FLUDARABINE PHOSPHATE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Fludarabine Phosphate (UNII: 1X9VK9O1SC) (Fludarabine - UNII:P2K93U8740)

Available from:

Sagent Pharmaceuticals

INN (International Name):

Fludarabine Phosphate

Composition:

Fludarabine Phosphate 25 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fludarabine Phosphate 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 Fludarabine Phosphate Injection in previously untreated or non-refractory patients with CLL have not been established. None Teratogenic Effects Pregnancy Category D [see Warnings and Precautions (5.6)]. Based on its mechanism of action, fludarabine phosphate can cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies of fludarabine phosphate in pregnant women. In rats, repeated intravenous doses of fludarabine phosphate at 2.4 times and 7.2 times the recommended human IV dose (25 mg/m2 ) administered during organogenesis caused an increase in resorptions, skeletal and visceral malformations (cleft palate, exencephaly, and fetal vertebrae deformities) and decreased f

Product summary:

Fludarabine Phosphate Injection, USP is supplied as follows: Fludarabine Phosphate Injection, USP is a clear, sterile solution. Each mL of Fludarabine Phosphate Injection, USP contains 25 mg of fludarabine phosphate, USP, 25 mg of mannitol, water for injection, qs; and sodium hydroxide to adjust pH to 6.8. The pH range for the final product is 6.0 to 7.1. Store refrigerated between 2° and 8°C (36° and 46°F). Protect from light. Retain in carton until time of use. 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 fludarabine phosphate 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. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUDARABINE PHOSPHATE- FLUDARABINE PHOSPHATE INJECTION, SOLUTION
SAGENT PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUDARABINE PHOSPHATE
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
FLUDARABINE
PHOSPHATE INJECTION.
FLUDARABINE PHOSPHATE INJECTION, FOR INTRAVENOUS USE ONLY
INITIAL U.S. APPROVAL: 1991
WARNING: CNS TOXICITY, HEMOLYTIC ANEMIA, AND PULMONARY TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
SEVERE CENTRAL NERVOUS SYSTEM TOXICITY OCCURRED IN 36% OF PATIENTS
TREATED WITH
DOSES APPROXIMATELY FOUR TIMES GREATER (96 MG/M /DAY FOR 5 TO 7 DAYS)
THAN THE
RECOMMENDED DOSE. THIS TOXICITY WAS SEEN IN ≤ 0.2% OF PATIENTS
TREATED AT THE
RECOMMENDED DOSE LEVELS (25 MG/M ). (5.1)
INSTANCES OF LIFE-THREATENING AND SOMETIMES FATAL AUTOIMMUNE HEMOLYTIC
ANEMIA
HAVE BEEN REPORTED AFTER ONE OR MORE CYCLES OF TREATMENT. (5.3)
IN A CLINICAL INVESTIGATION OF THE COMBINATION OF FLUDARABINE
PHOSPHATE WITH
PENTOSTATIN (DEOXYCOFORMYCIN) FOR THE TREATMENT OF REFRACTORY CHRONIC
LYMPHOCYTIC
LEUKEMIA (CLL), THERE WAS AN UNACCEPTABLY HIGH INCIDENCE OF FATAL
PULMONARY
TOXICITY. (5.5)
INDICATIONS AND USAGE
Fludarabine Phosphate Injection is a nucleotide metabolic inhibitor
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. Benefit in treatment-naïve or non-refractory CLL
patients is not established. (1.1)
DOSAGE AND ADMINISTRATION
The recommended adult dose is 25 mg/m 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. (2.1)
Reduce dose in patients with creatinine clearance 30 to 70
mL/min/l.73m . Do not use in patients with
severe renal impairment (2.2).
DOSAGE FORMS AND STRENGTHS
Fludarabine Phosphate Injectio