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Drug Interactions between eliglustat and givinostat

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

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Interactions between your drugs

Moderate

eliglustat givinostat

Applies to: eliglustat and givinostat

GENERALLY AVOID: Coadministration with weak inhibitors of CYP450 3A4 may increase the plasma concentrations of eliglustat, which is primarily metabolized by CYP450 2D6 and, to a lesser extent, CYP450 3A4. Eliglustat at substantially elevated plasma concentrations is predicted to cause prolongation of the PR, QTc and QRS cardiac intervals, which may increase the risk of bradycardia, atrioventricular block, cardiac arrest, and serious ventricular arrhythmias such as torsade de pointes. Simulations using physiologically-based pharmacokinetic (PBPK) models suggest that the potent CYP450 3A4 inhibitor ketoconazole may increase eliglustat systemic exposure (AUC) by 4.4-, 5.4- and 6.2-fold in CYP450 2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs) and poor metabolizers (PMs), respectively, while the moderate CYP450 3A4 inhibitor fluconazole may increase eliglustat AUC by 3.2-, 2.9- and 3.0-fold, respectively. No data are available for use with other, less potent inhibitors.

MANAGEMENT: Concomitant use of eliglustat with weak CYP450 3A4 inhibitors such as chloramphenicol, cyclosporine, danazol, dasatinib, ethinyl estradiol, fluvoxamine, goldenseal, isoniazid, ivacaftor, lapatinib, lomitapide, nifedipine, nilotinib, palbociclib, pazopanib, suvorexant, ticagrelor, and zafirlukast is not recommended in CYP450 2D6 poor metabolizers. No dosage adjustment for eliglustat is necessary when used with weak CYP450 3A4 inhibitors in extensive or intermediate metabolizers.

References (1)
  1. (2014) "Product Information. Cerdelga (eliglustat)." Genzyme Corporation

Drug and food interactions

Major

eliglustat food

Applies to: eliglustat

GENERALLY AVOID: Grapefruit juice may significantly increase the systemic exposure to eliglustat. The proposed mechanism is inhibition of CYP450 3A4-mediated first-pass metabolism in the gut wall by certain compounds present in grapefruit. Because eliglustat is predicted to cause prolongation of the PR, QTc, and QRS cardiac intervals at substantially elevated plasma concentrations, consumption of grapefruit juice during treatment may increase the risk of bradycardia, atrioventricular block, cardiac arrest, and serious ventricular arrhythmias such as torsade de pointes.

MANAGEMENT: Patients treated with eliglustat should avoid consumption of grapefruit and grapefruit juice.

References (1)
  1. (2014) "Product Information. Cerdelga (eliglustat)." Genzyme Corporation
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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