HIGHLIGHTS OF PRESCRIBING INFORMATION

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

FLUDARABINE PHOSPHATE (UNII: 1X9VK9O1SC) (FLUDARABINE - UNII:P2K93U8740)

থেকে পাওয়া:

Actavis Pharma, Inc.

INN (আন্তর্জাতিক নাম):

FLUDARABINE PHOSPHATE

রচনা:

FLUDARABINE PHOSPHATE 25 mg in 1 mL

প্রশাসন রুট:

INTRAVENOUS

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Fludarabine Phosphate Injection, USP 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, USP 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 injection in pregnant women, In rats, repeated intravenous doses of fludarabine phosphate at 2.4 times and 7.2 times the recommended human intravenous dose (25 mg/m2 ) administered during organogenesis caused an increase in resorptions, skeletal and visceral malformations (cleft palate, exencephaly, and fetal vertebra

পণ্য সারাংশ:

Fludarabine Phosphate Injection, USP is supplied as a clear, colorless or almost colorless sterile solution containing 25 mg/mL of fludarabine phosphate, USP in a single use vial. NDC 45963-621-51 one carton containing a 50 mg/2 mL glass vial of Fludarabine Phosphate Injection, USP. Store under refrigeration, between 2° and 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. Sterile, Nonpyrogenic, Preservative-free. The vial stopper is not made with natural rubber latex.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

FLUDARABINE PHOSPHATE- FLUDARABINE PHOSPHATE INJECTION, SOLUTION
ACTAVIS PHARMA, INC.
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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, USP, FOR INTRAVENOUS USE
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 LESS THAN OR EQUAL TO 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, USP 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
Fludarabi