alemtuzumab

What is the most important information I should know about alemtuzumab?

What is alemtuzumab?

Campath is used to treat B-cell chronic lymphocytic leukemia in adults.

Lemtrada is used to treat relapsing forms of multiple sclerosis in adults (including active secondary progressive disease), after at least two other medicines did not work or have stopped working.

Lemtrada will not cure MS, but it can make relapses occur less often. Lemtrada is not for use in treating clinically isolated syndrome.

Alemtuzumab may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving alemtuzumab?

• an active infection; or
• HIV (human immunodeficiency virus).

Tell your doctor if you have ever had:

• tuberculosis or other infections;
• a thyroid disorder;
• kidney disease;
• bleeding problems, or if you receive blood transfusions; or
• if you have received any vaccine in the past 6 weeks.

Tell your doctor if you have never had chickenpox or if you have never received a varicella vaccine (Varivax). You may need to receive the vaccine and then wait 6 weeks before using Lemtrada.

Lemtrada may increase your risk of developing other types of cancer, such as melanoma, thyroid cancer, lymphoma, or leukemia. Ask your doctor about this risk.

If you use Campath while you are pregnant, make sure any doctor caring for your new baby knows that you used the medicine during pregnancy. Being exposed to Campath in the womb could affect your baby's vaccination schedule.

Alemtuzumab may affect fertility (ability to have children) in both men and women. However, women should still use birth control to prevent pregnancy because alemtuzumab can harm an unborn baby.

How is alemtuzumab given?

Alemtuzumab is given as an infusion into a vein. A healthcare provider will give you this injection.

Campath is usually given 3 times per week for 12 weeks. Lemtrada is usually given in 2 or more treatment courses, separated by 1 year. Your doctor will determine how long to treat you and the number of courses you need.

This medicine must be given slowly. The Campath infusion can take 2 hours to complete. The Lemtrada infusion can take 4 hours to complete.

You will be watched closely for up to 2 hours or longer after the infusion, to make sure you do not have a serious reaction.

Alemtuzumab affects your immune system. You may get infections more easily, even serious or fatal infections. You will need frequent medical tests, and your next dose may be delayed based on the results.

Alemtuzumab can have long lasting effects on your body. You may need medical tests for up to 2 months after you stop using Campath, or 4 years after you stop using Lemtrada.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while receiving alemtuzumab?

Do not receive a "live" vaccine while using alemtuzumab. The vaccine may not work as well or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

What are the possible side effects of alemtuzumab?

Some side effects may occur during or shortly after the injection. Tell your caregiver if you feel weak, feverish, chilled, dizzy, nauseated, light-headed, or have a rash, wheezing, chest pain, trouble breathing, swelling in your mouth or throat, or fast, slow, or irregular heartbeats.

• unusual bleeding or bruising, nosebleeds, bleeding gums, heavy menstrual periods, blood in your urine or stools, coughing up blood;
• problems with speech, thought, vision, or muscle movement;
• a mole that has changed in size or color;
• cough, wheezing, chest pain, feeling short of breath, coughing up blood;
• an overactive immune system --fever, swollen glands, rash, feeling unsteady or less alert, trouble waking, seizure;
• liver problems --loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes); or
• kidney problems --swelling in your lower legs, weight gain, loss of appetite, sudden pain in your stomach and back, urine that looks pink/brown or foamy;
• signs of infection --fever, chills, sore throat, cough, mouth sores, skin sores or blisters, tingling, burning pain, pale or yellowed skin, pain or burning when you urinate, dark urine, feeling light-headed, cold hands and feet;
• signs of tuberculosis --cough, night sweats, loss of appetite, weight loss, and feeling very tired;
• signs of a stroke or tear in an artery --sudden severe headache, weakness on one side of your body, drooping in your face, slurred speech;
• gallbladder problems --fever, nausea, vomiting, and stomach pain;
• thyroid problems --sweating, feeling cold, fast heartbeats, feeling nervous or tired, eye swelling, weight gain or loss; or
• symptoms of thyroid cancer --a lump or swelling in your neck or throat, trouble swallowing, hoarse voice, or a new cough (not caused by a cold).

Common side effects may include:

• reactions to the injection;
• stomach pain, nausea, vomiting, diarrhea;
• infections (fever, chills, runny or stuffy nose, mouth or throat pain, painful urination);
• chest pain or tightness, coughing up blood;
• rash, itching, tingling, hives;
• dizziness, tiredness, trouble sleeping;
• headache, joint pain, back pain, pain in your arms or legs;
• thyroid problems; or
• flushing (sudden warmth, redness, or tingly feeling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect alemtuzumab?

Tell your doctor about all your other medicines, especially drugs that weaken the immune system such as cancer medicine, or medicines to prevent organ transplant rejection.

Other drugs may affect alemtuzumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your doctor or pharmacist can provide more information about alemtuzumab (Campath).