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Drug Interactions between Prograf and simeprevir

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

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Interactions between your drugs

Moderate

tacrolimus simeprevir

Applies to: Prograf (tacrolimus) and simeprevir

MONITOR: Coadministration with simeprevir may affect the pharmacokinetics of immunosuppressants that are substrates of the P-glycoprotein efflux transporter and/or CYP450 3A4 isoenzyme. In vivo, simeprevir mildly inhibits P-glycoprotein and intestinal CYP450 3A4, but does not affect hepatic CYP450 3A4 activity. In 14 healthy study subjects, administration of simeprevir 150 mg once daily for 7 days decreased the mean Cmax and AUC of a single 2 mg dose of tacrolimus by 24% and 17%, respectively. No data are available for everolimus or sirolimus, although they are known substrates of both P-glycoprotein and CYP450 3A4.

MANAGEMENT: No empiric dosage adjustment is required for everolimus, sirolimus, or tacrolimus when prescribed with simeprevir. However, because these agents have a narrow therapeutic index, it may be appropriate to monitor pharmacologic response and drug levels more closely following initiation or discontinuation of simeprevir, and the dosage adjusted if necessary.

References

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. Cerner Multum, Inc. "Australian Product Information."
  3. (2013) "Product Information. Olysio (simeprevir)." Janssen Pharmaceuticals

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Drug and food interactions

Moderate

tacrolimus food

Applies to: Prograf (tacrolimus)

ADJUST DOSING INTERVAL: Consumption of food has led to a 27% decrease in the bioavailability of orally administered tacrolimus.

MANAGEMENT: Tacrolimus should be administered at least one hour before or two hours after meals.

GENERALLY AVOID: Grapefruit juice has been reported to increase tacrolimus trough concentrations. Data are limited, but inhibition of the CYP450 enzyme system appears to be involved.

MANAGEMENT: The clinician may want to recommend that the patient avoid ingesting large amounts of grapefruit juice while taking tacrolimus.

References

  1. (2001) "Product Information. Prograf (tacrolimus)." Fujisawa
  2. Hooks MA (1994) "Tacrolimus, a new immunosuppressant--a review of the literature." Ann Pharmacother, 28, p. 501-11

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Moderate

simeprevir food

Applies to: 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. (2013) "Product Information. Olysio (simeprevir)." Janssen Pharmaceuticals

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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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