Acalabrutinib can cause adverse reactions ranging from mild or manageable symptoms to potentially serious complications. The adverse-effect profile can vary according to the disease, treatment regimen, duration and concomitant medicines.
Common adverse reactions
Current U.S. labeling identifies commonly occurring reactions including:
- Diarrhea
- Upper respiratory tract infection
- Headache
- Musculoskeletal pain
- Lower respiratory tract infection
- Fatigue
Laboratory abnormalities commonly include decreases in neutrophils, lymphocytes, platelets and hemoglobin.
The EMA also identifies infections, headache, diarrhea, bruising, musculoskeletal pain, nausea, fatigue, cough, joint pain and rash among common effects observed with Calquence.
Important serious risks
| Risk | Why it matters |
|---|---|
| Serious infections | Infections can become severe or opportunistic |
| Hemorrhage | Bleeding can occasionally be serious or life-threatening |
| Cytopenias | Reduced blood-cell counts can increase complications |
| Cardiac arrhythmias | Abnormal heart rhythms can occur |
| Hepatotoxicity | Liver injury, including drug-induced liver injury, has been reported |
| Second primary malignancies | Additional malignancies have occurred |
| Tumor lysis syndrome | Can occur in susceptible patients with high tumor burden |
When urgent medical attention may be needed
Prompt medical assessment may be appropriate for:
- significant or uncontrolled bleeding,
- severe shortness of breath,
- fainting or new palpitations,
- high fever or signs of serious infection,
- severe weakness,
- jaundice or other signs of liver injury,
- severe allergic symptoms, or
- other rapidly worsening symptoms.
Monitoring
Healthcare professionals may monitor complete blood counts, signs of infection, bleeding symptoms, cardiac symptoms and liver function during treatment.