Alemtuzumab

Medical Alert

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Warning

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 to decrease the risk of these serious side effects.

Precautions

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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: recent/current infections (such as tuberculosis), bleeding/blood problems, cancer, kidney problems, heart problems, immune system problems (e.g., HIV), thyroid problems.

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 about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

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. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor immediately. Women of child-bearing age should use reliable forms of birth control (such as condoms, birth control pills) during and after treatment with this medication. Talk with your doctor for more details and to discuss the risks and benefits of treatment with this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended during treatment and for at least 3 to 4 months after treatment with this drug. Consult your doctor before breast-feeding.

Side Effects

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.

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Drug information is selected from data included with permission and copyrighted by First DataBank, Inc. This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your healthcare professional. Always seek the advice of your healthcare professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your healthcare professional. This information does not contain any assurances that this product is safe, effective or appropriate for you.

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Information expires June 2015.