When This Medicine Should Not Be Used:
You should not receive this medicine if you have had an allergic reaction to fludarabine, or if you are pregnant. Do not use this medicine if you are also taking pentostatin (Nipent®).

How to Use This Medicine:
Injectable

• 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.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
• 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. Each treatment usually takes about 30 minutes.
• If any of this medicine gets on your skin or in your eyes, nose, or mouth, tell your caregiver right away.

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 medicines that weaken the immune system. This includes cancer medicines, radiation treatment, or steroid medicines.
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant.
• Make sure your doctor knows if you are breastfeeding, or if you have kidney disease, lung disease, bleeding problems (such as hemophilia), bone marrow problems (such as anemia, neutropenia, or thrombocytopenia), gout, or any type of infection. 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 could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• This medicine may cause dizziness, drowsiness, trouble in thinking, trouble in controlling movements, or trouble in seeing clearly. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert and not able to think or see well.
• 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.
• Some of the side effects of this medicine may appear up to 60 days after you have stopped using this medicine.
• Cancer medicine can cause nausea or vomiting, sometimes even after you receive medicine to prevent these effects. Ask your doctor or nurse about other ways to control any nausea or vomiting that might happen.
• 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
• Blistering, peeling, or red skin rash.
• Blood in your urine, difficult or painful urination, or lower back or side pain.
• Bloody, or black, tarry stools.
• Blurred vision or changes in vision.
• Change in how much or how often you urinate.
• Chest pain or troubled breathing.
• Confusion, extreme tiredness, fainting, thirst, or increased sweating.
• Feeling anxious, nervous, or restless.
• Fever, chills, cough, runny or stuffy nose, sore throat, and body aches.
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
• Problems with vision, speech, or walking.
• Seizures.
• Severe stomach pain.
• Shortness of breath, uneven heartbeat, and yellowing of your skin or the whites of your eyes.
• Swelling in your hands, ankles, or feet.
• Unusual bleeding or bruising.
• Unusual tiredness or weakness.
• Vomiting of blood or material that looks like coffee grounds.
• Worsening of cancer lesions.

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

• Hearing loss.
• Mild rash or itching skin.
• Muscle or joint pain.
• Nausea, vomiting, diarrhea, loss of appetite, or stomach pain.
• Sores or white patches in your lips or mouth.

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