ADR that result in revision of patient information
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| The United States: FDA warns about rare but severe lung inflammation with Ibrance, Kisqali, and Verzenio for breast cancer |
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The US Food and Drug Administration (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. 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.
FDA reviewed CDK 4/6 inhibitors cases from completed and ongoing clinical trials undertaken by manufacturers and their postmarket safety databases that described specific types of inflammation of the lungs, called interstitial lung disease (ILD) and pneumonitis. Across the entire drug class, there were reports of serious cases, including fatalities.
Patients should notify their health care professional right away if they have any new or worsening symptoms involving their 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 and shortness of breath while at rest or with low activity. They should not stop taking their medicine without first talking to their health care professional.
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 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.
Please refer to the following website in FDA for details:
http://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-rare-severe-lung-inflammation-ibrance-kisqali-and-verzenio-breast-cancer
In Hong Kong, there are 3 registered pharmaceutical products containing palbociclib, and one product containing ribociclib. All products are prescription-only medicines. There is no registered pharmaceutical product containing abemaciclib. So far, the Department of Health (DH) has received adverse drug reaction related to palbociclib (103 cases) and ribociclib (7 cases), but these cases are not related to interstitial lung disease or pneumonitis. In light of the above FDA’s announcement, letters to inform local healthcare professionals will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Monday, Sep 16, 2019
Issued at HKT 18:00
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