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Generic Name: efalizumab (EF-a-LIZ-oo-mab)
Brand Name: Raptiva
Efalizumab may increase the risk for serious and sometimes fatal infections. These may include bacterial sepsis, viral meningitis, invasive fungal disease, and other opportunistic infections. A serious nervous system problem called progressive multifocal leukoencephalopathy (PML) caused by JC virus infection has also occurred in patients using efalizumab. Seek medical attention right away if you notice signs of infection (eg, fever, sore throat, chills) or new or worsening nervous system problems (eg, trouble walking or talking, loss of balance, confusion, numbness, tingling, or weakness).
Efalizumab is used for:
Treating chronic, moderate to severe plaque psoriasis.
Efalizumab is a 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 cancer, low blood platelet levels, or a severe infection
- you have PML
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, planning to become pregnant, or are breast-feeding
- 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 immune system problems, an ongoing or recurring infection, herpes, syphilis, tuberculosis (TB), or a history of these conditions
- if you have arthritis, anemia or other blood problems, or nervous system problems
- if you have cancer, a history of cancer, or if you are at risk of developing cancer
- if you take medicines that suppress the immune system (eg, cyclosporine) or if you or anyone in your household has recently been vaccinated
- if you use other psoriasis medicines or treatments
Some MEDICINES MAY INTERACT with efalizumab. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Medicines that suppress the immune system (eg, cyclosporine) because the risk of severe infections or cancer may be increased
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 extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get efalizumab refilled.
- Efalizumab is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using efalizumab at home, a health care provider will teach you how to use it. Be sure you understand how to use efalizumab. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Do not mix the medicine ahead of time for later use. Use the medicine right away or within 8 hours after you mix it. Mix the medicine as instructed by your health care provider.
- Do not shake the vial to mix. Swirl gently.
- Do not use efalizumab if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- 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. Inject it deep under the skin, NOT into the muscle. 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 pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- If you miss a dose of efalizumab, contact your doctor right away 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 use more than the recommended dose of efalizumab. Contact your doctor if your weight changes. Your dose may need to be adjusted.
- Tell your doctor or dentist that you take efalizumab before you receive any medical or dental care, emergency care, or surgery.
- Efalizumab may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
- Efalizumab may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- You may experience minor headache, chills, fever, nausea, and muscle aches within the first 48 hours after you use a dose of efalizumab. These effects usually decrease after the first few weeks of use. If these effects persist or are severe, contact your doctor.
- Do not receive a live vaccine (eg, measles, mumps) while you are taking efalizumab. Talk with your doctor before you receive any vaccine.
- 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 receive phototherapy treatments while using efalizumab unless your doctor tells you to.
- Lab tests, including complete blood cell counts, may be performed while you use efalizumab. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use efalizumab with caution in the ELDERLY; they may be more at risk of infection.
- Efalizumab should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: It is not known if efalizumab can cause harm to the fetus. If you become pregnant while you take efalizumab or within 6 weeks after you stop it, contact your doctor. You will need to discuss the benefits and risks of using efalizumab while you are pregnant. It is not known if this medicine is found 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:
Seek medical attention right away if any of these SEVERE side effects occur:
Acne; back pain; headache; muscle aches; nausea; swelling in the arms or legs; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the stool; dark urine; dizziness when standing or sitting up; fainting; hearing changes or hearing loss; infection or flu-like symptoms (eg, fever, chills, cough, sore throat, stiff neck); new growths or lumps; new or worsening arthritis symptoms (eg, joint pain, redness, stiffness, swelling); new or worsening nervous system problems (eg, confusion; loss of balance; numbness, tingling, or weakness in the arms, legs, or face; trouble walking or talking); red, swollen, blistered, or peeling skin; severe or persistent headache; shortness of breath; unusual bruising or bleeding; unusual tiredness or weakness; vision changes; 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 about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include severe vomiting.Proper storage of efalizumab:
Store efalizumab 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.
- 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.