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Drug Interactions between givinostat and pretomanid

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

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Interactions between your drugs

Moderate

pretomanid givinostat

Applies to: pretomanid and givinostat

MONITOR: Coadministration with pretomanid may increase the plasma concentrations and the risk of adverse effects of drugs that are substrates of breast cancer resistance protein (BCRP), organic anion-transporting polypeptide (OATP1B3), and/or P-glycoprotein (P-gp). The proposed mechanism, based on in vitro data, is decreased clearance due to pretomanid-mediated inhibition of BCRP, OATP1B3, and/or P-gp. The clinical significance is unknown as data are limited and conflicting.

MANAGEMENT: Until more information is available, the manufacturers of pretomanid recommend that clinicians should be aware of the potential for enhanced pharmacologic effects with drugs that are substrates of BCRP, OATP1B3, and/or Pg-p, particularly those with a narrow therapeutic range, when pretomanid is coadministered. Dosage adjustments as well as clinical and laboratory monitoring of the BCRP, OATP1B3, and/or P-gp substrate drug should be considered whenever pretomanid is added to or withdrawn from therapy with these drugs. Patients should be monitored for the development of adverse effects.

References (3)
  1. (2019) "Product Information. Pretomanid (pretomanid)." The Global Alliance for TB Drug Development
  2. (2024) "Product Information. Dovprela (pretomanid)." Imported (Italy)
  3. Center for Drug Evaluation and Research (2025) Center for drug evaluation and research. Application number: 212862Orig1s000. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212862Orig1s000MultidisciplineR.pdf

Drug and food interactions

Moderate

pretomanid food

Applies to: pretomanid

GENERALLY AVOID: Coadministration with alcohol may increase the risk of hepatotoxicity associated with the use of combination drug regimens that include pretomanid.

ADJUST DOSING INTERVAL: Food enhances the oral bioavailability of pretomanid. The mechanism has not been reported. Compared with the fasted state, oral administration of pretomanid with a high-fat, high-calorie meal (approximately 150, 250, and 500 to 600 calories from protein, carbohydrate, and fat, respectively) increased mean systemic exposure (AUC) and peak plasma concentration (Cmax) of pretomanid by 88% and 76%, respectively.

MANAGEMENT: Patients should avoid alcohol use during treatment with pretomanid. In addition, to ensure maximal oral absorption, pretomanid should be administered with food. Tablets should be swallowed whole.

References (1)
  1. (2019) "Product Information. Pretomanid (pretomanid)." The Global Alliance for TB Drug Development
Moderate

givinostat food

Applies to: givinostat

ADJUST DOSING INTERVAL: Food increases the systemic exposure of givinostat. An open-label, randomized, crossover, single dose food effect study conducted in 12 healthy males used givinostat liquid filled capsules. Subjects received a single oral dose of givinostat (100 mg) in the fasting state or after a high-fat standard meal, with a washout period of at least 1 week in between. The high-fat standard meal resulted in an increase in systemic exposure (AUC) and maximum plasma concentration (Cmax) of about 40% and 23%, respectively, when compared to the fasted state. Additionally, the time to maximum concentration (Tmax) was delayed slightly from 2 to 3 hours.

MANAGEMENT: Givinostat should be administered with food to increase its absorption. In the case of the oral suspension, this can also help mask its bitter taste.

References (2)
  1. (2024) "Product Information. Duvyzat (givinostat)." ITF Therapeutics, LLC
  2. Italfarmaco Spa (2024) Center for drug evaluation and research. Application number: 217865Orig1s000. Integrated review. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/217865Orig1s000IntegratedR.pdf

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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