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Drug Interactions between AccessPak for HIV PEP Expanded with Viracept and Osphena

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

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Interactions between your drugs

Moderate

nelfinavir ospemifene

Applies to: AccessPak for HIV PEP Expanded with Viracept (emtricitabine / nelfinavir / tenofovir) and Osphena (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

ospemifene food

Applies to: Osphena (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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Minor

tenofovir food

Applies to: AccessPak for HIV PEP Expanded with Viracept (emtricitabine / nelfinavir / tenofovir)

Food enhances the oral absorption and bioavailability of tenofovir, the active entity of tenofovir disoproxil fumarate. According to the product labeling, administration of the drug following a high-fat meal increased the mean peak plasma concentration (Cmax) and area under the concentration-time curve (AUC) of tenofovir by approximately 14% and 40%, respectively, compared to administration in the fasting state. However, administration with a light meal did not significantly affect the pharmacokinetics of tenofovir compared to administration in the fasting state. Food delays the time to reach tenofovir Cmax by approximately 1 hour. Tenofovir disoproxil fumarate may be administered without regard to meals.

References

  1. (2001) "Product Information. Viread (tenofovir)." Gilead Sciences

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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

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