Sidapvia Adverse Reactions

Clinical Trials: The safety of the combined use of 10 mg dapagliflozin and 100 mg sitagliptin has been evaluated in a placebo-controlled Phase 3 clinical study of 48 weeks duration. In this study, a total of 225 patients with type 2 diabetes mellitus received dapagliflozin as add-on therapy to sitagliptin (with or without metformin), and 226 received placebo plus sitagliptin (with or without metformin). No additional adverse reactions were identified for the combined use of dapagliflozin and sitagliptin compared with those reported for the individual components (see Table 3).
The safety profile of dapagliflozin in type 2 diabetes mellitus has been evaluated in clinical studies including more than 15,000 subjects treated with dapagliflozin. The incidence of adverse reactions was determined using a pre-specified pool of patients from 13 short term (mean duration 22 weeks), placebo-controlled studies in type 2 diabetes. Across these 13 studies, 2,360 patients were treated once daily with dapagliflozin 10 mg and 2,295 were treated with placebo (either as monotherapy or in combination with other antidiabetic therapies, including add-on therapy to sitagliptin).
Adverse drug reactions: The adverse drug reactions in patients treated with dapagliflozin 10 mg (with or without other antidiabetic medications, including add-on therapy to sitagliptin) and sitagliptin (as monotherapy) in clinical trials are shown in Table 3. Adverse drug reactions are organised by MedDRA System Organ Class (SOC). Frequencies of occurrence of adverse reactions are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data). (See Table 3.)


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Post-marketing experience: The adverse drug reactions identified during post-marketing experience with the individual mono-components are shown in Table 4. Because these reactions are reported voluntarily from a population of an uncertain size, it is not always possible to reliably estimate their frequency. Adverse drug reactions are organised by MedDRA System Organ Class (SOC). Frequencies of occurrence of adverse reactions are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data). (See Table 4.)


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Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via: Pusat Farmakovigilans/MESO Nasional Direktorat Pengawasan.