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Drug Interactions between givinostat and methylnaltrexone

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

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Interactions between your drugs

Moderate

methylnaltrexone givinostat

Applies to: methylnaltrexone and givinostat

MONITOR: Givinostat may increase the systemic exposure and effects of organic cation transporter 2 (OCT2) substrates via inhibition of this renal uptake transporter. During a phase 3 study of givinostat, an average increase in the OCT2 substrate creatinine of 4.76 micromol/L (0.05 mg/dL) from baseline was observed within the first 2 months of treatment. This change in creatinine led the study investigators to conclude that givinostat is a weak inhibitor of OCT2.

MANAGEMENT: Caution and clinical monitoring are advised if givinostat is used in combination with an organic cation transporter 2 (OCT2) substrate, particularly a sensitive substrate for which a small change in the substrate's plasma concentration could result in serious toxicity. The labeling of the substrate should be consulted for specific monitoring, dose adjustment, and discontinuation recommendations should adverse reactions result from this combination.

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

Drug and food interactions

Moderate

methylnaltrexone food

Applies to: methylnaltrexone

ADJUST DOSING INTERVAL: Food may reduce the rate and extent of absorption of methylnaltrexone following oral administration. When a single 450 mg oral dose of methylnaltrexone was administered with a high-fat breakfast (approximately 800 to 1000 calories; 60% from fat, 25% from carbohydrate, and 15% from protein) in healthy study subjects, methylnaltrexone peak plasma concentration (Cmax) and systemic exposure (AUC) decreased by 60% and 43%, respectively, while time to reach Cmax delayed by 2 hours.

MANAGEMENT: Oral methylnaltrexone should be taken with water on an empty stomach at least 30 minutes before the first meal of the day.

References (1)
  1. (2008) "Product Information. Relistor (methylnaltrexone)." Wyeth Laboratories
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

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