How does this medication work? What will it do for me?

Fludarabine belongs to the group of cancer-fighting medications known as antineoplastics, and specifically to the family of antineoplastics called antimetabolites.

Fludarabine causes the death of cancer cells by interfering with their growth and reproduction. Fludarabine is used to treat a type of cancer known as chronic lymphocytic leukemia (CLL) for people for whom other treatments have not worked. The injectable form of this medication may also be used to treat low-grade non-Hodgkin's lymphoma (Lg-NHL) for people for whom other treatments have not worked.

Your doctor may have suggested this medication for conditions other than the ones listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

What form(s) does this medication come in?

Each film-coated tablet contains 10 mg of fludarabine. Nonmedicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, ferric oxide (red, yellow), hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, and titanium dioxide.

How should I use this medication?

The recommended dose and dosing schedule of fludarabine varies according to the response to treatment, other medications or treatments being used, and body size. Fludarabine may be taken by mouth or injected into a vein through a site on your skin that has been prepared for this purpose. Women who are pregnant should not touch the tablets. The appropriate dose is typically taken once daily for 5 days every 28 days. Usually six 28-day cycles are needed.

Fludarabine tablets may be taken with or without food. Swallow the tablets whole with water. Do not chew, crush, or break the tablets.

Many things can affect the schedule of medication that a person needs, such as body weight, other medical conditions, and other medications. Fludarabine is always used under the supervision of a doctor. Very careful handling of this medication is required.

As well as interfering with the genetic material DNA of cancer cells, fludarabine can interfere with some of your normal cells. This can cause a number of side effects such as hair loss. Fludarabine may cause nausea and vomiting, but it is important to keep using it, unless otherwise directed by your doctor. Your doctor, nurse, or pharmacist can advise you on how to reduce the effects of nausea and vomiting. Keep track of any side effects and report them to your doctor as suggested in the section, ";What side effects are possible with this medication?";

While you are using fludarabine, your doctor may advise you to drink extra fluids to help prevent kidney problems.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose or vomit after taking the tablets, contact your doctor or pharmacist for advice on how to continue with your treatment.

Store fludarabine tablets at room temperature. Keep out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take fludarabine if you:

  • are allergic to fludarabine or to any of the ingredients of this medication
  • are pregnant or breast-feeding a child
  • are taking pentostatin
  • have a blood disorder called decompensated hemolytic anemia
  • have severely impaired kidney function

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • aching muscles
  • appetite loss
  • diarrhea
  • fatigue
  • headache
  • nausea and vomiting
  • skin rash
  • temporary loss of hair

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • agitation
  • bladder irritation
  • blurred vision
  • confusion
  • eye pain
  • irregular heartbeat
  • loss of hearing
  • numbness or tingling in fingers, toes, or face
  • sores in mouth and on lips
  • skin rash
  • swelling of feet or lower legs
  • signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
  • signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
  • signs of infection (e.g., fever, severe chills, sore throat, mouth ulcers)
  • signs of kidney problems (e.g., increased urination at night, decreased urine production, blood in the urine)
  • unusual tiredness or weakness

Seek immediate medical attention if any of the following occur:

  • chest pain
  • difficulty breathing or shortness of breath
  • signs of a serious allergic reaction (e.g., abdominal cramps, swelling of lips, hives, difficulty breathing, nausea, vomiting, swelling face and throat)
  • signs of bleeding in the stomach (e.g., bloody, black, or tarry stools; coughing up blood; vomiting blood or material that looks like coffee grounds)
  • seizures
  • severe skin reactions on a large area of the body or on the lips (e.g., ulcers, blisters, pain, redness, severe rash, skin peeling)
  • signs of swelling in the brain (e.g., clumsiness, gradually worsening weakness, visual, speech or personality changes, seizures)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Anemia: Fludarabine may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired, or pale skin, contact your doctor as soon as possible.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.

Blood clotting: This medication can reduce the number of platelet cells in the blood. Platelets help the blood to clot, and a shortage could make you bleed more easily. Tell your doctor of any signs that your blood is not clotting as quickly as usual. Such symptoms may include black and tarry stools, blood in the urine, easy bruising, or cuts that won't stop bleeding. 

Infection: As well as killing cancer cells, this medication can reduce the number of cells that fight infection in the body (white blood cells). Avoid contact with people who have contagious infections and tell your doctor if you begin to notice signs of an infection, such as fever or chills.

Encephalopathy: Fludarabine has been reported to cause a condition of the brain called encephalopathy. Signs and symptoms of encephalopathy include unusual clumsiness; gradually worsening weakness; visual, speech, or personality changes; seizures; and possibly coma or death. If you experience any of these symptoms, contact your doctor immediately.

Kidney function: If you have kidney problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: Fludarabine may affect liver function. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Tumour lysis syndrome: Fludarabine, like many other cancer medications, causes many cancer cells to be suddenly killed when treatment is first started. This can overwhelm the body with waste products from the cells. As a result, the body may not be able to keep up with getting rid of all the waste. When this happens, you may experience nausea and shortness of breath, and notice cloudy urine or joint pain. This is called tumour lysis syndrome. Your doctor may prescribe some medications to help your body get rid of the waste products. Make sure you understand how to use these medications and report any of these signs or symptoms to your doctor immediately.

Pregnancy: There is a possibility of birth defects if either partner is using fludarabine at the time of conception, or if it is taken during pregnancy. Use effective birth control while using fludarabine, and for 6 months after stopping the medication. This medication may harm the baby if used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if fludarabine passes into breast milk. Women should not breast-feed while using fludarabine due to the risk of harm to the child.

Children: The safety and effectiveness of using this medication have not been established for children.

What other drugs could interact with this medication?

There may be an interaction between fludarabine and any of the following:

  • amphotericin
  • baricitinib
  • BCG
  • clozapine
  • denosumab
  • dipyridamole
  • echinacea
  • leflunomide
  • mesalamine
  • natalizumab
  • ocrelizumab
  • other cancer medications
  • pentostatin
  • pimecrolimus
  • sphingosine 1-phosphate (S1P) receptor modulators (e.g., fingolimod, ozanimod, ponesimod, siponimod)
  • sulfasalazine
  • tacrolimus
  • upadacitinib
  • vaccines

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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