Breast cancer survivors
Men with breast cancer
People with a genetic mutation linked to cancer risk
Women under 45
Women over 45
Special populations: People taking CDK inhibitors
The U.S. Food and Drug Administration issued a safety alert for CDK inhibitors, including Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib). (9/24/19)
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The U.S. Food and Drug Administration’s (FDA) safety alert warning that Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib) may cause a rare but severe inflammation of the lungs.
The FDA approved Ibrance in 2015, and both Kisqali and Verzenio in 2017 to treat some patients with advanced breast cancer. These drugs, called CDK 4/6 inhibitors have been shown to significantly improve the amount of time a cancer does not grow and the patient is alive. However, in some patients they may cause rare but severe lung inflammation
CDK 4/6 inhibitors are a class of prescription medicines that are used in combination with hormone therapies to treat adults with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.
The FDA reviewed cases of lung disease associated with use of CDK 4/6 inhibitors. Cases were identified from both ongoing and completed clinical trials. Cases were also identified from the FDA’s drug safety database.
The FDA found that, although rare, there were serious cases and/or deaths with Ibrance (palbociclib), Verzenio (abemaciclib), and Kisqali (ribociclib).
The FDA recommends that anyone taking these CDK inhibitors notify their health care provider if they have any new or worsening symptoms involving their lungs.
Symptoms to watch for include:
Rarely, CDK 4/6 inhibitors can cause severe lung inflammation. However, the benefits of taking these medicines may outweigh this risk. The FDA is urging patients to not stop taking a CDK 4/6 inhibitors without first talking to their health care provider.
Experts do not yet know the factors that make a patient high-risk for severe lung inflammation when taking Ibrance, Kisqali, or Verzenio.
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