Ibrutinib dosing is determined by the indication, age, formulation, drug interactions, hepatic function and adverse reactions. The following information summarizes current U.S. IMBRUVICA labeling and is not an individualized prescription.
| Indication | Current U.S. labeled dosage |
|---|---|
| Adult CLL/SLL | 420 mg once daily |
| Adult WM | 420 mg once daily |
| cGVHD age 12 years and older | 420 mg once daily |
| cGVHD age 1 to <12 years | 240 mg/m² once daily, maximum 420 mg |
Relationship to 140 mg capsules
A 420 mg dose corresponds to three 140 mg capsules when that capsule formulation is used.
A 140 mg capsule therefore represents one dosage unit rather than a universal daily dose.
Dose modification
Current labeling provides dose modifications for serious adverse reactions and for interactions with CYP3A inhibitors. For example, dose reductions may be required with certain azole antifungals and other CYP3A inhibitors.
Hepatic impairment
For adult B-cell malignancies, the current U.S. label recommends:
- Mild hepatic impairment: 140 mg once daily
- Moderate hepatic impairment: 70 mg once daily
- Severe hepatic impairment: avoid use
Missed dose
A missed dose may be taken later on the same day according to current U.S. labeling. If it is not taken that day, the normal schedule resumes the next day. Extra doses should not be taken to compensate.
Important jurisdictional limitation
Ibruxen is a separate branded product. Its official local prescribing information should be consulted for the exact authorized indications and dosage instructions applicable to the product and country.