From the Research
The percentage of micro hemorrhages with Kisqali (ribociclib) is not a commonly reported adverse effect in clinical trials or post-marketing surveillance. Kisqali is a CDK4/6 inhibitor approved for hormone receptor-positive, HER2-negative advanced or metastatic breast cancer, and its most common side effects include neutropenia, nausea, infections, fatigue, diarrhea, leukopenia, vomiting, alopecia, headache, constipation, and rash. Micro hemorrhages are not listed among the known adverse reactions in the drug's prescribing information. The medication's primary safety concerns relate to QT interval prolongation, hepatobiliary toxicity, neutropenia, and embryo-fetal toxicity. If there are concerns about bleeding risks, patients should discuss this with their healthcare provider, who can evaluate individual risk factors and monitor for any unusual symptoms. Regular monitoring of complete blood counts and liver function tests is recommended during treatment with Kisqali, but specific monitoring for micro hemorrhages is not part of standard care for this medication, as supported by the most recent study 1.
Some studies have investigated the safety and efficacy of ribociclib in various patient populations, including those with renal impairment 2, but these studies do not provide specific information on the incidence of micro hemorrhages. The lack of data on micro hemorrhages in these studies suggests that this adverse effect is not a significant concern in patients treated with Kisqali.
Key points to consider when evaluating the risk of micro hemorrhages in patients treated with Kisqali include:
- The medication's known adverse effects, which do not include micro hemorrhages
- The primary safety concerns associated with Kisqali, such as QT interval prolongation and hepatobiliary toxicity
- The importance of regular monitoring of complete blood counts and liver function tests during treatment with Kisqali
- The need for patients to discuss any concerns about bleeding risks with their healthcare provider, who can evaluate individual risk factors and monitor for any unusual symptoms.
Overall, based on the available evidence, there is no clear indication that Kisqali is associated with a significant risk of micro hemorrhages, and patients should be monitored for the medication's known adverse effects, as recommended in the prescribing information 1.