FDA Issues Safety Communication for Ibrance, Kisqali, and Verzenio

September 13, 2019 – The U.S. FDA has warned that Ibrance® (palbociclib – Pfizer), Kisqali® (ribociclib – Novartis), and Verzenio® (abemaciclib – Eli Lilly) may cause rare but severe inflammation of the lungs in some patients being treated for advanced breast cancer. As a result, the agency is requiring new warnings be added to the prescribing information and package inserts for the entire class of cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor medicines.

According to the agency, the overall benefit of CDK 4/6 inhibitors remains greater than the potential risks when these medications are used as prescribed. Typically, CDK 4/6 inhibitors are used in conjunction with hormone therapy to treat 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. This class of medication has been shown to extend progression-free survival, meaning the time during which cancer does not grow significantly.

The FDA advises patients on CDK 4/6 inhibitors to notify their healthcare providers immediately if they experience new or worsening symptoms involving the lungs. Symptoms to watch for include breathing difficulty or discomfort, or shortness of breath while at rest or with low activity. Patients should not discontinue their medication without first speaking to their healthcare provider. The FDA emphasizes that individual patients can have unique responses to medicines depending on factors that include the patient’s health, the diseases they may have, genetic factors, and other medicines they are taking. At this time, specific risk factors for severe lung inflammation with CDK 4/6 inhibitors have not been identified.

Healthcare professionals are advised to monitor patients regularly for pulmonary symptoms indicative of interstitial lung disease (ILD) and/or pneumonitis. Treatment with CDK 4/6 inhibitors should be interrupted in patients who have new or worsening respiratory symptoms, and permanently discontinued in patients who have severe ILD and/or pneumonitis.

The FDA urges patients and healthcare professionals to report side effects involving CDK 4/6 inhibitors and other medications to the FDA MedWatch program.

For more information regarding CDK 4/6 inhibitors and lung inflammation, visit the FDA's website.