Xigduo XR(dapagliflozin plus metformin hydrochloride fixed-dose combination)

Xigduo XR is a fixed-dose combination of dapagliflozin and metformin hydrochloride. The absolute oral bioavailability of dapagliflozin is 78%, with a high-fat meal reducing its Cmax by 50%. Dapagliflozin is 91% protein-bound and has a mean plasma terminal half-life of 12.9 hours. Metformin has an absolute bioavailability of 50-60%, with food reducing its absorption by 50%. Its plasma elimination half-life is 6.2 hours, and its blood elimination half-life is 17.6 hours.

In clinical trials, Xigduo XR demonstrated reductions in HbA1c. One study showed a mean change from baseline of -2.0%, with a difference of -0.5% compared to dapagliflozin alone and -0.5% compared to metformin alone. Another study reported a mean change from baseline of -2.1%, with a difference of -0.9% compared to dapagliflozin alone. Discontinuation due to adverse events was 4% for DAPA 10 mg + MET and 2% for DAPA 5 mg + MET. Notable safety findings included female genital mycotic infections (9.4% for Dapagliflozin 5 mg and Metformin, 9.3% for Dapagliflozin 10 mg and Metformin) and urinary tract infections (3.6% for Placebo and Metformin).

The NDA number for Xigduo XR is 205649. While dapagliflozin itself is approved, Xigduo was not approved at the time of this review. A shelf-life recommendation for the fixed-dose combination is 24 months.