Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3012
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Fludara (Injection, Powder, Lyophilized, For Solution)
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Usual Dose: The recommended adult dose of FLUDARA FOR INJECTION is 25 mg/madministered intravenously over a period of approximately 30 minutes daily for five consecutive days. Each 5 day course of treatment should commence every 28 days. Dosage may be decreased or delayed based on evidence of hematologic or non-hematologic toxicity. Physicians should consider delaying or discontinuing the drug if neurotoxicity occurs. A number of clinical settings may predispose to increased toxicity from FLUDARA FOR INJECTION. These include advanced age, renal insufficiency, and bone marrow impairment. Such patients should be monitored closely for excessive toxicity and the dose modified accordingly. The optimal duration of treatment has not been clearly established. It is recommended that three additional cycles of FLUDARA FOR INJECTION be administered following the achievement of a maximal response and then the drug should be discontinued.<br/>Renal Insufficiency: Adult patients with moderate impairment of renal function (creatinine clearance 30-70 mL/min/1.73 m) should have a 20% dose reduction of FLUDARA FOR INJECTION. FLUDARA FOR INJECTION should not be administered to patients with severely impaired renal function (creatinine clearance less than 30 mL/min/1.73 m).<br/>Preparation of Solutions: FLUDARA FOR INJECTION should be prepared for parenteral use by aseptically adding Sterile Water for Injection USP. When reconstituted with 2mL of Sterile Water for Injection, USP, the solid cake should fully dissolve in 15 seconds or less; each mL of the resulting solution will contain 25 mg of fludarabine phosphate, 25 mg of mannitol, and sodium hydroxide to adjust the pH to 7.7. The pH range for the final product is 7.2-8.2. In clinical studies, the product has been diluted in 100 cc or 125 cc of 5% Dextrose Injection USP or 0.9% Sodium Chloride USP. Reconstituted FLUDARA FOR INJECTION contains no antimicrobial preservative and thus should be used within 8 hours of reconstitution. Care must be taken to assure the sterility of prepared solutions. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. FLUDARA FOR INJECTION should not be mixed with other drugs.<br/>Handling and Disposal: Procedures for proper handling and disposal should be considered. Consideration should be given to handling and disposal according to guidelines issued for cytotoxic drugs. Several guidelines on this subject have been published.There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate. Caution should be exercised in the handling and preparation of FLUDARA FOR INJECTION solution. The use of latex gloves and safety glasses is recommended to avoid exposure in case of breakage of the vial or other accidental spillage. If the solution contacts the skin or mucous membranes, wash thoroughly with soap and water; rinse eyes thoroughly with plain water. Avoid exposure by inhalation or by direct contact of the skin or mucous membranes. FLUDARA FOR INJECTION should not be handled by pregnant staff.
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FLUDARA FOR INJECTION contains fludarabine phosphate, a fluorinated nucleotide analog of the antiviral agent vidarabine, 9-��-D-arabinofuranosyladenine (ara-A) that is relatively resistant to deamination by adenosine deaminase. Each vial of sterile lyophilized solid cake contains 50 mg of the active ingredient fludarabine phosphate, 50 mg of mannitol, and sodium hydroxide to adjust pH to 7.7. The pH range for the final product is 7.2-8.2. Reconstitution with 2 mL of Sterile Water for Injection USP results in a solution containing 25 mg/mL of fludarabine phosphate intended for intravenous administration. The chemical name for fludarabine phosphate is 9H-Purin-6-amine, 2-fluoro-9-(5-0-phosphono-��-D-arabino-furanosyl) (2-fluoro-ara-AMP). The molecular formula of fludarabine phosphate is CHFNOP (MW 365.2) and the structure is:
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Fludarabine phosphate is rapidly dephosphorylated to 2-fluoro-ara-A and then phosphorylated intracellularly by deoxycytidine kinase to the active triphosphate, 2-fluoro-ara-ATP. This metabolite appears to act by inhibiting DNA polymerase alpha, ribonucleotide reductase and DNA primase, thus inhibiting DNA synthesis. The mechanism of action of this antimetabolite is not completely characterized and may be multi-faceted. Phase I studies in humans have demonstrated that fludarabine phosphate is rapidly converted to the active metabolite, 2-fluoro-ara-A, within minutes after intravenous infusion. Consequently, clinical pharmacology studies have focused on 2-fluoro-ara-A pharmacokinetics. After the five daily doses of 25 mg 2-fluoro-ara-AMP/mto cancer patients infused over 30 minutes, 2-fluoro-ara-A concentrations show a moderate accumulation. During a 5-day treatment schedule, 2-fluoro-ara-A plasma trough levels increased by a factor of about 2. The terminal half-life of 2-fluoro-ara-A was estimated as approximately 20 hours. In vitro, plasma protein binding of fludarabine ranged between 19% and 29%. A correlation was noted between the degree of absolute granulocyte count nadir and increased area under the concentration x time curve (AUC).<br/>Special Populations:<br/>Pediatric Patients: Limited pharmacokinetic data for FLUDARA FOR INJECTION are available from a published study of children (ages 1-21 years) with refractory acute leukemias or solid tumors (Children's Cancer Group Study 097). When FLUDARA FOR INJECTION was administered as a loading dose over 10 minutes immediately followed by a 5-day continuous infusion, steady-state conditions were reached early.<br/>Patients with Renal Impairment: The total body clearance of the principal metabolite 2-fluoro-ara-A correlated with the creatinine clearance, indicating the importance of the renal excretion pathway for the elimination of the drug. Renal clearance represents approximately 40% of the total body clearance. Patients with moderate renal impairment (17 - 41 mL/min/m) receiving 20% reduced Fludara dose had a similar exposure (AUC; 21 versus 20 nM���h/mL) compared to patients with normal renal function receiving the recommended dose. The mean total body clearance was 172 mL/min for normal and 124 mL/min for patients with moderately impaired renal function.
