TOLSURA provides a predictable and reliable treatment1

TOLSURA consistently maintains therapeutic range1

Traditionally, serum trough levels of itraconazole below 1000 ng/mL are predictive of therapeutic failure2

It has also been shown that levels above 1200 ng/mL are associated with stabilization or resolution of fungal infections3,4

When Ctrough was corrected for dose administration, the relative bioavailability of TOLSURA was nearly 2x that of conventional itraconazole capsules

81% of subjects treated with TOLSURA achieved a Ctrough mean level of >1000 ng/mL compared to 44% taking conventional itraconazole capsules5

Relative bioavailability of TOLSURA to conventional itraconazole capsules1

1500140013001200110010009008007006005004003002001000Plasma Itraconazole (ng/mL)Time relative to first drug administration (day)1514131211109876543210TOLSURA 2 x 65 mg capsulesSporanox®2 x 100 mg capsules

The bioavailability of TOLSURA at steady state, under fed conditions, was determined by a comparative pharmacokinetic study with 100 mg itraconazole capsules. 16 healthy subjects were dosed orally immediately after a meal twice daily for 14.5 days.1

Bioavailability of TOLSURA vs conventional itraconazole capsules

See More +See Less −

Pharmacokinetics of TOLSURA and conventional itraconazole capsules in 16 healthy patients

Parameter*
AUC0-tau (hr•ng/mL)

TOLSURA
130 mg
twice daily
(2 x 65 mg Capsules)

15600 ± 3700

Itraconazole
200 mg
twice daily
(2 x 100 mg Capsules)

14900 ± 3800

Parameter*
Ctrough (ng/mL)

TOLSURA
130 mg
twice daily
(2 x 65 mg Capsules)

1200 ± 400

Itraconazole
200 mg
twice daily
(2 x 100 mg Capsules)

1000 ± 300

Parameter*
Cmax,ss (ng/mL)

TOLSURA
130 mg
twice daily
(2 x 65 mg Capsules)

1600 ± 400

Itraconazole
200 mg
twice daily
(2 x 100 mg Capsules)

1500 ± 400

Parameter*
Tmax,ss (h)

TOLSURA
130 mg
twice daily
(2 x 65 mg Capsules)

7 (1–10)

Itraconazole
200 mg
twice daily
(2 x 100 mg Capsules)

5 (1–8)

*Geometric mean ± standard deviation

†Tmax presented as median (range)

Patients with a mean Ctrough level of >1000 ng/mL1

100%50%0%TOLSURA 65 mgItraconazole 100 mg81%44%

In a clinical study, the absolute bioavailability for patients receiving TOLSURA was 85% compared to 51% for those receiving conventional itraconazole capsules1

The bioavailability of TOLSURA at steady state, under fed conditions, was determined by a comparative pharmacokinetic study with 100 mg itraconazole capsules. 16 healthy subjects were dosed orally immediately after a meal, twice-daily for 14.5 days.

Discover what makes TOLSURA different

SUBA™ technology

Dosing and administration for TOLSURA

Dosing

View the safety and tolerability profile

Safety