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Drug Interactions between sodium phenylbutyrate and sorafenib

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

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Interactions between your drugs

Moderate

sodium phenylbutyrate SORAfenib

Applies to: sodium phenylbutyrate and sorafenib

MONITOR: Coadministration with inducers of CYP450 3A4 may decrease the plasma concentrations of sorafenib. According to the prescribing information, sorafenib undergoes oxidative metabolism by hepatic CYP450 3A4 as well as glucuronidation by UGT1A9. When a single 400 mg oral dose of sorafenib was administered to healthy volunteers following treatment with the potent CYP450 3A4 inducer rifampin at a dosage of 600 mg once daily for 5 days, mean sorafenib systemic exposure (AUC) decreased by 37% compared to sorafenib administered alone. In another study conducted in 9 patients with advanced hepatocellular carcinoma initiating treatment with sorafenib 400 mg once daily or twice daily, addition of the potent CYP450 3A4 inducer enzalutamide at 160 mg daily starting on day 8 of sorafenib therapy reportedly led to a 60% reduction in mean AUC and 59% reduction in mean peak plasma concentration (Cmax) of sorafenib. The clinical significance of this interaction has not been established, but reduced therapeutic efficacy of sorafenib may occur. The interaction has not been studied with other, less potent inducers.

MANAGEMENT: The potential for diminished pharmacologic effects of sorafenib should be considered during coadministration with CYP450 3A4 inducers. Alternative treatments may be required if an interaction is suspected.

References (4)
  1. (2023) "Product Information. NexAVAR (SORAfenib)." Bayer Pharmaceutical Inc
  2. (2023) "Product Information. Nexavar (sorafenib)." Bayer Plc
  3. (2023) "Product Information. nexAVAR (soRAFENib)." Bayer Australia Limited
  4. Harding JJ, Kelley RK, Tan B, et al. (2020) "Phase Ib study of enzalutamide with or without sorafenib in patients with advanced hepatocellular carcinoma." Oncologist, 25, e1825-36

Drug and food interactions

Moderate

sodium phenylbutyrate food

Applies to: sodium phenylbutyrate

ADJUST DOSING INTERVAL: Coadministration with a high-fat meal may reduce the rate and extent of absorption of sodium phenylbutyrate. When a single 3 g-1 g dose of sodium phenylbutyrate-taurursodiol (sodium phenylbutyrate-ursodoxicoltaurine) was administered to healthy volunteers in the presence of a high-fat, high-calorie meal (approximately 800 to 1000 calories; 500 to 600 calories from fat, 250 calories from carbohydrate, 150 calories from protein), sodium phenylbutyrate peak plasma concentration (Cmax) decreased by 75% and systemic exposure (AUC) decreased by 55%. The Cmax for taurursodiol was not significantly affected, but AUC was increased by 46%. The clinical significance of these changes has not been established. In premarketing studies, patients were advised to take the drug before a meal.

MANAGEMENT: The prescribing information recommends administration of sodium phenylbutyrate-taurursodiol before a meal or snack, particularly in patients of low body weight (less than 70 kg).

References (2)
  1. (2022) "Product Information. Relyvrio (sodium phenylbutyrate-taurursodiol)." Amylyx Pharmaceuticals, 1
  2. (2022) "Product Information. Albrioza (sodium phenylbutyrate-ursodoxicoltaurine)." Innomar Strategies Inc.
Moderate

SORAfenib food

Applies to: sorafenib

ADJUST DOSING INTERVAL: Food may reduce the oral absorption and bioavailability of sorafenib. According to the product labeling, sorafenib bioavailability was reduced by 29% when administered with a high-fat meal compared to administration in the fasted state. When given with a moderate-fat meal, bioavailability was similar to that in the fasted state.

MANAGEMENT: To ensure maximal and consistent oral absorption, sorafenib should be taken at least one hour before or two hours after eating.

References (1)
  1. (2005) "Product Information. Nexavar (sorafenib)." 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.

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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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