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FLUDARA FOR INJECTION is contraindicated in those patients who are hypersensitive to this drug or its components, in patients with severely impaired renal function (creatinine clearance less than 30 ml/min/1.73 m) and in patients with decompensated hemolytic anemia.
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FLUDARA FOR INJECTION is supplied as a white, lyophilized solid cake. Each vial contains 50 mg of fludarabine phosphate, 50 mg of mannitol, and sodium hydroxide to adjust pH to 7.7. The pH range for the final product is 7.2-8.2. Store under refrigeration, between 2��-8��C (36��-46��F). FLUDARA FOR INJECTION is supplied in a clear glass single dose vial (6mL capacity) and packaged in a single dose vial carton in a shelf pack of five. NDC 50419-511-06 Manufactured by: Ben Venue Laboratories, Bedford, OH 44146 Manufactured for: Bayer HealthCare Pharmaceuticals Inc., Wayne, NJ 07470 U.S. Patent Number: 4,357,324
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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/m/day for 5-7 days) than the recommended dose. Similar severe central nervous system toxicity has been reported rarely (���0.2%) (coma, seizures and agitation) or uncommonly (���1%) (confusion) 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.
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General: FLUDARA FOR INJECTION is a potent antineoplastic agent with potentially significant toxic side effects. Patients undergoing therapy should be closely observed for signs of hematologic and nonhematologic toxicity. Periodic assessment of peripheral blood counts is recommended to detect the development of anemia, neutropenia and thrombocytopenia. Tumor lysis syndrome associated with FLUDARA FOR INJECTION treatment has been reported in CLL patients with large tumor burdens. Since FLUDARA FOR INJECTION can induce a response as early as the first week of treatment, precautions should be taken in those patients at risk of developing this complication. In patients with impaired state of health, FLUDARA FOR INJECTION should be given with caution and after careful risk/benefit consideration. This applies especially for patients with severe impairment of bone marrow function (thrombocytopenia, anemia, and/or granulocytopenia), immunodeficiency or with a history of opportunistic infection. Prophylactic treatment should be considered in patients at increased risk of developing opportunistic infections. There are inadequate data on dosing of patients with renal insufficiency. FLUDARA FOR INJECTION must be administered cautiously in patients with renal insufficiency. The total body clearance of 2-fluoro-ara-A has been shown to be directly correlated with creatinine clearance. Patients with moderate impairment of renal function (creatinine clearance 30-70 mL/min/1.73 m) should have their Fludara dose reduced by 20% and be monitored closely. FLUDARA FOR INJECTION is not recommended for patients with severely impaired renal function (creatinine clearance less than 30 mL/min/1.73 m). Fludara may reduce the ability to drive or use machines, since fatigue, weakness, visual disturbances, confusion, agitation and seizures have been observed.<br/>Laboratory Tests: During treatment, the patient's hematologic profile (particularly neutrophils and platelets) should be monitored regularly to determine the degree of hematopoietic suppression.<br/>Drug Interactions: The use of FLUDARA FOR INJECTION in combination with pentostatin is not recommended due to the risk of severe pulmonary toxicity .<br/>Carcinogenesis: No animal carcinogenicity studies with FLUDARA FOR INJECTION have been conducted.