HIGHLIGHTS OF PRESCRIBING INFORMATION
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 tohealthy human volunteers and dogs, negative inotropic effectswere seen.
If signs or symptoms of congestive heart failureoccur or worsen during administration of TOLSURA, reassessthe benefit-risk of continuing treatment.
• Drug Interactions
o Co-administration of certain drugs that are metabolized byhuman CYP3A4 enzymes are contraindicated withTOLSURA because plasma concentrations of such drugsare increased.
o Co-administration with colchicine, fesoterodine andsolifenacin is contraindicated in subjects with varyingdegrees of renal or hepatic impairment.
o Co-administration with eliglustat is contraindicated in pooror intermediate metabolizers of CYP2D6 and in subjectstaking strong or moderate CYP2D6 inhibitors.
o Increased plasma concentrations of some of these drugs canlead to QT prolongation and ventricular tachyarrhythmiasincluding occurrences of torsades de pointes, a potentiallyfatal arrhythmia.
INDICATIONS AND USAGE
TOLSURA is an azole antifungal indicated for the treatment of the followingfungal infections in immunocompromised and non-immunocompromisedadult patients (1):
• Blastomycosis, pulmonary and extrapulmonary
• Histoplasmosis, including chronic cavitary pulmonary disease anddisseminated, non-meningeal histoplasmosis, and
• Aspergillosis, pulmonary and extrapulmonary, in patients who areintolerant of or who are refractory to amphotericin B therapy.
Limitations of Use:
TOLSURA is not indicated for the treatment of onychomycosis.
TOLSURA is NOT interchangeable or substitutable with other itraconazoleproducts.
DOSAGE AND ADMINISTRATION
• Blastomycosis and Histoplasmosis - 130 mg to 260mg daily.
• Aspergillosis - 130 mg to 260 mg daily.
• See full prescribing information for additional dosing for lifethreateningsituations.
• TOLSURA must be administered with food.
• Swallow whole. Do not chew crush or break.
DOSAGE FORMS AND STRENGTHS
Capsules: 65mg
CONTRAINDICATIONS
• Co-administration with certain drugs that either affect metabolism ofitraconazole or whose metabolism is affected by itraconazole.
• Hypersensitivity to itraconazole.
WARNINGS AND PRECAUTIONS
• Hepatotoxicity: Serious hepatotoxicity, including liver failure anddeath were reported with the use of itraconazole. Discontinue treatment if signs of liver dysfunction occur.
• Cardiac Dysrhythmias: Life-threatening cardiac dysrhythmias and/orsudden death have occurred in patients using certain drugs that aremetabolized by human CYP450 enzymes concomitantly with oralitraconazole and/or other CYP3A4 inhibitors.
• Peripheral Neuropathy: This has been reported in patients on long-termtherapy with itraconazole. Monitor and promptly eva luate neurologicsymptoms.
• Hearing Loss: Reversible