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Drug Interactions between FemSeven Sequi Phase I and Ravicti

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

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Interactions between your drugs

Moderate

estradiol glycerol phenylbutyrate

Applies to: FemSeven Sequi Phase I (estradiol) and Ravicti (glycerol phenylbutyrate)

MONITOR: Coadministration with glycerol phenylbutyrate may decrease the systemic exposure to and therapeutic efficacy of drugs that are substrates of CYP450 3A4. Glycerol phenylbutyrate, its active moiety phenylbutyrate, and active metabolite phenylacetic acid are considered weak CYP450 3A4 inducers in vivo. In healthy subjects, coadministration of glycerol phenylbutyrate (4.4 g orally three times daily for 3 days) with oral midazolam, a sensitive CYP450 3A4 substrate, decreased the peak plasma concentration (Cmax) and systemic exposure (AUC) of midazolam of approximately 25% and 32%, respectively, and increased the mean Cmax and AUC of its metabolite 1-hydroxy midazolam, by 28% and 58%, respectively, compared to administration of midazolam alone. The clinical significance has not been established.

MANAGEMENT: Concomitant use of glycerol phenylbutyrate with sensitive CYP450 3A4 substrates (e.g., oral midazolam) or CYP450 3A4 substrates with a narrow therapeutic index (e.g., alfentanil, oral contraceptives, quinidine, and cyclosporine) should be done with caution and monitoring for reduced efficacy. Dosage adjustment as well as clinical and laboratory monitoring may be appropriate whenever glycerol phenylbutyrate is added to or withdrawn from therapy.

References

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Ravicti (glycerol phenylbutyrate)." Hyperion Therapeutics Inc (2013):

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Drug and food interactions

Minor

estradiol food

Applies to: FemSeven Sequi Phase I (estradiol)

Coadministration with grapefruit juice may increase the bioavailability of oral estrogens. The proposed mechanism is inhibition of CYP450 3A4-mediated first-pass metabolism in the gut wall induced by certain compounds present in grapefruits. In a small, randomized, crossover study, the administration of ethinyl estradiol with grapefruit juice (compared to herbal tea) increased peak plasma drug concentration (Cmax) by 37% and area under the concentration-time curve (AUC) by 28%. Based on these findings, grapefruit juice is unlikely to affect the overall safety profile of ethinyl estradiol. However, as with other drug interactions involving grapefruit juice, the pharmacokinetic alterations are subject to a high degree of interpatient variability. Also, the effect on other estrogens has not been studied.

References

  1. Weber A, Jager R, Borner A, et al. "Can grapefruit juice influence ethinyl estradiol bioavailability?" Contraception 53 (1996): 41-7
  2. Schubert W, Eriksson U, Edgar B, Cullberg G, Hedner T "Flavonoids in grapefruit juice inhibit the in vitro hepatic metabolism of 17B-estradiol." Eur J Drug Metab Pharmacokinet 20 (1995): 219-24

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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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