nelarabine 5 mg/mL
nelarabine · INJECTION · Shorla Oncology Inc.
nelarabine is a injection containing nelarabine at 5 mg/mL, taken intravenous. Manufactured by Shorla Oncology Inc..
Key Facts
- Brand Name
- nelarabine
- Generic Name
- nelarabine
- NDC Code (Product)
81927-375- Manufacturer
- Shorla Oncology Inc.
- Strength
- 5 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA214809
- Drug Class
- Nucleoside Metabolic Inhibitor [EPC]
- Marketing Start
- 08/31/2025
Recall History
Zydus Pharmaceuticals (USA) Inc
Failed Impurities/Degradation Specifications
GlaxoSmithKline, LLC.
Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits.
Zydus Pharmaceuticals (USA) Inc
Failed Impurities/Degradation Specifications
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND 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 whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. Nelarabine injection is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma 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 & Administration
2 DOSAGE AND ADMINISTRATION Adult Dose : 1,500 mg/m² administered intravenously over 2 hours on Days 1, 3, and 5 repeated every 21 days. ( 2.1 ) Pediatric Dose : 650 mg/m² 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 hematologic reactions. ( 2.2 ) Take measures to prevent hyperuricemia. ( 2.4 ) 2.1 Recommended Dosage This product is for intravenous use only. Adult Dosage : The recommended adult dose of nelarabine injection is 1,500 mg/m² administered intravenously over 2 hours on Days 1, 3, and 5 repeated every 21 days. Administer nelarabine injection undiluted. Pediatric Dosage : The recommended pediatric dose of nelarabine injection is 650 mg/m² administered intravenously over 1 hour daily for 5 consecutive days repeated every 21 days. Administer nelarabine injection undiluted. The recommended duration of treatment for adult and pediatric patients has not been clearly established. In clinical trials, treatment was generally continued until there was evidence of disease progression, the patient experienced unaccep…
Contraindications
4 CONTRAINDICATIONS None. None ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Administration of nelarabine injection in combination with adenosine deaminase inhibitors, such as pentostatin, is not recommended [see Clinical Pharmacology (12.3)] . Administration in combination with adenosine deaminase inhibitors, such as pentostatin, is not recommended. ( 7 , 12.3 )
Adverse Reactions
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 )] Hematologic [see Warnings and Precautions ( 5.2 )] Tumor Lysis Syndrome [see Warnings and Precautions ( 5.4 )] Effects on Ability to Drive and Use Machines [see Warnings and Precautions ( 5.6 )] The most common (≥ 20%) adverse reactions were: Adult: anemia, thrombocytopenia, neutropenia, nausea, diarrhea, vomiting, constipation, fatigue, pyrexia, cough, and dyspnea ( 6.1 ) Pediatric: anemia, neutropenia, thrombocytopenia, and leukopenia ( 6.1 ) The most common (> 10%) neurological adverse reactions were: Adult: somnolence, dizziness, peripheral neurologic disorders, hypoesthesia, headache, and paresthesia ( 6.1 ) Pediatric: headache and peripheral neurologic disorders ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals, Inc. at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug…
Frequently Asked Questions
What is nelarabine used for?
nelarabine contains nelarabine. It is a injection taken intravenous. Consult your doctor for specific uses.
Is nelarabine a controlled substance?
nelarabine is not classified as a controlled substance by the DEA.
What is the generic name for nelarabine?
The generic name for nelarabine is nelarabine. There are 11 other brand versions of nelarabine.
What is the NDC code for nelarabine 5 mg/mL?
The NDC (National Drug Code) for nelarabine 5 mg/mL is 81927-375, listed by Shorla Oncology Inc..