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The recommended dosage of Ibrutinib for CLL/SLL and WM is 420 mg orally once daily until disease progression or unacceptable toxicity.
For CLL/SLL, Ibrutinib can be administered as a single agent, in combination with rituximab or obinutuzumab, or in combination with bendamustine and rituximab (BR).
For WM, Ibrutinib can be administered as a single agent or in combination with rituximab.
When administering Ibrutinib in combination with rituximab or obinutuzumab, consider administering Ibrutinib prior to rituximab or obinutuzumab when given on the same day.
The recommended dosage of Ibrutinib for patients age 12 years and older with cGVHD is 420 mg orally once daily, and for patients 1 to less than 12 years of age with cGVHD is 240 mg/m2 orally once daily (up to a dose of 420 mg), until cGVHD progression, recurrence of an underlying malignancy, or unacceptable toxicity. When a patient no longer requires therapy for the treatment of cGVHD, Ibrutinib should be discontinued considering the medical assessment of the individual patient.
Administer Ibrutinib at approximately the same time each day.
Swallow tablets or capsules whole with a glass of water. Do not open, break, or chew the capsules. Do not cut, crush, or chew the tablets.
Follow Instructions for Use for further administration details of Ibrutinib oral suspension.
If a dose of Ibrutinib is not taken at the scheduled time, it can be taken as soon as possible on the same day with a return to the normal schedule the following day. Do not take extra doses of Ibrutinib to make up for the missed dose.
For adverse reactions listed in Table 2, interrupt Ibrutinib therapy. Once the adverse reaction has improved to Grade 1 or baseline (recovery), follow the recommended dosage modifications (see Table 2).
Recommended dosage modifications are described below:
The recommended dosage is 140 mg daily for patients with mild hepatic impairment (Child-Pugh class A).
The recommended dosage is 70 mg daily for patients with moderate hepatic impairment (Child-Pugh class B).
Avoid the use of Ibrutinib in patients with severe hepatic impairment (Child-Pugh class C).
The recommended dosage is 140 mg daily for patients 12 years of age and older with total bilirubin level >1.5 to 3 x upper limit of normal (ULN) (unless of non-hepatic origin or due to Gilbert’s syndrome).
The recommended dosage is 80 mg/m2 daily for patients 1 to less than 12 years of age with total bilirubin level >1.5 to 3 x ULN (unless of non-hepatic origin or due to Gilbert’s syndrome).
Avoid the use of Ibrutinib in these patients with total bilirubin level > 3 x ULN (unless of non-hepatic origin or due to Gilbert’s syndrome).
from FDA，2024.05
