Fludarabine (Oral)

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

Fludarabine works by interfering with the growth of cancer cells, which are eventually destroyed. However, the growth of normal cells may also be affected, leading to other effects that may be serious and should be reported to your doctor. Some effects may not be serious but could cause concern. Some effects might happen even after treatment with fludarabine has stopped.

Before starting treatment with fludarabine, you and your doctor should discuss the benefits of this medicine as well as the risks involved.

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 Oral fludarabine was withdrawn from the US market in September 2011.

It is very important for your doctor to check your progress at regular visits to ensure 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, which increases the chance of getting an infection (e.g., pneumonia). It can also lower the number of platelets, which are needed for proper blood clotting. If this happens, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If possible, avoid people with infections. Contact 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.
• Contact 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 suggest other ways to clean your teeth and gums. Consult 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 using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could happen.

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

This medicine may cause a serious 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; 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 prevent getting pregnant. You should not become pregnant while 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.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

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

Pediatric

There have not been appropriate studies on how age affects the use of fludarabine in children. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the usefulness of fludarabine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medicine while breastfeeding. Weigh the potential benefits against the potential risks before taking this medicine during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if there could be an interaction. In these situations, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below when you are using this medicine. The following interactions are based on their potential significance and are not necessarily a complete list.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose 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 necessary in some cases. If both medicines are prescribed together, your doctor may adjust 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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtime or with certain types of food as interactions may happen. Using alcohol or tobacco with some medicines can also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

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

• Infection—Fludarabine may lower your body's ability to fight infections.

• Kidney disease—Use with caution. Effects may be stronger because the medicine is removed from the body more slowly.

• Transfusions—Receiving non-irradiated blood transfusions may increase the risk of side effects from fludarabine.

Along with its necessary effects, a medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Contact your doctor right away if you experience any of the following side effects:

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 happen that usually do not require medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Additionally, your health care professional may have ways to help prevent or reduce some of these side effects. Contact your health care professional if any of the following side effects continue, 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, consult 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.

Pharmacologic Class: Antimetabolite

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.