NMEs with HI-related labeling impact
The 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 | ||||
| Eluxadoline | 13.74 (severe) | 14.25 (severe) | Reduce dose (mild and moderate); contraindication (severe) | FDA (2015zc) |
| Flibanserin | 4.53 (mild) | 0.91 (mild) | Contraindication (any HI) | FDA (2015a) |
| Lenvatinib | 2.57 (severe) | 0.54 (severe) | Reduce dose (severe) | FDA (2015q) |
| Isavuconazonium sulfate | Isavuconazole: 2.19 (moderate)c | Isavuconazole: 0.77 (moderate)c | Not recommended (severe) | FDA (2015i) |
| Panobinostat | 2.05 (moderate) | 1.83 (moderate) | Reduce dose (mild and moderate); avoid use (severe) | FDA (2015l) |
| Selexipag | 4 (moderate); ACT-333679: 2 (moderate) | N/P | Avoid use (severe) | FDA (2015z) |
| Sacubitril | 3.45 (moderate); LBQ657: 1.9 (moderate) | N/P | Reduce dose (moderate); not recommended (severe) | FDA (2015k) |
| Lumacaftor | 1.50 (moderate) | 1.30 (moderate) | Reduce dose (moderate and severe) | FDA (2015u) |
| Brexpiprazole | 1.46 (moderate) | 0.76 (moderate) | Reduce dose (moderate and severe) | FDA (2015v) |
| Lesinurad | 1.33 (moderate) | 1.08 (moderate) | Not recommended (severe) | FDA (2015zg) |
| Ixazomib citrate | Ixazomib: 1.27 (moderate) | Ixazomib: 1.21 (moderate) | Reduce dose (moderate, severe) | FDA (2015s) |
| Edoxaban | 0.95 (mild); metabolite M4: 1.25 (mild) | 0.9 (mild); metabolite M4: 1.1 (mild) | Not recommended (moderate and severe) | FDA (2015w) |
| AUC ratio < 1.25b | ||||
| Rolapitant | 1.04 (moderate) | 0.77 (moderate) | Avoid use (severe) | FDA (2015za) |
| Cariprazine | 1.15 (moderate) | 1.14 (moderate) | Not recommended (severe) | FDA (2015zd) |
| Tenofovir alafenamide fumarate | 0.92 (mild); tenofovir: 0.89 (mild) | N/P | Not recommended (severe) | FDA (2015m) |
| No dedicated HI studyb | ||||
| Ivabradine | N/T | N/T | Contraindication (severe) | FDA (2015g) |
| PMR Requested | ||||
| Palbociclib | N/T | N/T | FDA (2015n) | |
| Trabectedin | N/T | N/T | FDA (2015zf) | |
| Cobimetinib | N/T | N/T | FDA (2015h) | |
| Osimertinib | N/T | N/T | FDA (2015x) | |
| Alectinib | N/T | N/T | FDA (2015b) | |