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Generic Name: cladribine (KLAD-ri-been)
Brand Name: Leustatin

Leustatin may decrease bone marrow function and decrease your ability to fight infection. At high doses, Leustatin may cause serious nervous system problems (eg, paralysis) and kidney problems. The risk of kidney problems may be increased in patients taking medicines that may harm the kidney. Ask your doctor if any of your medicines might harm the kidney.

Notify your doctor immediately if you develop signs of infection (eg, fever, chills, persistent sore throat), kidney problems (eg, decreased urination), or nervous system problems (eg, burning, numbness, or tingling of the hands or feet; weakness in the arms or legs).

Leustatin is used for:

Treating hairy cell leukemia. It may also be used for other conditions as determined by your doctor.

Leustatin is a cytotoxic agent. It works by stopping the growth of tumor cells.

Do NOT use Leustatin if:

  • you are allergic to any ingredient in Leustatin

Contact your doctor or health care provider right away if this applies to you.

Before using Leustatin:

Some medical conditions may interact with Leustatin. 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 able to become pregnant
  • 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 an infection, bone marrow problems, or liver or kidney problems

Some MEDICINES MAY INTERACT with Leustatin. 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
  • Medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, cyclosporine, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], tacrolimus, vancomycin) because the risk of kidney side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the kidney

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

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

  • Leustatin is given as an injection at your doctor's office, hospital, or clinic. Contact your health care provider if you have any questions.
  • Do not use Leustatin if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • If Leustatin accidentally spills on your skin, wash it off right away with soap and water. Clean any areas (counters, tables) where Leustatin 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. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • If you miss a dose of Leustatin, contact your doctor immediately.

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

Important safety information:

  • Leustatin may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Leustatin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Leustatin may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Leustatin may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • A serious and possibly fatal condition called tumor lysis syndrome (TLS) has been rarely reported in certain patients taking Leustatin. Contact your doctor right away if you develop symptoms such as fast or irregular heartbeat; fainting; decreased urination; muscle weakness or cramps; nausea, vomiting, diarrhea, or loss of appetite; or sluggishness. Discuss any questions or concerns with your doctor.
  • If you may become pregnant, you must use an effective form of birth control while you take Leustatin. If you have questions about effective birth control, talk with your doctor.
  • Do not receive a live vaccine (eg, measles, mumps) while you are taking Leustatin. Talk with your doctor before you receive any vaccine.
  • Tell your doctor or dentist that you take Leustatin before you receive any medical or dental care, emergency care, or surgery.
  • Lab tests, including complete blood cell counts, kidney function, and liver function, may be performed while you use Leustatin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Leustatin has benzyl alcohol in it. Do not use it in NEWBORNS or INFANTS. It may cause serious and sometimes fatal nervous system problems and other side effects.
  • Leustatin should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Leustatin may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Leustatin while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while taking Leustatin.

Possible side effects of Leustatin:

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:

Constipation; decreased appetite; diarrhea; dizziness; headache; mild pain or redness at the injection site; mild tiredness or weakness; muscle or joint pain; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back or stomach pain; blood in the urine; bloody or black, tarry stools; chest pain or tightness; confusion; cough; dark urine; decreased urination; fever, chills, or persistent sore throat; fast or irregular heartbeat; numbness, tingling, or burning of the hands or feet; painful or difficult urination; red, swollen, blistered, or peeling skin; severe or persistent pain, redness, or swelling at the injection site; severe or persistent tiredness or weakness; shortness of breath; swelling of the hands, ankles, or feet; unusual bleeding or bruising; unusually pale skin; weakness in the arms or legs; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include burning, numbness, or tingling of the hands or feet; decreased urination; fever, chills, or persistent sore throat; unusual bruising or bleeding; unusual tiredness or weakness; weakness in the arms or legs.

Proper storage of Leustatin:

Leustatin is usually handled and stored by a health care provider. Keep Leustatin out of the reach of children and away from pets.

General information:

  • If you have any questions about Leustatin, please talk with your doctor, pharmacist, or other health care provider.
  • Leustatin 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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Leustatin or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Leustatin. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Leustatin. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Leustatin.

Issue Date: June 3, 2015