Fludara

Fludara is a prescription medication used to treat adult patients with a type of cancer called chronic lymphocytic leukemia. Fludara belongs to a group of drugs called antimetabolites. It works by interfering with cancer cell growth and reproduction.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects include fever, chills, nausea, and vomiting.

Fludara is a prescription medication used to treat adult patients with chronic lymphocytic leukemia (CLL). Chronic lymphocytic leukemia is a type of cancer of the white blood cells.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Genzyme Corporation

Fludara may cause side effects, some of which can be serious. See "Fludara Precautions" section.

The most common side effects include:

• bone marrow suppression which can cause low levels of red and white blood cells as well as low levels of platelets (increasing risk of infection, anemia, and blood clotting problems)
• fever
• chills
• infection
• nausea
• vomiting

Other common side effects include:

• a general feeling of illness
• unusual tiredness
• decreased appetite
• weakness
• swelling of arms, hands, feet, ankles, or lower legs

This is not a complete list of Fludara side effects. Ask your doctor or pharmacist for more information.

 Tell your doctor if any side effect is severe or does not go away.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• pentostatin (Nipent)
• cytarabine (Cytostar-U, DepoCyt)

This is not a complete list of Fludara drug interactions. Ask your doctor or pharmacist for more information.

Fludara can cause serious side effects, some of which can be life-threatening, including:

• a decrease in the number of blood cells produced by the bone marrow, causing anemia, increased risk for infection, and increased risk of bleeding. Tell your doctor if you experience any of the following symptoms:
  • shortness of breath
  • fast heartbeat
  • headache
  • dizziness
  • pale skin
  • extreme tiredness
  • unusual bleeding or bruising
  • black, tarry or bloody stool
  • vomit that is bloody or has coffee ground appearance
  • fever
  • chills
  • cough
  • sore throat
  • difficult, painful, or frequent urination
• damage to the nervous system. Tell your doctor if you experience any of the following symptoms:
  • seizures
  • agitation
  • confusion
  • coma
  • changes in vision
• a serious or life-threatening condition in which the body attacks and destroys its own blood cells
• serious lung damage (this has occurred in some people with CLL who were given Fludara in combination with pentostatin [Nipent])
• severe, sometimes fatal skin rashes including Steven's Johnson syndrome
• a serious or life-threatening reaction can occur if you receive a blood transfusion during or after Fludara treatment. Tell your doctor if you are receiving or have received Fludara injections before you receive a blood transfusion.
• infertility (sterility) in women by interfering with the normal menstrual cycle, and in men by stopping the production of sperm

Do not take this medication if you are allergic to any ingredient in Fludara.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Fludara there are no specific foods that you must exclude from your diet when receiving this medication.

Before receiving Fludara, tell your doctor about all your medical conditions including if you have:

• kidney disease
• previously been treated with other chemotherapy medications or radiation therapy

Tell your doctor if you are:

• allergic to any ingredient in Fludara or any other medication
• pregnant or breastfeeding

Tell your doctor about all of the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your healthcare provider if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy. Fludara falls into category D. It is not known if Fludara will harm your unborn baby. Because Fludara has the potential to harm your unborn baby, take precautions to avoid pregnancy during Fludara therapy and for at least 6 months after treatments.

Tell your healthcare provider right away if you become pregnant while receiving this medication.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if Fludara is excreted in human breastmilk or if it will harm your nursing baby.

Fludara is a liquid to be infused (slowly injected into a vein) by a healthcare provider in a medical facility. The infusion lasts approximately 30 minutes and is given once daily for five days in a row. This cycle may be repeated every 28 days.

Your doctor will order certain tests to check your body's response to Fludara.

The dose your doctor recommends will be determined based on your height and weight, your medical conditions, other medicines you take, and other factors.

The usual recommended Fludara dose is 25 mg per m² infused (injected into a vein) over 30 minutes, once daily, for five days in a row. This cycle may be repeated every 28 days.

Your doctor may recommend a lower dosage if you have kidney disease or a delay in treatment if you experience severe side effects.

Fludara is usually administered by a healthcare provider in a medical setting making it unlikely for an overdose to occur. However, if overdose is suspected, seek emergency medical attention.

Before receiving chemotherapy or radiation therapy in the future, tell your healthcare provider that you have received Fludara treatments.

WARNING

Fludara for injection should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy. Fludara for injection can severely suppress bone marrow function. When used at high doses in dose-ranging studies in patients with acute leukemia, Fludara 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/m2/day for 5-7 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.

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 Fludara for injection. Patients undergoing treatment with Fludara for injection should be evaluated and closely monitored for hemolysis.

In a clinical investigation using Fludara 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 Fludara for injection in combination with pentostatin is not recommended.