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Drug Interactions between Evotaz and ospemifene

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

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Interactions between your drugs

Moderate

atazanavir ospemifene

Applies to: Evotaz (atazanavir / cobicistat) and ospemifene

MONITOR: Coadministration with potent inhibitors of CYP450 3A4 may increase the plasma concentrations of ospemifene, which is partially metabolized by the isoenzyme. In 12 postmenopausal women given the potent CYP450 3A4 inhibitor ketoconazole 400 mg once daily for 8 days, administration of ospemifene 60 mg after breakfast on day 5 of ketoconazole treatment resulted in 1.5- and 1.4-fold increases in ospemifene peak plasma concentration (Cmax) and systemic exposure (AUC), respectively, compared to administration of ospemifene alone. The potential for increased risk of adverse events such as hot flush, thromboembolism, and endometrial or breast cancer should be considered.

MANAGEMENT: Caution is advised when ospemifene is used with potent CYP450 3A4 inhibitors. Patients should be advised to seek medical attention if they develop potential signs and symptoms of thromboembolism such as chest pain, shortness of breath, and pain or swelling in the arms or legs.

References

  1. (2013) "Product Information. Osphena (ospemifene)." Shionogi USA Inc

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Moderate

cobicistat ospemifene

Applies to: Evotaz (atazanavir / cobicistat) and ospemifene

MONITOR: Coadministration with potent inhibitors of CYP450 3A4 may increase the plasma concentrations of ospemifene, which is partially metabolized by the isoenzyme. In 12 postmenopausal women given the potent CYP450 3A4 inhibitor ketoconazole 400 mg once daily for 8 days, administration of ospemifene 60 mg after breakfast on day 5 of ketoconazole treatment resulted in 1.5- and 1.4-fold increases in ospemifene peak plasma concentration (Cmax) and systemic exposure (AUC), respectively, compared to administration of ospemifene alone. The potential for increased risk of adverse events such as hot flush, thromboembolism, and endometrial or breast cancer should be considered.

MANAGEMENT: Caution is advised when ospemifene is used with potent CYP450 3A4 inhibitors. Patients should be advised to seek medical attention if they develop potential signs and symptoms of thromboembolism such as chest pain, shortness of breath, and pain or swelling in the arms or legs.

References

  1. (2013) "Product Information. Osphena (ospemifene)." Shionogi USA Inc

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Drug and food interactions

Moderate

atazanavir food

Applies to: Evotaz (atazanavir / cobicistat)

ADJUST DOSING INTERVAL: Administration of atazanavir with food enhances oral bioavailability and reduces pharmacokinetic variability. According to the manufacturer, administration with a light meal increased the peak plasma concentration (Cmax) and area under the concentration-time curve (AUC) of a single 400 mg dose of atazanavir by 57% and 70%, respectively, relative to the fasting state. Administration with a high-fat meal resulted in a mean increase of 35% in atazanavir AUC and no change in Cmax compared to fasting. The coefficient of variation of AUC and Cmax decreased by approximately one-half when given with either a light or high-fat meal compared to the fasting state.

MANAGEMENT: To ensure maximal oral absorption, atazanavir should be administered with or immediately after a meal.

References

  1. (2003) "Product Information. Reyataz (atazanavir)." Bristol-Myers Squibb

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Moderate

ospemifene food

Applies to: ospemifene

ADJUST DOSING INTERVAL: Food significantly enhances the oral bioavailability of ospemifene. In a cross-study comparison, administration of a single 60 mg dose of ospemifene with a high-fat/high-calorie meal (860 kcal) in postmenopausal women increased ospemifene peak plasma concentration (Cmax) and systemic exposure (AUC) by 2.3- and 1.7-fold, respectively, compared to administration under fasted condition. Elimination half-life and time to maximum concentration (Tmax) were not altered. In two separate food effect studies where different ospemifene tablet formulations were given to healthy male volunteers, ospemifene Cmax and AUC increased by 2.3- and 1.8-fold, respectively, with a low-fat/low-calorie meal (300 kcal) and 3.6- and 2.7-fold, respectively, with a high-fat/high-calorie meal (860 kcal) relative to fasting.

MANAGEMENT: Ospemifene should be taken once daily with food.

References

  1. (2013) "Product Information. Osphena (ospemifene)." Shionogi USA Inc

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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

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