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Nelarabine (Arranon)

Trade Name : Arranon

Novartis Pharmaceuticals Corporation

INJECTION

Strength 5 mg/mL

NELARABINE Nucleoside Metabolic Inhibitor [EPC],Nucleic Acid Synthesis Inhibitors [MoA]

Delivery Process

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Nelarabine (Arranon) which is also known as Arranon and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 5 mg/mL per ml. Read more

Nelarabine (Arranon) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Severe neurologic adverse reactions have been reported with the use of ARRANONn- Arrayn- . 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-Barru00e9 syndrome n- [see Warnings and Precautions (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 during treatment with ARRANON. Discontinue ARRANON for neurologic adverse reactions of NCI Common Toxicity Criteria for Adverse Events (CTCAE) Grade 2 or greater n- [see Warnings and Precautions (5.1)].
  • u00a0u00a0u00a0u00a0u00a0
  • 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. ()nttttttttt
  • No data
  • ARRANON 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.
  • 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. ()
  • No data
  • Adult Dose
  • Pediatric Dose
  • Discontinue treatment for neurologic reactions greater than or equal to Grade 2. ()n
  • Dosage may be delayed for hematologic reactions. ()n
  • Take measures to prevent hyperuricemia. ()
  • Injection: 250 mg/50 mL (5 mg/mL) single-dose vial
  • Injection: 250u00a0mg/50u00a0mL (5u00a0mg/mL) single-dose vial. ()
  • None.
  • None.
  • No data
  • Neurologic Adverse Reactions
  • Hematologic Reactions
  • Embryo-Fetal Toxicity
  • Effects on Ability to Drive and Use Machines
  • The following clinically-significant adverse reactions are discussed in greater detail in other sections of the label:
  • The most common (u2265 20%) adverse reactions were:
  • The most common (> 10%) neurological adverse reactions were:
  • To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or .
  • Administration of ARRANON in combination with adenosine deaminase (ADA) inhibitors, such as pentostatin, is not recommended .
  • Administration in combination with adenosine deaminase (ADA) inhibitors, such as pentostatin, is not recommended. (, )
  • No data
  • Lactation
  • Renal Impairment
  • Hepatic Impairment
  • There is no known antidote for overdoses of ARRANON. It is anticipated that overdosage would result in severe neurotoxicity (possibly including paralysis, coma), myelosuppression, and potentially death. In the event of overdose, supportive care consistent with good clinical practice should be provided.
  • At a dose of 2200 mg/m given on Days 1, 3, and 5 every 21 days, 2 patients developed a significant Grade 3 ascending sensory neuropathy. Magnetic resonance imaging evaluations of the 2 patients demonstrated findings consistent with a demyelinating process in the cervical spine.
  • ARRANON (nelarabine) is a prodrug of the cytotoxic deoxyguanosine analogue, 9-u03b2--arabinofuranosylguanine (ara-G).
  • The chemical name for nelarabine is 2-amino-9-u03b2--arabinofuranosyl-6-methoxy-9-purine. It has the molecular formula CHNO and a molecular weight of 297.27. Nelarabine has the following structural formula:
  • Nelarabine is slightly soluble to soluble in water and melts with decomposition between 209u00baC and 217u00baC.
  • ARRANON Injection is supplied as a clear, colorless, sterile solution in glass single-dose vials. Each vial contains 250u00a0mg of nelarabine (5u00a0mg nelarabine per mL) and the inactive ingredient sodium chloride (4.5u00a0mg per mL) in 50u00a0mL Water for Injection, USP. ARRANON is intended for intravenous infusion.
  • Hydrochloric acid and sodium hydroxide may have been used to adjust the pH. The solution pH ranges from 5.0 to 7.0.
  • No data
  • Carcinogenicity testing of nelarabine has not been done. However, nelarabine was mutagenic when tested in L5178Y/TK mouse lymphoma cells with and without metabolic activation. No studies have been conducted in animals to assess genotoxic potential or effects on fertility. The effect on human fertility is unknown.
  • No data
  • No data
  • ARRANON 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 aluminum seal with a red 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 0078-0683-61 (package of 1).
  • NDC 0078-0683-06 (package of 6).
  • Store ARRANON (nelarabine) Injection between 20u00b0C and 25u00b0C (68u00b0F and 77u00b0F); excursions permitted to 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F). See USP Controlled Room Temperature.
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Hematologic Adverse Reactions
  • Embryo-Fetal Toxicity
  • Tumor Lysis Syndrome
  • Vaccinations
  • Effects on Ability to Drive and Use Machines
  • Neurologic Adverse Reactions
  • Infection
  • Lactation
  • Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936
  • u00a9 Novartis
  • T2019-90
  • No data
  • PRINCIPAL DISPLAY PANEL
  • Arranon (nelarabine) Injection
  • Rx Onlynttu00a0u00a0u00a0u00a0u00a0nnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0683-06
  • For I.V. Infusion Only
  • 250 mg/50 mL (5 mg/mL)
  • Six 50-mL Vials
  • Novartis

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