Table 2.
Dose adjustment criteria of lenvatinib according to the AEs.
| AEs | Degree of AEs | Management | Taper and resume lenvatinib mesylate |
|---|---|---|---|
| Hpertension | Grade 3 (despite optimal antihypertensive therapy) |
Suspend | Remission to grade 0, 1 or 2. |
| Grade 4 | Permanently discontinue | Treatment must not be restarted | |
| Pteinuria | ≥ 2 g/24 hours | Suspend | Remission to less than 2g/24 hours |
| Nephrotic syndrome | ------- | Permanently discontinue | Treatment must not be restarted |
| Renal insufficiency or kidney failure | Grade 3 | Suspend | Remission to Grade 0-1 or Baseline |
| Grade 4* | Permanently discontinue | Treatment must not be restarted | |
| Heart dysfunction | Grade 3 | Suspend | Remission to Grade 0-1 or baseline |
| Grade 4 | Permanently discontinue | Treatment must not be restarted | |
| Posterior Reversible Encephalopathy Syndrome (PRES) / Reversible Posterior Leukoencephalopathy Syndrome (RPLS) | Any grade | Suspend | If remission reaches grade 0-1, consider restarting treatment at a reduced dose |
| Liver toxicity | Grade 3 | Suspend | Remission to Grade 0-1 or baseline |
| Grade 4* | Permanently discontinue | Treatment must not be restarted | |
| Arterial thromboembolism | Any grade | Permanently discontinue | Treatment must not be restarted |
| Bleeding | Grade 3 | Suspend | Remission to Grade 0-1 |
| Grade 4 | Permanently discontinue | Treatment must not be restarted | |
| Gastrointestinal perforation or gastrointestinal fistula | Grade 3 | Suspend | Remission to Grade 0-1 or baseline |
| Grade 4 | Permanently discontinue | Treatment must not be restarted | |
| Parenteral fistula | Grade 4 | Permanently discontinue | Treatment must not be restarted |
| QT interval prolongation | >500 ms | Suspend | Remission to ≤ 480 ms or baseline |
| diarrhea | Grade 3 | Suspend | Remission to Grade 0-1 or baseline |
| Grade 4 (although medically managed) |
Permanently discontinue | Treatment must not be restarted |
* It can be treated according to Grade 3 adverse reactions if it is judged to be non-life-threatening when the adverse reaction is laboratory abnormal Grade 4.