Breast-feeding: It is not known whether XALKORI and its metabolites are excreted in human milk. Because of the potential harm to the infant, mothers should be advised to avoid breast-feeding while receiving XALKORI.
Hepatic Impairment: XALKORI has not been studied in patients with hepatic impairment. Treatment with XALKORI should be used with caution in patients with mild and moderate hepatic impairment. XALKORI should not be used in patients with severe hepatic impairment.
Renal Impairment: No starting dose adjustment is recommended for patients with mild and moderate renal impairment. No data are available for patients with severe and end-stage renal disease. Therefore, no formal dosing recommendation can be made.
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DISCLOSURE NOTICE: The information contained in this release is as of October 24, 2012. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information that involves substantial risks and uncertainties about an oncology product, XALKORI. Such risks and uncertainties include, among other things,
whether and when the European Commission (EC) will convert the conditional marketing authorization to a normal marketing authorization in the EU, as well as the EC’s decisions regarding labeling and other matters that could affect XALKORI’s availability or commercial potential in the EU; whether and when regulatory authorities in various other jurisdictions in which applications for XALKORI have been filed will approve such applications,
as well as their decisions regarding labeling and other matters that could affect XALKORI’s availability or commercial potential in such jurisdictions; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2011 and in its reports on Form 10-Q and Form 8-K.
| 1 Kwak E, Bang Y, Camidge R, et al. Anaplastic Lymphoma Kinase Inhibition in Non-Small Cell Lung Cancer. N Engl J Med. 2010;363:1693-1703. 2 Chiarle R, Voena C, Ambrogio C, et al. The Anaplastic Lymphoma Kinase in the Pathogenesis of Cancer. Nat Rev Cancer. 2008;8(1):11-23. 3 Zou HY, Li Q, Lee JH, et al. An Orally Available Small-Molecule Inhibitor of c-MET, PF-2341066, Exhibits Cytoreductive Antitumor Efficacy through Antiproliferative and Antiangiogenic Mechanisms. Cancer Res. 2007;67:4408-4417. 4 XALKORI Summary of Product Characteristics (SmPC) for the European Union.