Pronunciation:

floo-DAYR-a-been

Classifications:

Pharmacologic—

Antimetabolite

Uses of This Medicine:

Fludarabine belongs to the group of medicines called antimetabolites. It is used to treat a type of cancer of the white blood cells called B-cell chronic lymphocytic leukemia (CLL). This medicine is used in patients with CLL who have already been treated with an alkylating agent (eg, bendamustine) that did not work well.

Fludarabine interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by the medicine, other effects may also occur. Some of these may be serious and must be reported to your doctor. Other effects may not be serious but may cause concern. Some effects may occur after treatment with fludarabine has been stopped.

Before you begin treatment with fludarabine, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

This medicine was available only with your doctor's prescription. Oral fludarabine was withdrawn from the US market in September 2011.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of fludarabine in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fludarabine in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Varicella Virus Vaccine, Live
• Zoster Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Influenza Virus Vaccine, Live
• Pentostatin
• Poliovirus Vaccine, Live
• Smallpox Vaccine
• Typhoid Vaccine, Live
• Yellow Fever Vaccine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bone marrow problems (e.g., anemia, neutropenia, or thrombocytopenia)—Fludarabine may worsen these conditions.

• Infection—Fludarabine may decrease your body's ability to fight infection.

• Kidney disease—Use with caution. Effects may be increased because of the slower removal of the medicine from the body.

• Transfusions—Non-irradiated blood transfusion may increase the risk of side effects of fludarabine.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking this medicine without checking with your doctor first.

Swallow the tablet whole with a full glass of water. Do not split, crush, or chew it. You may take the tablet with or without food.

Be careful in handling this medicine. Do not crush the tablets. If any of this medicine gets on your skin or in your eyes, nose, or mouth, wash it with soap and water or wash the eyes immediately with gently flowing water for at least 15 minutes. Also, check with your doctor right away if a skin reaction occurs.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For chronic lymphocytic leukemia:
    • Adults—Dose is based on body surface area and must be determined by your doctor. However, the dose is usually 40 mg/m(2) once a day for 5 days. This 5-day treatment is given again every 28 days until your body responds to the medicine.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

If you vomit after taking your medicine, call your doctor or pharmacist for instructions.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Fludarabine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection (e.g., pneumonia). It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of an infection or bleeding:

• If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection or if you have fever or chills; cough or hoarseness; lower back or side pain; painful or difficult urination; shortness of breath; or unusual bleeding or bruising.
• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

You should not use this medicine if you are also taking pentostatin (Nipent®). Taking it together with this medicine may increase the chance of serious side effects.

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.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. You should not become pregnant while you are taking this medicine and for 6 months after stopping it. If you think you have become pregnant while using the medicine, tell your doctor right away.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Bloating or swelling of the face, arms, hands, lower legs, or feet

body aches or pain

burning or stinging of the skin

chest pain

cough or hoarseness

cough producing mucus

diarrhea

difficult or labored breathing

difficulty in breathing

ear congestion

fever or chills

general feeling of discomfort or illness

headache

joint pain

loss of appetite

loss of voice

lower back or side pain

muscle aches and pains

nasal congestion

nausea

painful cold sores or blisters on the lips, nose, eyes, or genitals

painful or difficult urination

rapid weight gain

runny nose

shivering

shortness of breath

sneezing

sore throat

stuffy nose

sweating

tightness in the chest

tingling of hands or feet

trouble sleeping

troubled breathing

unusual tiredness or weakness

unusual weight gain or loss

vomiting

wheezing

Less common

Bladder pain

bloody or cloudy urine

difficult, burning, or painful urination

frequent urge to urinate

pain or tenderness around the eyes and cheekbones

Incidence not known

Back pain

bloody, black, or tarry stools

blue lips, fingernails, or skin

blurred vision

confusion

convulsions

coughing up blood

difficult or fast breathing

dizziness

drowsiness

high fever

irregular, fast or slow, or shallow breathing

pale skin

sores, ulcers, or white spots on the lips or in the mouth

swollen glands

unexplained bleeding or bruising

unusual bleeding or bruising

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Abdominal pain

increased sweating

weight loss

Less common

Rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.