Fludarabine (floo-DAYR-a-been)

Treats chronic lymphocytic leukemia (CLL). This medicine was withdrawn from the US market in September 2011.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will tell you how much medicine to use. Do not use more than directed. The medicine is usually given every day for 5 days. This 5-day treatment is given again every 28 days until your body responds to the medicine.
• You may take this medicine with or without food.
• Swallow the tablet whole with a full glass of water. Do not break, crush, or chew it.
• If any of this medicine gets on your skin or in your eyes, nose, or mouth, wash it with soap and water or wash the eyes immediately with gently flowing water for at least 15 minutes. Also, check with your doctor right away if a skin reaction occurs.

If a dose is missed:

• This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor for instructions. If you vomit after taking your medicine, call your doctor or pharmacist for instructions.

How to Store and Dispose of This Medicine:

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using pentostatin (Nipent®). Also, tell your doctor if you have ever been treated with radiation or other cancer medicines.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Make sure your doctor knows if you are breastfeeding, or if you have kidney disease, lung disease, infections, or bone marrow problems (such as anemia, neutropenia, or thrombocytopenia). Also, tell your doctor if you have had transfusions.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• This medicine may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount; joint pain, stiffness, or swelling; lower back, side, or stomach pain; a rapid weight gain; swelling of the feet or lower legs; or unusual tiredness or weakness.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bloody or cloudy urine, pain in your side or joints.
• Change in how much or how often you urinate.
• Confusion, extreme tiredness, fainting, or trouble seeing.
• Cough, chest pain, shortness of breath, or trouble breathing.
• Fever, chills, sore throat, and body aches.
• Painful cold sores or blisters on the lips, nose, eyes, or genitals.
• Swelling in your hands, ankles, or feet.
• Unusual bleeding, bruising, or weakness.

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, loss of appetite, nausea, or stomach pain.
• Headache.
• Increased sweating.
• Rash.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088