Fludarabine phosphate

By Medically reviewed by hellodoktor

Generic Name: Fludarabine phosphate Brand Name(s): Generics only. No brands available.


What is Fludarabine phosphate used for?

Fludarabine phosphate is commonly used to treat leukemia and other cancers. It works by slowing or stopping the growth of cancer cells.

How should I take Fludarabine phosphate?

This medication is given by injection into a vein over 30 minutes by a health care professional. It is usually given once a day for 5 days or as directed by your doctor.

Dosage is based on your medical condition, body size, and response to treatment. Your doctor will check your blood counts to make sure you can receive your next cycle. Keep all medical/lab appointments.

If this medication touches your skin, immediately wash the area well with soap and water. If this medication gets in your eye, open the eyelid and flush with water, then seek immediate medical attention.

How do I store Fludarabine phosphate?

Fludarabine Phosphate for Injection, USP is supplied as a white, lyophilized solid cake. Each vial contains 50 mg of Fludarabine phosphate, USP, 50 mg of mannitol, and sodium hydroxide to adjust pH to 7.7. The pH range for the final product is 7.2 to 8.2. Store at 20 to 25°C (68 to 77°F). Store upright.

Precautions & warnings

What should I know before using Fludarabine phosphate?

Before using fludarabine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Tell your doctor your medical history, especially of: current infections, certain virus illnesses (herpes, chickenpox), blood disorders (e.g., anemia, clotting problems), kidney problems.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

Wash your hands well to prevent the spread of infections. Avoid contact with people who have illnesses that may spread to others (e.g., flu, chickenpox).

To lower your chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for side effects (e.g., infection, bleeding) while using this drug.

This drug is not recommended for use during pregnancy. It may harm the unborn baby. If you become pregnant or think you may be pregnant, tell your doctor right away. To avoid pregnancy, both males and females using this drug should use reliable form(s) of birth control (e.g., birth control pills, condoms) during treatment and for 6 months after treatment has ended. Consult your doctor for details and to discuss effective forms of birth control.

It is not known whether this medication passes into breast milk. However, it may have undesirable effects on a nursing infant. Therefore, breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Fludarabine phosphate during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Fludarabine phosphate. Fludarabine phosphate is pregnancy risk category D according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Fludarabine phosphate?

Nausea, vomiting, diarrhea, headache, muscle aches, tiredness, loss of appetite, and pain/redness at the injection site may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects persist or worsen, tell your doctor or pharmacist promptly.

Many people using this medication may have serious side effects. However, your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. To lower your risk of serious side effects, your doctor will follow your condition closely and order lab tests.

Pain or sores in the mouth and throat may occur. Brush your teeth gently/carefully, avoid using mouthwash that contains alcohol, and rinse your mouth frequently with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods.

Tell your doctor right away if you have any serious side effects, including: fast/irregular heartbeat, swelling ankles/feet.

This medication affects your blood cells, reducing your ability to fight infections. Although fever and chills are commonside effects of fludarabine, they may also be signs of an infection. Tell your doctor if you develop chills or fever.

Fludarabine sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms/weakness.

Get medical help right away if any of these rare but very serious side effects occur: bloody/black/tarry stool, persistent cough, coughing up blood, painful/difficult breathing, chest pain, seizures.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.


What drugs may interact with Fludarabine phosphate?

Some products that may interact with this drug include: “blood thinners” (e.g., warfarin, enoxaparin), live vaccines (e.g., flu vaccine inhaled through the nose, typhoid/polio vaccine taken by mouth), pentostatin, other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab), salicylates/NSAIDs (e.g., aspirin, ibuprofen, naproxen).

Check all prescription and nonprescription medicine labels carefully since many contain pain relievers/fever reducers (NSAIDs such as ibuprofen, naproxen, and aspirin) that can increase your risk of bleeding. Low-dose aspirin should be continued if prescribed by your doctor for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day). Consult your doctor or pharmacist for more details.

Fludarabine phosphate may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Fludarabine phosphate?

Fludarabine phosphate may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Fludarabine phosphate?

Fludarabine phosphate may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.


The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Fludarabine phosphate.

What is the dose of Fludarabine phosphate for an adult?

Usual Adult Dose for Chronic Lymphocytic Leukemia


25 mg/m2 IV once over 30 minutes for 5 days every 28 days. Following a maximal tumor response, 3 additional cycles are recommended.


40 mg/m2 once daily for 5 days every 28 days

Fludarabine phosphate can be taken either on an empty stomach or with food. The tablets have to be swallowed whole with water; they should not be chewed or broken.

Usual Adult Dose for non-Hodgkin’s Lymphoma

25 mg/m2/day for 5 days every 28 days

Renal Dose Adjustments

CrCl 30-70 mL/min/1.73 m2:

Reduce dose by 20% and monitor closely for toxicity

CrCl less than 30 mL/min/1.73 m2:

IV: Not recommended for use

Oral (adults): Administer 50% of dose.

Liver Dose Adjustments

Caution is recommended

Dose Adjustments

The recommended dose of fludarabine may depend on whether other cytotoxic agents are coadministered. Reference to specific protocols is recommended.

Delay or decrease doses in cases of hematologic or other serious toxicities. In case of hemolysis, treatment should be discontinued.

Neurotoxicity: Consider treatment delay or discontinuation


-This drug should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy. It can severely suppress bone marrow function. When used at high doses in patients with acute leukemia, it was associated with severe neurologic effects, including blindness, coma, and death. This severe central nervous system toxicity occurred in 36% of patients treated with doses approximately 4 times greater (96 mg/m2/day for 5 to 7 days) than the recommended dose. Similar severe central nervous system toxicity, including coma, seizures, agitation, and confusion has been reported in patients treated at doses in the range of the dose recommended for chronic lymphocytic leukemia.

-Life-threatening and sometimes fatal autoimmune phenomena such as hemolytic anemia, autoimmune thrombocytopenia/thrombocytopenic purpura (ITP), Evans syndrome, and acquired hemophilia have been reported after one or more cycles of therapy. Patients should be monitored for hemolysis.

-When this drug is given in combination with pentostatin (deoxycoformycin) for the treatment of refractory chronic lymphocytic leukemia (CLL), there is an unacceptably high incidence of fatal pulmonary toxicity; therefore, this combination is not recommended.


There are no data specifically regarding use in dialysis. However, the following guidelines should be noted:

CrCl less than 30 mL/min/1.73 m2:

IV: Not recommended for use

Oral (adults): Administer 50% of dose

Other Comments

It is recommended to monitor the CBC with differential, platelet count, AST, ALT, creatinine, serum albumin, and uric acid during therapy.

What is the dose of Fludarabine phosphate for a child?

Usual Pediatric Dose for Malignant Disease

Solid tumors: 7 to 9 mg/m2 IV bolus followed by 20 to 27 mg/m2/day continuous IV infusion for 5 days

Usual Pediatric Dose for Leukemia

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.

Usual Pediatric Dose for Stem Cell Transplant Conditioning

Reduced-intensity conditioning regimen prior to allogenic hematopoietic stem cell transplantation: 30 mg/m2/day for 5 days

How is Fludarabine phosphate available?

Fludarabine phosphate is available in the following dosage forms and strengths:

  • Oral tablet
  • Intravenous solution
  • Intravenous powder for injection

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Fludarabine phosphate, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Review Date: February 1, 2018 | Last Modified: September 12, 2019

You might also like