Cerdelga and PCE Dispertab

In the database of official manuals used in the service creation an interaction registered by statistical results of studies was found, which can either lead to negative consequences for the patient health or strengthen a mutual positive effect. A doctor should be consulted to address the issue of joint drug administration.

Before using eliglustat, you should have received a test to determine your CYP450 2D6 genotype, which lets the doctor know whether or not you can take the medication and at what dosage. Depending on your CYP450 2D6 genotype and what other medications you may be on, using eliglustat together with erythromycin may not be recommended at all, or a dosage adjustment of eliglustat may be needed. Treatment with erythromycin can significantly increase the blood levels of eliglustat. This may increase the risk of serious and potentially life-threatening cardiac side effects such as irregular heart rhythm, heart block, and cardiac arrest. Talk to your doctor if you have any questions or concerns. Your doctor may already be aware of the interaction, but has determined that this is the best course of treatment for you and has taken appropriate precautions and is monitoring you closely for any potential complications. You should seek immediate medical attention if you develop sudden dizziness, lightheadedness, fainting, shortness of breath, slow heart rate, weak pulse, or heart palpitations during treatment with eliglustat. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

CONTRAINDICATED: Coadministration with moderate inhibitors of CYP450 3A4 may significantly 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 moderate CYP450 3A4 inhibitor fluconazole may increase eliglustat peak plasma concentration (Cmax) and systemic exposure (AUC) by 2.8- and 3.2-fold, respectively, in CYP450 2D6 extensive metabolizers (EMs) given eliglustat 84 mg twice daily, and 2.5- and 2.9-fold, respectively, in intermediate metabolizers (IMs) given the same dosage. PBPK modeling also suggest that fluconazole may increase eliglustat Cmax by 2.4-fold and AUC by 3.0-fold in poor metabolizers (PMs) given eliglustat 84 mg once daily. The magnitude of interaction is expected to increase further with the addition of a CYP450 2D6 inhibitor like terbinafine. Simulations using PBPK models predicted a 10.2-fold increase in eliglustat Cmax and 13.6-fold increase in AUC for EMs given eliglustat 84 mg twice daily, and a 4.2-fold increase in eliglustat Cmax and 5.0-fold increase in AUC for IMs.

MANAGEMENT: The use of eliglustat in combination with one or more drugs that may result in moderate inhibition of CYP450 3A4 and moderate to potent inhibition of CYP450 2D6 is considered contraindicated in CYP450 2D6 extensive metabolizers (EMs) and intermediate metabolizers (IMs). In the absence of a concomitant CYP450 2D6 inhibitor, eliglustat may be prescribed at a reduced dosage of 84 mg once daily to EMs treated with a moderate CYP450 3A4 inhibitor. However, eliglustat should not be used with a moderate CYP450 3A4 inhibitor in CYP450 2D6 IMs or poor metabolizers (PMs). Moderate CYP450 3A4 inhibitors include aprepitant, ciprofloxacin, clotrimazole, crizotinib, darunavir, diltiazem, dronedarone, fluconazole, fusidic acid, imatinib, isavuconazonium, miconazole, mifepristone, netupitant, quinupristin-dalfopristin, ranolazine, stiripentol, and verapamil. Potent and moderate CYP450 2D6 inhibitors include abiraterone, bupropion, celecoxib, cimetidine, cinacalcet, clobazam, darifenacin, diphenhydramine, duloxetine, fluoxetine, methotrimeprazine, mirabegron, paroxetine, propoxyphene, quinidine, ranolazine, sertraline, stiripentol, and terbinafine.

Cerdelga

Generic Name: eliglustat

Brand name: Cerdelga

Synonyms: n.a.

What is Cerdelga?

PCE Dispertab

Generic Name: erythromycin

Brand name: EES. Granules, EES-400 Filmtab, EryPed 200, EryPed 400, Ery-Tab, Erythrocin Lactobionate, Erythrocin Stearate Filmtab, PCE Dispertab, E. E. S, EryPed, Erythrocin, Erythromycin Filmtabs, Erythromycin Lactobionate - IV

Synonyms: PCE Dispertab (Oral), PCE, PCE (Oral)

What is PCE Dispertab?