Clinical Information
Gen. Code and Des.
59981 nelarabine INTRAVEN VIAL 250MG/50ML
GCN and Des.
25932 nelarabine INTRAVEN VIAL 250MG/50ML
Strength
250MG
Dose Form
VIAL (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
10000000 ANTINEOPLASTIC AGENTS
Active Ingredients
11068 nelarabine 121032299
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/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)
DOSAGE FORMS AND STRENGTHS
Injection: 250 mg/50 mL (5 mg/mL) single-dose vial. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Neurologic Adverse Reactions: Severe neurologic reactions have been reported. Monitor for signs and symptoms of neurologic toxicity. (5.1)
Hematologic Reactions: Complete blood counts including platelets should be monitored regularly. (5.2)
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception; and advise males to use condoms. (5.3, 8.1, 8.3)
Effects on Ability to Drive and Use Machines: Somnolence may occur. Advise patients to refrain from these activities until somnolence has resolved. (5.6)
ADVERSE REACTIONS
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 Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Administration in combination with adenosine deaminase (ADA) inhibitors, such as pentostatin, is not recommended. (7, 12.3)
USE IN SPECIFIC POPULATIONS
Lactation: Advise not to breastfeed. (8.2)
Renal Impairment: Closely monitor patients with moderate or severe renal impairment for toxicities. (8.6)
Hepatic Impairment: Closely monitor patients with severe hepatic impairment for toxicities. (8.7)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 7/2019
