The Drug-Induced Respiratory Disease Website and App

Frequency - Incidence

Incidence of respiratory adverse event(s) due to the specific drug as assessed by number of reported/published cases in the literature. Red digits in stars indicate: 0 = Very rare, questionable signal · 1 = < 10 cases · 2 = 10-50 cases · 3 = 50–100 cases · 4 = 100-200 cases · 5 = >200 cases

Evidence level/grade

Evidence level for respiratory adverse event(s) due to the specific drug as estimated using Hill’s (1965), Naranjo’s (1981), and Bégaud’s (1985) criteria applied to published cases. Blue digits in stars indicate: 0 = Questionable · 1 = Low · 2 = Moderate · 3 = Robust · 4 = Definite · 5 = Unquestionable, pathognomonic

I.a

Pneumonitis (ILD), acute and/or severe (may produce the ARDS pattern)

Publications

Akamatsu H, Inoue A, Mitsudomi T, Kobayashi K, Nakagawa K, Mori K, Nukiwa T, Nakanishi Y, Yamamoto N

Interstitial lung disease associated with gefitinib in Japanese patients with EGFR-mutated non-small-cell lung cancer: combined analysis of two Phase III trials (NEJ 002 and WJTOG 3405).

Japanese journal of clinical oncology. 2013;43(6):664-8

Zhang Y, Yang H, Zhao M, He J

Successful treatment of gefitinib-induced acute interstitial pneumonitis with corticosteroid and non-invasive BIPAP-ventilation.

Journal of thoracic disease. 2012;4(3):316-9

Chang SC, Chang CY, Chang SJ, Yuan MK, Lai YC, Liu YC, Chen CY, Kuo LC, Yu CJ

Gefitinib-related interstitial lung disease in Taiwanese patients with non-small-cell lung cancer.

Clinical lung cancer. 2013;14(1):55-61

Nyberg F, Ogiwara A, Harbron CG, Kawakami T, Nagasaka K, Takami S, Wada K, Tu HK, Otsuji M, Kyono Y, Dobashi T, Komatsu Y, Kihara M, Akimoto S, Peers IS, South MC, Higenbottam T, Fukuoka M, Nakata K, Ohe Y, Kudoh S, Clausen IG, Nishimura T, Marko-Varga G,

Proteomic biomarkers for acute interstitial lung disease in gefitinib-treated Japanese lung cancer patients.

PloS one. 2011;6(7):e22062

Maemondo M, Inoue A, Kobayashi K, Sugawara S, Oizumi S, Isobe H, Gemma A, Harada M, Yoshizawa H, Kinoshita I, Fujita Y, Okinaga S, Hirano H, Yoshimori K, Harada T, Ogura T, Ando M, Miyazawa H, Tanaka T, Saijo Y, Hagiwara K, Morita S, Nukiwa T, North-East

Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR.

The New England journal of medicine. 2010;362(25):2380-8

Endo M, Johkoh T, Kimura K, Yamamoto N

Imaging of gefitinib-related interstitial lung disease: multi-institutional analysis by the West Japan Thoracic Oncology Group.

Lung cancer (Amsterdam, Netherlands). 2006;52(2):135-40

Kataoka K, Taniguchi H, Hasegawa Y, Kondoh Y, Kimura T, Nishiyama O, Imaizumi K, Kawabe T, Kume H, Shimokata K

Interstitial lung disease associated with gefitinib.

Respiratory medicine. 2006;100(4):698-704

Rabinowits G, Herchenhorn D, Rabinowits M, Weatge D, Torres W

Fatal pulmonary toxicity in a patient treated with gefitinib for non-small cell lung cancer after previous hemolytic-uremic syndrome due to gemcitabine.

Anti-cancer drugs. 2003;14(8):665-8

Inoue A, Saijo Y, Maemondo M, Gomi K, Tokue Y, Kimura Y, Ebina M, Kikuchi T, Moriya T, Nukiwa T

Severe acute interstitial pneumonia and gefitinib.

Lancet (London, England). 2003;361(9352):137-9