Selpercatinib can cause adverse reactions ranging from mild or manageable effects to potentially serious complications. The pattern can vary according to cancer type, treatment setting, dose, age and other clinical factors.
Common adverse reactions
In the LIBRETTO-001 safety population, commonly reported adverse reactions included:
- Edema
- Diarrhea
- Fatigue
- Dry mouth
- Hypertension
- Abdominal pain
- Constipation
- Nausea
- Rash
- Headache
- Vomiting
- Cough
- Dyspnea
- Hemorrhage
- Musculoskeletal pain
The exact frequencies depend on the clinical population and label version.
Important serious risks
| Risk | Why it matters |
|---|---|
| Hepatotoxicity | Can produce clinically significant liver injury |
| ILD/pneumonitis | Can be severe, life-threatening or fatal |
| Hypertension | Can become clinically significant |
| QT prolongation | Can increase the risk of cardiac rhythm abnormalities |
| Hemorrhage | Serious and potentially fatal bleeding can occur |
| Hypersensitivity | May include fever, rash and muscle or joint pain |
| Tumor lysis syndrome | Rapid tumor breakdown can produce metabolic complications |
| Severe laboratory abnormalities | Liver enzymes and electrolytes may change |
Liver abnormalities
In the current U.S. label, increased AST occurred in 62% and increased ALT in 58% of treated patients in the relevant pooled safety population, with Grade 3 or 4 elevations occurring in 11% and 13%, respectively.
Hypertension
Hypertension occurred in 43% of patients in the pooled safety information, including Grade 3 hypertension in 20%. Blood pressure should be optimized before treatment and monitored after one week and at least monthly thereafter under current U.S. labeling.
When urgent assessment may be needed
Medical assessment may be necessary for new or worsening breathing difficulty, severe headache or neurologic symptoms, chest symptoms, severe bleeding, marked swelling, persistent vomiting, symptoms of severe hypertension, or signs of a serious allergic reaction.