ARRANON- nelarabine injection

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Novartis Pharmaceuticals Corporation

INN (Nama Internasional):

NELARABINE

Komposisi:

NELARABINE 5 mg in 1 mL

Rute administrasi :

INTRAVENOUS

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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

Ringkasan produk:

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.

Status otorisasi:

New Drug Application

Karakteristik produk

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. (