Fludarabine Injection

IMPORTANT WARNING:

Fludarabine injection must be given under the supervision of a doctor who is experienced in giving chemotherapy medications for cancer.

Fludarabine injection can cause a severe decrease in the number of all types of blood cells in your blood. This may increase the risk you will develop a serious infection or bleeding. Tell your doctor if you have or have ever had a low number of any type of blood cells in your blood; any condition that affects your immune system; or if you have any type of infection now, orif you have or have ever had an infection that would not go away or an infection that comes and goes. If you experience any of the following symptoms, call your doctor immediately: unusual bleeding or bruising; black, tarry, or bloody stools; vomit that is bloody or that looks like coffee grounds; or fever, chills, cough, sore throat, difficult, painful, or frequent urination, or other signs of infection.

Fludarabine injection can also cause severe damage to the nervous system. If you experience any of the following symptoms, call your doctor immediately: seizures; agitation; confusion; coma (loss of consciousness for a period of time); vision changes; unusual weakness; or numbness, burning, pain, or tingling in the hands, arms, feet, or legs.

Fludarabine injection may cause serious or life-threatening conditions in which the body attacks and destroys its own blood cells. Tell your doctor if you have ever developed this type of condition after receiving fludarabine in the past. If you experience any of the following symptoms, call your doctor immediately: shortness of breath, fast or irregular heartbeat; headache; lightheadedness; pale skin; unusual tiredness or weakness, tiny red or purple dots on the skin, nosebleeds, heavy menstrual bleeding, or blood in the urine or stool.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to fludarabine injection.

Talk to your doctor about the risks of receiving fludarabine injection.

WHY is this medicine prescribed?

Fludarabine injection is used to treat certain types of chronic lymphocytic leukemia (CLL; a type of cancer of the white blood cells). Fludarabine injection is in a class of medications called purine analogs. It works by slowing or stopping the growth of cancer cells in your body.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Fludarabine injection comes as a solution (liquid) and a powder to be mixed with liquid and injected over 30 minutes intravenously (into a vein) by a doctor or nurse in a medical facility. Your doctor will tell you how often you will receive fludarabine injection. The schedule depends on the condition you have and on how your body responds to the medication.

Your doctor may need to delay your treatment or adjust your dose if you experience certain side effects. Be sure to tell your doctor how you are feeling during your treatment with fludarabine injection.

What SPECIAL PRECAUTIONS should I follow?

Before receiving fludarabine injection,

• tell your doctor and pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while receiving fludarabine injection. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had kidney disease. Also tell your doctor about all the other chemotherapy medications you have received and if you have ever been treated with radiation therapy (cancer treatment that uses waves of high energy particles to kill cancer cells). Before you receive chemotherapy or radiation therapy in the future, tell your doctor that you have been treated with fludarabine.

• tell your doctor if you are pregnant or plan to become pregnant. You or your partner should not become pregnant while you are receiving fludarabine injection. If you or your partner can become pregnant, you should use birth control to prevent pregnancy during and after your treatment with fludarabine injection. Talk to your doctor for further details. If you or your partner becomes pregnant while receiving fludarabine injection, call your doctor immediately.Fludarabine injection may harm the fetus.

• tell your doctor if you are breastfeeding. You should not breastfeed during fludarabine injection therapy.

• you should know that this medication may cause infertility in men. Talk to your doctor about the risks of receiving fludarabine injection.

• you should know that fludarabine injection may cause tiredness, weakness, confusion, agitation, seizures, and vision changes. Do not drive a car or operate machinery until you know how this medication affects you.

• do not have any vaccinations without talking to your doctor.

• you should know that you may develop a serious or life-threatening reaction if you need to receive a blood transfusion during your treatment with fludarabine injection or at any time after your treatment. Be sure to tell your doctor that you are receiving or have received fludarabine injection before you receive a blood transfusion.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Fludarabine injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• loss of appetite
• nausea
• vomiting
• constipation
• diarrhea
• mouth sores
• hair loss
• muscle or joint pain
• swelling of the arms, hands, feet, ankles, or lower legs
• sleep problems
• hearing loss

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• chest pain or discomfort
• pain along the side of the body and blood in the urine
• peeling or blistering skin, rash, hives, or difficulty breathing or swallowing

Fludarabine injection may increase the risk that you will develop skin cancer. Talk to your doctor about the risks of receiving this medication.

Fludarabine injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What OTHER INFORMATION should I know?

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

^¶ This branded product is no longer on the market. Generic alternatives may be available.