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Drug Interactions between Demulen 1/50 and glecaprevir / pibrentasvir

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

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Interactions between your drugs

Major

ethinyl estradiol glecaprevir

Applies to: Demulen 1 / 50 (ethinyl estradiol / ethynodiol) and glecaprevir / pibrentasvir

GENERALLY AVOID: Coadministration of ethinyl estradiol with glecaprevir-pibrentasvir may increase the risk of alanine aminotransferase (ALT) elevations. In clinical trials, women using ethinyl estradiol-containing medications such as combined oral contraceptives were significantly more likely to have ALT elevations, in some cases greater than 20 times the upper limit of normal. ALT elevations are also associated with glecaprevir, particularly at high exposures, thus an additive risk may occur. Pharmacokinetically, glecaprevir-pibrentasvir may increase the plasma concentrations of ethinyl estradiol, presumably due to mild inhibition of CYP450 3A4-mediated metabolism. In 11 study subjects, once daily coadministration of ethinyl estradiol-norgestimate 35 mcg-250 mcg with glecaprevir-pibrentasvir 300 mg-120 mg increased ethinyl estradiol peak plasma concentration (Cmax), systemic exposure (AUC) and trough plasma concentration (Cmin) by 31%, 28% and 38%, respectively. Likewise, once daily coadministration of ethinyl estradiol-levonorgestrel 20 mcg-100 mcg with glecaprevir-pibrentasvir 300 mg-120 mg to 12 study subjects increased ethinyl estradiol Cmax, AUC and Cmin by 30%, 40% and 56%, respectively. Plasma levels of the progestins were also increased by glecaprevir-pibrentasvir in these studies. No effects were observed in the pharmacokinetics of glecaprevir and pibrentasvir.

MANAGEMENT: Concomitant use of ethinyl estradiol-containing medications with glecaprevir-pibrentasvir is not recommended and is considered contraindicated by some authorities.

References

  1. (2017) "Product Information. Mavyret (glecaprevir-pibrentasvir)." Abbott Pharmaceutical

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Drug and food interactions

Moderate

glecaprevir food

Applies to: glecaprevir / pibrentasvir

ADJUST DOSING INTERVAL: Food enhances the oral bioavailability of glecaprevir and pibrentasvir. Relative to fasting conditions, mean glecaprevir systemic exposure (AUC) increased by 83% to 163% and mean pibrentasvir AUC increased by 40% to 53% when administered with moderate to high fat meals.

MANAGEMENT: Glecaprevir-pibrentasvir should be administered with food.

References

  1. (2017) "Product Information. Mavyret (glecaprevir-pibrentasvir)." Abbott Pharmaceutical

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Minor

ethinyl estradiol food

Applies to: Demulen 1 / 50 (ethinyl estradiol / ethynodiol)

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

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Minor

ethinyl estradiol food

Applies to: Demulen 1 / 50 (ethinyl estradiol / ethynodiol)

The central nervous system effects and blood levels of ethanol may be increased in patients taking oral contraceptives, although data are lacking and reports are contradictory. The mechanism may be due to enzyme inhibition. Consider counseling women about this interaction which is unpredictable.

References

  1. Hobbes J, Boutagy J, Shenfield GM (1985) "Interactions between ethanol and oral contraceptive steroids." Clin Pharmacol Ther, 38, p. 371-80

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Minor

ethynodiol food

Applies to: Demulen 1 / 50 (ethinyl estradiol / ethynodiol)

The central nervous system effects and blood levels of ethanol may be increased in patients taking oral contraceptives, although data are lacking and reports are contradictory. The mechanism may be due to enzyme inhibition. Consider counseling women about this interaction which is unpredictable.

References

  1. Hobbes J, Boutagy J, Shenfield GM (1985) "Interactions between ethanol and oral contraceptive steroids." Clin Pharmacol Ther, 38, p. 371-80

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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.

See also

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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

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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