When This Medicine Should Not Be Used:
This medicine is not right for everyone. You should not receive it if you had an allergic reaction to alemtuzumab, or you have HIV infection.

How to Use This Medicine:
Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
• A nurse or other health provider will give you this medicine.
• This medicine is usually given for 2 treatment courses. The first treatment course is given for 5 consecutive days. Each treatment takes about 4 hours per day. The second treatment course is given 1 year later for 3 consecutive days.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Call your doctor or pharmacist for instructions.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Avoid foods that may contain a bacteria called listeria. These foods include deli meat, unpasteurized milk and cheese, and undercooked meat, seafood, or chicken.
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Use an effective form of birth control to prevent pregnancy while you receive this medicine and for 4 months after your treatment ends.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, bleeding problems, thyroid disease, a history of cancer, or any type of infection.
• This medicine may cause the following problems:
  
  • Increased risk of autoimmune disease, such as thyroid disorders
  • Infusion reactions that could be life-threatening
  • Increased risk of cancer, including thyroid, skin, lymph nodes
  • Kidney failure
  • Lung disease
• This medicine may make you bleed, bruise, or get infections more easily. You will be at risk for infections such as herpes, human papilloma virus (HPV), tuberculosis (TB), and fungal infections. Take precautions to prevent illness and injury. Wash your hands often.
• You will need to have a TB skin test 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.
• Tell your doctor if you have ever received alemtuzumab (Campath®) to treat leukemia.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments. You should also have skin checks for melanoma (skin cancer) each year. Women should have HPV screenings each year.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, pain or burning during urination, bloody or cloudy urine
• Chest pain, trouble breathing, or fast, slow, or uneven heartbeat
• Coughing up blood, small red or purple spots on your skin, bloody nose
• Fever, chills, cough, runny or stuffy nose, sore throat, and body aches
• New lump or swelling in your neck, neck pain, trouble breathing or swallowing
• Swelling in your legs or feet
• Unexplained weight gain or loss, heavy sweating or feeling cold, constipation
• Unusual bleeding, bruising, or weakness
• Yellow skin or eyes

If you notice these less serious side effects, talk with your doctor:

• Back, joint, or muscle pain
• Dizziness, trouble sleeping
• Headache
• Nausea, vomiting, diarrhea, stomach pain or upset
• Rash, itching, or hives

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088