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Drug Safety Alerts
Ibrance® (palbociclib), Kisqali® (ribociclib), and Verzenio® (abemaciclib) MedWatch
09/13/2019
On September 13, 2019, the United States Food and Drug Administration (FDA) issued a warning that Ibrance® (palbociclib), Kisqali® (ribociclib), and Verzenio® (abemaciclib) used to treat some patients with advanced breast cancers may cause rare but severe inflammation of the lungs. The FDA has approved new warnings about this risk to the prescribing information and Patient Package Insert for the entire class of these cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor medicines. The overall benefit of CDK 4/6 inhibitors is still greater than the risks when used as prescribed.
CDK 4/6 inhibitors are a class of prescription medicines that are used in combination with hormone therapies to treat adults with hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative advanced or metastatic breast cancer that has spread to other parts of the body. CDK 4/6 inhibitors block certain molecules involved in promoting the growth of cancer cells. FDA approved Ibrance in 2015, and both Kisqali and Verzenio in 2017. CDK 4/6 inhibitors have been shown to improve the amount of time after the start of treatment the cancer does not grow substantially and the patient is alive, called progression-free survival.
A list of FDA-Approved CDK 4/6 Inhibitors is provided here:
The FDA states that healthcare professionals should monitor patients regularly for pulmonary symptoms indicative of interstitial lung disease (ILD) and/or pneumonitis. Signs and symptoms may include:
- Hypoxia
- Cough
- Dyspnea
- Interstitial infiltrates on radiologic exams in patients in whom infectious, neoplastic, and other causes have been excluded.
Interrupt CDK 4/6 inhibitor treatment in patients who have new or worsening respiratory symptoms, and permanently discontinue treatment in patients with severe ILD and/or pneumonitis.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program
CVS Caremark® Response:
Please note: There have been no recalls issued on this product by the manufacturer. CVS Caremark® will continue to dispense these products.
For more information about this issue, health care providers may contact the FDA consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.fda.gov.