DrugindexOnline^{2nd edition}

Generic Name: Alemtuzumab (al-em-TUE-zue-mab)
Brand Name: Campath

Serious infections, blood disorders, and infusion reactions have occurred from the use of Alemtuzumab . You will be closely monitored during the infusion and it may be necessary to stop treatment if an infusion reaction occurs. Notify your doctor immediately if you experience rigid muscles, fever, shortness of breath, tightness in the throat, fainting, chest pain, chills, or rash.

Alemtuzumab is used for:

Treating B cell chronic lymphocytic leukemia (CLL) in patients who have not successfully responded to treatment with other chemotherapy medicines.

Alemtuzumab is a monoclonal antibody. It works by recognizing certain proteins that are found on the surface of certain types of cancer cells. Once the proteins are recognized, the body's immune system can kill the cancer cells.

Do NOT use Alemtuzumab if:

• you are allergic to any ingredient in Alemtuzumab
• you have an active infection
• you have a disease that affects the immune system, such as HIV

Contact your doctor or health care provider right away if any of these apply to you.

Before using Alemtuzumab :

Some medical conditions may interact with Alemtuzumab . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, plan to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have bone marrow depression, shingles or chickenpox, high blood pressure, or heart disease
• if you are scheduled to have a dental procedure or a vaccination

Some MEDICINES MAY INTERACT with Alemtuzumab . However, no specific interactions with Alemtuzumab are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Alemtuzumab may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Alemtuzumab :

Use Alemtuzumab as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Alemtuzumab is usually administered as an injection at your doctor's office, hospital, or clinic. Ask your doctor any questions that you may have about Alemtuzumab .
• You may be given fever reducers or antibiotics before receiving Alemtuzumab .
• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
• If you miss a dose of Alemtuzumab , contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Alemtuzumab .

Important safety information:

• Alemtuzumab may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Alemtuzumab . Using Alemtuzumab alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Alemtuzumab may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.
• Avoid vaccinations with live virus vaccines (eg, measles, mumps, oral polio) while you are taking Alemtuzumab .
• Alemtuzumab may lower your body's ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection, including fever, sore throat, rash, or chills.
• LAB TESTS, including complete blood counts, will be required to monitor your progress and check for side effects. Be sure to keep all doctor and lab appointments.
• Alemtuzumab is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.
• Men should use effective birth control methods (eg, condoms) while receiving Alemtuzumab and for 6 months after the last dose.
• PREGNANCY and BREAST-FEEDING: Women should use effective birth control methods (eg, condoms) while receiving Alemtuzumab and for 6 months after the last dose. Alemtuzumab may cause harm to the fetus. If you become pregnant, discuss with your doctor the benefits and risks of using Alemtuzumab during pregnancy. It is unknown if Alemtuzumab is excreted in breast milk. Do not breast-feed while you are using Alemtuzumab and for at least 3 months after your last dose of Alemtuzumab .

Possible side effects of Alemtuzumab :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Abnormal skin sensations; back pain; bone pain; constipation; cough; depression; dizziness; general body discomfort; increased sweating; indigestion; loss of appetite; muscle pain; nosebleed; runny nose; sensation of temperature change; sleeplessness; stomach pain; tiredness; tremor; weakness; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in urine; bronchitis; chest pain; decreased hearing; diarrhea; extreme tiredness; fainting; fast or irregular heartbeat; fever; headache; hoarseness; itching; lightheadedness upon sitting or standing up; nausea; painful or difficult urination; pale skin; pneumonia; rapid weight gain; rigid muscles; shortness of breath; sores or ulcers on the lips or mouth; sudden sweating; swelling of the legs or feet; unusual bruising or bleeding; vomiting.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include chest tightness; cough; difficulty breathing; inability to urinate; shortness of breath.

Proper storage of Alemtuzumab :

Store Alemtuzumab in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Discard if vial has been frozen. Keep Alemtuzumab out of the reach of children and away from pets.

General information:

• If you have any questions about Alemtuzumab , please talk with your doctor, pharmacist, or other health care provider.
• Alemtuzumab is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Alemtuzumab . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.