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Fludarabine tablets

Generic Name: fludarabine (floo-DAYR-a-been)
Brand Name: Oforta

Some patients who received high doses of fludarabine tablets to treat acute leukemia developed severe nervous system side effects, including blindness, coma, and death. Similar nervous system side effects, including coma, seizures, agitation, and confusion, have occurred in patients at doses recommended for the treatment of chronic lymphocytic leukemia. Discuss any questions or concerns with your doctor. Contact your doctor right away if any of these effects occur.

Fludarabine tablets may severely decrease bone marrow function. This can lower your body's ability to fight infection and reduce the ability of your blood to clot properly. Some patients have developed severe and sometimes fatal blood problems (eg, hemolytic anemia, autoimmune thrombocytopenia, hemophilia) while using fludarabine tablets. Your doctor will need to monitor you closely for these conditions. Tell your doctor right away if you develop signs or symptoms of an infection (eg, swollen glands, sore throat, fever, chills), bleeding problems (eg, easy bruising; black, tarry stools; bleeding from the gums), or hemolytic anemia (eg, yellowing of eyes or skin, dark urine, severe tiredness or weakness). Be sure to keep all doctor and laboratory appointments.

Fatal lung problems have been reported in patients receiving fludarabine tablets along with pentostatin. Fludarabine tablets are not recommended for use with pentostatin.


Fludarabine tablets are used for:

Treating patients with certain types of leukemia who have not responded to other therapy or whose disease has progressed during treatment with other medicines. It may also be used for other conditions as determined by your doctor.

Fludarabine tablets are an antimetabolite. It works by preventing the cancer cell from reproducing, which results in death of the cell.

Do NOT use fludarabine tablets if:

  • you are allergic to any ingredient in fludarabine tablets
  • you are taking pentostatin

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

Before using fludarabine tablets:

Some medical conditions may interact with fludarabine tablets. 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 a history of bone marrow problems, blood or bleeding problems, kidney problems, immune system problems, nervous system problems, infections, or skin cancer
  • if you receive other chemotherapy, radiation therapy, or you have received radiation or chemotherapy in the past
  • if you will be having a blood transfusion

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

  • Pentostatin because the risk of fatal lung problems may be increased
  • Digoxin because its effectiveness may be decreased by fludarabine tablets

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

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

  • An extra patient leaflet is available with fludarabine tablets. Talk to your pharmacist if you have questions about this information.
  • Take fludarabine tablets by mouth with or without food. Take it with plenty of water.
  • Swallow fludarabine tablets whole. Do not break, crush, chew, or hold it in your mouth before swallowing.
  • Do not remove the tablet from the blister until immediately before you take your dose. Push the tablet through the foil to remove it from the blister.
  • Ask your doctor how you should safely handle fludarabine tablets. Do not get fludarabine tablets on your skin. If contact occurs, wash well with soap and water. Tell your doctor if you develop a skin reaction from fludarabine tablets.
  • Do not get any dust from fludarabine tablets in your eyes or nose. If contact occurs, rinse immediately with gently flowing water for at least 15 minutes. Tell your doctor if you get fludarabine tablets in your eyes.
  • If you no longer need fludarabine tablets, do not throw it in the trash. Ask your doctor or pharmacist how to safely dispose of it.
  • If you miss a dose of fludarabine tablets, contact your doctor right away.

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

Important safety information:

  • Fludarabine tablets may cause drowsiness, dizziness, tiredness, weakness, vision problems, confusion, agitation, or seizures. Some of these effects may be worse if you take it with alcohol or certain medicines. Use fludarabine tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
  • Fludarabine tablets 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.
  • Fludarabine tablets may lower the ability of your body to fight infection and may increase the risk of severe and sometimes fatal 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.
  • Do not receive a live vaccine (eg, measles, mumps) during or after treatment with fludarabine tablets. Talk with your doctor before you receive any vaccine.
  • New or worsening skin cancer has been reported with fludarabine tablets. Tell your doctor if you have a history of skin cancer. Contact your doctor right away if you notice a change in the appearance of a mole, new growth on the skin, or any unusual skin change.
  • A severe and possibly fatal nervous system problem (progressive multifocal leukoencephalopathy [PML]) has been reported in patients who use fludarabine tablets. This has been reported to develop between a few weeks and as long as about 1 year after starting treatment. Many of these patients were also taking other chemotherapy or had received other chemotherapy in the past. Contact your doctor right away if you develop signs of PML, such as trouble walking or talking, confusion, vision problems, or vision loss.
  • Men who may father a child and women who may become pregnant must use an effective form of birth control while using fludarabine tablets and for 6 months after stopping treatment. If you have questions about effective birth control, talk with your doctor.
  • Lab tests, including complete blood cell counts, may be performed while you use fludarabine tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Fludarabine tablets should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Fludarabine tablets has been shown to cause harm to the fetus. Avoid becoming pregnant while you use it and for 6 months after you stop treatment. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using fludarabine tablets while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while taking fludarabine tablets.

Possible side effects of fludarabine tablets:

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; general body discomfort; increased sweating; loss of appetite; muscle pain; nausea; sinus inflammation; stuffy nose; tiredness; vomiting; weakness.

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); abnormal thinking; black, tarry, or bloody stools; blood in the urine; changes in strength or the way you walk; chest pain; confusion; coughing or vomiting blood; dark urine; difficult or painful urination; fainting; hearing loss; irregular heartbeat; lower back or side pain; mental or mood changes (eg, agitation, confusion); muscle weakness or cramps; numbness or tingling in the hands or feet; red, swollen, blistered, or peeling skin; seizures; severe or persistent tiredness or weakness; shortness of breath; signs of infection (eg, fever, chills, cough, or sore throat); skin changes; sores on the mouth or lips; swelling of the fingers, hands, or feet; unusual bruising or bleeding; vision changes or blindness; vomit that looks like coffee grounds; yellowing of the eyes or skin.

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 bleeding; blindness; coma; infection.

Proper storage of fludarabine tablets:

Store fludarabine tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep fludarabine tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about fludarabine tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Fludarabine tablets are 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 fludarabine tablets 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 fludarabine tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to fludarabine tablets. 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 fludarabine tablets.

Review Date: August 8, 2016

Disclaimer: This information should not be used to decide whether or not to take this medicine 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 this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. 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 this medicine.

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