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Cladribine is used for:

Treating hairy cell leukemia.

Cladribine is a cytotoxic agent. It works by stopping the replication and repair of the tumor cells.

Do NOT use Cladribine if:

• you are allergic to any ingredient in Cladribine

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

Before using Cladribine :

Some medical conditions may interact with Cladribine . 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 bone marrow problems, or liver or kidney problems

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

• Medicines that may weaken your immune system (eg, cyclosporine) because the risk of side effects may be increased. Check with your doctor or pharmacist if you are unsure if any of your other medicines may weaken your immune system.

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

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

• Cladribine is usually administered as an injection at your doctor's office, hospital, or clinic. Cladribine must be properly diluted prior to use. If you are using Cladribine at home, carefully follow the preparation and injection procedures taught to you by your health care provider.
• If Cladribine contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• If Cladribine accidentally spills on your skin, wash it off immediately with soap and water. Clean any areas (tables, counters) where Cladribine may have spilled or sprayed.
• 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 Cladribine , contact your doctor immediately.

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

Important safety information:

• Cladribine 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.
• Cladribine may lower your body's ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Do not touch your eyes or the inside of your nose unless you have thoroughly washed your hands first. Notify your doctor of any signs of infection, including fever, sore throat, rash, or chills.
• Check with your doctor before having vaccinations while you are taking Cladribine .
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Cladribine .
• LAB TESTS, including complete blood counts, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Cladribine with caution in the ELDERLY because they may be more sensitive to its effects.
• Use Cladribine with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
• Use of Cladribine is not recommended in neonates or premature infants. Cladribine contains benzyl alcohol, which may cause severe nervous system problems, seizures, breathing problems, and death in neonates and premature infants.
• PREGNANCY and BREAST-FEEDING: Cladribine may cause harm to the fetus. Avoid becoming pregnant while taking Cladribine . If you think you may be pregnant, discuss with your doctor the benefits and risks of using Cladribine during pregnancy. It is unknown if Cladribine is excreted in breast milk. Do not breast-feed while taking Cladribine .

Possible side effects of Cladribine :

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:

Diarrhea; dizziness; headache; low fever; muscle or joint pain; nausea; tiredness or weakness; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back or side pain; black, tarry stools; blood in the urine; chills; cough; irritation or pain at the injection site; painful or difficult urination; persistent low or high fever; severe or persistent vomiting; unusual bleeding or bruising.

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 change in amount of urine; paralysis (with high doses); tingling or numbness in the arms or legs.

Cladribine is usually handled and stored by a health care provider. If you are using Cladribine at home, store Cladribine as directed by your pharmacist or health care provider.

General information:

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