NELARABINE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals LLC

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 1,500

Product summary:

Nelarabine Injection, 250 mg/50 mL (5 mg/mL) is supplied as a sterile, clear, colorless solution filled in Type I, clear glass single-dose vials with a gray chlorobutyl rubber stopper and a red flip-off aluminum seal. Each single-dose 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. It is available as follows: 50 mL single-dose vials (NDC 70121-1743-1) are available in the following carton size: NDC 70121-1743-4 (package of 6). Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. The vial stoppers are not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NELARABINE- NELARABINE INJECTION
AMNEAL PHARMACEUTICALS LLC
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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 FOR NEUROLOGIC ADVERSE REACTIONS OF
NCI COMMON
TOXICITY CRITERIA FOR ADVERSE EVENTS (CTCAE) GRADE 2 OR GREATER. (5.1)
INDICATIONS AND USAGE
Nelarabine 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 reactions. (2.2)
Take measures to