Drug Interaction Report
3 potential interactions and/or warnings found for the following 2 drugs:
- ospemifene
- telaprevir
Interactions between your drugs
telaprevir ospemifene
Applies to: telaprevir, 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
- (2013) "Product Information. Osphena (ospemifene)." Shionogi USA Inc
Drug and food interactions
telaprevir food
Applies to: telaprevir
ADJUST DOSING INTERVAL: Food significantly enhances the oral bioavailability of telaprevir. When given with a meal containing 533 kcal and 21 g fat, telaprevir systemic exposure (AUC) increased by 237% compared to administration under fasting conditions. The type of meal also affects the exposure to telaprevir. Relative to fasting, telaprevir AUC increased by approximately 117% with a low-fat meal (249 kcal; 3.6 g fat) and 330% with a high-fat meal (928 kcal; 56 g fat). In Phase 3 clinical trials, telaprevir doses were administered within 30 minutes of completing a meal or snack containing approximately 20 grams of fat.
MANAGEMENT: Telaprevir should be administered with food containing approximately 20 grams of fat. Patients should be advised that the fat content of the meal or snack is critical to the absorption of telaprevir. Food taken with telaprevir should be ingested within 30 minutes prior to each dose. Examples of some foods that could be taken with telaprevir include: bagel with cream cheese; half cup of nuts; 3 tablespoons of peanut butter; 1 cup of ice cream; 2 ounces of American or cheddar cheese; 2 ounces of potato chips; or half cup of trail mix.
References
- (2011) "Product Information. Incivek (telaprevir)." Vertex Pharmaceuticals
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
- (2013) "Product Information. Osphena (ospemifene)." Shionogi USA Inc
Therapeutic duplication warnings
No duplication 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.
Drug Interaction Classification
Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit. | |
Moderately clinically significant. Usually avoid combinations; use it only under special circumstances. | |
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. | |
No interaction information available. |
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