This medication may cause very serious (rarely fatal) blood disorders (decreased bone marrow function leading to low number of blood cells such as red cells, white cells, and platelets). This effect can cause anemia, decrease your body's ability to fight an infection, or cause your body to bruise or bleed more easily. Tell your doctor immediately if you develop any of the following symptoms: signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding, unusual tiredness, fast/pounding heartbeat, dark urine.

This medication may also cause very serious (rarely fatal) infusion-related reactions. (See also Side Effects section.)

Your doctor will monitor you closely and increase your dose slowly to reduce the chances of these serious side effects.

Alemtuzumab is used to treat a certain type of leukemia (B-cell chronic lymphocytic leukemia, also known as B-CLL) in patients who have not responded to other cancer chemotherapy drugs (e.g., fludarabine). This medication works by stopping the growth of cancer cells.

This medication is given by injection into a vein by a health care professional. Dosage is based on your response to treatment. You will be started on a low dose of the medication, and your dose will be slowly increased. This medication is usually given over 2 hours.

Before you receive this medication, your doctor will direct you to take other medications (e.g., acetaminophen, diphenhydramine) to help prevent side effects. Your doctor should also prescribe other medications (e.g., antibiotics, antiviral medications) to help prevent infection in your body. Use these additional medications exactly as prescribed by your doctor.

See also Warning section.

Fever, chills, dizziness, muscle stiffness, nausea, vomiting, headache, diarrhea, mild rash/itching, tiredness, or trouble breathing may occur during or after the infusion. These reactions occur more often during the first week of treatment. Tell your doctor or pharmacist immediately if any of these effects occur, persist, or worsen. Your doctor may prescribe additional medications to help control these symptoms. Mouth sores, loss of appetite, shaking (tremor), stomach/abdominal pain, constipation, drowsiness, cough, increased sweating, or trouble sleeping may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor immediately if any of these serious side effects occur: shortness of breath, mental/mood changes (e.g., depression, anxiety), bone pain, muscle pain/spasm, unusual weakness, swelling ankles/feet, yellowing skin/eyes, change in the amount of urine, painful urination, numbness/tingling of arms/legs, pain/redness/swelling of arms/legs/injection site.

Seek immediate medical attention if any of these rare but very serious side effects occur: fainting, trouble breathing, chest/jaw/left arm pain, irregular heartbeat, seizures, confusion, vision changes, weakness on one side of the body.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before receiving this medication, tell your doctor or pharmacist if you are allergic to it; or if you have ever had a severe reaction to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: any current infections, immune system problems (e.g., HIV).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems, low blood pressure.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are using this medication.

Before receiving a blood transfusion, tell your doctor that you are using this medication.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

Wash your hands well to prevent the spread of infections.

To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Since the effects of this medication on an unborn baby are unknown, it is recommended that both men and women receiving this medication use reliable forms of birth control (e.g., condoms, birth control pills) during treatment with this medication and for at least 6 months afterwards. If you become pregnant or think you may be pregnant, or if your partner becomes pregnant, tell your doctor immediately.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended during treatment with this medication and for at least 3 months afterwards. Consult your doctor before breast-feeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab).

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: trouble breathing, change in the amount of urine.

Laboratory and/or medical tests (e.g., complete blood count, platelets, CD4 count, blood pressure) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor immediately to establish a new dosing schedule.

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Information last revised April 2013. Copyright(c) 2013 First Databank, Inc.