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Drug Interactions between Aptivus and telaprevir

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

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Interactions between your drugs

Moderate

tipranavir telaprevir

Applies to: Aptivus (tipranavir) and telaprevir

GENERALLY AVOID: Concomitant use of telaprevir with tipranavir/ritonavir has not been studied. Coadministration of telaprevir and some ritonavir-boosted protease inhibitor regimens has been associated with decreased plasma concentrations of both telaprevir and/or the protease inhibitors. The mechanism of interaction has not been described. In 14 study subjects, administration of telaprevir (750 mg every 8 hours for 10 days) in combination with darunavir/ritonavir (600 mg/100 mg twice daily for 20 days) reduced the telaprevir peak plasma concentration (Cmax), systemic exposure (AUC) and trough plasma concentration (Cmin) by an average of 36%, 35% and 32%, respectively. The Cmax, AUC and Cmin of darunavir were also reduced by approximately 40% each. In a similar study with 18 volunteers, fosamprenavir/ritonavir (700 mg/100 mg twice daily for 20 days) reduced the Cmax, AUC and Cmin of telaprevir by approximately one-third each, while telaprevir reduced the Cmax, AUC and Cmin of amprenavir by an average of 35%, 47% and 56%, respectively. Telaprevir given in a different dosing regimen (1125 mg every 12 hours for 4 days) reduced the Cmax, AUC and Cmin of amprenavir by 40%, 49% and 58%, respectively. When telaprevir (750 mg every 8 hours for 10 days) was given with atazanavir/ritonavir (300 mg/100 mg once daily for 20 days) to 14 study subjects, telaprevir Cmax, AUC and Cmin decreased by an average of 21%, 20% and 15%, respectively, while the AUC and Cmin of atazanavir increased by 17% and 85%, respectively. In 12 study subjects, lopinavir/ritonavir (400 mg/100 mg twice daily for 20 days) reduced the telaprevir Cmax, AUC and Cmin by approximately one-half, while telaprevir had no significant effect on lopinavir pharmacokinetics.

MANAGEMENT: Given the risk of reduced viral susceptibility and resistance development associated with subtherapeutic antiviral drug levels, coadministration of telaprevir and tipranavir/ritonavir is not recommended based on available data.

References (2)
  1. (2005) "Product Information. Aptivus (tipranavir)." Boehringer-Ingelheim
  2. (2011) "Product Information. Incivek (telaprevir)." Vertex Pharmaceuticals

Drug and food interactions

Moderate

tipranavir food

Applies to: Aptivus (tipranavir)

ADJUST DOSING INTERVAL: Food does not appear to substantially alter the pharmacokinetics of tipranavir. When tipranavir capsules or oral solution was coadministered with ritonavir capsules at steady-state, no clinically significant changes in tipranavir peak plasma concentration (Cmax) and systemic exposure (AUC) were observed under fed conditions (500 to 682 kcal, 23% to 25% calories from fat) relative to fasted conditions. The effect of food on tipranavir exposure during coadministration with ritonavir tablets has not been evaluated. High-fat foods may enhance the gastrointestinal absorption of tipranavir. In a multiple-dose study, administration of tipranavir capsules with a high-fat meal (868 kcal, 53% from fat, 31% from carbohydrates) increased the oral bioavailability of tipranavir by 31% compared to administration with toast and skimmed milk, but did not significantly affect tipranavir Cmax. Thus, tipranavir may be safely taken with standard or high-fat meals.

MANAGEMENT: Tipranavir coadministered with low-dose ritonavir should be taken with food to improve the gastrointestinal tolerability of ritonavir. According to the product labeling, tipranavir coadministered with ritonavir capsules or solution can be taken with or without meals, whereas tipranavir coadministered with ritonavir tablets must be taken with meals.

References (4)
  1. (2005) "Product Information. Aptivus (tipranavir)." Boehringer-Ingelheim
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. Canadian Pharmacists Association (2006) e-CPS. http://www.pharmacists.ca/function/Subscriptions/ecps.cfm?link=eCPS_quikLink
  4. Cerner Multum, Inc. "Australian Product Information."
Moderate

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 (1)
  1. (2011) "Product Information. Incivek (telaprevir)." Vertex Pharmaceuticals

Therapeutic duplication warnings

Therapeutic duplication is the use of more than one medicine from the same drug category or therapeutic class to treat the same condition. This can be intentional in cases where drugs with similar actions are used together for demonstrated therapeutic benefit. It can also be unintentional in cases where a patient has been treated by more than one doctor, or had prescriptions filled at more than one pharmacy, and can have potentially adverse consequences.

Duplication

Protease inhibitors

Therapeutic duplication

The recommended maximum number of medicines in the 'protease inhibitors' category to be taken concurrently is usually one. Your list includes two medicines belonging to the 'protease inhibitors' category:

  • Aptivus (tipranavir)
  • telaprevir

Note: In certain circumstances, the benefits of taking this combination of drugs may outweigh any risks. Always consult your healthcare provider before making changes to your medications or dosage.

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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