Fludara Injection

Generic Name: Fludarabine (floo-DAYR-a-been)Brand Name: Fludara

Some patients who received high doses of Fludara Injection 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.

Fludara Injection 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 Fludara Injection. 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 the 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 Fludara Injection along with pentostatin. Fludara Injection is not recommended for use with pentostatin.

Fludara Injection is 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.

Fludara Injection is an antimetabolite. It works by preventing the cancer cell from reproducing, which results in death of the cell.

Do NOT use Fludara Injection if:

  • you are allergic to any ingredient in Fludara Injection
  • you are taking pentostatin
  • you have severely decreased kidney function

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

Before using Fludara Injection:

Some medical conditions may interact with Fludara Injection. 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 Fludara Injection. 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 Fludara Injection

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

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

  • Fludara Injection is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Fludara Injection at home, a health care provider will teach you how to use it. Be sure you understand how to use Fludara Injection. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Avoid contact with skin and mucous membranes (eg, mouth, nose). If Fludara Injection accidentally spills on your skin, wash it off immediately with soap and water. If it gets in your eyes, rinse thoroughly with plain tap water.
  • Do not use Fludara Injection if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • If you miss a dose of Fludara Injection, contact your doctor right away.

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

Important safety information:

  • Fludara Injection 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 Fludara Injection 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.
  • Fludara Injection 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.
  • Fludara Injection 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 Fludara Injection. Talk with your doctor before you receive any vaccine.
  • New or worsening skin cancer has been reported with Fludara Injection. 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 Fludara Injection. 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 Fludara Injection 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 Fludara Injection. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Fludara Injection should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Fludara Injection 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 Fludara Injection while you are pregnant. It is not known if Fludara Injection is found in breast milk. Do not breast-feed while taking Fludara Injection.

Possible side effects of Fludara Injection:

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; loss of appetite; muscle pain; nausea; 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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects 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), or emergency room immediately. Symptoms may include bleeding; blindness; coma; infection.

Proper storage of Fludara Injection:

Fludara Injection is usually handled and stored by a health care provider. If you are using Fludara Injection at home, store Fludara Injection as directed by your pharmacist or health care provider. Keep Fludara Injection out of the reach of children and away from pets.

General information:

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