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|Daclizumab

Daclizumab

Daclizumab is used for:

Preventing organ rejection in kidney transplant patients in combination with other medicines. It may also be used for other conditions as determined by your doctor.

Daclizumab is a monoclonal antibody and immunosuppressive agent. It works by blocking the activation of the immune system, which decreases the risk of the body rejecting a transplanted organ.

Do NOT use Daclizumab if:

• you are allergic to any ingredient in Daclizumab

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

Before using Daclizumab :

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

• if you are pregnant, planning 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 diabetes or an infection

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

This may not be a complete list of all interactions that may occur. Ask your health care provider if Daclizumab 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 Daclizumab :

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

• Daclizumab is administered as an intravenous (IV; into a vein) infusion only in a medical setting.
• If Daclizumab contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• If you miss a dose of Daclizumab , contact your doctor immediately.

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

Important safety information:

• Daclizumab may cause dizziness or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Daclizumab . Using Daclizumab alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Daclizumab .
• Daclizumab 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.
• Women of childbearing age should use effective birth control methods (eg, condoms, diaphragms, spermicide) before beginning treatment with Daclizumab and continue to use birth control for 4 months after completing therapy.
• Diabetes patients - Daclizumab may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
• LAB TESTS, including complete blood cell counts, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Daclizumab with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: It is unknown if Daclizumab can cause harm to the fetus. If you become pregnant, discuss with your doctor the benefits and risks of using Daclizumab during pregnancy. It is unknown if Daclizumab is excreted in breast milk. Do not breast-feed while taking Daclizumab .

Possible side effects of Daclizumab :

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:

Back pain; constipation; coughing; diarrhea; difficult or painful urination; dizziness; fever; gas; generalized weakness; headache; impaired wound healing without infection; increase or decrease in blood pressure; leg cramps; muscle pain; nausea; night sweats; pain; reaction at the injection site; stomach fullness; stomach pain; swelling; swelling of the legs and feet; tiredness; tremors; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal heartbeat; chest pain; difficulty swallowing; fast heartbeat; fainting; fluid in the lungs; hoarseness; infection; unusual bruising or bleeding; urinary tract bleeding; weakened immune system.

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.

Daclizumab is usually handled and stored by a health care provider. If you are using Daclizumab at home, store Daclizumab as directed by your pharmacist or health care provider. Keep Daclizumab out of the reach of children and away from pets.

General information:

• If you have any questions about Daclizumab , please talk with your doctor, pharmacist, or other health care provider.
• Daclizumab 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 Daclizumab . 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.