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Drug Interactions between Besremi and givinostat

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

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Interactions between your drugs

Moderate

ropeginterferon alfa-2b givinostat

Applies to: Besremi (ropeginterferon alfa-2b) and givinostat

GENERALLY AVOID: Coadministration with other myelosuppressive agents may potentiate the hematologic toxicities of ropeginterferon alfa-2b. Decreased peripheral blood counts have been reported in patients receiving interferon alfa products, including ropeginterferon alfa-2b. In two open label trials consisting of 178 patients receiving ropeginterferon alfa-2b monotherapy (dosed every 2 to 4 weeks) for the treatment of polycythemia vera, 80% of whom were exposed for 12 months or longer, leukopenia occurred in 20% of patients and thrombocytopenia in 19% of patients. Leukopenia, thrombocytopenia and anemia of grade 3 or higher occurred in 2%, 2% and 1% of patients, respectively. Moreover, infections occurred in 48% of patients, while serious infections occurred in 8% of patients.

MANAGEMENT: Concomitant use of ropeginterferon alfa-2b with other myelosuppressive agents should be avoided when possible. Otherwise, close clinical and laboratory monitoring are advised. Complete blood counts should be performed at baseline, during titration, and every 3 to 6 months or more frequently as clinically indicated during the maintenance phase.

References (2)
  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. (2021) "Product Information. BESREMi (ropeginterferon alfa-2b)." PharmaEssentia USA Corp

Drug and food interactions

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.

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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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