Drug Interactions between baloxavir marboxil and citric acid/magnesium oxide/sodium picosulfate

ADJUST DOSING INTERVAL: Bowel cleansing products can increase the gastrointestinal transit rate. Oral medications administered within one hour of the start of administration of the bowel cleansing solution may be flushed from the gastrointestinal tract and not properly absorbed.

MANAGEMENT: Patients should be advised that absorption of oral medications may be impaired during bowel cleansing treatment. Oral medications (e.g., anticonvulsants, oral contraceptives, antidiabetic agents, antibiotics) should not be administered during and within one hour of starting bowel cleansing treatment whenever possible. However, if concomitant use cannot be avoided, monitoring for reduced therapeutic effects may be advisable.

GENERALLY AVOID: Coadministration with foods or medications that contain polyvalent cations such as dairy products, calcium-fortified beverages, certain laxatives, antacids, or oral supplements may decrease the plasma concentrations and therapeutic efficacy of baloxavir. The proposed mechanism is chelation of baloxavir by polyvalent cations, forming a complex that is poorly absorbed from the gastrointestinal tract. A significant decrease in baloxavir exposure was observed in monkeys when the prodrug, baloxavir marboxil, was coadministered with calcium, aluminum, magnesium, or iron. However, clinical data in humans are lacking.

When baloxavir marboxil was administered with food, baloxavir peak plasma concentration (Cmax) and systemic exposure (AUC) decreased by 48% and 36%, respectively, relative to administration under fasting. These changes are not considered clinically significant.

MANAGEMENT: Baloxavir marboxil may be taken with or without food. However, coadministration with dairy products, calcium-fortified beverages, or polyvalent cation-containing laxatives, antacids, or oral supplements (e.g., calcium, iron, magnesium, selenium, or zinc) should be avoided.