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Drug Interaction Report

4 potential interactions and/or warnings found for the following 2 drugs:

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Interactions between your drugs

Moderate

dabrafenib trametinib

Applies to: dabrafenib, trametinib

MONITOR: Although this combination is used therapeutically and recommended for certain indications (e.g., melanoma, anaplastic thyroid cancer, non-small cell lung cancer), concomitant use of dabrafenib and trametinib may be associated with increased risk of severe and possibly life-threatening adverse events. These include skin toxicities (e.g., Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms), intracranial and gastrointestinal hemorrhage, venous thromboembolism, and serious febrile events. In an open label study patients with metastatic melanoma with BRAF V600 mutations (n=247) were treated with dabrafenib alone or dabrafenib and trametinib. Serious pyrexia with severe chills or hypotension or that required hospitalization occurred in 19 to 25% of patients treated with the combination as compared to 2% of patients in the monotherapy group.

MANAGEMENT: The manufacturer's product labeling should be consulted for recommendations on dosage adjustments or discontinuation in the event of severe toxicities. Patients should be instructed to contact their doctor if they experience unusual bleeding or bruising or severe weakness; fever; red, purple or intolerable rash; shortness of breath, chest pain, or arm or leg swelling.

References

  1. (2013) "Product Information. Tafinlar (dabrafenib)." GlaxoSmithKline
  2. (2013) "Product Information. Mekinist (trametinib)." GlaxoSmithKline
  3. Flaherty; Infante; Daud; Gonzalez; Kefford; Sosman; Hamid; Schuchter; Cebon; Ibrahim; Kudchadkar; Burris Nag (2012) "Combined BRAF and MEK Inhibition in Melanoma with BRAF V600 Mutations." NEJM, 367:1694-1703, p. 5

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Drug and food interactions

Moderate

dabrafenib food

Applies to: dabrafenib

ADJUST DOSING INTERVAL: Food may reduce as well as delay the absorption of dabrafenib. In study subjects, administration of dabrafenib with a high-fat meal decreased peak plasma concentration (Cmax) and systemic exposure (AUC) by 51% and 31%, respectively, and delayed median Tmax by approximately 3.6 hours compared to administration in the fasted state.

MANAGEMENT: Dabrafenib should be taken at least 1 hour before or 2 hours after a meal.

References

  1. (2013) "Product Information. Tafinlar (dabrafenib)." GlaxoSmithKline

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Moderate

trametinib food

Applies to: trametinib

ADJUST DOSING INTERVAL: Food may reduce as well as delay the absorption of trametinib. In study subjects, administration of a single dose of trametinib with a high-fat, high-calorie meal decreased peak plasma concentration (Cmax) and systemic exposure (AUC) by 70% and 24%, respectively, and delayed Tmax by approximately 4 hours compared to administration in the fasted state.

MANAGEMENT: Trametinib should be taken at least 1 hour before or 2 hours after a meal.

References

  1. (2013) "Product Information. Mekinist (trametinib)." GlaxoSmithKline

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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

Multikinase inhibitors

Therapeutic duplication

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

  • dabrafenib
  • trametinib

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.


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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.

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Further information

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