SOLOSEC is generally well-tolerated1
  • The adverse event (AE) profile for trichomoniasis was consistent with that seen with the treatment of bacterial vaginosis (BV).1,2
  • There were no serious treatment-emergent AEs.2


Pooled SOLOSEC Safety Results from Clinical Studies
Safety During Pregnancy
SOLOSEC has no pregnancy restrictions.1
  • Available data on pregnancy are limited to animal studies.1
Metronidazole and tinidazole are contraindicated in the first trimester of pregnancy.5,6
REVIEW ACOG & CDC GUIDELINES
REVIEW ACOG & CDC GUIDELINES
References:
1. SOLOSEC [prescribing information]. Baltimore, MD: Lupin Pharmaceuticals, Inc; 2022. 2. Muzny CA, Schwebke JR, Nyirjesy P, et al. Efficacy and Safety of Single Oral Dosing of Secnidazole for Trichomoniasis in Women: Results of a Phase 3, Randomized, Double-Blind, Placebo-Controlled, Delayed-Treatment Study. Clin Infect Dis 2021. 3. Hillier SL, Nyirjesy P, Waldbaum AS, et al. Secnidazole treatment of bacterial vaginosis: a randomized controlled trial. Obstet Gynecol 2017;130(2):379-386. 4. Schwebke JR, Morgan FG Jr, Koltun W, Nyirjesy P. A phase-3, double-blind, placebo-controlled study of the effectiveness and safety of single oral doses of secnidazole 2 g for the treatment of women with bacterial vaginosis [published correction appears in Am J Obstet Gynecol 2018;219(1):110]. Am J Obstet Gynecol 2017;217(6):678.e1-678.e9. 5. Flagyl [prescribing information]. New York, NY: Pfizer; 2021. 6. Tinidazole Tablets [prescribing information]. Buffalo Grove, IL: G.D. PACK Pharmaceuticals, LLC; 2018.
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Privacy Policy

LUPIN'S PLEDGE ON PRIVACY ("PLEDGE")

You care about the protection of your Personal Data – so do we. At Lupin Inc. ("Lupin"), we endeavor to ensure and maintain the privacy and data security of all Personal Data collected or retrieved by your use, as a visitor, of our websites. The term "Personal Data" as used throughout this Pledge refers to any information by which you may be personally identified, such as name, postal address, email address, telephone number, or any other identified by which you may be contacted, identified, located or tracked.

This Pledge applies to Personal Data collected by or on behalf of Lupin and its service providers through this website, online resources and communications. This Pledge does not apply to Personal Data collected from offline resources and communications, except in cases where such Personal Data is consolidated with Personal Data that we, or others on our behalf, collect online. This Pledge also does not apply to third-party online resources to which our websites may link, where we do not control the content or the privacy practices of such resources.

Our Pledge complies with internationally recognized standards of privacy protection. Please read this Pledge carefully to understand our policies and practices regarding your information and how we will treat it. If you do not agree with our policies and practices, your choice is not to use our Website. By accessing or using this Website, you agree to this privacy policy. This policy may change from time to time (see Contact). Your continued use of this Website after we make changes is deemed to be acceptance of those changes, so please check the policy periodically for updates. Should you have any questions about this Pledge or our Personal Data practices, please contact us at ComplianceOffice@Lupin.com.

CATEGORIES OF PERSONAL DATA

As most of our website content is informational and does not require account creation or registration, individuals may access many parts of our websites and online resources without disclosing any Personal Data. However, where we do collect Personal Data, we do so online through websites and other online resources. We also offer online resources in collaboration with other online service providers, from which we may receive Personal Data about users of such resources. These online collaborations are governed by agreements that require Personal Data to be protected appropriately. There are three methods that we use to collect Personal Data on our Website:

1. Information that you provide: We collect Personal Data and other data that you or your household may enter into forms or data fields on our websites or online resources. Such information may include, but not be limited to, contact information (such as your name, postal address, e-mail address, telephone number), date of birth, professional credentials, experiences, activities, skills, preferences, hobbies and interests. We may also collect, when relevant for the processing purpose, health information about you that you provide by responding to our questions and surveys or through your use of online and downloadable health-related tools we provide.

2. Information from public or third party sources: We may collect Personal Data about health care professionals who register on our websites from public or third-party sources to verify their professional credentials and identity. We may also collect Personal Data about you from third parties and public internet source via what is known as social media listening, examples including social networking, communities, forums, message boards, blogging. We may combine that data with Personal Data or other data we collect. This enhances our existing data about our users (e.g., adding address data), improves our ability to contact you, and enhances our marketing capabilities.

