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eGFR=estimated glomerular filtration rate. CKD=chronic kidney disease. ASCVD=atherosclerotic cardiovascular disease.
Ezetimibe: Cholesterol absorption inhibitor
Diltiazem LA: Calcium channel blocker
Itraconazole: Azole antifungal
Enalapril: Angiotensin-converting enzyme inhibitor
Digoxin: Cardiac glycoside
Atazanavir: HIV protease inhibitor
Lopinavir/Ritonavir: HIV protease inhibitors
Darunavir/Ritonavir: HIV protease inhibitors
Lipitor is a registered trademark of Pfizer Inc.
Zocor is a registered trademark of the Organon group of companies.
Pravachol is a registered trademark of Bristol-Myers Squibb Company.
Three 12-week, randomized, multicenter, double-blind, double-dummy, non-inferiority, Phase 3 studies in adult patients with primary hyperlipidemia or mixed dyslipidemia: Study 301: pitavastatin 2 mg (n=315) and 4 mg (n=298); Study 302: pitavastatin 2 mg (n=307) and 4 mg (n=319); Study 306: in patients ≥65 years, pitavastatin 1 mg (n=207), 2 mg (n=224), and 4 mg (n=210).
Lipitor is a registered trademark of Pfizer, Inc.
Zocor is a registered trademark of Merck & Co., Inc.
*Based on the mean change from baseline in LDL-C and Apo B observed in three 12-week, randomized, multicenter, double-blind, double-dummy, Phase 3 studies in adult patients with primary hyperlipidemia or mixed dyslipidemia taking pitavastatin 2 mg and 4 mg.
of patients taking LIVALO 4 mg experienced myalgia
patients discontinued LIVALO 4 mg due to myalgia
discontinuation rates with LIVALO; not dose dependent
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Kowa Pharmaceuticals America, Inc. (“Kowa”) maintains the website located at LivaloHCP.com (“Site”) to provide information and education about LIVALO® (pitavastatin). You agree to comply with the Terms in effect at the time of each such access or other use. You also acknowledge that Kowa may, from time to time, in its sole discretion and without notification to you, change these Terms. You should review the Terms each time you visit or use the Site. If you do not agree to these Terms, do not use the Site. As used in these Terms, “we” includes Kowa, each of its affiliates, and any third-party vendors we hire to assist in the administration of the Site, the collection, cataloging and/or analysis of data, and/or the processing or handling of any visitor transactions.
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Use of the Site
The Site is for informational and educational uses only. You may print, download, or otherwise reproduce the information contained on the Site for your personal use only. Any commercial use of the information contained on the Site is strictly prohibited. The above license shall not include any resale or commercial use of the Site or its contents; any derivative use of the Site or its contents; or any use of data mining, robots, or similar data gathering and extraction tools. You may not frame or utilize framing techniques to enclose any trademark, logo, or other proprietary information (including images, text, page layout, or form) of Kowa or our affiliates without our prior express written consent.
We make no guarantees regarding the availability of the Site. Furthermore, we reserve the right, within our sole discretion, to discontinue the Site. You agree that we will not be liable to you for any such discontinuance or modification of the Site. Any rights not expressly granted by these Terms are reserved by us.
You are under no obligation to use or continue to use the Site and may temporarily or permanently cease using the Site without notice to Kowa. Any use of the Site, or any portion thereof, in violation of the foregoing shall constitute a violation of these Terms and may result in, among other things, termination or suspension of your rights to use the Site or any portion thereof.
Kowa will use reasonable efforts to provide information that is timely and accurate. Kowa makes no warranty of any kind regarding the site and/or any materials provided on the site, all of which are provided on an “as is,” “as available” basis. Kowa does not warrant the accuracy, completeness, currency, or reliability of any of the content or data found on the site and expressly disclaims all warranties, including implied warranties of merchantability, fitness for a particular purpose and non-infringement, and those arising by statute or otherwise in law or from a course of dealing or usage of trade. Kowa does not warrant that the site, its servers, or any e-mail sent from it are free of viruses or other harmful components.
Neither Kowa, nor its affiliates, makes any representations, warranties, or guarantees regarding (1) the operation or performance of the site or (2) the internet generally.
Some jurisdictions do not allow the exclusion of implied warranties, so the above exclusions may not apply to you. You may also have other rights that vary from jurisdiction to jurisdiction and that may not be limited by these terms, provided however you agree and acknowledge that, to the extent permissible under applicable law, you waive any such statutory rights with respect to implied warranties.
Limitation of Liability
Kowa assumes no responsibility, and shall not be liable for, any damages to, or viruses that may infect your computer equipment or other property on account of your access to, use of, or browsing in the site or your downloading of any materials, data, text, images, video, or audio from the web site. In no event shall Kowa be liable for any injury, loss, claim, damages, or any special, exemplary, punitive, direct, indirect, incidental, or consequential damages of any kind (including, but not limited to lost profits or lost savings), whether based in contract, tort, strict liability, or otherwise, which arises out of or is in any way connected with any use of the web site or content found therein.
All content contained on the Site is copyrighted and/or trademarked by Kowa. All content is the property of Kowa unless otherwise stated. All trademarks are the property of Kowa unless otherwise stated. The Terms do not grant any license to modify or alter the content on the Site that are viewed, downloaded, or otherwise accessed by you. You shall keep intact all proprietary notices, including copyright notices, contained on any downloadable materials. You shall be solely liable for any damages resulting from any infringement of copyright, trademark, or other proprietary right, or any and all harm resulting from your use of the Site.
