References
- Imbruvica® (ibrutinib) [package insert]. Horsham (PA): Janssen Biotech, Inc.; 2019.
- Tam CSJ, Trotman J, Opat S, et al. Phase 1 study of selective BTK inhibitor zanubrutinib in B-cell malignancies and safety and efficacy evaluation in CLL. Blood. 2019;134(11):851–859.
- Song Y, Zhou K, Zou D, et al. Zanubrutinib in patients with relapsed or refractory mantle cell lymphoma: a single-arm, multicenter, pivotal phase 2 study. Presented at: 15th International Conference on Malignant Lymphoma; 2019 Jun 18–22. Lugano, Switzerland.
- Tam CS, Wang M, Simpson D, et al. Updated safety and efficacy data in the phase ½ trial of zanubrutinib in patients with mantle cell lymphoma. Poster presented at: 15th International Conference on Malignant Lymphoma; 2019 Jun 18–22; Lugano, Switzerland [Abstract 191].
- Dimopoulos MA, Opat S, Lee H-P, et al. Major responses in MYD88 wildtype (MYD88WT) Waldenstrom macroglobulinemia (WM) patients treated with Bruton tyrosine kinase inhibitor zanubrutinib (BGB-3111). Poster presented at: 24th Annual Congress of the European Hematology Association; 2019 Jun 13–16; Amsterdam, Netherlands.
- Mu S, Tang Z, Novotny W, et al. Effect of rifampin and itraconazole on the pharmacokinetics of zanubrutinib (a Bruton's tyrosine kinase inhibitor) in Asian and non-Asian healthy subjects. Cancer Chemother Pharmacol. 2019. DOI:10.1007/s00280-019-04015-w
- Albers I, Hartmann H, Bircher J, et al. Superiority of the Child–Pugh classification to quantitative liver function tests for assessing prognosis of liver cirrhosis. Scand J Gastroenterol. 1989;24(3):269–276.
- Food and Drug Administration. Guidance for industry. Pharmacokinetics in patients with impaired hepatic function: study design, data analysis, and impact on dosing and labeling; [cited 2019 Aug 1]. Available from: https://www.fda.gov/media/71311/download
- Committee for Medicinal Products for Human Use (CHMP). Guideline on the evaluation of the pharmacokinetics of medicinal products in patients with impaired hepatic function; [cited 2019 Jul 29]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-evaluation-pharmacokinetics-medicinal-products-patients-impaired-hepatic-function_en.pdf
- deJong J, Skee D, Hellemans P, et al. Single-dose pharmacokinetics of ibrutinib in subjects with varying degrees of hepatic impairment. Leuk Lymphoma. 2017;58:185–194.
- Calquence® (acalabrutinib) [package insert]. Wilmington (DE): AstraZeneca Pharmaceuticals, LP; 2017.
- Prasad B, Bhatt K, Johnson K, et al. Abundance of phase 1 and 2 drug-metabolizing enzymes in alcoholic and hepatitis C cirrhotic livers: a quantitative targeted proteomics study. Drug Metab Dispos. 2018;46(7):943–952.
- Rothschild MA, Oratz M, Zimmon D, et al. Albumin synthesis in cirrhotic subjects with ascites studied with carbonate-14C. J Clin Invest. 1969;48(2):344–350.