Protocol guidelines for nilotinib dose adaptation according to hematologic and nonhematologic toxicity
| Guidelines for nilotinib dose adaptation . | |
|---|---|
| For hematologic toxicity | |
| Grade 1 and 2: ANC > 1.0 × 109/L Platelets > 50 × 109/L | No dose reduction |
| Grade 3 and 4: 1st and 2nd time | Discontinue nilotinib and resume (800 mg daily) when grade < 3 |
| Grade 3 and 4: 3rd time | Discontinue nilotinib and resume (400 mg daily) when grade < 3, and 800 mg after 1 wk |
| Grade 3 and 4: 4th time | Discontinue nilotinib and resume (400 mg daily) when grade < 3, and 800 mg after 1 mo |
| Grade 3 and 4: 5th time | Discontinue nilotinib |
| For nonhematologic toxicity, noncardiac | |
| Grade 1 | No dose reduction |
| Grade 2 and 3: 1st and 2nd time | Discontinue nilotinib and resume (800 mg daily) when grade < 2 |
| Grade 2 and 3: 3rd time | Discontinue nilotinib and resume (400 mg daily) when grade < 2 and 800 mg after 1 wk |
| Grade 2 and 3: 4th time | Discontinue nilotinib and resume (400 mg daily) when grade < 2 |
| Grade 4 | Discontinue nilotinib permanently* |
| For nonhematologic toxicity, cardiac | |
| QTc prolongation up to 499 msec | Discontinue nilotinib and resume (400 mg daily) when QTc < 450 msec |
| QTc prolongation > 500 msec | Discontinue nilotinib permanently |
| Guidelines for nilotinib dose adaptation . | |
|---|---|
| For hematologic toxicity | |
| Grade 1 and 2: ANC > 1.0 × 109/L Platelets > 50 × 109/L | No dose reduction |
| Grade 3 and 4: 1st and 2nd time | Discontinue nilotinib and resume (800 mg daily) when grade < 3 |
| Grade 3 and 4: 3rd time | Discontinue nilotinib and resume (400 mg daily) when grade < 3, and 800 mg after 1 wk |
| Grade 3 and 4: 4th time | Discontinue nilotinib and resume (400 mg daily) when grade < 3, and 800 mg after 1 mo |
| Grade 3 and 4: 5th time | Discontinue nilotinib |
| For nonhematologic toxicity, noncardiac | |
| Grade 1 | No dose reduction |
| Grade 2 and 3: 1st and 2nd time | Discontinue nilotinib and resume (800 mg daily) when grade < 2 |
| Grade 2 and 3: 3rd time | Discontinue nilotinib and resume (400 mg daily) when grade < 2 and 800 mg after 1 wk |
| Grade 2 and 3: 4th time | Discontinue nilotinib and resume (400 mg daily) when grade < 2 |
| Grade 4 | Discontinue nilotinib permanently* |
| For nonhematologic toxicity, cardiac | |
| QTc prolongation up to 499 msec | Discontinue nilotinib and resume (400 mg daily) when QTc < 450 msec |
| QTc prolongation > 500 msec | Discontinue nilotinib permanently |
Notify treatment advisory committee.