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Drug Interactions between regorafenib and Sotyktu

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

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Interactions between your drugs

Major

regorafenib deucravacitinib

Applies to: regorafenib and Sotyktu (deucravacitinib)

GENERALLY AVOID: Coadministration of deucravacitinib with other immunosuppressive agents may potentiate the risk of infections as well as lymphoma and other malignancies. Serious infections have been reported in patients with psoriasis who received deucravacitinib. The most common serious infections reported with deucravacitinib included pneumonia and COVID-19. Herpes zoster and herpes simplex viral reactivation were also reported during clinical studies with deucravacitinib, as well as malignancies including lymphoma.

MANAGEMENT: The safety and efficacy of deucravacitinib in combination with immunosuppressive agents has not been evaluated. The manufacturer recommends that the concomitant use of deucravacitinib with potent immunosuppressants (e.g., azathioprine, cyclosporine) should be avoided. Patients receiving deucravacitinib should be closely monitored for the development of signs and symptoms of infection during and after treatment, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. If a serious infection develops, deucravacitinib should be interrupted until the infection is controlled.

References (4)
  1. (2022) "Product Information. Sotyktu (deucravacitinib)." Bristol-Myers Squibb, 1
  2. (2022) "Product Information. Sotyktu (deucravacitinib)." (Obsolete) Bristol-Myers Squibb Australia Pty Ltd
  3. (2022) "Product Information. Sotyktu (deucravacitinib)." Bristol-Myers Squibb Canada Inc
  4. (2023) "Product Information. Sotyktu (deucravacitinib)." Bristol-Myers Squibb Pharmaceuticals Ltd

Drug and food interactions

Moderate

regorafenib food

Applies to: regorafenib

ADJUST DOSING INTERVAL: Depending on the amount of fat, food may enhance the oral bioavailability of both regorafenib and its active metabolites, M-2 and M-5. In 24 healthy male subjects, administration of regorafenib with a high-fat meal (945 calories; 54.6 g fat) increased the mean systemic exposure (AUC) of regorafenib by 48% but decreased the mean AUC of M-2 and M-5 by 20% and 51%, respectively, compared to administration under the fasted state. In contrast, administration with a low-fat meal (319 calories; 8.2 g fat) increased the mean AUC of regorafenib, M-2 and M-5 by 36%, 40% and 23%, respectively, compared to administration during fasting.

GENERALLY AVOID: Coadministration with grapefruit juice may alter the pharmacokinetics of regorafenib and its active metabolites. The proposed mechanism is inhibition of CYP450 3A4-mediated first-pass metabolism in the gut wall by certain compounds present in grapefruit. The interaction has not been studied specifically with grapefruit juice, but has been reported with the potent CYP450 3A4 inhibitor, ketoconazole. In 18 healthy male study subjects, administration of a single 160 mg dose of regorafenib on day 5 of treatment with ketoconazole (400 mg daily for 18 days) resulted in a 33% increase in mean regorafenib systemic exposure (AUC) compared to administration of regorafenib alone. Additionally, there was a 93% decrease each in the mean AUC of the M-2 and M-5 metabolites. Both have been shown to have similar in vitro pharmacological activity and steady-state concentrations as regorafenib, thus the net clinical effect of these pharmacokinetic changes is unknown.

MANAGEMENT: To ensure optimal oral absorption, regorafenib should be administered with a low-fat breakfast that contains less than 30% fat. Examples of a low-fat breakfast include: 2 slices of white toast with 1 tablespoon of low-fat margarine and 1 tablespoon of jelly, plus 8 ounces of skim milk (319 calories; 8.2 g fat); or 1 cup of cereal, 8 ounces of skim milk, 1 slice of toast with jam, apple juice, and 1 cup of coffee or tea (520 calories; 2 g fat). Patients should be advised to avoid consuming grapefruit or grapefruit juice during treatment with regorafenib.

References (1)
  1. (2012) "Product Information. Stivarga (regorafenib)." Bayer Pharmaceutical Inc

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

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

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