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nelarabine
Overview
What is ARRANON?
ARRANON (nelarabine) is a prodrug of the cytotoxic deoxyguanosine analogue, 9-β--arabinofuranosylguanine (ara-G).
The chemical name for nelarabine is 2-amino-9-β--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 209° and 217° C.
ARRANON Injection is supplied as a clear, colorless, sterile solution in glass vials. 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. 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.
What does ARRANON look like?
What are the available doses of ARRANON?
250 mg/50 mL (5 mg/mL) vial ()
What should I talk to my health care provider before I take ARRANON?
How should I use ARRANON?
ARRANON is 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.
This product is for intravenous use only.
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 unacceptable toxicity, the patient became a candidate for bone marrow transplant, or the patient no longer continued to benefit from treatment.
Adult Dosage:
Pediatric Dosage:
What interacts with ARRANON?
Sorry No Records found
What are the warnings of ARRANON?
Sorry No Records found
What are the precautions of ARRANON?
Sorry No Records found
What are the side effects of ARRANON?
Sorry No records found
What should I look out for while using ARRANON?
None.
What might happen if I take too much ARRANON?
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.
Nelarabine has been administered in clinical trials up to a dose of 2,900 mg/m on Days 1, 3, and 5 to 2 adult patients. At a dose of 2,200 mg/m given on Days 1, 3, and 5 every 21 days, 2 patients developed a significant Grade 3 ascending sensory neuropathy. MRI evaluations of the 2 patients demonstrated findings consistent with a demyelinating process in the cervical spine.
How should I store and handle ARRANON?
Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].Dispense in tight container as defined in the USP, with a child-resistant closure (as required).Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].Dispense in tight container as defined in the USP, with a child-resistant closure (as required). ARRANON Injection is supplied as a clear, colorless, sterile solution in Type I, clear glass vials with a gray bromobutyl rubber stopper (not made with natural rubber latex) and a red snap-off aluminum seal. 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. Vials (NDC 0007-4401-01) are available in the following carton size: NDC 0007-4401-06 (package of 6)Store at 25° C (77° F); excursions permitted to 15° to 30° C (59° to 86° F) [see USP Controlled Room Temperature]. ARRANON Injection is supplied as a clear, colorless, sterile solution in Type I, clear glass vials with a gray bromobutyl rubber stopper (not made with natural rubber latex) and a red snap-off aluminum seal. 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. Vials (NDC 0007-4401-01) are available in the following carton size: NDC 0007-4401-06 (package of 6)Store at 25° C (77° F); excursions permitted to 15° to 30° C (59° to 86° F) [see USP Controlled Room Temperature]. ARRANON Injection is supplied as a clear, colorless, sterile solution in Type I, clear glass vials with a gray bromobutyl rubber stopper (not made with natural rubber latex) and a red snap-off aluminum seal. 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. Vials (NDC 0007-4401-01) are available in the following carton size: NDC 0007-4401-06 (package of 6)Store at 25° C (77° F); excursions permitted to 15° to 30° C (59° to 86° F) [see USP Controlled Room Temperature].
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Nelarabine is a prodrug of the deoxyguanosine analogue 9-β--arabinofuranosylguanine (ara-G), a nucleoside metabolic inhibitor. Nelarabine is demethylated by adenosine deaminase (ADA) to ara-G, mono-phosphorylated by deoxyguanosine kinase and deoxycytidine kinase, and subsequently converted to the active 5’-triphosphate, ara-GTP. Accumulation of ara-GTP in leukemic blasts allows for incorporation into deoxyribonucleic acid (DNA), leading to inhibition of DNA synthesis and cell death. Other mechanisms may contribute to the cytotoxic and systemic toxicity of nelarabine.
Non-Clinical Toxicology
None.HMG-CoA reductase inhibitors:
Co-administration of multiple doses of 10 mg of verapamil with 80 mg simvastatin resulted in exposure to simvastatin 2.5-fold that following simvastatin alone. Limit the dose of simvastatin in patients on verapamil to 10 mg daily. Limit the daily dose of lovastatin to 40 mg. Lower starting and maintenance doses of other CYP3A4 substrates (e.g., atorvastatin) may be required as verapamil may increase the plasma concentration of these drugs.
Ivabradine:
Beta-blockers:
Asymptomatic bradycardia (36 beats/min) with a wandering atrial pacemaker has been observed in a patient receiving concomitant timolol (a beta-adrenergic blocker) eyedrops and oral verapamil.
A decrease in metoprolol and propranolol clearance has been observed when either drug is administered concomitantly with verapamil. A variable effect has been seen when verapamil and atenolol were given together.
Digitalis
Antihypertensive agents
Antiarrhythmic agents:
The electrophysiologic effects of quinidine and verapamil on AV conduction were studied in 8 patients. Verapamil significantly counteracted the effects of quinidine on AV conduction. There has been a report of increased quinidine levels during verapamil therapy.
Other agents:
Neurotoxicity is the dose-limiting toxicity of nelarabine. Patients undergoing therapy with ARRANON should be closely observed for signs and symptoms of neurologic toxicity . Common signs and symptoms of nelarabine-related neurotoxicity include somnolence, confusion, convulsions, ataxia, paresthesias, and hypoesthesia. Severe neurologic toxicity can manifest as coma, status epilepticus, craniospinal demyelination, or ascending neuropathy similar in presentation to Guillain-Barré syndrome.
Patients treated previously or concurrently with intrathecal chemotherapy or previously with craniospinal irradiation may be at increased risk for neurologic adverse events.
The following serious adverse reactions are discussed in greater detail in other sections of the label:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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