FLUDARABINE PHOSPHATE injection solution

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Teva Parenteral Medicines, Inc.

INN（国际名称）:

FLUDARABINE PHOSPHATE

组成:

FLUDARABINE PHOSPHATE 25 mg in 1 mL

处方类型:

PRESCRIPTION DRUG

授权状态:

Abbreviated New Drug Application

产品特点

FLUDARABINE PHOSPHATE- FLUDARABINE PHOSPHATE INJECTION, SOLUTION
TEVA PARENTERAL MEDICINES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUDARABINE PHOSPHATE INJECTION USP SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLUDARABINE
PHOSPHATE INJECTION USP.
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_
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INDICATIONS AND USAGE
Fludarabine Phosphate Injection USP is a nucleotide metabolic
inhibitor indicated for:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Fludarabine phosphate injection is supplied as a 50 mg/2mL (25 mg/mL)
sterile solution. (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (incidence > 30%) include
myelosuppression (neutropenia, thrombocytopenia and
anemia), fever, infection, nausea and vomiting, fatigue, anorexia,
cough and weakness (6).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TEVA USA,
PHARMACOVIGILANCE AT 1-866-832-8537
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)
2
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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)
The treatment of adult patients with B-cell chronic lymphocytic
leukemia (CLL) who have not responded to or whose
disease has progressed during treatment w