"The US Food and Drug Administration (FDA) has approved a supplemental biologics license application (sBLA) for ofatumumab (Arzerra, Genmab/Novartis) for its use in combination with fludarabine and cyclophosphamide for the treatment of pati"...
FLUDARA (fludarabine) 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 (fludarabine) FOR INJECTION in previously untreated or non-refractory patients with CLL have not been established.
DOSAGE AND ADMINISTRATION
The recommended adult dose of FLUDARA (fludarabine) FOR INJECTION is 25 mg/m² administered 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 nonhematologic toxicity. Physicians should consider delaying or discontinuing the drug if neurotoxicity occurs.
A number of clinical settings may predispose to increased toxicity from FLUDARA (fludarabine) FOR INJECTION. These include advanced age, renal impairment, 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 (fludarabine) FOR INJECTION be administered following the achievement of a maximal response and then the drug should be discontinued.
Adjustments to the starting dose are recommended to provide appropriate drug exposure in patients with creatinine clearance 30-79 mL/min, as estimated by the Cockroft-Gault equations. These adjustments are based on a pharmacokinetic study in patients with renal impairment. FLUDARA (fludarabine) FOR INJECTION should not be administered to patients with creatinine clearance less than 30 mL/min.
Starting Dose Adjustment for Renal Impairment
|Creatinine Clearance||Starting Dose|
|≥ 80 mL/min||25 mg/m² (full dose)|
|50 - 79 mL/min||20 mg/m²|
|30 - 49 mL/min||15 mg/m²|
|< 30 mL/min||do not administer|
Renally impaired patients should be monitored closely for excessive toxicity and the dose modified accordingly.
Preparation of Solutions
FLUDARA (fludarabine) FOR INJECTION should be prepared for parenteral use by aseptically adding Sterile Water for Injection, USP. When reconstituted with 2 mL 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 fludara (fludarabine) bine 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 (fludarabine) 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 (fludarabine) FOR INJECTION should not be mixed with other drugs.
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.1-4
Caution should be exercised in the handling and preparation of FLUDARA (fludarabine) 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 (fludarabine) FOR INJECTION is supplied as a white, lyophilized solid cake. Each vial contains 50 mg of fludara (fludarabine) bine 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 (fludarabine) FOR INJECTION is supplied in a clear glass single dose vial (6 mL capacity) and packaged in a single dose vial carton in a shelf pack of five.
1. Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings. NIOSH Alert 2004-165.
2. OSHA Technical Manual, TED 1-0. 15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi_2.html
3. American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 2006: 63: 1172-1193.
4. Polvich, M., White, J.M., & Kelleher, L.O. (eds.) 2005. Chemotherapy and biotherapy guidelines and recommendations for practice (2nd ed.). Pittsburgh, PA: Oncology Nursing Society.
Manufactured by: Ben Venue Laboratories, Bedford, OH 44146. Manufactured for: Genzyme Corporation, Cambridge, MA 02142. Revised July 2010.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 8/18/2010
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