The FDA has approved the new drug application for Tolsura (SUBA-itraconazole, Mayne Pharma). SUBA-itraconazole is indicated for the treatment of certain systemic fungal infections in adult patients.
The new formulation of traconazole is indicated for the treatment of blastomycosis, pulmonary and extrapulmonary; histoplasmosis, including chronic cavitary pulmonary disease and disseminated, nonmeningeal histoplasmosis; and aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or refractory to amphotericin B therapy.
These serious infections most commonly occur in vulnerable or immunocompromised patients, for example, those with a history of cancer, transplants, HIV/AIDS, or chronic rheumatic disorders.
Among the most common adverse reactions are nausea, rash, vomiting, edema, headache, diarrhea, fatigue, fever, pruritus, and hypertension.
SUBA-itraconazole 65-mg tablets are expected to be available in January 2019.