Drug Interactions between baloxavir marboxil and Dilaudid

GENERALLY AVOID: Alcohol may potentiate the central nervous system (CNS) depressant effects of opioid analgesics including hydromorphone. Concomitant use may result in additive CNS depression and impairment of judgment, thinking, and psychomotor skills. In more severe cases, hypotension, respiratory depression, profound sedation, coma, or even death may occur.

GENERALLY AVOID: Consumption of alcohol while taking sustained-release formulations of hydromorphone may cause rapid release of the drug, resulting in high systemic levels of hydromorphone that may be potentially lethal even in opioid-tolerant patients. Alcohol appears to disrupt the extended release mechanism, causing 'dose-dumping' into the bloodstream. In 48 healthy volunteers, coadministration of a 12 mg dose of sustained-release hydromorphone with 240 mL of 40% (80 proof) alcohol resulted in a mean peak hydromorphone concentration (Cmax) approximately six times greater than when taken with water. One subject had a 16-fold increase in hydromorphone Cmax with 40% alcohol compared to water. In some subjects, coadministration with 8 ounces of 4% alcohol (equivalent to 2/3 of a typical serving of beer) resulted in almost twice the hydromorphone Cmax than when coadministered with water. The effect of alcohol was more pronounced in a fasted state.

MANAGEMENT: Patients taking sustained-release formulations of hydromorphone should not consume alcohol or use medications that contain alcohol on days of hydromorphone dosing. In general, potent narcotics such as hydromorphone should not be combined with alcohol.

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.