Blastomycosis; Histoplasmosis; Aspergillosis
Tolsura (itraconazole) is an azole antifungal indicated for the treatment of certain fungal infections including blastomycosis, histoplasmosis and aspergillosis. TOLSURA (itraconazole capsules) is supplied in a size 1, hard gelatin capsules with light blue cap and white body, imprinted with "i-65" in black on the cap and containing 65 mg of itraconazole.
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 Controlled Room Temperature]. Dispense in a tight, light resistant container.
These highlights do not include all the information needed to use TOLSURA� safely and effectively. See full prescribing information for TOLSURA�.
TOLSURA� (itraconazole capsules), for oral use
Initial U.S. Approval: 1992
WARNING: CONGESTIVE HEART FAILURE and DRUG INTERACTIONS
See full prescribing information for complete boxed warning.
Congestive Heart Failure
TOLSURA can cause or exacerbate congestive heart failure (CHF). When itraconazole was administered intravenously to healthy human volunteers and dogs, negative inotropic effects were seen. If signs or symptoms of congestive heart failure occur or worsen during administration of TOLSURA, reassess the benefit-risk of continuing treatment. (5.1, 6).
Drug Interactions
Co-administration of certain drugs that are metabolized by human CYP3A4 enzymes are contraindicated with TOLSURA because plasma concentrations of such drugs are increased. (4.1, 5.4, 7.1)
Co-administration with colchicine, fesoterodine and solifenacin is contraindicated in subjects with varying degrees of renal or hepatic impairment. (4.1, 7.1)
Co-administration with eliglustat is contraindicated in poor or intermediate metabolizers of CYP2D6 and in subjects taking strong or moderate CYP2D6 inhibitors. (4.1, 7.1)
Increased plasma concentrations of some of these drugs can lead to QT prolongation and ventricular tachyarrhythmias including occurrences of torsades de pointes, a potentially fatal arrhythmia. (4.1, 5.4, 7.1)
INDICATIONS AND USAGE
TOLSURA is an azole antifungal indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised adult patients (1):
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 (1)
TOLSURA is NOT interchangeable or substitutable with other itraconazole products (1)
DOSAGE AND ADMINISTRATION
Blastomycosis and Histoplasmosis - 130 mg to 260 mg daily (2)
Aspergillosis - 130 mg to 260 mg daily (2)
See full prescribing information for additional dosing for life-threatening situations. (2)
TOLSURA must be administered with food. (2)
Swallow whole. Do not chew crush or break. (2)
DOSAGE FORMS AND STRENGTHS
Capsules: 65 mg (3)
CONTRAINDICATIONS
Co-administration with certain drugs that either affect metabolism of itraconazole or whose metabolism is affected by itraconazole. (4.1)
Hypersensitivity to itraconazole (4.2)
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 (5.1)
Cardiac 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. (4, 5.3, 5.4)
Peripheral Neuropathy: This has been reported in patients on long-term therapy with itraconazole. Monitor and promptly evaluate neurologic symptoms. (5.5)
Hearing Loss: Reversible or permanent has been reported in patients. Discontinue treatment if hearing loss occurs (5.6)
ADVERSE REACTIONS
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 (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Itraconazole is mainly metabolized through CYP3A4. Other drugs that either share this metabolic pathway or modify CYP3A4 activity may influence the pharmacokinetics of itraconazole. (4, 5, 7.1, 7.2)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 5/2019
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