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Drug Interactions between mitotane and Olysio

This report displays the potential drug interactions for the following 2 drugs:

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Interactions between your drugs

Major

mitotane simeprevir

Applies to: mitotane and Olysio (simeprevir)

GENERALLY AVOID: Coadministration with potent and some moderate inducers of CYP450 3A4 may significantly decrease the plasma concentrations of simeprevir, which is primarily metabolized by the isoenzyme. In 18 healthy study subjects administered simeprevir (200 mg once daily) in combination with the potent CYP450 3A4 inducer rifampin (600 mg once daily) for 7 days, mean simeprevir peak plasma concentration (Cmax) increased by 31% but systemic exposure (AUC) and trough plasma concentration (Cmin) decreased by 48% and 92%, respectively. Likewise, when simeprevir (150 mg once daily) was given with the moderate inducer efavirenz (600 mg once daily) to 23 healthy subjects for 14 days, mean simeprevir Cmax, AUC and Cmin decreased by 51%, 71% and 91%, respectively. Simeprevir had no significant effects on the pharmacokinetics of efavirenz or rifampin, but increased the AUC of metabolite 25-desacetyl-rifampin by 24%.

MANAGEMENT: The use of simeprevir in combination with potent and some moderate CYP450 3A4 inducers such as carbamazepine, dexamethasone, efavirenz, enzalutamide, eslicarbazepine, etravirine, nevirapine, oxcarbazepine, phenobarbital, phenytoin, primidone, rifamycins, St. John's wort, and tipranavir should generally be avoided.

References (2)
  1. (2001) "Product Information. Sustiva (efavirenz)." DuPont Pharmaceuticals
  2. (2013) "Product Information. Olysio (simeprevir)." Janssen Pharmaceuticals

Drug and food interactions

Moderate

mitotane food

Applies to: mitotane

ADJUST DOSING INTERVAL: Fat-rich food enhances the absorption of mitotane. One study evaluated blood levels of mitotane (o,p'-DDD) after subjects ingested a single dose of 2 g administered using various delivery vehicles (e.g., tablets, granules, milk, chocolate or oil emulsion). Mitotane plasma levels were significantly higher for milk, chocolate, and oil emulsion when compared to those who received tablets or granules alone. In the same study, mitotane levels were evaluated in subjects following long-term treatment (total dose of 200 g over 30 to 60 days) in tablet, oil emulsion, or milk formulations. Significantly higher mean plasma levels were recorded in subjects who received mitotane as an oil emulsion or mixed in milk, when compared to tablets alone. Additionally, the recovery of o,p'-DDD from the feces was about 5 times higher in subjects who received tablets alone, suggesting absorption was reduced when compared to subjects who received mitotane mixed with a fat-rich vehicle (e.g., oil emulsion or milk).

GENERALLY AVOID: Concomitant use of mitotane with central nervous system (CNS) depressants, including alcohol, may potentiate adverse effects such as somnolence and sedation.

MANAGEMENT: According to product labeling, mitotane tablets should be taken during meals containing fat-rich food (e.g., milk, chocolate, or oil) and with a full glass of water. Patients should be advised to avoid or limit consumption of alcohol and to avoid activities requiring mental alertness such as driving or operating hazardous machinery until they know how the medication affects them.

References (4)
  1. (2023) "Product Information. Lysodren (mitotane)." HRA Pharma America
  2. (2023) "Product Information. Lysodren (mitotane)." Medunik Canada
  3. (2023) "Product Information. Lysodren (mitotane)." HRA Pharma UK & Ireland Ltd
  4. Moolenaar AJ, van Slooten H, van Seters AP, Smeenk D (2023) Blood levels of o,p-DDD following administration in various vehicles after a single dose and during long-term treatment https://link.springer.com/article/10.1007/BF00258213
Moderate

simeprevir food

Applies to: Olysio (simeprevir)

ADJUST DOSING INTERVAL: Food significantly enhances the oral bioavailability of simeprevir, although the type of food does not seem to matter. In healthy study subjects, administration of simeprevir after a high-fat, high-caloric (928 kcal) breakfast increased systemic exposure (AUC) by 61% and delayed absorption by 1 hour, while administration after a normal caloric (533 kcal) breakfast increased AUC by 69% and delayed absorption by 1.5 hours.

MANAGEMENT: To ensure maximal oral absorption, simeprevir should be administered with food.

References (1)
  1. (2013) "Product Information. Olysio (simeprevir)." Janssen Pharmaceuticals

Therapeutic duplication warnings

No warnings were found for your selected drugs.

Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.

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Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown No interaction information available.

Further information

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