Safety in Clinical Trials

In clinical trials1:

of patients taking LIVALO 4 mg experienced myalgia

patients discontinued LIVALO 4 mg due to myalgia

discontinuation rates with LIVALO; not dose dependent

Adverse reactions and discontinuation rates

new-M_Adverse Reactions

LIVALO discontinuation rates are <4% and not dose dependent1

  • Discontinuation rates due to adverse reactions were similar across all doses in controlled, short-term clinical studies and their open-label extensions from 44-60 weeks
  • The most common adverse reactions that led to treatment discontinuation were elevated creatine phosphokinase (0.6% on 4 mg) and myalgia (0.5% on 4 mg)
LI V ALO Dose Discontinuation Rate 1 mg 2 mg 4 mg 3.9% 3.3% 3.7%

Review LDL-C results against 3 commonly prescribed statins.

Show Reference

  1. LIVALO [prescribing information]. Montgomery, AL: Kowa Pharmaceuticals America, Inc.; September 2020.
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Terms of Use
LIVALO

These Terms of Use (“Terms”) were last updated on February 6, 2019.

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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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.

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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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General Information

For more information about Kowa’s Privacy Policy, please contact us:
Kowa Pharmaceuticals America, Inc.
530 Industrial Park Boulevard
Montgomery, AL 36117
1-334-288-1288
info@kowapharma.com

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Privacy Policy
LIVALO

Last updated February 6, 2019

Kowa Pharmaceuticals America, Inc. (“Kowa”), respects the privacy of every individual visiting our websites. This Privacy Policy discloses the online information gathering and dissemination practices of Kowa. Please be sure to read this entire Privacy Policy before using or submitting information to this website.

Our Privacy Policy only applies to Kowa-owned and -licensed websites, which include www.livalorx.com, www.livalohcp.com, www.takecholesteroltoheart.com, www.kowapharma.com, and any other Kowa product website that links to this Privacy Policy.

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:

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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.

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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.

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Kowa may use the information we collect through our website(s) for the following purposes:

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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.

Security Measures

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 info@kowapharma.com. When you update information, we may keep a copy of the prior version for our records.

Children

Children and young people under 18 are requested to get permission from their parent or guardian before they submit personal data to Kowa websites.

Third-party websites

On Kowa’s website, we may provide links to third-party websites with content that we think may be of interest to you. Third-party websites are not controlled by Kowa and have their own privacy practices. You should read the Privacy Policy at each website that you visit after you leave our website. We do not endorse, and are not responsible for, the privacy practices or the content of any third-party websites.

Changes

This policy may be modified from time to time, and changes will be communicated promptly on this page.

General Information

For more information about Kowa’s Privacy Policy, please contact us:
Kowa Pharmaceuticals America, Inc.
530 Industrial Park Boulevard
Montgomery, AL 36117
1-334-288-1288
info@kowapharma.com