Ibrutinib can produce adverse reactions ranging from relatively common treatment effects to potentially life-threatening complications. The adverse-effect profile varies according to disease, treatment duration, combination therapy and patient characteristics.
Common adverse reactions
Current U.S. labeling identifies commonly reported reactions in B-cell malignancy patients including:
- Thrombocytopenia
- Diarrhea
- Fatigue
- Musculoskeletal pain
- Neutropenia
- Rash
- Anemia
- Bruising
- Nausea
Serious adverse reactions
| Risk | Why it matters |
|---|---|
| Hemorrhage | Ibrutinib can increase bleeding risk |
| Infection | Serious bacterial, viral and fungal infections can occur |
| Cardiac arrhythmias | Atrial fibrillation and other arrhythmias have been reported |
| Cardiac failure | Serious cardiac dysfunction can occur |
| Hypertension | Blood pressure can become elevated |
| Cytopenias | Low blood-cell counts can increase complications |
| Second primary malignancies | Additional malignancies have been reported |
| Hepatotoxicity | Serious liver injury can occur |
| Tumor lysis syndrome | Rapid tumor breakdown can produce metabolic complications |
| Embryo-fetal toxicity | Can harm a developing fetus |
Cardiac effects
Current U.S. labeling reports grade 3 or higher atrial fibrillation/flutter in 3.7% and grade 3 or higher cardiac failure in 1.3% among 4,896 clinical-trial patients exposed to IMBRUVICA.
When urgent medical assessment may be needed
Urgent medical evaluation may be appropriate for:
- Significant or uncontrolled bleeding
- Fainting or severe dizziness
- New or worsening shortness of breath
- Chest discomfort
- Palpitations
- Severe infection symptoms
- High fever
- Severe abdominal symptoms
- Confusion or other concerning neurologic changes
Monitoring
Monitoring may include blood counts, blood pressure, infection symptoms, cardiovascular assessment and liver-related testing when clinically indicated.