contact your doctor or health care provider right away if any of these apply to you.

Before using Efalizumab :

Some medical conditions may interact with Efalizumab . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant or planning to become pregnant
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have an ongoing or recurring infection, herpes, syphilis, tuberculosis (TB), or you have recently been vaccinated
• if you have arthritis

Some MEDICINES MAY INTERACT with Efalizumab . However, no specific interactions with Efalizumab are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Efalizumab may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Efalizumab :

Use Efalizumab as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

• Efalizumab comes with an additional patient leaflet. Read it carefully and reread it each time you get Efalizumab refilled. Ask your doctor or pharmacist any questions that you may have about Efalizumab .
• Efalizumab is usually administered as an injection at your doctor"s office, hospital, or clinic. If you are using Efalizumab at home, carefully follow the injection procedures taught to you by your health care provider.
• Do not mix the medicine ahead of time for later use. Use the medicine immediately after mixing. Mix the medicine as instructed by your health care provider.
• Do not shake the vial to mix. Swirl gently.
• If Efalizumab contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• When drawing a dose into a syringe, be sure to follow the procedure demonstrated to you to prevent contamination of the vial, syringe, or medicine. Never touch the rubber stopper of the vial or the needle of the syringe with your fingers. Carefully check that you have drawn the correct dose before administration.
• Efalizumab is only to be injected once a week beneath the skin (subcutaneously). It may be injected into the thigh, abdomen, buttocks, or upper arm. The injection site should be rotated. Use Efalizumab the same day of each week.
• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal. You may obtain a container from your heath care provider or pharmacist.
• If you miss a dose of Efalizumab , contact your doctor immediately for instructions and to establish a new dosing schedule.

Ask your health care provider any questions you may have about how to use Efalizumab .

Important safety information:

• Do not stop using Efalizumab without first checking with your doctor. Some conditions may become worse when the medicine is stopped. If you have concerns about this, discuss them with your doctor.
• Your dose is based on your weight, medical condition, and response to therapy. Do not exceed the recommended dose of Efalizumab . Contact your doctor if your weight changes. Your dose may need to be adjusted.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Efalizumab .
• Efalizumab may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.
• Efalizumab may lower your body"s ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection including fever, sore throat, rashes, or chills.
• Avoid vaccinations with live virus vaccines (eg, measles, mumps, oral polio) while you are taking Efalizumab . Vaccinations may be less effective.
• Efalizumab may increase your risk for certain cancers. Discuss all the benefits and risks of using Efalizumab with your doctor. Contact your health care provider immediately if you develop any unusual growths or lumps.
• Do not take medicines that suppress the immune system or receive phototherapy treatments while using Efalizumab .
• LAB TESTS, including complete blood cell counts, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Efalizumab is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Efalizumab during pregnancy. It is unknown if Efalizumab is excreted in breast milk. Do not breast-feed while taking Efalizumab .

Possible side effects of Efalizumab :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; back pain; headache; muscle aches; nausea; pain, swelling, or redness at the injection site; swelling in the arms or legs; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the stool; chest pain; dark, tarry stools; dark urine; dizziness upon standing or sitting up; easy bleeding from the gums; flu syndrome; infection (fever, chills, sore throat); joint pain; new growths or lumps; new rashes; red, swollen, blistered, or peeling skin; shortness of breath; sudden weight loss; unusual bruising or bleeding; unusual tiredness or weakness; worsening of psoriasis; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include severe vomiting.

Store this medicine in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C), in the original carton before mixing. Do not freeze. Protect the vial from light. After mixing, if you cannot use the medicine immediately, it may be stored at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), for up to 8 hours. Do not use after 8 hours. Keep Efalizumab , as well as syringes and needles, out of the reach of children and away from pets.

General information:

• If you have any questions about Efalizumab , please talk with your doctor, pharmacist, or other health care provider.
• Efalizumab is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Efalizumab . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.