TOLSURA is an evolution in antifungal therapy

The Tolsura Difference

TOLSURA is an orally administered antifungal agent with the active ingredient itraconazole, designed with Mayne Pharma’s unique SUBA™ technology1,2

Conventional itraconazole 100 mg capsules have poor absorption and erratic bioavailability

Absorption of conventional itraconazole capsules can widely vary depending on the pH of the gastric environment and therefore must be taken with a full meal10

Blood levels of conventional itraconazole capsules can vary as much as 15-fold11

Itraconazole capsules have been relied on due to their efficacy; however, the 100 mg formulation is unpredictable, due to 55% bioavailability and high interpatient variability10,12

SUBA™ technology delivers approximately double the bioavailability of conventional itraconazole capsules in a smaller dose2

A unique spray-drying technology that improves the bioavailability of poorly soluble drugs2

Conventional itraconazole

Itraconazole drug substance prior to processing

TOLSURA (itraconazole treated with SUBA™ technology)

SUBA™ itraconazole solid dispersions containing 40% itraconazole: 60% HP-50

The SUBA™ process produces microencapsulated nanoparticles of itraconazole dispersed in a polymer matrix, which are less soluble in stomach acid. This creates significantly improved solubility in the higher pH of the upper small intestine, resulting in improved absorption.

Learn more about SUBA™ Technology

TOLSURA 65 mg capsules have been developed to provide1,2:

1

Improved bioavailability

2

Reduced variability in plasma levels between patients

3

Less potential for accumulation of unabsorbed drug in the gastrointestinal tract

4

A dosing option that works even when patients are taking a PPI*

*Co-administration of PPIs, including omeprazole, with TOLSURA increases the systemic exposure to itraconazole. Monitor for adverse reactions.

The bioavailability of TOLSURA 65 mg capsules is approximately double that of conventional 100 mg itraconazole capsules.1

Although the active substance, pharmaceutical form, and route of administration are the same, due to the increased drug absorption seen with TOLSURA 65 capsules, it should not be used interchangeably with other formulations of itraconazole.1

Indicated for multiple fungal infections

TOLSURA 65 mg capsules

TOLSURA (itraconazole) 65 mg Capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients:

Blastomycosis

pulmonary and extrapulmonary

Histoplasmosis

including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis

Aspergillosis

pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy

See the consistent delivery of TOLSURA

TOLSURA bioavailability

Dosing and administration for TOLSURA

Dosing