fludarabine (Rx)

Brand and Other Names:Fludara, Oforta
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 25mg/mL

powder for injection

  • 50mg

tablet

  • 10mg

B-Cell Chronic Lymphocytic Leukemia

25 mg/sq.meter IV infusion over 30 minutes qD x5 days (up to 30 mg/sq.meter)  

40 mg/sq.meter PO x5 days

Repeat q28Days

Renal impairment

  • CrCl 30-70 mL/min: reduce by 20%
  • CrCl <30 mL/min: IV not recommended; PO reduce 50%

Non-Hodgkin Lymphoma (Orphan)

Treatment and management of non-Hodgkin lymphoma

Orphan indication sponsor

  • Berlex Laboratories, Inc; 15049 San Pablo Avenue, P.O. Box 4099; Richmond, CA 94804-0099

Other Information

Monitor: CBC, chemistries, pulmonary function

Other Indications & Uses

Off-label: hairy cell leukemia, NHL, prolymphocytic leukemia, mycosis fungoides, Hodgkin's disease

Safety and efficacy not established

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Interactions

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            Adverse Effects

            >10%

            Fever (69%)

            Objective weakness (65%)

            Anemia (60%)

            Neutropenia (60%)

            Thrombocytopenia (55%)

            Leukopenia (partly therapeutic)

            Infection (44%-not necessarily drug-induced)

            Cough (44%)

            Pain (44%)

            Fatigue (38%)

            N/V (36%)

            Anorexia (34%)

            Malaise (22%)

            Dyspnea (22%)

            Pneumonia (9-22%)

            Edema (19%)

            Myalgia (16%)

            URI (16%)

            UTI (15%)

            Rash (15%)

            Diarrhea (15%)

            Visual disturbances (15%)

            Diaphoresis (13%)

            GI bleeding (13%)

            Paresthesia (12%)

            1-10% (selected)

            Abdominal pain (10%)

            Back pain (9%)

            Headache (9%)

            Pharyngitis (9%)

            Stomatitis (9%)

            Flu like syndrome (5-9%)

            Malaise (6%)

            Angina (6%)

            Hearing Loss (2-6%)

            Peripheral edema (7%)

            Alopecia (3%)

            Constipation (1-3%)

            Arrhythmia (3%)

            DVT (1%)

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            Warnings

            Black Box Warnings

            The drug should be administered under the supervision of an experienced cancer chemotherapy physician

            Bone marrow suppression may occur. Fludarabine has been associated with severe neurologic effects, including blindness, coma when high doses were used in patients with acute leukemia. Agitation, coma, confusion, and seizures have been reported in patients treated at recommended doses for the treatment of chronic lymphocytic leukemia

            If one or more cycles of treatment with fludarabine administered, autoimmune phenomena including acquired hemophilia, autoimmune thrombocytopenia/thrombocytopenic purpura, Evan syndrome, and hemolytic anemia may occur. Monitor patients closely for hemolysis

            Fludarabine in combination with pentostatin (deoxycoformycin) for the treatment of refractory chronic lymphocytic leukemia is not recommended due to a high incidence of fatal pulmonary toxicity

            Contraindications

            Hypersensitivity

            Concomitant pentostatin: risk of fatal pulmonary toxicity

            IV: severe renal impairment

            Cautions

            Bone marrow depression, renal impairment, elderly

            Allopurinol and hydration recommended for patients newly diagnosed with CLL or those at risk of tumor lysis syndrome

            Very high doses (and rarely, normal doses) have caused irreversible or fatal neurotoxicity manifesting after 21-60 days

            Risk of potentially fatal autoimmune hemolytic anemia

            Avoid pregnancy

            No efficacy in children

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            Pregnancy & Lactation

            Pregnancy Category: D

            Lactation: not known if excreted in breast milk, do not nurse

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Peak plasma time: 2 hr

            Vd: 96-98 L/sq.meter

            Protein bound: 19-29%

            Metabolites: 2-fluoro-ara-ATP

            Clearance: 8.9 L/hr/sq.meter

            Excretion: urine

            Mechanism of Action

            Fluorinated purine analog, inhibits DNA polymerase alpha

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            Administration

            IV Incompatibilities

            Y-site: acyclovir, amphotericin B, chlorpromazine, daunorubicin, ganciclovir, hydroxyzine, prochlorperazine

