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Drug Interactions between Imbruvica and Tivorbex

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

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Interactions between your drugs

Major

indomethacin ibrutinib

Applies to: Tivorbex (indomethacin) and Imbruvica (ibrutinib)

MONITOR CLOSELY: Coadministration of ibrutinib and drugs that interfere with platelet function or coagulation may potentiate the risk of bleeding complications. In clinical trials, 5% of patients with mantle cell lymphoma had Grade 3 or higher bleeding events such as subdural hematoma, gastrointestinal bleeding, and hematuria. Overall, bleeding events including bruising of any grade occurred in 48% of patients treated with ibrutinib 560 mg daily. The mechanism for the bleeding events is not well understood, although treatment with ibrutinib is associated with a high frequency of thrombocytopenia. Treatment-emergent grade 3 or 4 thrombocytopenia was reported in 17% of patients during clinical trials, while thrombocytopenia of all grades was reported in 57%. Fatal bleeding events have been reported during postmarketing use.

MANAGEMENT: Concomitant use of other medications that interfere with platelet function or coagulation should be considered cautiously in patients treated with ibrutinib. Close clinical and laboratory observation for bleeding complications is recommended during therapy. The INR should be monitored more frequently during coadministration of warfarin. In addition, some authorities recommend avoiding the use of supplements that have an inhibitory effect on platelet function such as fish oil (omega-3 polyunsaturated fatty acids), flaxseed, and vitamin E preparations (AU, CA, UK) because of an increased risk of bleeding. Patients should be advised to promptly report any signs of bleeding to their physician, including pain, swelling, headache, dizziness, weakness, prolonged bleeding from cuts, increased menstrual flow, vaginal bleeding, nosebleeds, bleeding of gums from brushing, unusual bleeding or bruising, red or brown urine, or red or black stools.

References

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Agencia Española de Medicamentos y Productos Sanitarios Healthcare "Centro de información online de medicamentos de la AEMPS - CIMA. https://cima.aemps.es/cima/publico/home.html" (2008):
  3. "Product Information. Imbruvica (ibrutinib)." Pharmacyclics Inc (2013):
  4. Cerner Multum, Inc. "Canadian Product Information." O 0 (2015):
View all 4 references

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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

indomethacin food

Applies to: Tivorbex (indomethacin)

GENERALLY AVOID: The concurrent use of aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) and ethanol may lead to gastrointestinal (GI) blood loss. The mechanism may be due to a combined local effect as well as inhibition of prostaglandins leading to decreased integrity of the GI lining.

MANAGEMENT: Patients should be counseled on this potential interaction and advised to refrain from alcohol consumption while taking aspirin or NSAIDs.

References

  1. "Product Information. Motrin (ibuprofen)." Pharmacia and Upjohn PROD (2002):

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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.

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