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|Clofarabine

Clofarabine

Clofarabine is used for:

Treating certain types of leukemia in children and adolescents who have had at least 2 previous treatment regimens of medicine.

Clofarabine is a form of antimetabolite chemotherapy. It works by blocking cancer cell growth, which results in death of the cancer cell.

Do NOT use Clofarabine if:

• you are allergic to any ingredient in Clofarabine
• you are currently taking medicines that may affect the kidney, such as aminoglycoside antibiotics (eg, gentamicin), amphotericin B, cyclosporine, nonsteroidal anti-inflammatory medicines (eg, ibuprofen), tacrolimus, and vancomycin. Ask your doctor if you are unsure whether any of your medicines might affect your kidneys.
• you are currently taking medicines that may affect the liver, such as acetaminophen, certain medicines for HIV infection, isoniazid, ketoconazole, and methotrexate. Ask your doctor if you are unsure whether any of your medicines might affect your liver.

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

Before using Clofarabine :

Some medical conditions may interact with Clofarabine . 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 high or low blood pressure, kidney problems, liver problems, or heart problems
• if you have an infection

Some MEDICINES MAY INTERACT with Clofarabine . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Medicines that may affect your heart function or blood pressure because the side effects of Clofarabine such as low blood pressure or heart effects may be increased. Ask your doctor if you are unsure whether any of your medicines might affect your heart function or blood pressure.
• Medicines that affect your kidneys or liver because side effects of Clofarabine may be increased

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

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

• Clofarabine is usually administered as an injection at your doctor"s office, hospital, or clinic. If you are using Clofarabine at home, carefully follow the injection procedures taught to you by your health care provider.
• If Clofarabine contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Do not administer any other medicines through the same intravenous line as Clofarabine .
• If Clofarabine accidentally spills on your skin, wash it off immediately with soap and water.
• Keep this product, as well as syringes and needles, out of the reach of children. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for proper disposal.
• If you miss a dose of Clofarabine , contact your doctor immediately.

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

Important safety information:

• Clofarabine may cause drowsiness, dizziness, or lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Clofarabine . Using Clofarabine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
• If you experience vomiting or diarrhea, contact your doctor about appropriate measures to avoid becoming dehydrated.
• Notify your doctor immediately if you experience symptoms of dehydration such as dry mouth; decreased urination; unusual thirst; weakness; unusual drowsiness or lethargy; muscle pain, cramps, or weakness; severe dizziness or fainting; or rapid heartbeat.
• Clofarabine may reduce the number of blood cells that are needed for clotting. To prevent bleeding, avoid situations where bruising or injury may occur. Report any unusual bleeding or bruising; bloody stools; or dark, tarry stools to your doctor.
• Clofarabine 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, rashes, or chills.
• While you are using Clofarabine , it is important to brush and floss your teeth carefully and to also have regular dental checkups.
• Before you have any medical or dental treatments, emergency care, or surgery, tell your doctor or dentist that you are using Clofarabine .
• LAB TESTS, including blood counts, blood pressure, lung function, liver function, kidney function, and blood uric acid levels, may be performed to monitor your progress and check for side effects. Be sure to keep all doctor and lab appointments.
• Safety and effectiveness of Clofarabine have not been established in ADULTS.
• PREGNANCY AND BREAST-FEEDING: Clofarabine has been shown to cause harm to the fetus. Avoid becoming pregnant while using Clofarabine . Women of childbearing potential should use effective contraceptive measures (eg, condoms) to prevent pregnancy. If you suspect that you could be pregnant, contact your doctor immediately. It is not known if Clofarabine is excreted in breast milk. Do not breast-feed while using Clofarabine .

Possible side effects of Clofarabine :

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; cough; decreased weight; diarrhea; dizziness; drowsiness; dry or irritated skin; fever; flushing; gum bleeding; headache; itching; loss of appetite; minor pain, swelling, or redness at the injection site; nausea; stomach pain; swelling or soreness of the mouth; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blistering or severe swelling or pain at the injection site; blood in the urine; cloudy urine; decreased urination; fainting; fast breathing; fast or irregular heartbeat; fever, chills, or sore throat; joint or muscle pain or weakness; mental or mood changes; nosebleed; persistent cough; pneumonia; severe dizziness or lightheadedness; severe or persistent vomiting or diarrhea; shaking; shortness of breath; small red spots under the skin; swelling of arms or legs; unusual bleeding or easy bruising; unusual tiredness or weakness; white patches in the mouth; yellowing of the skin or eyes.

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 rash; vomiting.

Store undiluted vials of Clofarabine at 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. After diluting, Clofarabine may be stored at room temperature and must be used within 24 hours. Keep Clofarabine out of the reach of children and away from pets.

General information:

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