FLUDARABINE PHOSPHATE tablet, film coated

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:

Antisoma Research Limited

INN（国際名）:

Fludarabine Phosphate

医薬品形態:

TABLET, FILM COATED

構図:

10 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Fludarabine phosphate is indicated as a single agent for the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) whose disease has not responded to or has progressed during or after treatment with at least one standard alkylating-agent containing regimen. Studies demonstrating clinical benefit such as prolongation of survival or relief of symptoms have not been performed. Studies providing a direct comparison of the clinical efficacy and safety of orally administered fludarabine phosphate relative to intravenously administered fludarabine phosphate have not been performed. None “Pregnancy Category D. See ‘ Warnings and Precautions ’ section.” 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. Fludarabine phosphate was embryolethal and teratogenic in both rats and rabbits. If fludarabine phosphate is used during pregnancy, or if

製品概要:

HOW SUPPLIED Fludarabine phosphate is supplied in 10 milligram tablets that are film-coated, capsule shaped, salmon pink in color, and marked on one side with ‘LN’ in a regular hexagon. Each film-coated tablet contains 10 mg fludarabine phosphate. The tablets are supplied in blisters, each blister strip containing 5 tablets. Packages of 15 and 20 tablets are available in child-resistant containers. NDC 45414-311-15: 15 - 10 milligram film-coated tablets per container. Each film-coated tablet is packaged in an individual blister package; 5 tablets per blister strip; 3 blister strips packaged in a plastic bottle with a child-resistant container closure; each bottle is packaged in an individual chip-board carton. NDC 45414-311-20: 20 - 10 milligram film-coated tablets per container. Each film-coated tablet is packaged in an individual blister package; 5 tablets per blister strip; 4 blister strips packaged in a plastic bottle with a child-resistant container closure; each bottle is packaged in an individual chip-board carton. STORAGE Store under normal lighting conditions at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled room temperature]. HANDLING AND DISPOSAL 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 of fludarabine phosphate. Do not crush tablets. Avoid exposure by direct contact of the skin or mucous membranes or by inhalation. If contact occurs, wash thoroughly with soap and water or wash the eyes immediately with gently flowing water for at least 15 minutes. Consult healthcare provider in case of a skin reaction or if the drug gets in the eyes.

情報リーフレット

Antisoma Research Limited
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17.1 BONE MARROW SUPPRESSION
Inform patients that fludarabine phosphate decreases blood cell counts
such as white blood cells, platelets,
and red blood cells. Thus, it is important that periodic assessment of
their blood count be performed to
detect the development of neutropenia, thrombocytopenia and anemia.
[See Warnings and Precautions
(5.2)]
Revised: 2/2009
Document Id: 7F01849B-BCE2-7C85-B997-3C53DA02637A
Set id: AC76ACA8-E718-4232-92AB-399166CE9E46
Version: 1
Effective Time: 20090218
Antisoma Research Limited

製品の特徴

FLUDARABINE PHOSPHATE- FLUDARABINE PHOSPHATE TABLET, FILM COATED
ANTISOMA RESEARCH LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
FLUDARABINE PHOSPHATE FILM-COATED TABLETS
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 DAYS TO 7 DAYS) THAN THE
RECOMMENDED INTRAVENOUS DOSE. THIS
TOXICITY WAS SEEN IN ≤0.2% OF PATIENTS TREATED AT THE RECOMMENDED
INTRAVENOUS DOSE LEVELS (25 MG/M ).
(5.1)
LIFE-THREATENING AND SOMETIMES FATAL AUTOIMMUNE HEMOLYTIC ANEMIA HAS
BEEN REPORTED AFTER ONE OR
MORE CYCLES OF TREATMENT. (5.2)
HIGH INCIDENCE OF FATAL PULMONARY TOXICITY WAS OBSERVED IN A CLINICAL
INVESTIGATION OF THE COMBINATION
OF FLUDARABINE PHOSPHATE WITH PENTOSTATIN (DEOXYCOFORMYCIN) FOR THE
TREATMENT OF REFRACTORY CHRONIC
LYMPHOCYTIC LEUKEMIA (CLL). (5.3)
INDICATIONS AND USAGE
Fludarabine phosphate is a nucleotide metabolic inhibitor indicated as
a single agent for the treatment of adult patients with
B-cell chronic lymphocytic leukemia (CLL) whose disease has not
responded to or has progressed during or after
treatment with at least one standard alkylating-agent containing
regimen. Studies demonstrating clinical benefit such as
prolongation of survival or relief of symptoms have not been
performed. A direct comparison of the clinical efficacy and
safety of orally administered fludarabine phosphate relative to
intravenously administered fludarabine phosphate has not
been studied. (_1_)
DOSAGE AND ADMINISTRATION
NOTE: THE ORAL DOSE IS DIFFERENT THAN THE INTRAVENOUS DOSE.
Chronic Lymphocytic Leukemia (CLL) (_2.1_):
The recommended adult dose is 40 mg/m administered daily for five
consecutive days by the oral route.
Begin each 5-day course of treatment every 28 days.
Renal Impairment (_2.2_):
Reduce dose by 20% in patients with mild to moderate renal impairment
(creatinine clearance 30 to 70 mL/min/1.73
m