TOPIC: Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib): Drug Safety Communication - Due to Rare but Severe Lung Inflammation
AUDIENCE: Patient, Health Professional, Oncology
ISSUE: FDA is 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. We have 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.
BACKGROUND: 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 (See List of FDA-Approved CDK 4/6 Inhibitors below).
RECOMMENDATION: Patients should notify your health care professional right away if you have any new or worsening symptoms involving your lungs, as they may indicate a rare but life-threatening condition that can lead to death. Symptoms to watch for include:
• Difficulty or discomfort with breathing
• Shortness of breath while at rest or with low activity
Do not stop taking your medicine without first talking to your health care professional. All medicines have side effects even when used correctly as prescribed, but in general the benefits of taking these medicines outweigh these risks. It is important to know that people respond differently to all medicines depending on their health, the diseases they have, genetic factors, other medicines they are taking, and many other factors. Specific risk factors to determine how likely it is that a particular person will experience severe lung inflammation when taking Ibrance, Kisqali, or Verzenio have not been identified.
Health care professionals should monitor patients regularly for pulmonary symptoms indicative of interstitial lung disease (ILD) and/or pneumonitis. Signs and symptoms may include:
• 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.
Read more about the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at:
美國FDA發布藥物安全警訊，治療某些晚期乳癌的Ibrance (palbociclib)，Kisqali (ribociclib)和Verzenio (abemaciclib)可能會引起罕見但嚴重的肺部發炎反應。目前美國FDA已針對此類所有細胞週期蛋白依賴型激酶4/6 (cyclin-dependent kinase 4/6, CDK 4/6)抑制劑的藥品仿單和病人用藥須知中加入此警語。然而使用CDK 4/6抑制劑的整體益處仍大於風險。
CDK 4/6抑制劑為處方藥，可與荷爾蒙療法結合使用，治療荷爾蒙受體(hormone receptor, HR)陽性，人類表皮生長因子2(human epidermal growth factor 2, HER2)陰性的晚期或轉移性乳癌的成人。CDK 4/6抑制劑可阻斷某些參與促進癌細胞生長的分子。美國FDA於2015年核可Ibrance，並於2017年核准Kisqali和Verzenio。CDK4/6抑制劑已被證明可改善疾病無惡化存活期(progression-free survival)。
醫療專業人員應定期監測病人的肺部症狀，以及早發現間質性肺疾病(interstitial lung disease, ILD)和/或肺部發炎反應。其表徵和症狀可能包括：
病人若出現新或惡化的呼吸道症狀應停止CDK 4/6抑制劑治療，若有嚴重ILD和/或肺部發炎反應的病人應永久停用CDK 4/6抑制劑治療。