            IV Compatibilities

            Y-site (partial list): allopurinol, ampicillin, bleomycin, carboplatin, most cephalosporins, cisplatin, dactinomycin, doxorubicin, fluconazole, hydromorphone, imipenem-cilastatin, lorazepam, MgSO4, metoclopramide, morphine SO4, KCl, NaHCO3, TMP-SMX, vancomycin, zidovudine

            IV Preparation

            Reconstitute powder for inj with 2 mL SWI to result in a concentration of 25 mg/mL

            Standard IV dilution: dose/100 mL D5W or NS

            IV Administration

            IV infusion over 30 min recommended by Mfr; has been given as continuous infusion or by rapid injection but risk of toxicity may be higher

            Storage

            Store intact vials under refrigeration

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            Patient Handout

            Patient Education
            fludarabine intravenous

            FLUDARABINE - INJECTION

            (flew-DARE-uh-bean)

            COMMON BRAND NAME(S): Fludara

            WARNING: This medication may cause certain severe blood and bone marrow problems (low red blood cells/white blood cells/platelets, hemolytic anemia). These problems can decrease your body's ability to prevent/stop bleeding, fight infection, or carry enough oxygen in your blood. Tell your doctor right away if you develop easy bleeding/bruising, unusual tiredness, fast/pounding heartbeat, pale/bluish skin color, or signs of infection (such as sore throat that doesn't go away, fever, chills).Fludarabine may rarely cause severe (sometimes fatal) central nervous system problems. Symptoms may not occur until weeks after your last treatment. Tell your doctor right away if you notice any vision changes, seizures, agitation, confusion, or numbness/tingling.Do not use fludarabine with pentostatin (deoxycoformycin). Use of these 2 medications together has caused fatal lung problems.

            USES: This medication is used to treat leukemia and other cancers. It works by slowing or stopping the growth of cancer cells.

            HOW TO USE: This medication is given by injection into a vein over 30 minutes by a health care professional. It is usually given once a day for 5 days or as directed by your doctor.Dosage is based on your medical condition, body size, and response to treatment. Your doctor will check your blood counts to make sure you can receive your next cycle. Keep all medical/lab appointments.If this medication touches your skin, immediately wash the area well with soap and water. If this medication gets in your eye, open the eyelid and flush with water, then seek immediate medical attention.

            SIDE EFFECTS: See also Warning section.Nausea, vomiting, diarrhea, headache, muscle aches, tiredness, loss of appetite, and pain/redness at the injection site may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects last or get worse, tell your doctor or pharmacist promptly.Many people using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.Pain or sores in the mouth and throat may occur. Brush your teeth gently/carefully, avoid using mouthwash that contains alcohol, and rinse your mouth frequently with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods.Tell your doctor right away if you have any serious side effects, including: fast/irregular heartbeat, swelling ankles/feet.This medication affects your blood cells, reducing your ability to fight infections. Although fever and chills are common side effects of fludarabine, they may also be signs of an infection. Tell your doctor if you develop chills or fever.Fludarabine sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms/weakness.Get medical help right away if you have any very serious side effects, including: cough that doesn't go away, bloody/black/tarry stool, coughing up blood, painful/difficult breathing, chest pain, seizures.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Before using fludarabine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: current infections, certain virus illnesses (herpes, chickenpox), blood disorders (such as anemia, clotting problems), kidney problems.Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.Wash your hands well to prevent the spread of infections. Avoid contact with people who have illnesses that may spread to others (such as flu, chickenpox).To lower your chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.Older adults may be at greater risk for side effects (such as infection, bleeding) while using this drug.Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using fludarabine. Fludarabine may harm an unborn baby. Women of childbearing age should ask about reliable forms of birth control while using this medication and for 6 months after the last dose. Men with female partners of childbearing age should use reliable forms of birth control while using this medication and for 6 months after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: "blood thinners" (such as warfarin, enoxaparin), live vaccines (such as flu vaccine inhaled through the nose, typhoid/polio vaccine taken by mouth), pentostatin, other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab), salicylates/NSAIDs (such as aspirin, ibuprofen, naproxen).Check all prescription and nonprescription medicine labels carefully since many contain pain relievers/fever reducers (NSAIDs such as ibuprofen, naproxen, and aspirin) that can increase your risk of bleeding. Low-dose aspirin should be continued if prescribed by your doctor for heart attack or stroke prevention (usually 81-162 milligrams a day). Consult your doctor or pharmacist for more details.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

            NOTES: Lab and/or medical tests (such as complete blood count) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

            MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

            STORAGE: Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

            MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

            Information last revised December 2022. Copyright(c) 2022 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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            • View the formulary and any restrictions for each plan.
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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.