Sidapvia Overdosage

Dapagliflozin/sitagliptin combination: There is no information available on overdose with SIDAPVIA. Experience with the individual mono components are described as follows.
Dapagliflozin: Orally administered dapagliflozin has been shown to be safe and well tolerated in healthy subjects at single doses up to 500 mg (50 times the MRHD). These subjects had detectable glucose in the urine for a dose related period of time (at least 5 days for the 500 mg dose) with no reports of dehydration, hypotension, or electrolyte imbalance, and with no clinically meaningful effect on QTc interval. The incidence of hypoglycaemia for patients treated with dapagliflozin was similar to placebo. In clinical studies where once daily doses of up to 100 mg (10 times the MRHD) of dapagliflozin were administered for 2 weeks in healthy subjects and type 2 diabetes patients, the incidence of hypoglycaemia for subjects administered dapagliflozin was slightly higher than placebo and was not dose related. Rates of adverse events including dehydration or hypotension for patients treated with dapagliflozin were similar to placebo, and there were no clinically meaningful dose related changes in laboratory parameters including serum electrolytes and biomarkers of renal function.
In the event of an overdose, appropriate supportive treatment should be initiated as dictated by the patient's clinical status. The removal of dapagliflozin by haemodialysis has not been studied.
Sitagliptin: During controlled clinical trials in healthy subjects, single doses of up to 800 mg sitagliptin were administered. Minimal increases in QTc, not considered to be clinically relevant, were observed in one study at a dose of 800 mg sitagliptin. There is no experience with doses above 800 mg in clinical studies. In Phase 1 multiple dose studies, there were no dose-related clinical adverse reactions observed with sitagliptin with doses of up to 600 mg per day for periods of up to 10 days and 400 mg per day for periods of up to 28 days.
In the event of an overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring (including obtaining an electrocardiogram), and institute supportive therapy if required.
Sitagliptin is modestly dialysable. In clinical studies, approximately 13.5% of the dose was removed over a 3- to 4-hour haemodialysis session. Prolonged haemodialysis may be considered if clinically appropriate. It is not known if sitagliptin is dialysable by peritoneal dialysis.