New Indication for Trisenox
January 12, 2017 – The U.S. FDA has approved a new indication for Trisenox® (arsenic trioxide), manufactured by Teva. The drug is now indicated as a first-line treatment for adults with newly-diagnosed, low-risk acute promyelocytic leukemia (APL) characterized by t(15;17) translocation, or by PML/RAR-alpha gene expression. Trisenox was previously indicated to treat this patient population only after they had undergone treatment with chemotherapy.
Trisenox, which is believed to speed the death of APL cancer cells and encourage the development of normal blood cells, should be used in conjunction with tretinoin, which is believed to help stop APL cancer cells from proliferating. Recommended dosing for Trisenox is based on the patient’s weight and stage of treatment, as well as the indication.
A black box warning cautions that the use of Trisenox is associated with differentiation syndrome, a potentially fatal condition that requires close monitoring and treatment with high-dose steroids. The black box warning also states that Trisenox may cause prolonged QT intervals and ventricular arrhythmia, which can lead to fatal cardiovascular events. Patients’ QT intervals should be assessed before they begin treatment with Trisenox, and care taken to address any electrolyte abnormalities and to identify other drugs patients may be taking that can cause QT interval prolongation.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.