Coadministration of iron supplements (fasted intake) decreased dolutegravir AUC, Cmax and C24 by 54%, 57% and 56%, respectively, due to complex binding to polyvalent ions. The stated reductions in dolutegravir exposure were observed with the intake of dolutegravir during fasted conditions. In fed state, the changes in exposure following intake together with iron supplements were modified by the food effect, resulting in an exposure similar to that obtained with dolutegravir administered in the fasted state. When taken with food, Dovato and supplements or multivitamins containing iron can be taken at the same time. If Dovato is taken in a fasted state, such supplements should be taken a minimum 2 hours after or 6 hours before the intake of Dovato.

Coadministration may decrease dolutegravir concentrations. Coadministration of ferrous fumarate (324 mg) and dolutegravir (50 mg single dose) was studied under fasted, fed and temporally separated conditions. Simultaneous coadministration to fasting subjects decreased dolutegravir Cmax, AUC and Cmin by 57%, 54% and56%, respectively. Simultaneous coadministration to fed subjects increased dolutegravir Cmax by 3%, decreased AUC by 2%, and had no effect on Cmin. Coadministration of ferrous fumarate 2 h after dolutegravir decreased dolutegravir Cmax, AUC and Cmin by 1%, 5% and 8%, respectively. When taken with food, Dovato and supplements containing iron can be taken at the same time. Under fasting conditions, Dovato should be taken 2 hours before or 6 hours after taking supplements containing iron.

Coadministration of ferrous fumarate (324 mg) and dolutegravir (50 mg single dose) was studied under fasted, fed and temporally separated conditions. Simultaneous coadministration to fasting subjects (n=11) decreased dolutegravir Cmax, AUC and Cmin by 57%, 54% and 56%, respectively. Simultaneous coadministration to fed subjects (n=11) increased dolutegravir Cmax by 3%, decreased AUC by 2%, and had no effect on Cmin. Coadministration of ferrous fumarate 2 h after dolutegravir (n=10) decreased dolutegravir Cmax, AUC and Cmin by 1%, 5% and 8%, respectively. Dolutegravir and iron supplements can be co-administered if taken with a meal. Under fasted conditions, dolutegravir should be administered 2 hours before or 6 hours after iron supplements.