Table 2.
Hematological and non-hematological criteria for suggested dose modification of mycophenolate mofetil
| Toxicity(a) | Hold study treatment | Dose modification |
|---|---|---|
| Hematological criteria | ||
| Grade 4 bone marrow hypocellular | No(b) | Decrease one dose level(c) |
| Grade 4 febrile neutropenia | No(b) | Decrease one dose level(c) |
| Grade 4 neutrophil count decreased | No(b) | Decrease one dose level(c) |
| ≥ Grade 3 of other hematologic toxicities | No(b) | Decrease one dose level(c) |
| Sepsis & any Grade 3 infection | Yes until ≤ Grade 2(d) | Resume at one dose level lower(c) |
| Sepsis & any Grade 4 infection | Yes until ≤ Grade 2(d) | Resume at two dose level lower(c) |
| Non-hematological criteria | ||
| Grade 3, except for: delayed puberty, growth suppression, breast atrophy, erectile dysfunction, diarrhea(e), vomiting(e), and AST/ALT increased or other biochemical laboratory abnormalities without any clinically significant sequelae | No(b) | Decrease one dose level(c) |
| Any Grade 4 toxicity | No(b) | Decrease two dose level(c) |
(a) If no recovery (until ≤ Grade 2) is noted after 7 days of dose modification of mycophenolate mofetil, that event will be considered as another toxicity requiring one more dose reduction; (b) Study treatment may be held whenever clinically needed (at the discretion of the PI and study team); (c) If more than 3 dose reductions are required, study treatment may be discontinued unless there is reasonable evidence of clinical benefit to justify continuation in the study; (d) If no recovery (until ≤ Grade 2) is noted after a 28-day delay, study treatment will be discontinued unless there is reasonable evidence of clinical benefit to justify continuation in the study; (e) Only if it occurs despite maximal medical treatment