New Jersey-based drug company Amneal Pharmaceuticals has launched a generic version of Trisenox (arsenic trioxide), which is used in patients with acute promyelocytic leukemia (APL), according to Pharma Times.
The drug is indicated for induction of remission and consolidation in APL patients who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy.
Arsenic trioxide is a small-molecule arsenic compound that has antineoplastic (anticancer) activity.
The drug’s exact mechanism of action is not completely understood, but it causes degradation of the promyelocytic leukemia protein or retinoic acid receptor-alpha (PML/RARa) fusion protein, according to PubMed.
The drug also induces apoptosis (cell death) in APL cells and in other tumor cell types. Furthermore, arsenic trioxide promotes cell differentiation and suppresses cell proliferation in tumor cells.
Common side effects of the drug include nausea, vomiting, diarrhea, abdominal pain, edema, fatigue, high blood glucose, cough, breathlessness, headaches, dizziness, and leukocytosis.
The drug comes with important safety information, as patients who have undergone treatment with arsenic trioxide reported differentiation syndrome, cardiac conduction abnormalities, and encephalopathy.
Arsenic trioxide is not advised in pregnant women as it can cause fetal harm. In men, the drug may impair fertility. Lactating mothers who undergo treatment with arsenic trioxide are advised not to breastfeed, as the drug can cause serious adverse reactions in newborns.
Arsenic trioxide injection comes in 10 mL single-dose vials. The route of administration is intravenous.
The first-ever generic version of Trisenox hit the market in October 2018. German-based healthcare company, Fresenius Kabi, announced the availability of generic arsenic trioxide injection on October 26, 2018.
Fresenius Kabi CEO John Ducker said at the time, “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.”
“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,” he added.
Other companies that develop generic versions of Trisenox include Amring, Ingenus, Nexus, Sti, and Zydus. Cephalon got the approval of Trisenox in October 2017.