The Site may contain information relating to diseases, disorders, or other medical conditions as well as pharmaceutical compounds, preparations, or products. The information is intended for general or educational use. Consult your health care practitioner for more specific information regarding your health.
Third-Party Websites and Links
The Site may contain, from time to time, links to other third-party websites. These links are provided for your convenience only. Kowa has no control over the content of these sites or their policies. You should review the terms and conditions, and privacy policies of each site you visit after you leave the Site. You further acknowledge and agree that Kowa shall not be responsible or liable, directly or indirectly, for any damage or loss caused or alleged to be caused by or in connection with use of or reliance on any such content or sites available on or through any such site or resource.
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Although this Site may be accessed from anywhere in the world, the information provided on this Site is intended to comply with the laws and regulations of the United States and its Territories. The information contained on the Site is for use by residents of the United States and its Territories. All offers for products or services contained on this Site are void where prohibited by law. See specific offers for further details.
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Changes to the Terms
We may periodically modify and supplement these Terms and the notice provided to you will be the updating of these Terms. You are responsible for regularly checking these Terms for revisions. All amended Terms become effective upon our posting to the Site, and any use of the Site after such revisions have been posted signifies your consent and agreement to the modified Terms.
Last updated February 6, 2019
Personally Identifiable Information
Kowa may collect personally identifiable information (such as name, address, telephone/fax number, and e-mail address) only when voluntarily provided by a visitor to our websites. This information will not be used for any direct marketing or unsolicited follow-up unless we have previously informed you of this possible use and you have given us your express permission when submitting it. Kowa may use this information for such purposes as:
Collection of Browser, Log, and Statistical Information
We may collect and/or track information provided to us by your browser, including the website you came from, the type of browser you use, the time and date of access, and other information that does not personally identify you. In addition, we may gather information about you that is automatically collected by our web server, such as your IP address and domain name.
Kowa may make use of non-personally identifiable statistical information collected from users (browser type, geographical location, age, gender) for optimization of its websites as part of its continual internal review process and in a general way to learn more about its clients. We may use IP addresses to analyze trends, administer the site, track users’ movements, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information. This information will not be disclosed to third parties by Kowa. This data will only be used for the stated purpose and will not be used for any unsolicited communication unless you give us permission.
Kowa may utilize "cookies," web beacons, and other similar technologies on our website. We may use first- and/or third-party "browser" or "HTTP" cookies, which are unique text files that may be used for data analysis and enable our website to tailor information for the visitor. We may use browser cookies for purposes such as to personalize the user's experience on our site, to remember a user when the user registers for products or services, for fraud prevention, or to track visits to our websites. We also may use "web beacons" (also referred to as pixel tags, clear gifs, or other terms) or similar technologies to collect information such as how long a visitor remains on a particular page. If you do not want us to deploy browser cookies to your device when you visit our websites, you may set the browser to reject cookies or to notify the user when a website tries to place cookies in the browser program (see below). Rejecting cookies may affect your ability to use some of the features offered by the website. If you use our website without setting your browser to block cookies, you consent to the placement of cookies on your device.
Third parties, including our service providers or marketing partners, may collect information about a visitor to our site over time and/or across different websites when the visitor uses our website. This information often is aggregate data or individual information that is tied to a browser or device rather than specific identifiers such as the visitor's name and address, but some of this information might be considered to be personally identifiable under some federal or state laws.
Some Internet browsers offer what often is referred to as "do-not-track" mechanisms for browser users to automatically signal privacy preferences to websites that they visit. Our site(s) do not currently respond to do-not-track signals; however, you can exercise other choices available to you, including limiting the placement of browser cookies on your device using your browser's cookie control features and other choices described in this Policy.
Use of Information
Kowa may use the information we collect through our website(s) for the following purposes:
Disclosure of Information
We may disclose information with your consent or as otherwise necessary or appropriate to process a transaction that you may request.
We may disclose information to comply with FDA or other regulatory requirements.
We may disclose information that we collect through our website(s) with agents, affiliated businesses, and service providers providing services on our behalf.
In the event that our company or some of our assets are sold or transferred or used as security or to the extent we engage in business negotiations with our business partners, the information collected on our websites or mobile applications, including this site, may be transferred or shared with third parties as part of that transaction or negotiation.
If we receive a request from law enforcement officials or judicial authorities to provide information on individuals, we may provide such information. In matters involving claims of personal or public safety or in litigation where the data is pertinent, we may use or disclose your personal information without a court order. We may use information you submit to investigate security breaches, misconduct, or otherwise cooperate with authorities pursuant to a legal matter.
We do not share, sell, or lease personal information about you except as set forth in this Policy.
Kowa has implemented reasonable security features to help protect the personally identifiable information that you have submitted from unauthorized access, use, alteration, or release. Please note, however, that although Kowa has endeavored to create a secure and reliable Site for users, we cannot guarantee the confidentiality of any communication or material transmitted to and/or from Kowa via the Site or e-mail. Accordingly, we are not responsible for the security of information transmitted via the Internet.
Access and Correction
It is our policy, with certain exceptions, to provide individuals with access to personal information that Kowa collects through our website(s). In some cases, the site you used may allow you to log in to directly access and/or correct information you have provided. In other cases, such as web forms that you may submit through the site, if you would like to obtain a copy of the information you provided or request a correction, you can contact us at email@example.com. When you update information, we may keep a copy of the prior version for our records.
Children and young people under 18 are requested to get permission from their parent or guardian before they submit personal data to Kowa websites.
This policy may be modified from time to time, and changes will be communicated promptly on this page.