Drug Interactions between belumosudil and mitotane

High fat food significantly enhances the absorption of mitotane. You should take each dose of mitotane with a full meal containing high fat (e.G., containing milk, chocolate, or oil) and with a full glass of water. Taking mitotane on an empty stomach may lead to inadequate blood levels and reduced effectiveness of the medication. Talk to your doctor if you have questions or have difficulty taking mitotane with food. It is best to avoid or limit the consumption of alcohol, as it can increase drowsiness or other nervous system side effects of mitotane. You should also avoid activities requiring mental alertness such as driving or operating hazardous machinery until you know how the medication affects you. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

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ADJUST DOSING INTERVAL: Administration with food increases the oral bioavailability of belumosudil. The mechanism has not been described. Administration of belumosudil (200 mg single oral dose) in healthy subjects, with a fatty and calorie-rich meal (approximately half of the calories were contained in the fat) increased the mean belumosudil peak plasma concentration (Cmax) and area under the concentration-time curve (AUC) by 120% and 100%, respectively, compared to administration under fasting conditions. The time to reach peak concentration (Tmax) was delayed by 30 minutes. Administration of oral belumosudil 200 mg once daily with food in patients with chronic graft-versus-host disease (chronic GVHD) lead to steady-state concentrations of the drug with an accumulation ration of 1.4.

MANAGEMENT: To ensure maximal oral absorption, belumosudil should be administered with a meal, every day at the same time.