Post-marketing study to assess the safety, tolerability and effectiveness of Fungisome: an Indian liposomal XXXX preparation.

@entity1 @entity2379 @entity234 @entity364 @entity1178 @entity1398
BACKGROUND: In May 2003, an indigenously developed liposomal @entity2379 (Fungisome) was introduced in the Indian market for the treatment of @entity364 and @entity234 . The present post marketing study assessed the safety and effectiveness of Fungisome in actual clinical practice. SETTING AND DESIGN: Retrospective post marketing surveillance from four cities of India. METHODS: The present study was carried out for a period of 6 months ( @entity1178 -Nov 2004), a year after the introduction of the drug. A list of doctors who had prescribed and procured the drug was obtained from the distributor. Consent to participate and scrutinize the @entity1 ' source notes were obtained from the concerned doctors. All @entity1 who had received Fungisome treatment were included. Data was collected from the @entity1 's source notes on a predesigned proforma. They were then analyzed by descriptive statistics. Cost of Fungisome was calculated on the basis of dose used and number of days of treatment. RESULTS: Data were available for 109/144 @entity1 from 35/40 physicians. Fungisome was administered at 1-3 mg/kg/day for 7-76 days. No serious adverse events related to the drug were observed in the study. Mild infusion-related adverse events were reported in 40 (36%), moderate in 11 (10%) of @entity1 and severe in 2 (1.8%). None of the adverse events were certain to Fungisome exposure, 12 (11%) were probable, 28 (25 %) were possible, and 13 (11.9%) were unlikely. Of the 91 assessable @entity1 (received at least eight doses of Fungisome) for efficacy complete response was observed in 67 (73.6%), 16 (17.5%) had partial responses, and 8 (8.7%) of @entity1 had no response. The acquisition cost per day and per course treatment of different @entity364 ranged from (apprx) Rs 4500-8000 and 0.9-2.1 lakh respectively. CONCLUSION: This postmarketing study documents the safety, tolerability, effectiveness and cost advantage of indigenously developed liposomal @entity2379 in the treatment of @entity364 and @entity1398 in actual clinical practice.
