Predicted safety profile of TOLSURA

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.1

Adverse events seen with conventional itraconazole capsules in clinical studies (≥1%)1

Body System/Adverse Reaction

Incidence (%) (N=602)

Gastrointestinal

Nausea

Vomiting

Diarrhea

Abdominal Pain

Anorexia

 

11

5

3

2

1

Body as a Whole

Edema

Fatigue

Fever

Malaise

 

4

3

3

1

Skin and Appendages

Rash*

Pruritus

 

9

3

Central/PeripheralNervous System

Headache

Dizziness

 

4

2

Psychiatric

Libido Decreased

Somnolence

 

1

1

Cardiovascular

Hypertension

 

3

Metabolic/Nutritional

Hypokalemia

 

2

Urinary System

Albuminuria

 

1

Liver and Biliary System

Hepatic Function Abnormal

 

3

Reproductive System, Male

Impotence

 

1

*Rash tends to occur more frequently in immunocompromised patients receiving immunosuppressive medications.

Infrequently reported adverse events and discontinuation rates seen with conventional itraconazole capsules1

Adverse events infrequently reported in all studies included constipation, gastritis, depression, insomnia, tinnitus, menstrual disorder, adrenal insufficiency, gynecomastia, and male breast pain.

Treatment was discontinued in 10.5% of patients due to adverse events. The median duration before discontinuation of therapy was 81 days (range: 2 to 776 days).

Dosing and administration for TOLSURA

Dosing

See the consistent delivery of TOLSURA

TOLSURA bioavailability