Nexus Pharmaceuticals Receives FDA Approval for Arsenic Trioxide Injection in 10mg per 10mL Vial

VERNON HILLS, Ill.--(BUSINESS WIRE)-- Nexus Pharmaceuticals, Inc. announced today the immediate availability in the United States for Arsenic Trioxide Injection. Nexus Pharmaceuticals’ Arsenic Trioxide Injection is available as 10mg per 10mL vial for injection.

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The product is the AP rated generic alternative of TRISENOX® indicated for relapsed or refractory acute promyelocytic leukemia.

“The approval of generic Arsenic Trioxide injection continues to show Nexus’s commitment in providing access to affordable critical-need generic injectables,” said Chief Commercial Officer Omair Ahmed. “Collectively, as drug manufacturers and healthcare providers, we have a commitment to patients to ensure they are receiving affordable drugs they need, when they need them, which is why we make it our highest priority to be a reliable partner in supplying critical need drugs.”

About Arsenic Trioxide Injection

Arsenic Trioxide Injection is indicated for induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.

About Nexus Pharmaceuticals Inc.

Nexus Pharmaceuticals, a US-based healthcare company, specializes in innovative processes to make difficult-to-manufacture specialty and generic drugs that are easier to use, less labor intensive, and more streamlined in practice. Nexus ensures that its high-quality FDA-approved drugs fulfill a critical unmet medical need and delivers dependable life-saving treatment options when and where they’re needed most.

Important Safety Information

WARNING: DIFFERENTIATION SYNDROME AND CARDIAC CONDUCTION ABNORMALITIES

See full prescribing information for complete boxed warning.

• Patients treated with Arsenic Trioxide Injection may develop differentiation syndrome, which can be fatal. If symptoms occur, initiate high-do se steroids immediately and monitor hemodynamics.

• Arsenic Trioxide Injection can cause QT interval prolongation and ventricular arrhythmia, which can be fatal. Before administering Arsenic Trioxide Injection, assess the QT interval, correct electrolyte abnormalities, and consider discontinuing drugs known to prolong QT interval. Do not administer Arsenic Trioxide Injection to patients with ventricular arrhythmia or prolonged QTcF.

CONTRAINDICATIONS

Hypersensitivity to arsenic.

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Monitor hepatic function tests at least twice weekly during arsenic trioxide injection therapy.

Carcinogenesis: Arsenic trioxide is a human carcinogen. Monitor patients for the development of second primary malignancies.

Embryo-Fetal Toxicity: Can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception.

ADVERSE REACTIONS

The most common adverse reactions (greater than 30%) were leukocytosis, neutropenia, thrombocytopenia, nausea, vomiting, diarrhea, abdominal pain, hepatic toxicity, fever, rigors, fatigue, insomnia, tachycardia, QTc prolongation, e de ma, hyperglycemia, hypokalemia, hypomagnesemia, dyspnea, cough, rash or itching, sore throat, arthralgia, headaches, paresthesia and dizziness.

To report SUSPECTED ADVERSE REACTIONS, contact Lambda Therapeutics Limited (Toll Free Number: 1-855-642-2594 or by email: safety@lambda-cro.com) or FDA at 1-800-FSA-1088 or www.fda.gov/medwatch.

This Important Safety Information does not include all the information needed to use Arsenic Trioxide Injection safely and effectively. Full prescribing information is available at https://nexuspharma.net/products/arsenic-trioxide-injection.

TRISENOX^® is a registered trademark of Teva Pharmaceutical Industries Ltd.

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