Incidence of Pedal Edema in Patients Treated with Ribociclib (Kisqali)
Pedal edema is not a commonly reported adverse effect of ribociclib, with no specific incidence rate mentioned in clinical trials or FDA labeling.
Adverse Effects Profile of Ribociclib
- The FDA drug label for Kisqali (ribociclib) does not list pedal edema as a common adverse effect in either the NATALEE adjuvant trial or the MONALEESA metastatic breast cancer trials 1
- The most common adverse reactions (≥20%) reported with ribociclib include neutropenia, infections, nausea, headache, fatigue, leukopenia, and abnormal liver function tests 1
- In the NATALEE trial, peripheral edema was reported in only 7% of patients receiving ribociclib plus a non-steroidal aromatase inhibitor (NSAI), making it a less common adverse effect 1
Comparison with Other Medications
- Unlike calcium channel blockers, which are known to cause pedal edema as a common side effect (with incidence rates of 3-5% for some classes), ribociclib does not have a high association with edema 2
- The MONALEESA-3 trial, which evaluated ribociclib plus fulvestrant in postmenopausal women with HR-positive, HER2-negative advanced breast cancer, did not report peripheral edema as a significant adverse event 2
Monitoring and Management Considerations
- Clinicians should be aware that while peripheral edema can occur with ribociclib (7% incidence), it is not among the adverse effects requiring dose modifications or treatment interruptions 1
- The most common adverse effects requiring dose modifications with ribociclib are neutropenia (14%), liver function abnormalities (8.3%), and COVID-19 (10%) 1
- Real-world studies confirm that ribociclib's adverse events are generally manageable with active monitoring, temporary treatment suspension, and dose reduction when necessary 3
Special Considerations
- When peripheral edema does occur in patients taking ribociclib, it's important to rule out other potential causes such as:
- Thromboembolic events, which have been reported in approximately 1.97% of patients taking ribociclib in real-world settings 4
- Renal dysfunction, as rare cases of acute kidney injury have been reported with ribociclib 5
- Drug interactions, as ribociclib is primarily metabolized by CYP3A4 and can interact with other medications that may cause fluid retention 6
Clinical Implications
- For patients concerned about edema, ribociclib may be a preferable CDK4/6 inhibitor option compared to others in the class, as its side effect profile focuses more on neutropenia, liver function abnormalities, and QT prolongation rather than fluid retention 7
- In the NATALEE trial, permanent discontinuation of ribociclib due to adverse events occurred in 20% of patients, but peripheral edema was not listed among the common reasons for discontinuation 1
- When monitoring patients on ribociclib, focus should be placed on neutropenia, liver function tests, and QT interval prolongation rather than edema 2