Tecentriq Receives New Indication
December 6, 2018Herzuma Approved as Biosimilar to Herceptin
December 14, 2018Tolsura Approved to Treat Fungal Infections
December 11, 2018 – The U.S. FDA has approved TolsuraTM (SUBA®-itraconazole), manufactured by Mayne Pharma Group, to treat certain serious fungal infections that typically occur in individuals who have weakened immune systems and are associated with high rates of fatality or long-term complications.
The drug is indicated for use in individuals who have blastomycosis (pulmonary and extrapulmonary), histoplasmosis (including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis), or aspergillosis (pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy). It uses Mayne’s SUBA technology, which is designed to improve the effectiveness of poorly soluble drugs. In clinical studies, Tolsura showed increased bioavailability and had more predictable effects compared to traditional oral formulations of its active ingredient, itraconazole.
Recommended dosing is 130mg to 260mg per day, based on individual patient needs. Tolsura should be taken with food. A black box warning indicates that Tolsura can cause or exacerbate congestive heart failure. The black box warning also cautions that Tolsura is contraindicated for use with:
- Certain drugs that are metabolized by human CYP3A4 enzymes;
- Colchicine, fesoterodine, and solifenacin in patients who have varying degrees of renal or hepatic impairment; and
- Eliglustat in patients who are poor or intermediate metabolizers of CYP2D6 and/or taking strong or moderate CYP2D6 inhibitors.
Increased plasma concentrations of some of these drugs can lead to QT prolongation and ventricular tachyarrhythmias, including occurrences of torsades de pointes, a potentially fatal arrhythmia.
Mayne Pharma plans to launch Tolsura in January 2019. Pricing plans have not yet been announced.
