Fludarabine injection

Fludarabine injection comes as a powder to be added to fluid and injected over 30 minutes intravenously (into a vein) by a doctor or nurse in a medical office or hospital outpatient clinic. It is usually injected once a day for 5 days in a row. This treatment period is called a cycle, and the cycle may be repeated every 28 days for several cycles.

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.

• Fludara^®

• 2-Fluoro-ara-A Monophosphate, 2-Fluoro-ara AMP, FAMP

• It is used to treat a type of leukemia.
• It may be given to you for other reasons. Talk with the doctor.

• If you have an allergy to fludarabine or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have kidney disease.
• If you have a type of anemia called hemolytic anemia.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with fludarabine injection.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take fludarabine injection. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how this medicine affects you.
• Skin cancer has happened during or after treatment with fludarabine injection. Talk with the doctor.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• Talk with your doctor before getting any vaccines while you take this medicine and after you stop taking it. Vaccine use with fludarabine injection may either raise the chance of an infection or make the vaccine not work as well. Talk with your doctor.
• Patients with cancer who take this medicine may be at a greater risk of getting a bad health problem called tumor lysis syndrome (TLS). Sometimes, this has been deadly. Call your doctor right away if you have a fast heartbeat or a heartbeat that does not feel normal; any passing out; trouble passing urine; muscle weakness or cramps; upset stomach, throwing up, loose stools, or not able to eat; or feel sluggish.
• A very bad brain problem called progressive multifocal leukoencephalopathy (PML) has happened with fludarabine injection. It may cause disability or can be deadly. Tell your doctor right away if you have signs like confusion, memory problems, low mood (depression), change in the way you act, change in strength on 1 side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight.
• If you have taken this medicine and you are getting a blood transfusion, talk with your doctor.
• If you are 65 or older, use fludarabine injection with care. You could have more side effects.
• This medicine may affect sperm in men. This may affect being able to father a child. Talk with the doctor.
• If you are a man and have sex with a female who could get pregnant, protect her from pregnancy during care and for some time after care ends. Use birth control that you can trust. Talk with your doctor to see how long to use birth control after you stop this medicine.
• If you are a man and your sex partner gets pregnant while you take fludarabine injection or within several months after your last dose, call your doctor right away.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.
• Use birth control that you can trust to prevent pregnancy during care and for some time after care ends. Talk with your doctor to see how long to use birth control after you stop this medicine.
• If you get pregnant while taking fludarabine injection or within several months after the last dose, call your doctor right away.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling tired or weak.
• Upset stomach or throwing up.
• Mouth irritation or mouth sores.
• Not hungry.
• Loose stools (diarrhea).
• Muscle pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Acute leukemia: 10 mg/m2 IV once over 15 minutes followed by continuous IV infusion of 30.5 mg/m2/day for 5 days or 10.5 mg/m2 IV once over 15 minutes followed by continuous IV infusion of 30.5 mg/m2/day for 2 days followed by cytarabine.

Severe bone marrow suppression, notably anemia, thrombocytopenia and neutropenia have been associated with the use of fludarabine.