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Drug Interactions between Imbruvica and Incivek

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

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Interactions between your drugs

Major

telaprevir ibrutinib

Applies to: Incivek (telaprevir) and Imbruvica (ibrutinib)

GENERALLY AVOID: Coadministration with potent inhibitors of CYP450 3A4 may significantly increase the plasma concentrations of ibrutinib, which is primarily metabolized by the isoenzyme. In 18 healthy volunteers administered a single 120 mg dose of ibrutinib alone on day 1 and a single 40 mg dose of ibrutinib on day 7 in combination with ketoconazole 400 mg daily on days 4 thru 9, there was a 29-fold increase in dose-normalized ibrutinib peak plasma concentration (Cmax) and 24-fold increase in dose-normalized systemic exposure (AUC) during treatment with ketoconazole compared to administration alone. Pharmacokinetic modeling suggests that moderate CYP450 3A4 inhibitors such as diltiazem and erythromycin may increase the AUC of ibrutinib by 6- to 9-fold under fasting condition. The safety and efficacy of these exposures are unknown. The highest ibrutinib dose evaluated in clinical trials was 12.5 mg/kg (actual doses of 840 to 1400 mg) given for 28 days, which yielded single dose AUC values that were approximately 50% greater than steady-state exposures seen at the highest indicated dose of 560 mg.

MANAGEMENT: The use of ibrutinib in combination with potent CYP450 3A4 inhibitors such as itraconazole, ketoconazole, posaconazole, voriconazole, conivaptan, nefazodone, cobicistat, delavirdine, protease inhibitors, and ketolide and certain macrolide antibiotics should generally be avoided, particularly those that are intended for chronic administration. Some authorities recommend avoiding concomitant use of ibrutinib during and for 2 weeks after treatment with itraconazole. Alternative agents with no or minimal CYP450 3A4 inhibitory potential are recommended whenever possible. If no alternatives exist and the CYP450 3A4 inhibitor is used short-term for 7 days or less, consider interrupting or delaying initiation of ibrutinib treatment until therapy with the inhibitor is complete. Patients should be closely monitored for signs of ibrutinib toxicity such as myelosuppression, bleeding, infection, and renal impairment.

References

  1. "Product Information. Sporanox (itraconazole)." Janssen Pharmaceuticals PROD (2002):
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Imbruvica (ibrutinib)." Pharmacyclics Inc (2013):

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Drug and food interactions

Major

ibrutinib food

Applies to: Imbruvica (ibrutinib)

GENERALLY AVOID: Coadministration with grapefruit, grapefruit juice, or Seville oranges may significantly increase the plasma concentrations of ibrutinib. The proposed mechanism is inhibition of CYP450 3A4-mediated first-pass metabolism in the gut wall by certain compounds present in grapefruit. Pharmacokinetic modeling suggests that other moderate CYP450 3A4 inhibitors such as diltiazem and erythromycin may increase ibrutinib systemic exposure (AUC) by 6- to 9-fold under fasting condition. The safety and efficacy of these exposures are unknown. The highest ibrutinib dose evaluated in clinical trials was 12.5 mg/kg (actual doses of 840 to 1400 mg) given for 28 days, which yielded single dose AUC values that were approximately 50% greater than steady-state exposures seen at the highest indicated dose of 560 mg.

ADJUST DOSING INTERVAL: Food increases the oral bioavailability of ibrutinib. The mechanism of interaction is unknown. According to the product labeling, administration with food increases ibrutinib exposure approximately 2-fold compared to administration after overnight fasting.

MANAGEMENT: Patients treated with ibrutinib should avoid consumption of Seville oranges, grapefruit, grapefruit juice, and any supplement containing grapefruit extract. Ibrutinib should be taken once daily at approximately the same time each day.

References

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Imbruvica (ibrutinib)." Pharmacyclics Inc (2013):

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Moderate

telaprevir food

Applies to: Incivek (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. "Product Information. Incivek (telaprevir)." Vertex Pharmaceuticals (2011):

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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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