NMEs with RI-related labeling impact
AUC and Cmax ratios presented were calculated by the University of Washington Drug Interaction Database Editorial Team using mean AUC and Cmax values available in the NDA review documents and may differ from those presented in the product label.
| Drug Name | Ratio | Labeling Impact | Reference | |
|---|---|---|---|---|
| Maximal AUC | Cmaxa | |||
| AUC ≥ 1.25b | ||||
| Avibactam | 19.55 (ESRD) | 1.40 (ESRD) | Reduce dose (moderate, severe and ESRD) | FDA (2015d) |
| Sugammadex | 17.24 (severe to ESRD) | Not Provided | Not recommended (severe) | FDA (2015e) |
| Tenofovir alafenamide fumarate | 1.92 (severe); tenofovir: 6.05 (severe) | 1.83 (severe); tenofovir: 2.78 (severe) | Not recommended (severe) | FDA (2015m) |
| Edoxaban | 1.93 (ESRD); metabolite M4: 4.5 (ESRD) | 0.93 (ESRD); metabolite M4: 2.0 (ESRD) | Reduce dose (15–50 ml/min); not recommended (CrCL < 15 ml/min) | FDA (2015w) |
| Sacubitril | 1.30 (severe); LBQ657: 2.7 (severe) | N/P | Reduce dose (severe) | FDA (2015k) |
| Lesinurad | 2.13 (severe) | 1.14 (severe) | Contraindication (severe and ESRD) | FDA (2015zg) |
| Brexpiprazole | 1.85 (severe) | 1.00 (severe) | Reduce dose (moderate, severe and ESRD) | FDA (2015v) |
| Lenvatinib | 1.66 (severe) | 0.95 (severe) | Reduce dose (severe) | FDA (2015q) |
| Ixazomib citrate | 1.41 (severe) | 1.76 (severe) | Reduce dose (severe and ESRD) | FDA (2015s) |
| AUC ratio < 1.25b | ||||
| No dedicated RI studyb | ||||
| Lumacaftor | N/T | N/T | Exercise caution (severe and ESRD) | FDA (2015u) |
| Cariprazine | N/T | N/T | Not recommended (severe) | FDA (2015zd) |
| Tipiracil | 1.65 (moderate; population PK) | N/T | Adjust dose (moderate) | FDA (2015r) |
| Cholic acidc | N/T | N/T | The urinary excretion of atypical bile acids maybe reduced in renal impaired patients. | FDA (2015f) |
| PMR Requested | ||||
| Eluxadoline | N/T | N/T | FDA (2015zc) | |
CrCL, creatinine clearance; ESRD, end stage renal disease; N/P, not provided; N/T, not tested.
↵a The Cmax ratios presented are for the same patient population as the maximal AUC ratio.
↵b With dosing recommendation.
↵c Labeling recommendations are extracted from clinical pharmacology and biopharmaceutics reviews.