Ribociclib can cause adverse reactions ranging from laboratory abnormalities and manageable symptoms to serious or potentially life-threatening complications.
Common adverse reactions
Current U.S. labeling identifies frequently reported reactions that vary according to treatment setting.
For early breast cancer, common adverse reactions and laboratory abnormalities include decreased lymphocytes, leukocytes and neutrophils, decreased hemoglobin, increased ALT and AST, infections, increased creatinine, decreased platelets, headache, nausea and fatigue.
For advanced or metastatic disease, commonly reported reactions include decreased blood-cell counts, liver-enzyme abnormalities, infections, nausea, increased creatinine, fatigue, diarrhea, vomiting, headache, constipation, alopecia, cough, rash and back pain.
Important serious risks
| Risk | Why it matters |
|---|---|
| Neutropenia | Can increase infection risk |
| Hepatotoxicity | Can cause clinically important liver injury |
| QT prolongation | Can increase risk of serious cardiac rhythm abnormalities |
| ILD/pneumonitis | Can be severe, life-threatening or fatal |
| Severe cutaneous reactions | Rare serious reactions can include SJS, TEN and DRESS |
| Embryo-fetal toxicity | Can cause fetal harm |
When urgent assessment may be needed
Prompt medical assessment may be appropriate for new or worsening breathing difficulty, fever or signs of infection, fainting, severe palpitations, significant rash or blistering, severe weakness, jaundice or other symptoms suggesting serious toxicity.
Monitoring
CBCs and liver-function tests are required before treatment and at specified intervals. ECG and electrolyte monitoring are also important because of QT-prolongation risk.