Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
NELARABINE (UNII: 60158CV180) (NELARABINE - UNII:60158CV180)
Shorla Oncology Inc.
INTRAVENOUS
PRESCRIPTION DRUG
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 2 chemotherapy regimens. None. Risk Summary Based on its mechanism of action and findings in animal studies, Nelarabine Injection can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ]. Limited available data with Nelarabine Injection 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
Nelarabine Injection is supplied as a clear, colorless, sterile solution in Type I, clear glass single- dose vials with a grey chlorobutyl rubber stopper (not made with natural rubber latex) and an aluminum seal with a white snap-off cap. 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 are available in the following carton sizes: NDC 81927-111-01 (package of 1). NDC 81927-111-06 (package of 6). Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].” Discard unused portion.
Abbreviated New Drug Application
NELARABINE- NELARABINE INJECTION SHORLA ONCOLOGY 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: 2023 WARNING: NEUROLOGIC ADVERSE REACTIONS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ SEVERE NEUROLOGIC ADVERSE REACTIONS HAVE BEEN REPORTED WITH THE USE OF NELARABINE INJECTION. 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 INJECTION. 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 (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. (1) DOSAGE AND ADMINISTRATION Adult Dose: 1500 mg/m administered intravenously over 2 hours on Days 1, 3, and 5 repeated every 21 days. (2.1) Pediatric Dose: 650 mg/m 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 hema read_full_document