Pharmacokinetic Drug Interactions of Afatinib with Rifampicin and Ritonavir
Tóm tắt
Từ khóa
Tài liệu tham khảo
Li D, Ambrogio L, Shimamura T, et al. BIBW2992, an irreversible EGFR/HER2 inhibitor highly effective in preclinical lung cancer models. Oncogene. 2008;27:4702–11.
Solca F, Dahl G, Zoephel A, et al. Target binding properties and cellular activity of afatinib (BIBW 2992), an irreversible ErbB family blocker. J Pharmacol Exp Ther. 2012;343:342–50.
Sequist LV, Yang JC, Yamamoto N, et al. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J Clin Oncol. 2013;31:3327–34.
Wu YL, Zhou C, Hu CP, et al. LUX-Lung 6: a randomized, open-label, phase III study of afatinib (A) versus gemcitabine/cisplatin (GC) as first-line treatment for Asian patients (pts) with EGFR mutation-positive (EGFR M+) advanced adenocarcinoma of the lung. J Clin Oncol 2013;31(Suppl):abstract 8016.
Cohen EEW, Fayette J, Cupissol D, et al. A randomized, open-label, phase II study of afatinib (BIBW 2992) versus cetuximab in recurrent or metastatic squamous cell carcinoma of the head and neck: final data [abstract no. PP101]. Eur Arch Otorhinolaryngol. 2012;269:1374.
Gilotrif™ (afatinib) tablet for oral use: US prescribing information. Ridgefield: Boehringer Ingelheim Pharmaceuticals, Inc.; 2013 Oct. http://www.gilotrif.com/ . Accessed 21 Nov 2013.
Wind S, Schmid M, Erhardt J, et al. Pharmacokinetics of afatinib, a selective irreversible ErbB family blocker, in patients with advanced solid tumours. Clin Pharmacokinet. 2013;52:1101–9.
Stopfer P, Marzin K, Narjes H, et al. Afatinib pharmacokinetics and metabolism after oral administration to healthy male volunteers. Cancer Chemother Pharmacol. 2012;69:1051–61.
Lin JH, Yamazaki M. Role of P-glycoprotein in pharmacokinetics: clinical implications. Clin Pharmacokinet. 2003;42:59–98.
Mizuno N, Niwa T, Yotsumoto Y, et al. Impact of drug transporter studies on drug discovery and development. Pharmacol Rev. 2003;55:425–61.
Marzolini C, Paus E, Buclin T, et al. Polymorphisms in human MDR1 (P-glycoprotein): recent advances and clinical relevance. Clin Pharmacol Ther. 2004;75:13–33.
European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP) assessment report for Giotrif (afatinib). 16 October 2013. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002280/WC500152394.pdf . Accessed 20 Nov 2013.
Zhang L, Strong JM, Qiu W, et al. Scientific perspectives on drug transporters and their role in drug interactions. Mol Pharm. 2006;3:62–9.
Backman JT, Olkkola KT, Ojala M, et al. Concentrations and effects of oral midazolam are greatly reduced in patients treated with carbamazepine or phenytoin. Epilepsia. 1996;37:253–7.
Backman JT, Kivisto KT, Olkkola KT, et al. The area under the plasma concentration-time curve for oral midazolam is 400-fold larger during treatment with itraconazole than with rifampicin. Eur J Clin Pharmacol. 1998;54:53–8.
FDA Center for Drug Evaluation and Research (CDER). Guidance for industry. Drug interaction studies—study design, data analysis, implications for dosing, and labeling recommendations. US FDA draft guidance, Feb 2012. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm292362.pdf Accessed 27 Aug 2013.
European Medicines Agency. Committee for Human Medicinal Products (CHMP). Guideline on the investigation of drug interactions, 21 June 2012. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/07/WC500129606.pdf . Accessed 27 Aug 2013.
Norvir® (ritonavir) tablet for oral use: US prescribing information. North Chicago: AbbVie Inc.; 2013 Nov. http://www.norvir.com/ . Accessed 21 Nov 2013.
Hsu A, Granneman GR, Bertz RJ. Ritonavir. Clinical pharmacokinetics and interactions with other anti-HIV agents. Clin Pharmacokinet. 1998;35:275–91.
Niemi M, Backman JT, Fromm MF, et al. Pharmacokinetic interactions with rifampicin: clinical relevance. Clin Pharmacokinet. 2003;42:819–50.
Galteau MM, Shamsa F. Urinary 6beta-hydroxycortisol: a validated test for evaluating drug induction or drug inhibition mediated through CYP3A in humans and in animals. Eur J Clin Pharmacol. 2003;59:713–33.
Tran JQ, Kovacs SJ, McIntosh TS, et al. Morning spot and 24-hour urinary 6 beta-hydroxycortisol to cortisol ratios: intraindividual variability and correlation under basal conditions and conditions of CYP 3A4 induction. J Clin Pharmacol. 1999;39:487–94.
Härtter S, Sennewald R, Nehmiz G, et al. Oral bioavailability of dabigatran etexilate (Pradaxa®) after co-medication with verapamil in healthy subjects. Br J Clin Pharmacol. 2013;75:1053–62.
International Transporter Consortium, Giacomini KM, Huang SM, et al. Membrane transporters in drug development. Nat Rev Drug Discov 2010;9:215–36.
Gupta A, Zhang Y, Unadkat JD, et al. HIV protease inhibitors are inhibitors but not substrates of the human breast cancer resistance protein (BCRP/ABCG2). J Pharmacol Exp Ther. 2004;310:334–41.
Tachibana T, Kato M, Watanabe T, et al. Method for predicting the risk of drug–drug interactions involving inhibition of intestinal CYP3A4 and P-glycoprotein. Xenobiotica. 2009;39:430–43.