The complete official prescribing information should always be consulted for authoritative instructions. The summary below is based primarily on the current U.S. IMBRUVICA label revised in October 2025.
Current U.S. indications
The current U.S. label includes:
- Adult CLL/SLL
- Adult CLL/SLL with 17p deletion
- Adult Waldenström’s macroglobulinemia
- Adult and pediatric patients aged 1 year and older with cGVHD after failure of one or more systemic therapies
Dosage
For adult CLL/SLL and WM, the recommended dose is 420 mg once daily.
For cGVHD, the recommended dose is 420 mg once daily for patients aged 12 years and older and 240 mg/m² once daily, up to 420 mg, for patients aged 1 to less than 12 years.
Dosage forms
Current U.S. labeling lists:
- 70 mg capsules
- 140 mg capsules
- 140 mg tablets
- 280 mg tablets
- 420 mg tablets
- 70 mg/mL oral suspension
Contraindications
The current U.S. label lists no contraindications. This does not mean that treatment is suitable for every patient; substantial warnings and precautions remain.
Major warnings
The label addresses:
- Hemorrhage
- Infections
- Cardiac arrhythmias, cardiac failure and sudden death
- Hypertension
- Cytopenias
- Second primary malignancies
- Hepatotoxicity
- Tumor lysis syndrome
- Embryo-fetal toxicity
Drug interactions
CYP3A inhibitors may increase ibrutinib exposure, while strong CYP3A inducers can reduce exposure. Dose modification or avoidance may be required.
Important product distinction
The U.S. IMBRUVICA label describes the reference product and should not automatically be treated as the complete local prescribing information for Ibruxen.