Alemtuzumab Injection (Multiple Sclerosis)
Alemtuzumab injection may cause serious or life-threatening autoimmune disorders (conditions in which the immune system attacks healthy parts of the body and causes pain, swelling, and damage), including thrombocytopenia (a low number of platelets [a type of blood cell needed for blood clotting]) and kidney problems. Tell your doctor if you have bleeding problems or kidney disease. If you experience any of the following symptoms, call your doctor immediately: unusual bleeding, swelling of your legs or feet, coughing up blood, bleeding from a cut that is hard to stop, heavy or irregular menstrual bleeding, spots on your skin that are red, pink, or purple, bleeding from gums or nose, blood in urine, chest pain, decrease in urine amount, and fatigue.
You may experience a serious or life-threatening infusion reaction while you receive a dose of alemtuzumab injection or for up to 3 days afterwards. You will receive each dose of medication in a medical facility, and your doctor will monitor you carefully during the infusion and after you receive the medication. It is important that you stay at the infusion center for at least 2 hours after your infusion is completed. If you experience any of the following symptoms during or after your infusion, tell your doctor immediately: fever; chills; nausea; headache; vomiting; hives; rash; itching; flushing; heartburn; dizziness; shortness of breath; difficulty breathing or swallowing; slowed breathing; tightening of throat; swelling of the eyes, face, mouth, lips, tongue or throat; hoarseness; dizziness; lightheadedness; fainting; fast or irregular heartbeat; or chest pain.
Alemtuzumab injection may cause a stroke or tears in your arteries that supply blood to your brain, especially within the first 3 days after treatment. If you experience any of the following symptoms during or after your infusion, tell your doctor immediately: drooping on one side of the face, severe headache, neck pain, sudden weakness or numbness of an arm or leg, especially on one side of the body, or difficulty speaking, or understanding.
Alemtuzumab injection may increase the risk that you will develop certain cancers, including thyroid cancer, melanoma (a type of skin cancer), and certain blood cancers. You should have your skin checked by a doctor for signs of cancer before you begin treatment and yearly thereafter. Call your doctor if you have the following symptoms that may be a sign of thyroid cancer: new lump or swelling in your neck; pain in front of neck; unexplained weight loss; bone or joint pain; lumps or swellings in your skin, neck, head, groin or stomach; changes in mole shape, size, or color or bleeding; small lesion with an irregular border and portions that appear red, white, blue or blue-black; hoarseness or other voice changes that do not go away; difficulty swallowing or breathing; or cough.
Because of the risks with this medication, alemtuzumab injection is available only through a special restricted distribution program. A program called A program called Lemtrada Risk Evaluation and Mitigation Strategy (REMS) Program. Ask your doctor if you have any questions about how you will receive your medication.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body’s response to alemtuzumab injection before and during your treatment and for 4 years after you receive your final dose.
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Talk to your doctor about the risks of receiving alemtuzumab injection.