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Drug Interactions between seladelpar and Tegretol XR

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

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Interactions between your drugs

Moderate

carBAMazepine seladelpar

Applies to: Tegretol XR (carbamazepine) and seladelpar

MONITOR: Concurrent use with CYP450 2C9 inducers that are also able to induce CYP450 2C8 and/or 3A4 may reduce the systemic exposure and clinical effects of seladelpar, which is primarily metabolized via CYP450 2C9 and to a lesser extent by CYP450 2C8 and 3A4. Coadministration of the weak CYP450 3A4 and potent CYP450 2C9 inducer, carbamazepine (titrated to 300 mg twice daily x 8 days) decreased the systemic exposure (AUC) and maximum plasma concentration (Cmax) of a single dose of seladelpar (10 mg) by approximately 44% and 24%, respectively. Clinical data with agents also capable of CYP450 2C8 induction, or differing strengths of CYP450 2C9 and/or 3A4 induction are not available.

MANAGEMENT: The potential for diminished pharmacologic effects of seladelpar should be considered if coadministration with agents capable of inducing CYP450 2C9, as well as CYP450 2C8 and/or 3A4 is clinically necessary. Additional monitoring of the patient's biochemical response (e.g., alkaline phosphatase (ALP) and bilirubin) to seladelpar may be advisable.

References (2)
  1. (2024) "Product Information. Livdelzi (seladelpar)." Gilead Sciences
  2. Cymabay Therapeutics Inc (2024) Center for drug evaluation and research. Application Number: 217899Orig1s000 integrated review. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/217899Orig1s000IntegratedR.pdf

Drug and food interactions

Moderate

carBAMazepine food

Applies to: Tegretol XR (carbamazepine)

GENERALLY AVOID: Alcohol may potentiate some of the pharmacologic effects of carbamazepine. Use in combination may result in additive central nervous system depression and/or impairment of judgment, thinking, and psychomotor skills.

In a small, randomized, crossover study, the administration of carbamazepine with grapefruit juice (compared to water) increased plasma drug concentrations by approximately 40%. The proposed mechanism is inhibition of CYP450 3A4-mediated first-pass metabolism in the gut wall by certain compounds present in grapefruits.

MANAGEMENT: Patients receiving carbamazepine should be advised to avoid or limit consumption of alcohol. Given the drug's narrow therapeutic index, patients receiving carbamazepine therapy should preferably avoid the regular consumption of grapefruits and grapefruit juice to prevent any undue fluctuations in plasma drug levels. Patients should be advised to report signs of carbamazepine toxicity (nausea, visual disturbances, dizziness, or ataxia) to their physicians.

References (3)
  1. (2002) "Product Information. Tegretol (carbamazepine)." Novartis Pharmaceuticals
  2. Garg SK, Kumar N, Bhargava VK, Prabhakar SK (1998) "Effect of grapefruit juice on carbamazepine bioavailability in patients with epilepsy." Clin Pharmacol Ther, 64, p. 286-8
  3. Bailey DG, Dresser GR, Kreeft JH, Munoz C, Freeman DJ, Bend JR (2000) "Grapefruit-felodipine interaction: Effect of unprocessed fruit and probable active ingredients." Clin Pharmacol Ther, 68, p. 468-77

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

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