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U.S. Department of Health and Human Services
National Pharmacy & Therapeutics Committee

Warning Issued about Lung Inflammation with Ibrance, Kisqali, and Verzenio for Breast Cancer

September 13, 2019

Cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors are a class of medicines used in combination with hormonal therapies to treat adult patients 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 include: Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib).

The FDA evaluated data from manufacturer's clinical trials and discovered that 13% of patients treated with CDK 4/6 Inhibitors developed interstitial lung disease (ILD) or pneumonitis. Less than 1% of these cases were fatal. The FDA concludes that the overall benefit of CDK 4/6 inhibitors is greater than the risks when used as prescribed.

FDA has included the risk of ILD or pneumonitis as a new warning in the package inserts.

Health care professionals should monitor patients regularly for pulmonary symptoms indicative of ILD and/or pneumonitis. Signs and symptoms may include:

  • hypoxia
  • cough
  • dyspnea, or
  • interstitial infiltrates on radio logic 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. Permanently discontinue treatment in patients with severe ILD and/or pneumonitis.

The full drug safety communication Exit Disclaimer: You Are Leaving www.ihs.gov  can is attached and can be found on the FDA website.

Report adverse events involving this or other medicines to the MedWatch program as recommended in the Indian Health Manual and include “IHS” in the reporter section (section G).

Instructions for reporting can be found online at the NPTC Pharmacovigilance website.