The pharmaceutical company Mayne Pharma announces the availability of Tolsura 65mg capsule in the United States. The drug was approved by the Food and Drug Administration in December 2018 for the treatment of systemic fungal infections including blastomycosis (pulmonary and extrapulmonary), histoplasmosis (including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis), and aspergillosis (pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy).
Tolsura is supplied as 65mg capsules in 60-count bottles.
“We are very pleased to launch TOLSURA – a new formulation of itraconazole incorporating Mayne Pharma’s proprietary SUBA-technology to improve the bioavailability of poorly soluble drugs. Tolsura provides a new treatment option for patients and physicians fighting these life-threatening fungal infections. This launch has enabled Mayne Pharma to establish a new institutional sales team focused on hospital-based infectious disease specialists. We look forward to bringing further specialty product innovations to market over the coming years with our pipeline of products under development,” said Scott Richards, CEO of Mayne Pharma said in a press release.
Tolsura, which contains the azole antifungal itraconazole, is formulated using the Company’s proprietary SUBA (SUper-BioAvailable) technology which improves the bioavailability of poorly soluble drugs. It is not interchangeable or substitutable with other itraconazole products because of the differences in dosing.
- Blastomycosis, pulmonary and extrapulmonary
- Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and
- Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy.
Limitations of Use:
- Tolsura is not indicated for the treatment of onychomycosis
- Tolsura is NOT interchangeable or substitutable with other itraconazole products
- Co-administration with certain drugs that either affect the metabolism of itraconazole or whose metabolism is affected by itraconazole.
- Hypersensitivity to itraconazole
Warnings and Precautions
- Hepatotoxicity: Serious hepatotoxicity, including liver failure and death were reported with the use of itraconazole. Discontinue treatment if signs of liver dysfunction occur.
- Hearing loss: Reversible or permanent has been reported in patients. Discontinue treatment if hearing loss occurs.
- Peripheral Neuropathy: This has been reported in patients on long-term therapy with itraconazole. Monitor and promptly evaluate neurologic symptoms.
- Cardia Dysrhythmias: Life-threatening cardiac dysrhythmias and/or sudden death have occurred in patients using certain drugs that are metabolized by human CYP450 enzymes concomitantly with
oral itraconazole and/or other CYP3A4 inhibitors.
Most common adverse reactions (incidence ≥ 1%) are nausea, rash, vomiting, edema, headache, diarrhea, fatigue, fever, pruritus, hypertension, abnormal hepatic function, abdominal pain, dizziness, hypokalemia, anorexia, malaise, decreased libido, somnolence, albuminuria, impotence.