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281. Lumacaftor/Ivacaftor (Orkambi)

was achieved in 3-5 days with an accumulation ratio ranging from 2.2 to 2.9. When given alone with food containing fat, exposure to IVA is 2 to 4 fold higher. IVA is almost totally bound to plasma proteins (99%). It is extensively metabolized in humans with the majority excreted in the feces. In vitro and clinical studies indicate that IVA is primarily metabolized by CYP3A. As such, co-administration with strong CYP3A inhibitors, such as ketoconazole, can significantly increase IVA exposure. Ketoconazole

2015 FDA - Drug Approval Package

282. Cariprazine HCl (Vraylar)

. ? Women had 13% higher total exposure than men. ? Ketoconazole increased total exposure by about 100%. ? There was a concentration-dependent improvement in schizophrenia patients in 6 week trials. ? There was no concentration-dependent improvement in bipolar patients in three week trials. ? There were no clinically meaningful exposure differences based upon body weight, gender, age, or race. Reference ID: 34086357 After 3-7 days, it seems (from the figures above) that the parent (CAR), and the first

2015 FDA - Drug Approval Package

284. Cerdelga - eliglustat

. eliglustat. Use of a strong CYP2D6 inhibitor (e.g. paroxetine, fluoxetine, quinidine) with Cerdelga is not recommended. • Inhibition of CYP3A4 and P-gp by ketoconazole (400 mg q.d.) resulted in a 3.8-fold increase in C max and in a 4.3-fold increase in AUC 0-12h of eliglustat in healthy non-PM subjects receiving 100 mg b.i.d. eliglustat. Caution is advised in case of use with strong CYP3A4 inhibitors, which is agreed. • Induction of CYP3A4 and P-gp by rifampin (600 mg q.d.) resulted in a 95% decrease (...) .) did not affect the pharmacokinetics of norethindrone or ethinyl estradiol (Ortho-Novum 1/35, given as the standard cycle). These interactions have been adequately described in the SmPC. Additional simulations using Physiologically-Based Pharmacokinetic Modelling with SimCYP ® were carried out to cover additional interactions. The model was validated using the data from the interaction studies with paroxetine and ketoconazole and showed good estimates of the effect. Based upon these simulations

2015 European Medicines Agency - EPARs

285. Akynzeo (netupitant / palonosetron)

at steady state Open-label 1 way Healthy subjects 8M, 8F Netupitant 450 mg on Day 8 NETU-10-08 PK interaction between Netupitant/Palonosetron and Ethinylestradiol / Levonorgestrel Randomised, open-label, 2-way crossover Healthy subjects 24F Single dose, Netupitant/Palonosetron FDC 300/0.5 mg NETU-10-11 PK interaction between Netupitant/Palonosetron with Ketoconazole and Rifampicine Randomised, open-label, 2-group, 2-way crossover Healthy subjects Ketoconazole: 11M, 6F Rifampicine: 10M, 8F Single dose (...) with Ketoconazole and Rifampicine Randomised, open-label, 2-group, 2-way crossover Healthy subjects Ketoconazole: 11M, 6F Rifampicine: 10M, 8F Single dose, Netupitant/Palonosetron FDC 300/0.5 mg PD studies 1009726 NP16602 Apomorphine challenge Randomised double-blind, placebo controlled, 4-group, single ascending dose Healthy subjects 30M, 2F Single PO , Netupitant 100, 300, 450 mg NETU-06-08 PET study to investigate the degree of occupancy of NK1 receptors in the brain Randomised, open-label, single dose PET

2015 European Medicines Agency - EPARs

289. Lixiana - edoxaban

of the following P-glycoprotein (P-gp) inhibitors: ciclosporine, dronedarone, erythromycin, ketoconazole. 2.2. Quality aspects 2.2.1. Introduction The finished product is presented as immediate release tablets containing 15 mg, 30 mg or 60 mg of edoxaban tosilate as active substance. Other ingredients are: Tablet core: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b); Film-coat: hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc, carnauba

2015 European Medicines Agency - EPARs

290. Kyprolis - carfilzomib

inhibitors 10 µM cyclosporine A and ketoconazole, respectively. In the assessment of carfilzomib as an inhibitor of P-gp, carfilzomib at 3 µM inhibited the efflux transport of digoxin by 25% in the Caco-2 system while the known P-gp inhibitors, Assessment report EMA/670306/2015 Page 23/142 cyclosporine A and ketoconazole at 10 µM, eliminated the efflux transport of digoxin completely. Given the very short T½ of carfilzomib in vivo, it is unlikely that even marginal inhibition would last >1 hour

2015 European Medicines Agency - EPARs

298. Xadago - safinamide

of safinamide. In a clinical study, ketoconazole had no clinically relevant effect on safinamide and its metabolites when co-administered (see clinical assessment), indicating that the involvement of CYP3A4 in the biotransformation pathway is minor. 2.3.4. Toxicology A large number of toxicology studies have been performed, probably reflecting the long period of development of the compound by different companies. Species differences among the non-clinical species and between the non-clinical species

2015 European Medicines Agency - EPARs

300. Zalviso - sufentanil

PK of the sufentanil sublingual tablet (SST) has been studied in seven phase I trials. Trials with the final formulation: • IAP102 - single-dose bioavailability trial comparing intravenous sufentanil and SST administered sublingually, buccally, or swallowed. • IAP101 - single- and multiple-dose (every 20 minutes for 40 doses) trial of SST dispensed from the SSTS. • IAP104 - single-dose drug interaction trial with SST and oral administration of a cytochrome P450 (CYP) 3A4 inhibitor (ketoconazole

2015 European Medicines Agency - EPARs

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