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What is the most important information I should know about cladribine?

Cladribine should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Serious side effects have been reported with the use of cladribine including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; fever or chills; or signs of infection such as fever; chills, or sore throat); neurologic problems; kidney problems; and others. Talk to your doctor about the possible side effects from treatment with cladribine.

Warning

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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What is cladribine?

Cladribine is a cancer (antineoplastic) medication. Cladribine interferes with the growth of cancer cells and slows their growth and spread in the body.

Cladribine is used to treat a type of blood cancer (Hairy Cell Leukemia).

Cladribine may also be used for purposes other than those listed in this medication guide.

Precautions

Before taking cladribine, tell your doctor if you have

  • have had recent vaccinations;
  • liver disease;
  • kidney disease; or
  • bone marrow problems.

You may not be able to take cladribine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Cladribine is in the FDA pregnancy category D. This means that cladribine is known to cause birth defects in an unborn baby.Do not take cladribine without first talking to your doctor if you are pregnant or could become pregnant during treatment.

It is not known whether cladribine passes into breast milk. Do not take cladribine without first talking to your doctor if you are breast feeding a baby.

Cladribine can lower the activity of your immune system making you susceptible to infections. Avoid contact with people who have colds, the flu, or other contagious illnesses and do not receive vaccines that contain live strains of a virus (e.g., live oral polio vaccine) during treatment with cladribine. In addition, avoid contact with individuals who have recently been vaccinated with a live vaccine. There is a chance that the virus can be passed on to you.

Skin accidentally exposed to cladribine injection should be rinsed thoroughly with soap and warm water.

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Instructions

If for any reason an overdose of cladribine is suspected, seek emergency medical attention or contact your healthcare provider immediately.

Symptoms of a cladribine overdose tend to be similar to side effects caused by the medication, although often more severe.

Contact your doctor if you miss a dose of cladribine.

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Side Effects

If you experience any of the following serious side effects, seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (shortness of breath; closing of your throat; difficulty breathing; swelling of your lips, face, or tongue; or hives);
  • decreased bone marrow function and blood problems (extreme fatigue; unusual bruising or bleeding; black, bloody or tarry stools; or fever, chills, sore throat, or signs of infection);
  • muscle weakness;
  • decreased or difficult urination, blood in the urine, or side pain; or
  • fever.

Other less serious side effects may be more likely to occur. Talk to your doctor if you experience:

  • nausea, vomiting, diarrhea, or abdominal pain;
  • loss of appetite;
  • rash, itching or hives;
  • cough;
  • dizziness; or
  • headache.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

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Interactions

Do not receive "live” vaccines during treatment with cladribine. Administration of a live vaccine may be dangerous during treatment with cladribine.

Other medications may interact with cladribine. Talk to your doctor and pharmacist before taking any other prescription or over-the-counter medicines, including herbal products, during treatment with cladribine.

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Disclaimer

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2004 Cerner Multum, Inc. Version 2.05. Revision date 8/23/04