.
14.4 Aspergillosis
Analyses were conducted on data from an open-label, “single-patient-use” protocol designed tomake itraconazole available in the U.S. for patients who either failed or were intolerant ofamphotericin B therapy (N=190). The findings were corroborated by two smaller open-label studies (N=31 combined) in the same patient population. Most adult patients were treated with a
daily dose of 200 (2 x 100 mg) to 400 (4 x 100 mg) mg, with a median duration of 3 months.
Results of these studies demonstrated substantial evidence of effectiveness of the 100 mgitraconazole capsules as a second-line therapy for the treatment of aspergillosis compared withthe natural history of the disease in patients who either failed or were intolerant of amphotericinB therapy.
16 HOW SUPPLIED/STORAGE AND HANDLING
TOLSURA (itraconazole capsules) is supplied in a size 1, hard gelatin capsules with light bluecap and white body, imprinted with “i-65” in black on the cap and containing 65 mg ofitraconazole.
TOLSURA capsules are supplied in bottles of 60 capsules, NDC 51862-462-60
Store at 25°C (77°F); excursions permitted 15°C to 30°C (59°F to 86°F) [see USP ControlledRoom Temperature]. Dispense in a tight, light resistant container.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Important Administration Instructions
Instruct the patients that TOLSURA:
• Cannot be interchanged or substituted with other itraconazole products.
• Must be swallowed whole and administered with food.
Congestive Heart Failure
Inform patients about the signs and symptoms of congestive heart failure. Instruct them todiscontinue TOLSURA and contact their healthcare provider immediately, if these signs orsymptoms occur during TOLSURA administration [see Warnings and Precautions (5.1)].
Hepatoxicity
Instruct patients to stop TOLSURA treatment immediately and contact their healthcare providerif any signs and symptoms suggestive of liver dysfunction develop. Such signs and symptomsmay include unusual fatigue, anorexia, nausea and/or vomiting, jaundice, dark urine, or palestools [see Warnings and Precautions (5.2)].
Use with Proton Pump Inhibitors and Potential Drug InteractionsAdvise patients to discuss with their physician the use of TOLSURA with proton pump
inhibitors, such as omeprazole. Instruct patients to contact their physician before taking anyother concomitant medications with TOLSURA to ensure there are no potential drug interactions[see Contraindications (4.1, 4.2), Warnings and Precautions (5.4) and Drug interactions (7.2)].
Hearing Loss
Instruct patients that hearing loss can occur with the use of TOLSURA. The hearing loss usually
resolves when treatment is stopped but can persist in some patients. Advise patients to inform
their healthcare provider if any hearing loss symptoms occur [see Warnings and Precautions
(5.6)].
Vision Problem
Instruct patients that dizziness or blurred/double vision can sometimes occur with TOLSURA.
Advise patients that if they experience these dizziness or blurred/double vision, they shouldcontact their healthcare provider, and instruct the patient not to drive or use machines [seeAdverse Reactions (6.1)].
Pregnancy
Advise patients to notify their physician if they become pregnant or intend to become p |
