CLOLAR clofarabine injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CLOFARABINE (UNII: 762RDY0Y2H) (CLOFARABINE - UNII:762RDY0Y2H)

Available from:

Genzyme Corporation

INN (International Name):

CLOFARABINE

Composition:

CLOFARABINE 1 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

CLOLAR- CLOFARABINE INJECTION
GENZYME CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLOLAR SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR CLOLAR.
CLO LAR (CLOFARABINE) INJECTION FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2004
RECENT MAJOR CHANGES
Dosage and Administration (2)
01/ 2013
Warnings and Precautions (5)
01/ 2013
INDICATIONS AND USAGE
Clolar (clofarabine) injection is a purine nucleoside metabolic
inhibitor indicated for the treatment of pediatric patients 1 to
21 years old with relapsed or refractory acute lymphoblastic leukemia
after at least two prior regimens. This indication is
based upon response rate. There are no trials verifying an improvement
in disease-related symptoms or increased
survival with Clolar. (1)
DOSAGE AND ADMINISTRATION
Administer the recommended pediatric dose of 52 mg/m as an intravenous
infusion over 2 hours daily for 5
consecutive days of a 28-day cycle. Repeat cycles every 2–6 weeks.
(2.1)
Provide supportive care, such as intravenous infusion fluids,
antihyperuricemic treatment, and alkalinization of urine
throughout the 5 days of Clolar administration to reduce the risk of
tumor lysis and other adverse events. (2.1)
Discontinue Clolar if hypotension develops during the 5 days of
administration. (2.1)
Reduce the dose in patients with renal impairment. (2.1)
Use dose modification for toxicity. (2.3)
DOSAGE FORMS AND STRENGTHS
20 mg/20 mL single-use vial. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Hematologic Toxicity: Clolar causes myelosuppression which may be
severe and prolonged. Monitor complete blood
counts and platelet counts during Clolar therapy. (5.1)
Infections: Clolar increases the risk of infection, including severe
and fatal sepsis, as a result of bone marrow
suppression. Monitor patients for signs and symptoms of infection,
discontinue Clolar, and treat promptly. (5.2)
Tumor Lysis syndrome: Anticipate, monitor for signs and symptoms and
treat promptly. (