<br/>Mutagenesis: Fludarabine phosphate was not mutagenic to bacteria (Ames test) or mammalian cells (HGRPT assay in Chinese hamster ovary cells) either in the presence or absence of metabolic activation. Fludarabine phosphate was clastogenic in vitro to Chinese hamster ovary cells (chromosome aberrations in the presence of metabolic activation) and induced sister chromatid exchanges both with and without metabolic activation. In addition, fludarabine phosphate was clastogenic in vivo (mouse micronucleus assay) but was not mutagenic to germ cells (dominant lethal test in male mice).<br/>Impairment of Fertility: Studies in mice, rats and dogs have demonstrated dose-related adverse effects on the male reproductive system. Observations consisted of a decrease in mean testicular weights in mice and rats with a trend toward decreased testicular weights in dogs and degeneration and necrosis of spermatogenic epithelium of the testes in mice, rats and dogs. The possible adverse effects on fertility in humans have not been adequately evaluated.<br/>Pregnancy:<br/>Pregnancy Category D:: .<br/>Nursing Mothers: There is evidence from preclinical data that FLUDARA FOR INJECTION and/or metabolites transfer from maternal blood to human milk. In a peri-/postnatal developmental toxicity study, fludarabine phosphate was intravenously administered to rats during late gestation and the lactation period at dose levels of 1, 10 and 40 mg/kg/day. The offspring of the high dose group showed a decrease in body weight gain and viability and a delay in skeletal maturation on day 4 post partum. However, it should be taken into account that the dosing period also covered the late prenatal development. It is not known whether this drug is excreted in human milk. Therefore, breastfeeding should not be initiated during FLUDARA FOR INJECTION treatment. Nursing women should discontinue breastfeeding.<br/>Pediatric Use: Data submitted to the FDA was insufficient to establish efficacy in any childhood malignancy. Fludarabine was evaluated in 62 pediatric patients (median age 10, range 1-21) with refractory acute leukemia (45 patients) or solid tumors (17 patients). The fludarabine regimen tested for pediatric acute lymphocytic leukemia (ALL) patients was a loading bolus of 10.5 mg/m/day followed by a continuous infusion of 30.5 mg/m/day for 5 days. In 12 pediatric patients with solid tumors, dose-limiting myelosuppression was observed with a loading dose of 8 mg/m/day followed by a continuous infusion of 23.5 mg/m/day for 5 days. The maximum tolerated dose was a loading dose of 7 mg/m/day followed by a continuous infusion of 20 mg/m/day for 5 days. Treatment toxicity included bone marrow suppression. Platelet counts appeared to be more sensitive to the effects of fludarabine than hemoglobin and white blood cell counts. Other adverse events included fever, chills, asthenia, rash, nausea, vomiting, diarrhea, and infection. There were no reported occurrences of peripheral neuropathy or pulmonary hypersensitivity reaction.<br/>Vaccination: During and after treatment with FLUDARA FOR INJECTION, vaccination with live vaccines should be avoided.<br/>Disease Progression: Disease progression and transformation (e.g. Richter's syndrome) have been reported in CLL patients.
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High doses of FLUDARA FOR INJECTION have been associated with an irreversible central nervous system toxicity characterized by delayed blindness, coma and death. High doses are also associated with severe thrombocytopenia and neutropenia due to bone marrow suppression. There is no known specific antidote for FLUDARA FOR INJECTION overdosage. Treatment consists of drug discontinuation and supportive therapy.
