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TOLSURA® (SUBA®-itraconazole) Capsules, 65mg

Indications and Usage

TOLSURA is an azole antifungal indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised adult patients:

  • 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.
TOLSURA is NOT interchangeable or substitutable with other itraconazole products.

IMPORTANT SAFETY INFORMATION
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.
  • 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.
    • Co-administration with colchicine, fesoterodine and solifenacin is contraindicated in subjects with varying degrees of renal or hepatic impairment.
    • Co-administration with eliglustat is contraindicated in poor or intermediate metabolizers of CYP2D6 and in subjects taking strong or moderate CYP2D6 inhibitors.
    • 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.


Contraindications

  • Co-administration with certain drugs that either affect metabolism of itraconazole or whose metabolism is affected by itraconazole.
  • Hypersensitivity to itraconazole.

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.
  • Cardia 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.
  • Peripheral Neuropathy: This has been reported in patients on long-term therapy with itraconazole. Monitor and promptly evaluate neurologic symptoms.
  • Hearing loss: Reversible or permanent has been reported in patients. Discontinue treatment if hearing loss occurs.

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.

For additional safety and other information, please see Prescribing information

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.