acin is contraindicatedin subjects with varying degrees of renal or hepatic impairment, and
o Co-administration with eliglustat is contraindicated in subjects that are poor orintermediate metabolizers of CYP2D6 and in subjects taking strong or moderate
CYP2D6 inhibitors.
o Increased plasma concentrations of some of these drugs caused by coadministrationwith TOLSURA can lead to QT prolongation and/or ventriculartachyarrhythmias, including occurrences of torsades de pointes, a potentially fatalarrhythmia [see Contraindications (4.1), Warnings and Precautions (5.4) and DrugInteractions (7.1)].
1 INDICATIONS AND USAGE
TOLSURA is indicated for the treatment of the following fungal infections inimmunocompromised and non-immunocompromised adult patients:
• Blastomycosis, pulmonary and extrapulmonary
• Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, nonmeningealhistoplasmosis, and
• Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who arerefractory to amphotericin B therapy.
Specimens for fungal cultures and other relevant laboratory studies (wet mount, histopathology,serology) should be obtained before therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known;
however, once these results become available, anti-fungal therapy should be adjusted
accordingly
Limitations of Use:
TOLSURA is not indicated for the treatment of onychomycosis.
TOLSURA is NOT interchangeable or substitutable with other itraconazole products due to thedifferences in the dosing between TOLSURA and other itraconazole products. Therefore, followthe specific dosage recommendations for TOLSURA [see Dosage and Administration (2)].
2 DOSAGE AND ADMINISTRATION
TOLSURA must be administered with food.
TOLSURA capsules must be swallowed whole. Do not chew, crush or break TOLSURAcapsules.
Table 1 below describes the recommended dosage for TOLSURA.
Table 1: Dosage and Administration of TOLSURA
Indications Daily Dosing
Treatment of Blastomycosis and Histoplasmosis
Recommended dose 130 mg (2 x 65 mg capsules) once daily
If no obvious improvement, or there is evidence of progressive
fungal disease, the dose should be increased in 65 mg
increments to a maximum of 260 mg/day (130 mg (2 x 65 mg
capsules) twice daily). Doses above 130 mg/day should be
given in two divided doses.
Treatment of Aspergillosis
Recommended dose 130 mg (2 x 65 mg capsules) once daily
260 mg/day (130 mg (2 x 65 mg capsules) twice daily)
Treatment in Life-Threatening Situations
Although clinical studies did
not provide for a loading
dose, it is recommended,
based on pharmacokinetic
data, that a loading dose
should be used.
A loading dose of 130 mg (2 x 65 mg capsules) three timesdaily (390 mg/day) is recommended to be given for the first 3days, followed by the appropriate recommended dosing basedon indication. Treatment should be continued for a minimumof three months and until clinical parameters and laboratorytests indicate that the active fungal infection has subsided. Aninadequate period of treatment may lead to recurrence of activeinfection.
3 DOSAGE FORMS AND STRENGTHS
TOLSURA (itraconazole capsules) is available in a size 1, hard gelatin capsules with light bluecap and white body, imprinted with |
