NELARABINE injection

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Shorla Oncology Inc.

Droga podania:

INTRAVENOUS

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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

Podsumowanie produktu:

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.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

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