Alemtuzumab (al-em-TOOZ-oo-mab)

Treats relapsing forms of multiple sclerosis.

Brand Name(s):

Lemtrada

When This Medicine Should Not Be Used:

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 12 months later for 3 consecutive days.
• Your doctor may ask you to stay for at least 2 hours after each treatment to check for unwanted effects.
• You will be given other medicines (including antiviral medicine, steroids) before starting treatment to help prevent possible unwanted effects during the injection. Antiviral medicines will be given for at least 2 months after treatment to prevent infections caused by the herpes virus.
• 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, undercooked meat, seafood, or chicken.
• Some medicines can affect how alemtuzumab works. Tell your doctor if you are using medicine that can weaken your immune system (including cancer medicine).
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines. You should have completed any needed immunizations at least 6 weeks before treatment with this medicine. You should not receive alemtuzumab until 6 weeks after a varicella zoster virus (chicken pox) vaccination.

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 are receiving this medicine and for at least 4 months after your last dose.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease, bleeding problems, thyroid disease, autoimmune disease, a history of cancer, or any type of infection (including chickenpox).
• This medicine may cause the following problems:
  • Increased risk of autoimmune disease, including Guillain-Barré syndrome, thyroid disorders, hepatitis, or encephalitis
  • Infusion reactions, which can be life-threatening
  • Increased risk of stroke and tears in the arteries in your brain
  • Increased risk of cancer, including thyroid, skin, and lymph node cancer
  • Kidney problems
  • Hemophagocytic lymphohistiocytosis (HLH), a severe inflammatory condition that could be life-threatening
  • Adult onset Still's disease (AOSD), a rare inflammatory condition that could be life-threatening
  • Thrombotic thrombocytopenic purpura, which can be life-threatening
  • Increased risk of bleeding problems, including acquired hemophilia A
  • Colitis (inflammation of the bowels)
  • Gallbladder problems
  • Lung disease
• This medicine may make you bleed, bruise, or get infections more easily. You will be at risk for infections including herpes, human papilloma virus (HPV), progressive multifocal leukoencephalopathy (PML), 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 to treat leukemia.
• Your doctor will need to check your blood or urine at regular visits while you are using this medicine 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. Be sure to 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 feeling during urination, bloody or cloudy urine
• Chest pain, trouble breathing, fast, slow, or uneven heartbeat
• Confusion, irritability, seizures, stiff neck
• Coughing up blood, small red or purple spots on your skin, bloody nose
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Joint pain, stiffness, or swelling, skin rash
• New lump or swelling in your neck, neck pain, trouble breathing or swallowing
• Numbness or weakness in your arm or leg, or on one side of your body
• Sudden or severe headache, problems with vision, speech, or walking
• Swelling in your legs or feet, pain in your lower leg (calf)
• Swollen glands, new or worsening unsteadiness, problems with balance or muscle control
• Unexplained weight gain or loss, heavy sweating or feeling cold, constipation
• Unusual bleeding, bruising, or weakness
• Watery or bloody diarrhea, stomach cramps or tenderness
• Weakness on one side of the body, clumsiness, blurred vision, changes in thinking, memory problems, personality changes

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

• Back or muscle pain
• Dizziness, trouble sleeping

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