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Tolsura FDA Approval History

Last updated by Judith Stewart, BPharm on Dec 12, 2018.

FDA Approved: Yes (First approved December 11, 2018)
Brand name: Tolsura
Generic name: itraconazole
Dosage form: Capsules
Company: Mayne Pharma US
Treatment for: Blastomycosis; Histoplasmosis; Aspergillosis

Tolsura (itraconazole) is an azole antifungal indicated for the treatment of certain fungal infections including blastomycosis, histoplasmosis and aspergillosis.

Tolsura is a patented formulation itraconazole which incorporates proprietary SUBA technology (SUper-BioAvailable) developed to improve the bioavailability of poorly soluble drugs.

The Tolsura product label includes a boxed warning advising the risks of serious side effects including the onset or worsening of congestive heart failure, and dangerous drug interactions.

Indications and Usage
Tolsura is 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.

Tolsura is NOT indicated for the treatment of onychomycosis.

Important Administration Instructions

  • Tolsura cannot be interchanged or substituted with other itraconazole products.
  • Tolsura capsules must be swallowed whole and taken with food.

Adverse Reactions
Common adverse reactions (incidence ≥ 1%) include nausea, rash, vomiting, edema, headache, diarrhea, fatigue, fever, pruritus, hypertension, abnormal hepatic function, abdominal pain, dizziness, hypokalemia, anorexia, malaise, decreased libido, somnolence, albuminuria, impotence.

Development timeline for Tolsura

Dec 11, 2018Approval FDA Approves Tolsura (SUBA┬«-itraconazole capsules) for the Treatment of Certain Fungal Infections

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.