NELARABINE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NELARABINE (UNII: 60158CV180) (NELARABINE - UNII:60158CV180)

Available from:

Dr. Reddy's Laboratories, Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nelarabine injection is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. None. Risk Summary   Based on its mechanism of action and findings in animal studies, nelarabine can cause fetal harm when administered to a pregnant woman [ see Clinical Pharmacology ( 12.1) ]. Limited available data with nelarabine use in pregnant women are insufficient to determine a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the pregnant woman associated with untreated leukemia or lymphoma (see Clinical Considerations ). In animal reproduction studies, intravenous administration of nelarabine to pregnant rabbits during the period of organogenesis resulted in teratogenicity at maternal doses below the recommended human adult dose of

Product summary:

Nelarabine injection is supplied as a clear, colorless, sterile solution in Type I, clear glass single-dose vials with a gray chlorobutyl rubber stopper (not made with natural rubber latex) and a red snap-off aluminum seal. Each vial contains 250 mg of nelarabine (5 mg nelarabine per mL) and the inactive ingredient sodium chloride (4.5 mg per mL) in 50 mL Water for Injection, USP. Single-dose Vials (NDC 43598-142-11) are available in the following carton size: (NDC 43598-142-11) (package of 1) NDC 43598‑142-06 (package of 6). Store nelarabine injection at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Discard Unused Portion.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NELARABINE- NELARABINE INJECTION
DR. REDDY'S LABORATORIES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NELARABINE INJECTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
NELARABINE INJECTION.
NELARABINE INJECTION FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2005
WARNING: NEUROLOGIC ADVERSE REACTIONS
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
SEVERE NEUROLOGIC ADVERSE REACTIONS HAVE BEEN REPORTED WITH THE USE OF
NELARABINE.THESE ADVERSE REACTIONS HAVE INCLUDED ALTERED MENTAL STATES
INCLUDING
SEVERE SOMNOLENCE, CENTRAL NERVOUS SYSTEM EFFECTS INCLUDING
CONVULSIONS, AND
PERIPHERAL NEUROPATHY RANGING FROM NUMBNESS AND PARESTHESIAS TO MOTOR
WEAKNESS
AND PARALYSIS. THERE HAVE ALSO BEEN REPORTS OF ADVERSE REACTIONS
ASSOCIATED WITH
DEMYELINATION, AND ASCENDING PERIPHERAL NEUROPATHIES SIMILAR IN
APPEARANCE TO
GUILLAIN-BARRÉ SYNDROME. (5.1).
FULL RECOVERY FROM THESE ADVERSE REACTIONS HAS NOT ALWAYS OCCURRED
WITH CESSATION OF
THERAPY WITH NELARABINE. MONITOR FREQUENTLY FOR SIGNS AND SYMPTOMS OF
NEUROLOGIC
TOXICITY. DISCONTINUE NELARABINE INJECTION FOR NEUROLOGIC ADVERSE
REACTIONS OF NCI
COMMON TOXICITY CRITERIA FOR ADVERSE EVENTS (CTCAE) GRADE 2 OR
GREATER. (5.1)
INDICATIONS AND USAGE
Nelarabine Injection is a nucleoside metabolic inhibitor indicated for
the treatment of patients with T-cell
acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma in
adult and pediatric patients age 1
year and older whose disease has not responded to or has relapsed
following treatment with at least two
chemotherapy regimens. (1)
DOSAGE AND ADMINISTRATION
• Adult Dose: 1,500 mg/m² administered intravenously over 2 hours
on Days 1, 3, and 5 repeated every
21 days. (2.1)
• Pediatric Dose: 650 mg/m² administered intravenously over 1 hour
daily for 5 consecutive days repeated
every 21 days. (2.1)
• Discontinue treatment for neurologic reactions greater than or
equal to Grade 2. (2.2)
• Dosage may be delayed for hematologic