FLUDARABINE PHOSPHATE- fludarabine phosphate injection, solution

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Sandoz Inc

INN (nemzetközi neve):

Fludarabine Phosphate

Összetétel:

Fludarabine Phosphate 25 mg in 1 mL

Az alkalmazás módja:

INTRAVENOUS

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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. Fludarabine Phosphate Injection should not be used in patients with severe renal impairment (creatinine clearance less than 30 mL/min/1.73 m2 ). [See Warnings and Precautions (5.7) ] None Pregnancy Category D. [See Warnings and Precautions (5.9) ] It is not known whether fludarabine phosphate is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions including tumorigenicity in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug for the mother

Termék összefoglaló:

NDC 66758-046-01: 50 mg/2 mL (25 mg/mL) Store at 2° to 8°C (36° to 46°F). 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.

Engedélyezési státusz:

New Drug Application

Termékjellemzők

FLUDARABINE PHOSPHATE- FLUDARABINE PHOSPHATE INJECTION, SOLUTION
SANDOZ INC
----------
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
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. (_5.2_)
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. (_5.6_)
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_)
Important limitations:
Fludarabine phosphate should not be used in patients with severe renal
impairment (creatinine clearance less than 30
mL/min/1.73 m ). (_5.7_)
DOSAGE AND ADMINISTRATION
Chronic Lymphocytic Leukemia (CLL) (_2.1_):
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.
Renal Insufficienc