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Fludarabine phosphate for injection should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy. Fludarabine phosphate for injection can severely suppress bone marrow function. When used at high doses in dose-ranging studies in patients with acute leukemia, fludarabine phosphate for injection 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 four times greater (96 mg/m(2)/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 (CLL).
Instances of life-threatening and sometimes fatal autoimmune phenomena such as hemolytic anemia, autoimmune thrombocytopenia/thrombocytopenic purpura (ITP), Evan's syndrome, and acquired hemophilia have been reported to occur after one or more cycles of treatment with fludarabine phosphate for injection. Patients undergoing treatment with fludarabine phosphate for injection should be evaluated and closely monitored for hemolysis.
In a clinical investigation using fludarabine phosphate for injection in combination with pentostatin (deoxycoformycin) for the treatment of refractory chronic lymphocytic leukemia (CLL), there was an unacceptably high incidence of fatal pulmonary toxicity. Therefore, the use of fludarabine phosphate for injection in combination with pentostatin is not recommended .
Can severely suppress bone marrow function and when used at high doses in dose-ranging studies in patients with acute leukemia, was associated with severe neurologic effects, including blindness, coma, and death. Life-threatening and sometimes fatal autoimmune hemolytic anemia, autoimmune thrombocytopenia/thrombocytopenic purpura (ITP), Evan's syndrome, and acquired hemophilia has been reported to occur after one or more cycles of treatment. Closely monitor patients for hemolysis. In a clinical investigation using fludarabine for injection in combination with pentostatin (deoxycoformycin) for the treatment of refractory CLL, there was an unacceptably high incidence of fatal pulmonary toxicity. Therefore, the use of fludarabine for injection in combination with pentostatin is not recommended .Oral routeTablet
Can severely suppress bone marrow function and when used at high doses in dose-ranging studies in patients with acute leukemia, was associated with severe neurologic effects, including blindness, coma, and death. Life-threatening and sometimes fatal autoimmune hemolytic anemia has been reported to occur after one or more cycles of treatment. Closely monitor patients for hemolysis. In a clinical investigation using fludarabine phosphate in combination with pentostatin (deoxycoformycin) for the treatment of refractory CLL, there was an unacceptably high incidence of fatal pulmonary toxicity. Therefore, the use of fludarabine phosphate in combination with pentostatin is not recommended .
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In the U.S.
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Pharmacologic Class: Antimetabolite
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). fludarabine is used in patients with CLL who have already been treated with an alkylating agent (e.g., 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 fludarabine will do as well as the risks of using it.
fludarabine is available only with your doctor's prescription.
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 fludarabine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to fludarabine 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.
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.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fludarabine in the elderly.
|All Trimesters||D||Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.|
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.
Using fludarabine 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.
Using fludarabine 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.
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.
The presence of other medical problems may affect the use of fludarabine. Make sure you tell your doctor if you have any other medical problems, especially:
Take fludarabine 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 fludarabine 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 fludarabine. Do not crush the tablets. If any of fludarabine 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.
The dose of fludarabine 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 fludarabine. 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.
fludarabine 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.
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.
It is very important that your doctor check your progress at regular visits to make sure that fludarabine 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:
You should not use fludarabine if you are also taking pentostatin (Nipent®). Taking it together with fludarabine may increase the chance of serious side effects.
fludarabine 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 fludarabine 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 fludarabine and for 6 months after stopping it. If you think you have become pregnant while using the medicine, tell your doctor right away.
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
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
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.
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