Label: NELARABINE injection
- NDC Code(s): 39822-0650-1, 39822-0650-6
- Packager: XGen Pharmaceuticals DJB, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 18, 2024
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use NELARABINE INJECTION safely and effectively. See full prescribing information for NELARABINE INJECTION. NELARABINE injection ...
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Table of ContentsTable of Contents
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BOXED WARNING
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WARNING: NEUROLOGIC ADVERSE REACTIONS
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[seeWarnings and Precautions (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 during treatment with nelarabine injection. Discontinue nelarabine injection for neurologic adverse reactions of NCI Common Toxicity Criteria for Adverse Events (CTCAE) Grade 2 or greater[seeWarnings and Precautions (5.1)].
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1 INDICATIONS & USAGE
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 ...
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2 DOSAGE & ADMINISTRATION
2.1 Recommended Dosage - This product is for intravenous use only. Adult Dosage: The recommended adult dose of nelarabine injection is 1500 mg/m - 2 administered intravenously over 2 hours on ...
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3 DOSAGE FORMS & STRENGTHS
Injection: 250 mg/50 mL (5 mg/mL) single-dose vial
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4 CONTRAINDICATIONS
None.
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5 WARNINGS AND PRECAUTIONS
5.1 Neurologic Adverse Reactions - Nervous system adverse reactions of any grade were reported for 223 (76%) adult patients across the Phase I and Phase II trials, and Grade 3 or higher ...
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6 ADVERSE REACTIONS
The following clinically-significant adverse reactions are discussed in greater detail in other sections of the label: Neurologic - [see - Boxed Warning, Warnings and Precautions (5.1) ...
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7 DRUG INTERACTIONS
Administration of nelarabine injection in combination with adenosine deaminase (ADA) inhibitors, such as pentostatin, is not recommended - [seeClinical Pharmacology (12.3)].
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8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy - 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 - [seeClinical ...
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10 OVERDOSAGE
There is no known antidote for overdoses of nelarabine injection. It is anticipated that overdosage would result in severe neurotoxicity (possibly including paralysis, coma), myelosuppression, and ...
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11 DESCRIPTION
Nelarabine is a prodrug of the cytotoxic deoxyguanosine analogue, 9-β- D-arabinofuranosylguanine (ara-G). The chemical name for nelarabine is 2-amino-9-β- D-arabinofuranosyl-6-methoxy-9 ...
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12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action - Nelarabine is a prodrug of the deoxyguanosine analogue 9-β- D-arabinofuranosylguanine (ara-G), a nucleoside metabolic inhibitor. Nelarabine is demethylated by ADA ...
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13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenicity testing of nelarabine has not been done. However, nelarabine was mutagenic when tested - in vitro in L5178Y/TK mouse ...
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14 CLINICAL STUDIES
14.1 Adult Clinical Trial in Relapsed or Refractory T-ALL and T-LBL - The safety and efficacy of nelarabine injection in adult patients were studied in a clinical trial which included 39 ...
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15 REFERENCES
1. “OSHA Hazardous Drugs.” OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html
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16 HOW SUPPLIED/STORAGE AND HANDLING
Nelarabine 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 ...
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17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information). Hematologic Adverse Reactions - Advise patients that leukopenia, thrombocytopenia, anemia, and neutropenia ...
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PATIENT INFORMATION
NELARABINE (nel ar' a been) Injection - Read the Patient Information that comes with nelarabine injection before you or your child starts treatment with nelarabine injection. Read the ...
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PACKAGE LABEL.PRINCIPAL DISPLAY PANELNelarabine Label - NDC #: 39822-0650-1 - Nelarabine Single Carton - NDC #: 39822-0650-1 - Nelarabine Multi-Carton - NDC #: 39822-0650-6
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INGREDIENTS AND APPEARANCEProduct Information