SPORANOX ORAL SOLUTION 10 MG/ML [SIN09823P]

Product Info

SPORANOX ORAL SOLUTION 10 MG/ML

[SIN09823P]

Indications
SPORANOX® oral solution is indicated:

• For the treatment of oral and/or esophageal candidosis in HIV-positive or other immunocompromised patients.

• As prophylaxis of deep fungal infections, in patients with hematological malignancy or undergoing bone marrow transplant, and who are expected to become neutropenic (i.e. < 500 cells/microlitre).

• For empiric therapy of febrile neutropenic patients with suspected systemic mycoses as follow-up therapy to SPORANOX® IV.

Dosage and Administration
For optimal absorption, SPORANOX® oral solution should be taken without food (patients are advised to refrain from eating for at least 1 hour after intake).

For the treatment of oral and/or esophageal candidosis, the oral solution should be swished around the oral cavity (approx. 20 seconds) and swallowed. There should be no rinsing after swallowing.

Treatment of oral candidosis
200 mg (2 measuring cups, i.e. 20 mL) per day in two intakes, or alternatively in one intake, for 1 week. If there is no response after 1 week, treatment should be continued for another week.

Treatment of esophageal candidosis
100 mg (1 measuring cup, i.e. 10 mL) daily for a minimum treatment of three weeks. Treatment should continue for 2 weeks following resolution of symptoms. Doses up to 200 mg (2 measuring cups, i.e. 20 mL) per day may be used based on the clinical response of the patient.

Treatment of fluconazole resistant oral and/or esophageal candidosis
100 to 200 mg (1–2 measuring cups) twice daily for 2 weeks. If there is no response after 2 weeks, treatment should be continued for another 2 weeks. The 400 mg daily dose should not be used for longer than 14 days if there are no signs of improvement.

Prophylaxis of fungal infections
5 mg/kg per day administered in two intakes. In clinical trials, prophylaxis treatment was started immediately prior to the cytostatic treatment and generally one week before transplant procedure. Treatment was continued until recovery of neutrophils (i.e. > 1000 cells/microlitre).

Empiric therapy of febrile neutropenic patients with suspected systemic mycoses
Treatment should be started with SPORANOX® IV. The recommended dose of SPORANOX® IV is 200 mg b.i.d. for four doses, followed by 200 mg once daily for up to 14 days. Each intravenous dose should be infused over 1 hour. Treatment should be continued with SPORANOX® oral solution 200 mg (20 mL) b.i.d. until resolution of clinically significant neutropenia. The safety and efficacy of SPORANOX® use exceeding 28 days in empiric therapy of febrile patients with suspected systemic mycoses is not known.

Special populations

Pediatrics
Clinical data on the use of SPORANOX® oral solution in pediatric patients are limited. The use of SPORANOX® oral solution in pediatric patients is not recommended unless it is determined that the potential benefit outweighs the potential risks (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Prophylaxis of fungal infections: there are no efficacy data available in neutropenic children. Limited safety experience is available with a dose of 5 mg/kg per day administered in two intakes. The incidence of adverse events such as diarrhea, abdominal pain, vomiting, fever, rash and mucositis was higher than in adults. However, it is not clear to what extent this is attributable to SPORANOX® oral solution or the chemotherapy.

Elderly
Clinical data on the use of SPORANOX® oral solution in elderly patients are limited. It is advised to use SPORANOX® oral solution in these patients only if it is determined that the potential benefit outweighs the potential risks. In general, it is recommended that the dose selection for an elderly patient should be taken into consideration, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment
Limited data are available on the use of oral itraconazole in patients with hepatic impairment. Caution should be exercised when this drug is administered in this patient population (see Pharmacokinetic Properties – Special populations, Hepatic impairment – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment
Limited data are available on the use of oral itraconazole in patients with renal impairment. The exposure of itraconazole may be lower in some patients with renal insufficiency. Caution should be exercised when this drug is administered in this patient population and adjusting the dose may be considered (see Pharmacokinetic Properties – Special populations, Renal impairment – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Contraindications

• SPORANOX® oral solution is contraindicated in patients with known hypersensitivity to itraconazole or to any of the excipients.

• Co-administration of a number of CYP3A4 substrates is contraindicated with SPORANOX® oral solution. Increased plasma concentrations of these drugs, caused by coadministration with itraconazole, may increase or prolong both therapeutic and adverse effects to such an extent that a potentially serious situation may occur. For example, increased plasma concentrations of some of these drugs can lead to QT prolongation and ventricular tachyarrhythmias including occurrences of torsade de pointes, a potentially fatal arrhythmia. Some specific examples are listed in Interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• SPORANOX® oral solution should not be administered to patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF except for the treatment of life-threatening or other serious infections (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• SPORANOX® oral solution must not be used during pregnancy (except for life-threatening cases) (see Pregnancy, Breast-feeding and Fertility – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Women of childbearing potential taking SPORANOX® oral solution should use contraceptive precautions. Highly effective contraception should be continued until the menstrual period following the end of SPORANOX® oral solution therapy.