Active Ingredient: Caspofungin
Treatment of invasive aspergillosis in paediatric patients who are refractory to or intolerant of amphotericin B, lipid formulations of amphotericin B and/or itraconazole. Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
25 - 70 mg per m² of body surface area (BSA)
From 25 To 70 mg per m² of body surface area (BSA) once every day
70 mg per m² of body surface area (BSA)
50 mg per m² of body surface area (BSA)
In paediatric patients (12 months to 17 years of age), dosing should be based on the patient’s body surface area. For all indications, a single 70-mg/m² loading dose (not to exceed an actual dose of 70 mg) should be administered on Day 1, followed by 50 mg/m² daily thereafter (not to exceed an actual dose of 70 mg daily). If the 50-mg/m² daily dose is well tolerated but does not provide an adequate clinical response, the daily dose can be increased to 70 mg/m² daily (not to exceed an actual daily dose of 70 mg).
The safety and efficacy of caspofungin have not been sufficiently studied in clinical trials involving neonates and infants below 12 months of age. Caution is advised when treating this age group. Limited data suggest that caspofungin at 25 mg/m² daily in neonates and infants (less than 3 months of age) and 50 mg/m² daily in young children (3 to 11 months of age) can be considered.
Duration of empirical therapy should be based on the patient’s clinical response. Therapy should be continued until up to 72 hours after resolution of neutropaenia (ANC>500). Patients found to have a fungal infection should be treated for a minimum of 14 days and treatment should continue for at least 7 days after both neutropaenia and clinical symptoms are resolved.
Duration of treatment of invasive candidiasis should be based upon the patient’s clinical and microbiological response. After signs and symptoms of invasive candidiasis have improved and cultures have become negative, a switch to oral antifungal therapy may be considered. In general, antifungal therapy should continue for at least 14 days after the last positive culture.
Duration of treatment of invasive aspergillosis is determined on a case by case basis and should be based upon the severity of the patient’s underlying disease, recovery from immunosuppression, and clinical response. In general, treatment should continue for at least 7 days after resolution of symptoms.
The safety information on treatment durations longer than 4 weeks is limited. However, available data suggest that caspofungin continues to be well tolerated with longer courses of therapy (up to 162 days in adult patients and up to 87 days in paediatric patients).
It should be administered by slow intravenous infusion over approximately 1 hour.
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