Interstitial lung disease risk with prostate cancer meds
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Interstitial lung disease risk with prostate cancer meds The risk of interstitial lung disease will be added to the package inserts for two prostate cancer medicines – apalutamide and enzalutamide, according to Japan’s PMDA.*1,2 Apalutamide (Erleada Tablets) is indicated for treatment of castration-resistant prostate cancer without remote metastasis.1 Since the launch of this product in Japan in May this year, there have been a total of four cases involving interstitial lung disease (including two cases for which a causal relationship to the drug could not be ruled out). In addition, there has been one patient death reported to date, but again, a causal relationship between the drug and death subsequent to the patient’s interstitial lung disease could not be ruled out. Enzalutamide (Xtandi Capsules, Xtandi Tablets) is indicated for the treatment of castration-resistant prostate cancer.2 Over the past 3 fiscal years in Japan, a total of 19 cases involving interstitial lung disease have been reported to date (including five cases for which a causal relationship to the drug could not be ruled out). Furthermore, three patient deaths have been reported, but a causal relationship between the drug and deaths could not be established in any of these cases. Based on its investigation of currently available evidence and consultation with expert advisors, the MHLW/PMDA concluded that the following package insert revisions are necessary for both apalutamide and enzalutamide: • "Patients with interstitial lung disease or a history of the disease" should be added to the "Careful Administration" section. • A cautionary statement for interstitial lung disease should be added to the "Important Precautions" section. • "Interstitial lung disease" should be added to the "Clinically Significant Adverse Reactions" section. * PMDA = Pharmaceuticals and Medical Devices Agency 1. Pharmaceuticals and Medical Devices Agency of Japan. Summary of Investigation Results - Apalutamide. Internet Document : [2 pages], 15 Nov 2019. Available from: URL: http://www.pmda.go.jp/files/000232288.pdf. 2. Pharmaceuticals and Medical Devices Agency of Japan. Summary of Investigation Results - Enzalutamide. Internet Document : [2 pages], 15 Nov 2019. Available from: URL: http://www.pmda.go.jp/files/000232289.pdf. 803437962
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Reactions 30 Nov 2019 No. 1781
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