FLUDARABINE PHOSPHATE injection solution

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Teva Parenteral Medicines, Inc.

INN（国際名）:

FLUDARABINE PHOSPHATE

構図:

FLUDARABINE PHOSPHATE 25 mg in 1 mL

処方タイプ:

PRESCRIPTION DRUG

認証ステータス:

Abbreviated New Drug Application

製品の特徴

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
2
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