Drug Information for SPORANOX (ITRACONAZOLE) ORAL SOLUTION (Ortho Biotech Products, L.P.): ADVERSE REACTIONS

SPORANOX^® has been associated with rare cases of serious hepatotoxicity, including liver failure and death. Some of these cases had neither pre-existing liver disease nor a serious underlying medical condition. If clinical signs or symptoms develop that are consistent with liver disease, treatment should be discontinued and liver function testing performed. The risks and benefits of SPORANOX^® use should be reassessed. (See WARNINGS: Hepatic Effects and PRECAUTIONS: General and Information for Patients.)

Adverse events considered at least possibly drug related in a clinical trial of empiric therapy in 384 febrile, neutropenic patients (192 treated with SPORANOX^® and 192 with amphotericin B) with suspected fungal infections are listed in Table 2 below. Patients received a regimen of SPORANOX^® Injection followed by SPORANOX^® Oral Solution. The dose of SPORANOX^® Injection was 200 mg twice daily for the first two days followed by a single daily dose of 200 mg for the remainder of the intravenous treatment period. The majority of patients received between 7 and 14 days of SPORANOX^® Injection. The dose of SPORANOX^® Oral Solution was 200 mg (20 mL) b.i.d. for the remainder of therapy.

The following additional adverse events considered at least possibly related occurred in between 1 and 2% of patients who received SPORANOX^® Injection and Oral Solution: constipation, hypophosphatemia, gamma-GT increased, erythematous rash, pruritus, dizziness, tremor, and pulmonary infiltration.

U.S. adverse experience data are derived from 350 immunocompromised patients (332 HIV seropositive/AIDS) treated for oropharyngeal or esophageal candidiasis. Table 3 below lists adverse events reported by at least 2% of patients treated with SPORANOX^® Oral Solution in U.S. clinical trials. Data on patients receiving comparator agents in these trials are included for comparison.

Treated Patients in U.S. Clinical Trials (Total)

Adverse events reported by less than 2% of patients in U.S. clinical trials with SPORANOX^® included: adrenal insufficiency, asthenia, back pain, dehydration, dyspepsia, dysphagia, flatulence, gynecomastia, hematuria, hemorrhoids, hot flushes, implantation complication, infection unspecified, injury, insomnia, male breast pain, myalgia, pharyngitis, pruritus, rhinitis, rigors, stomatitis ulcerative, taste perversion, tinnitus, upper respiratory tract infection, vision abnormal, and weight decrease. Edema, hypokalemia and menstrual disorders have been reported in clinical trials with itraconazole capsules.

Worldwide post-marketing experiences with the use of SPORANOX^® (all formulations) include very rare reports (<1/10,000) of the adverse events listed below:

There is limited information on the use of SPORANOX^® during pregnancy. Cases of congenital abnormalities including skeletal, genitourinary tract, cardiovascular and ophthalmic malformations as well as chromosomal and multiple malformations have been reported during post-marketing experience. A causal relationship with SPORANOX^® has not been established. (See CLINICAL PHARMACOLOGY: Special Populations, CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS: Drug Interactions for more information.)