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fludarabine phosphate
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Fludara (Injection, Powder, Lyophilized, For Solution)
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The most common adverse events include myelosuppression (neutropenia, thrombocytopenia and anemia), fever and chills, infection, and nausea and vomiting. Other commonly reported events include malaise, fatigue, anorexia, and weakness. Serious opportunistic infections have occurred in CLL patients treated with FLUDARA FOR INJECTION. Adverse events, and those reactions which are more clearly related to the drug are arranged below according to body system.<br/>Hematopoietic Systems: Hematologic events (neutropenia, thrombocytopenia, and/or anemia) were reported in the majority of CLL patients treated with FLUDARA FOR INJECTION. During FLUDARA FOR INJECTION treatment of 133 patients with CLL, the absolute neutrophil count decreased to less than 500/mmin 59% of patients, hemoglobin decreased from pretreatment values by at least 2 grams percent in 60%, and platelet count decreased from pretreatment values by at least 50% in 55%. Myelosuppression may be severe, cumulative, and may affect multiple cell lines. Bone marrow fibrosis occurred in one CLL patient treated with FLUDARA FOR INJECTION. Several instances of trilineage bone marrow hypoplasia or aplasia resulting in pancytopenia, sometimes resulting in death, have been reported in postmarketing surveillance. The duration of clinically significant cytopenia in the reported cases has ranged from approximately 2 months to approximately 1 year. These episodes have occurred both in previously treated or untreated patients. 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 in patients receiving FLUDARA FOR INJECTION . The majority of patients rechallenged with FLUDARA FOR INJECTION developed a recurrence in the hemolytic process. In postmarketing experience, cases of myelodysplastic syndrome and acute myeloid leukemia, mainly associated with prior, concomitant or subsequent treatment with alkylating agents, topoisomerase inhibitors or irradiation, have been reported.<br/>Infections: Serious, and sometimes fatal infections, including opportunistic infections and reactivations of latent viral infections such as VZV (Herpes zoster), Epstein-Barr virus and JC virus (progressive multifocal leukoencephalopathy) have been reported in patients treated with FLUDARA FOR INJECTION. Rare cases of Epstein Barr Virus (EBV) associated lymphoproliferative disorders have been reported in patients treated with FLUDARA FOR INJECTION.<br/>Metabolic: Tumor lysis syndrome has been reported in CLL patients treated with FLUDARA FOR INJECTION. This complication may include hyperuricemia, hyperphosphatemia, hypocalcemia, metabolic acidosis, hyperkalemia, hematuria, urate crystalluria, and renal failure. The onset of this syndrome may be heralded by flank pain and hematuria.<br/>Nervous System: Objective weakness, agitation, confusion, seizures, visual disturbances, optic neuritis, optic neuropathy, blindness and coma have occurred in CLL patients treated with FLUDARA FOR INJECTION at the recommended dose. Peripheral neuropathy has been observed in patients treated with FLUDARA FOR INJECTION and one case of wrist-drop was reported. In postmarketing experience, cases of progressive multifocal leukoencephalopathy have been reported. Most cases had a fatal outcome. Many of these cases were confounded by prior and/or concurrent chemotherapy. The time to onset has ranged from a few weeks to approximately one year after initiating treatment.<br/>Pulmonary System: Pneumonia, a frequent manifestation of infection in CLL patients, occurred in 16%, and 22% of those treated with FLUDARA FOR INJECTION in the MDAH and SWOG studies, respectively. Pulmonary hypersensitivity reactions to FLUDARA FOR INJECTION characterized by dyspnea, cough and interstitial pulmonary infiltrate have been observed. In postmarketing experience, cases of severe pulmonary toxicity have been observed with Fludara use which resulted in ARDS, respiratory distress, pulmonary hemorrhage, pulmonary fibrosis, and respiratory failure. After an infectious origin has been excluded, some patients experienced symptom improvement with corticosteroids.<br/>Gastrointestinal System: Gastrointestinal disturbances such as nausea and vomiting, anorexia, diarrhea, stomatitis and gastrointestinal bleeding have been reported in patients treated with FLUDARA FOR INJECTION.<br/>Cardiovascular: Edema has been frequently reported. One patient developed a pericardial effusion possibly related to treatment with FLUDARA FOR INJECTION. No other severe cardiovascular events were considered to be drug related.<br/>Genitourinary System: Rare cases of hemorrhagic cystitis have been reported in patients treated with FLUDARA FOR INJECTION.<br/>Skin: Skin toxicity, consisting primarily of skin rashes, has been reported in patients treated with FLUDARA FOR INJECTION. Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and pemphigus have been reported, with fatal outcomes in some cases. Worsening or flare up of pre-existing skin cancer lesions, as well as new onset of skin cancer, has been reported in patients during or after treatment with FLUDARA FOR INJECTION. Data in the following table are derived from the 133 patients with CLL who received FLUDARA FOR INJECTION in the MDAH and SWOG studies. More than 3000 adult patients received FLUDARA FOR INJECTION in studies of other leukemias, lymphomas, and other solid tumors. The spectrum of adverse effects reported in these studies was consistent with the data presented above.
