On October 26, 2018 Fresenius Kabi reported the immediate availability in the United States of Arsenic Trioxide Injection in a 10 mg per 10 mL vial presentation (Press release, Fresenius, OCT 26, 2018, View Source [SID1234530213]).
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The product is the first-to-market generic of TRISENOX indicated for relapsed or refractory acute promyelocytic leukemia.
Fresenius Kabi is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. The company is a leading developer, manufacturer and provider of injected and infused medicines in the United States with expertise in producing affordable generic alternatives to more expensive brand-name drugs.
"With the introduction of Arsenic Trioxide Injection, Fresenius Kabi is pleased to continue to expand its broad oncology portfolio, providing patients and clinicians with access to affordable generic alternatives of vital medicines," said John Ducker, president and CEO of Fresenius Kabi USA. "We’re also pleased to bring back the 10 mg per 10 mL (1mg per mL) presentation of Arsenic Trioxide Injection – now in a vial – to provide a familiar alternative to clinicians."
About Arsenic Trioxide Injection
Arsenic Trioxide Injection is indicated for induction of remission and consolidation in patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the translocation or PML/RAR-alpha gene expression.
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-dose 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.
Arsenic Trioxide injection is contraindicated in patients with hypersensitivity to arsenic.
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.
Serious adverse reactions reported include: Differentiation Syndrome, cardiac conduction abnormalities, hepatotoxicity, carcinogenesis, and embryo-fetal toxicity. 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, edema, hyperglycemia, hypokalemia, hypomagnesemia, dyspnea, cough, rash or itching, sore throat, arthralgia, headaches, paresthesia and dizziness.
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-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. Please see accompanying full prescribing information (View Source) for ARSENIC TRIOXIDE INJECTION, including BOXED WARNING. Full prescribing information is also available at www.fresenius-kabi.co/us.