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Drug Interactions between clarithromycin and elbasvir / grazoprevir

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

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Interactions between your drugs

Major

clarithromycin grazoprevir

Applies to: clarithromycin and elbasvir / grazoprevir

GENERALLY AVOID: Coadministration with potent inhibitors of CYP450 3A4 may significantly increase the plasma concentrations of grazoprevir, which is a substrate of the isoenzyme. In 8 study subjects, administration of a single 100 mg dose of grazoprevir with the potent CYP450 3A4 inhibitor ketoconazole (400 mg once daily) increased grazoprevir peak plasma concentration (Cmax), systemic exposure (AUC) and trough plasma concentration (Cmin) by 13%, 200% and 100%, respectively, compared to administration of grazoprevir alone. High plasma levels of grazoprevir may increase the risk of adverse effects such as alanine aminotransferase (ALT) elevations. Ketoconazole also increased the Cmax, AUC and Cmin of a single 50 mg dose of elbasvir by 29%, 80% and 89%, respectively.

MANAGEMENT: Concomitant use of elbasvir-grazoprevir with potent CYP450 3A4 inhibitors should generally be avoided.

References

  1. "Product Information. Zepatier (elbasvir-grazoprevir)." Merck & Co., Inc (2016):

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Moderate

clarithromycin elbasvir

Applies to: clarithromycin and elbasvir / grazoprevir

GENERALLY AVOID: Coadministration with potent inhibitors of CYP450 3A4 may significantly increase the plasma concentrations of elbasvir, which is a substrate of the isoenzyme. In 10 study subjects, administration of elbasvir (50 mg once daily) with the potent CYP450 3A4 inhibitors atazanavir/ritonavir (300 mg/100 mg once daily) increased elbasvir peak plasma concentration (Cmax), systemic exposure (AUC) and trough plasma concentration (Cmin) by 4.15-fold, 4.76-fold and 6.45-fold, respectively, compared to elbasvir alone. Likewise, administration with lopinavir/ritonavir 400 mg/100 mg twice daily increased elbasvir Cmax, AUC, and Cmin by 2.87-, 3.71-, and 4.58-fold, respectively (n=10), while administration with darunavir/ritonavir 600 mg/100 mg twice daily increased elbasvir Cmax, AUC, and Cmin by 1.67-, 1.66-, and 1.82-fold, respectively (n=10). Another potent CYP450 3A4 inhibitor, ketoconazole (400 mg once daily), increased the Cmax, AUC, and Cmin of a single 50 mg dose of elbasvir by 1.29-, 1.80, and 1.89-fold, respectively (n=7).

MANAGEMENT: Concomitant use of elbasvir with potent CYP450 3A4 inhibitors should generally be avoided.

References

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Zepatier (elbasvir-grazoprevir)." Merck & Co., Inc (2016):

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Drug and food interactions

Minor

clarithromycin food

Applies to: clarithromycin

Grapefruit juice may delay the gastrointestinal absorption of clarithromycin but does not appear to affect the overall extent of absorption or inhibit the metabolism of clarithromycin. The mechanism of interaction is unknown but may be related to competition for intestinal CYP450 3A4 and/or absorptive sites. In an open-label, randomized, crossover study consisting of 12 healthy subjects, coadministration with grapefruit juice increased the time to reach peak plasma concentration (Tmax) of both clarithromycin and 14-hydroxyclarithromycin (the active metabolite) by 80% and 104%, respectively, compared to water. Other pharmacokinetic parameters were not significantly altered. This interaction is unlikely to be of clinical significance.

References

  1. Cheng KL, Nafziger AN, Peloquin CA, Amsden GW "Effect of grapefruit juice on clarithromycin pharmacokinetics." Antimicrob Agents Chemother 42 (1998): 927-9

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Minor

grazoprevir food

Applies to: elbasvir / grazoprevir

Food does not appear to have clinically significant effects on the pharmacokinetics of elbasvir and grazoprevir. When a single 50 mg-100 mg dose of elbasvir-grazoprevir was administered to healthy study subjects with a high-fat meal (900 kcal; 500 kcal from fat), elbasvir peak plasma concentration (Cmax) and systemic exposure (AUC) decreased by 15% and 11%, respectively, while grazoprevir Cmax and AUC increased by 2.8- and 1.5-fold, respectively, compared to administration under fasting conditions. According to the product labeling, elbasvir-grazoprevir may be administered with or without food.

References

  1. "Product Information. Zepatier (elbasvir-grazoprevir)." Merck & Co., Inc (2016):

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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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