Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
NELARABINE (UNII: 60158CV180) (NELARABINE - UNII:60158CV180)
Novartis Pharmaceuticals Corporation
NELARABINE
NELARABINE 5 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
ARRANON 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, ARRANON can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . Limited available data with ARRANON 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 1500 mg/m2 /day (see Data
ARRANON Injection is supplied as a clear, colorless, sterile solution in Type I, clear glass single-dose vials with a gray bromobutyl rubber stopper (not made with natural rubber latex) and an aluminum seal with a red 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 0078-0683-61 (package of 1). NDC 0078-0683-06 (package of 6). Store ARRANON (nelarabine) Injection between 20°C and 25°C (68°F and 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.
New Drug Application
ARRANON- NELARABINE INJECTION NOVARTIS PHARMACEUTICALS CORPORATION ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ARRANON SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ARRANON. ARRANON (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 ARRANON. 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 ARRANON. MONITOR FREQUENTLY FOR SIGNS AND SYMPTOMS OF NEUROLOGIC TOXICITY. DISCONTINUE ARRANON FOR NEUROLOGIC ADVERSE REACTIONS OF NCI COMMON TOXICITY CRITERIA FOR ADVERSE EVENTS (CTCAE) GRADE 2 OR GREATER. (5.1) RECENT MAJOR CHANGES Warnings and Precautions, Neurologic Adverse Reactions (5.1) 11/2018 INDICATIONS AND USAGE ARRANON 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. ( Läs hela dokumentet