ARRANON nelarabine injection

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

GlaxoSmithKline LLC

INN (Kansainvälinen yleisnimi):

NELARABINE

Koostumus:

NELARABINE 5 mg in 1 mL

Prescription tyyppi:

PRESCRIPTION DRUG

Valtuutuksen tilan:

New Drug Application

Valmisteyhteenveto

ARRANON- NELARABINE INJECTION
GLAXOSMITHKLINE LLC
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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
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. CLOSE MONITORING FOR NEUROLOGIC ADVERSE REACTIONS IS STRONGLY
RECOMMENDED, AND ARRANON
SHOULD BE DISCONTINUED FOR NEUROLOGIC ADVERSE REACTIONS OF NCI COMMON
TOXICITY CRITERIA GRADE 2 OR
GREATER. (5.1)
INDICATIONS AND USAGE
ARRANON is a nucleoside metabolic inhibitor indicated for the
treatment of patients with T-cell acute lymphoblastic
leukemia and T-cell lymphoblastic lymphoma whose disease has not
responded to or has relapsed following treatment with
at least two chemotherapy regimens. This use is based on the induction
of complete responses. Randomized trials
demonstrating increased survival or other clinical benefit have not
been conducted. (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
250 mg/50 mL (5 mg/mL) vial (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common (≥ 20%) adverse reactions were:
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The most common (>10%) neurological adverse reactions were:
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Adult dose: 1,500 mg/m² administered intravenously over 2 hours on
D