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There are clear dose dependent toxic effects seen with FLUDARA FOR INJECTION. Dose levels approximately 4 times greater (96 mg/m/day for 5 to 7 days) than that recommended for CLL (25 mg/m/day for 5 days) were associated with a syndrome characterized by delayed blindness, coma and death. Symptoms appeared from 21 to 60 days following the last dose. Thirteen of 36 patients (36%) who received FLUDARA FOR INJECTION at high doses (96 mg/m/day for 5 to 7 days) developed this severe neurotoxicity. This syndrome has been reported rarely (coma, seizures and agitation) or uncommonly (confusion) in patients treated with doses in the range of the recommended CLL dose of 25 mg/m/day for 5 days every 28 days. In postmarketing experience, neurotoxicity has been reported to occur either earlier or later than in clinical trials. The effect of chronic administration of FLUDARA FOR INJECTION on the central nervous system is unknown; however, patients have received the recommended dose for up to 15 courses of therapy. Patients should be observed for signs of neurologic effects. Severe bone marrow suppression, notably anemia, thrombocytopenia and neutropenia, has been reported in patients treated with FLUDARA FOR INJECTION. In a Phase I study in adult solid tumor patients, the median time to nadir counts was 13 days (range, 3-25 days) for granulocytes and 16 days (range, 2-32) for platelets. Most patients had hematologic impairment at baseline either as a result of disease or as a result of prior myelosuppressive therapy. Cumulative myelosuppression may be seen. While chemotherapy-induced myelosuppression is often reversible, administration of FLUDARA FOR INJECTION requires careful hematologic monitoring. Several instances of trilineage bone marrow hypoplasia or aplasia resulting in pancytopenia, sometimes resulting in death, have been reported in adult patients. The duration of clinically significant cytopenia in the reported cases has ranged from approximately 2 months to approximately 1 year. These episodes have occurred both in previously treated or untreated patients. 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 in patients with or without a previous history of autoimmune hemolytic anemia or a positive Coombs' test and who may or may not be in remission from their disease. Steroids may or may not be effective in controlling these hemolytic episodes. The majority of patients rechallenged with FLUDARA FOR INJECTION developed a recurrence in the hemolytic process. The mechanism(s) which predispose patients to the development of this complication has not been identified. Patients undergoing treatment with FLUDARA FOR INJECTION should be evaluated and closely monitored for hemolysis. Discontinuation of therapy with Fludara is recommended in case of hemolysis. Transfusion-associated graft-versus-host disease has been observed after transfusion of non-irradiated blood in FLUDARA FOR INJECTION treated patients. Fatal outcome as a consequence of this disease has been reported. Therefore, to minimize the risk of transfusion-associated graft-versus-host disease, patients who require blood transfusion and who are undergoing, or who have received, treatment with FLUDARA FOR INJECTION should receive irradiated blood only. In a clinical investigation using FLUDARA FOR INJECTION in combination with pentostatin (deoxycoformycin) for the treatment of refractory chronic lymphocytic leukemia (CLL) in adults, there was an unacceptably high incidence of fatal pulmonary toxicity. Therefore, the use of FLUDARA FOR INJECTION in combination with pentostatin is not recommended. Of the 133 adult CLL patients in the two trials, there were 29 fatalities during study. Approximately 50% of the fatalities were due to infection and 25% due to progressive disease.<br/>Pregnancy Category D: FLUDARA FOR INJECTION may cause fetal harm when administered to a pregnant woman. Fludara should not be used during pregnancy unless clearly necessary (e.g., life-threatening situation, no alternative safer treatment available without compromising the therapeutic benefit, treatment cannot be avoided). Prescribers may only consider it to be used if the potential benefits justify the potential risks to the fetus. Fludarabine phosphate was teratogenic in rats and in rabbits. Fludarabine phosphate was administered intravenously at doses of 0, 1, 10 or 30 mg/kg/day to pregnant rats on days 6 to 15 of gestation. At 10 and 30 mg/kg/day in rats, there was an increased incidence of various skeletal malformations. Fludarabine phosphate was administered intravenously at doses of 0, 1, 5 or 8 mg/kg/day to pregnant rabbits on days 6 to 15 of gestation.Dose-related teratogenic effects manifested by external deformities and skeletal malformations were observed in the rabbits at 5 and 8 mg/kg/day. Post-implantation loss and/or reduced fetal weights were observed in rats given 10 mg/kg/day and in rabbits given 8 mg/kg/day, but no drug-related deaths or toxic effects on maternal weights were observed. There are no adequate and well-controlled studies in pregnant women and there is very limited data of FLUDARA FOR INJECTION use in pregnant women in the first trimester: One newborn has been described with absent bilateral radii and normal thumbs, thrombocytopenia, fossa ovalis aneurysm and a small patent ductus arteriosus. Early pregnancy loss has been reported in FLUDARA FOR INJECTION monotherapy as well as in combination therapy. Premature delivery has been reported. If FLUDARA FOR INJECTION is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential or fertile males must take contraceptive measures during and at least for 6 months after cessation of therapy.
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FLUDARA FOR INJECTION is indicated for the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. The safety and effectiveness of FLUDARA FOR INJECTION in previously untreated or non-refractory patients with CLL have not been established.
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Fludara
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