Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
NELARABINE (UNII: 60158CV180) (NELARABINE - UNII:60158CV180)
Amneal Pharmaceuticals LLC
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 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
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.
Abbreviated New Drug Application
NELARABINE- NELARABINE INJECTION AMNEAL PHARMACEUTICALS LLC ---------- 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 Baca dokumen lengkap