Ponatinib can cause adverse reactions ranging from laboratory abnormalities and manageable symptoms to life-threatening vascular and cardiovascular events. The safety profile depends on dose, treatment setting, combination therapy and patient characteristics.
Common adverse reactions
The current U.S. label reports, among others:
- Rash and related skin reactions
- Arthralgia
- Abdominal pain
- Fatigue
- Headache
- Constipation
- Hypertension
- Dry skin
- Hepatotoxicity
- Fluid retention and edema
- Fever
- Pancreatitis or lipase elevation
- Nausea
- Hemorrhage
- Anemia
- Arterial occlusive events
- Cardiac arrhythmias
Important serious risks
| Risk | Why it matters |
|---|---|
| Arterial occlusive events | May cause myocardial infarction, stroke or limb ischemia |
| Venous thromboembolism | May include serious venous clotting |
| Heart failure | Can be severe or fatal |
| Hepatotoxicity | Liver injury and liver failure can occur |
| Pancreatitis | Can require treatment interruption |
| Hemorrhage | Serious bleeding can occur |
| Arrhythmias | Can produce clinically significant cardiac effects |
| Myelosuppression | Can lower blood-cell counts |
| Ocular toxicity | Vision-threatening effects may occur |
| RPLS | Rare neurologic complication |
| GI perforation | Serious gastrointestinal complication |
When urgent assessment may be required
Symptoms such as chest pain, sudden weakness, difficulty speaking, severe shortness of breath, severe abdominal pain, significant bleeding, new neurologic symptoms or sudden visual changes require prompt medical assessment.
Monitoring
Clinical monitoring may include blood pressure, liver tests, pancreatic enzymes, blood counts, cardiovascular assessment and eye examinations.