Alemtuzumab (intravenous route)

It is very important that your doctor check your progress closely and at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for any unwanted effects during treatment and for 48 months after your last dose. If you have signs or symptoms of an autoimmune disease, your doctor may continue to check your progress after 48 months. It is also important that your doctor check your skin for melanoma (tumor) yearly. Be sure to keep all appointments.

Do not use this medicine if you are also receiving or have received Campath®.

Receiving this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to prevent from getting pregnant while you are receiving this medicine and for at least 4 months after the last dose. If you think you have become pregnant while receiving this medicine, tell your doctor right away.

This medicine may cause serious infusion reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a cough, difficulty with swallowing, dizziness, fast heartbeat, trouble breathing, chest tightness, swelling in your face or hands, fever, chills, itching or hives, or lightheadedness or faintness while you are receiving this medicine.

This medicine may increase your risk of having a stroke (eg, ischemic and hemorrhagic stroke) and tears in your arteries that supply blood to your brain (carotid and vertebral arteries). Check with your doctor right away if you have parts of your face that are drooping, weakness on one side of your body, sudden, severe headache, difficulty with speech, or neck pain.

This medicine may increase your risk of cancer, including thyroid, skin, or lymph node cancer. Call your doctor right away if you have a new lump or swelling in the neck, cough, hoarseness or voice changes, neck pain, or trouble with breathing or swallowing.

This medicine may cause autoimmune disorders, including immune thrombocytopenia (ITP), hepatitis (swelling of the liver), or encephalitis (swelling of the brain). Tell your doctor right away if you have confusion, irritability, headache, seizures, stiff neck, unusual nausea, vomiting, stomach pain, tiredness, loss of appetite, or yellow eyes or skin, dark urine, a bloody nose, coughing or spitting up blood, small red or purple spots on skin, or heavier than normal or irregular monthly periods.

This medicine may cause a serious kidney problem called anti-glomerular basement membrane disease. Call your doctor right away if you have blood in the urine, coughing up blood, or swelling in your legs or feet.

Alemtuzumab may cause hemophagocytic lymphohistiocytosis, a severe inflammatory condition which can be life-threatening, which is caused by an overactive immune system. The symptoms of this disease may occur within 13 to 33 months after starting treatment with this medicine. Check with your doctor right away if you have a fever, right upper abdominal or stomach pain and fullness, rash, swollen, painful, or tender lymph glands in the neck, armpit, or groin, mental status changes, shakiness and unsteady walk, unsteadiness, trembling, or other problems with muscle control or coordination, or seizures.

This medicine may cause Adult onset Still's disease (AOSD), a rare inflammatory condition which can be life-threatening. Call your doctor right away if you have a high fever lasting more than 1 week, pain, stiffness with or without swelling in multiple joints, or skin rash.

This medicine may cause thrombotic thrombocytopenic purpura, which can be life-threatening. Check with your doctor right away if you have black, tarry stools, blood in the urine, bloody nose, fever, heavier menstrual periods, pinpoint red spots on the skin, skin rash, unusual bleeding or bruising or unusual tiredness or weakness.

This medicine may increase your risk for serious bleeding problems, including acquired hemophilia A. Check with your doctor right away if you have nosebleeds, blood in the urine or stools, or any unusual bleeding or bruising.

Colitis (inflammation of the bowels) may occur with this medicine. Tell your doctor right away if you have stomach pain or tenderness, watery or bloody diarrhea, or fever after receiving the medicine.

While you are being treated with alemtuzumab, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. You should receive live vaccines for at least 6 weeks before starting treatment with this medicine. You should not also receive alemtuzumab until 6 weeks after a varicella zoster virus (chicken pox) vaccination. Alemtuzumab may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Alemtuzumab can temporarily lower the number of white blood cells in your blood, which will increase the risk of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, these are precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor right away if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

This medicine may increase your risk of developing infections. Avoid being near people who are sick or have infections while you are receiving this medicine. Wash your hands often. Tell your doctor if you have any kind of infection before you start receiving this medicine. Also tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back. Tell your doctor right away if you have been exposed to someone with chickenpox.

If you are a female, you should have a human papilloma virus (HPV) screening every year to avoid getting a cervical HPV infection.

You will need to have a skin test for tuberculosis (TB) before you start this medicine. Tell your doctor if you or anyone in your home has ever had a positive TB skin test or been exposed to TB.

Do not eat foods that may contain a bacteria called Listeria, such as deli meat, unpasteurized milk and cheese products, or not properly cooked meat, seafood, or chicken. Make sure that the food you eat which may contain listeria is heated well when you receive this medicine.

Tell your doctor right away if you have unexplained weight gain or loss, constipation, fast, pounding, or uneven heartbeat, feeling cold, swelling of the eye. These may be symptoms of a thyroid problem.

This medicine may increase your risk of developing a serious and rare brain infection called progressive multifocal leukoencephalopathy (PML). Check with your doctor if you have weakness on one side of the body, clumsiness, blurred vision, changes in thinking, memory problems, confusion, or personality changes.

This medicine can increase your risk of having gallbladder (eg, acalculous cholecystitis) and lung problems (eg, pneumonitis). Check with your doctor right away if you have stomach pain or tenderness, fever, nausea, vomiting, trouble breathing, cough, chest pain or tightness, or coughing up blood.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.