3. Information collected from your computer or other electronic device: We collect information about your computer or other electronic device when you visit our websites and use our online resources. This information may include your Internet Protocol (IP) address, Internet Service Provider (ISP), domain name, browser type, operating system, location, websites you visit before or after you visit this website, pages you click on this website, search requests, date and time of your requests, the amount of time spent on the website and information provided by tracking technologies, such as cookies, singlepixel tags, local share objects (Flash), local storage, Etags and scripts. If you leave one of our websites without becoming a registered user, we may use cookies in conjunction with third parties to service advertisements to your computer or other electronic device to remind you about our website that you had previously visited. Please reference our Cookie Policy Section for more information about cookies and how you can control them. If you use a mobile device to access our websites and online resources, we may also collect information about your device, such as your device ID and device type, as well as usage information about your device and your use of our mobile websites and other mobile resources.

We may use other companies to deliver email communications on our behalf or to place our advertisements on other websites. Please review the privacy policies of these third parties to familiarize yourself with their practices.

INTENDED USE OF PERSONAL DATA

We may use all categories of Personal Data listed above for the following business purposes:

As Stated or Agreed to at the Point of Collection. We may use Personal Data for the purposes stated or agreed-to (or as is obvious) at the point of collection. For example, we use Personal Information to respond to your questions, comments, or complaints. We may also use Personal Information as requested or consented to by you.

Administration. We use Personal Data for administrative purposes, such as managing your accounts, facilitating transactions, to inform our business strategies, to understand the Site's demographics and user preferences, for evaluating applications, and managing profiles. We also may use Personal Data to audit our online resources for compliance, authorized access and security.

Site Management. We use Personal Data for Site management, such as troubleshooting problems, improving the content and functionality of the Site, statistical and other analyses of the Site, and to customize the Site to you and our users.

Advertising/Marketing. We may use Personal Data to send you promotions or to perform targeted advertising, to notify you of new services, products or programs, to notify you of new features of our website, to notify you of changes to our Terms or this Policy, and for other similar communications. Social medial listening is the process by which we identify and assess what is being said about a company, individual, product or brand on the Internet. We will only collect relevant, adequate and not excessive publicly available Personal Data. Because of the nature of Social Media, it may not be possible for us to identify the individual who posted the original content that we collect. If Personal Data is collected and will be processed beyond the original intent when you posted the content, reasonable efforts will be made to provide notice to you as soon as is practical. Note, in some cases, it may not be possible to collect and verify your contact details given the available information. Reasonable efforts might entail identifying your contact details from the social media platform, if possible, or within the posting. Moreover, we will make reasonable efforts to provide you with a mechanism by which to opt-out of our data processing or exercise your rights as required by our policy and applicable regulations.

To Protect Our Rights. We may use Personal Data to protect our legal rights or interests, or those of third parties, including to bring a legal action against you or anyone who may be causing harm to us, our Site, or to other users of the Site. We may also use Personal Information to seek business, financial or legal advice, and to respond to other legal requests.

Consistent with the purposes identified and standards set within this Pledge and other applicable privacy notices that have been provided, in some cases we consolidate and use Personal Data that individuals share with us through various services and channels, such as the telephone, surveys, websites and other online resources and communications, in order to enhance the quality of services that we offer.

STATEMENT ON CHILDREN

In general, our websites and online resources are not directed at children and most of the online services that we offer are designed for individuals who are 18 years of age or older. Where requests for information about a medication are permitted by law, individuals requesting information about a medication that is indicated for use in children must be 18 years or age or older.

We do not knowingly collect Personal Data from children under 13 years of age, or according to local law, without obtaining verifiable parental consent prior to collection. If you are a parent or guardian that has knowledge that we have collected information from your child, please contact ComplianceOffice@Lupin.com to request removal and we will endeavor to verify the identity of any applicable child Personal Data and make commercially reasonable attempts to delete such Personal Data.

YOUR CHOICES

You may choose not to provide any Personal Data to us online by electing not to enter any Personal Data into a form or data field on our websites, and by not using any personalized services provided by our online resources. However, some of our online resources require users to identify themselves in order to use personalized services or advanced features, which will not be available without such data.

Some of our websites may request your permission to use and disclose Personal Data about you in order to add you to our contact lists, to enable you to list yourself in a directory or social media resources, and to identify and offer additional services and promotions that we believe you might find interesting. You can limit the use of Personal Data about you by checking or un-checking options provided at the time that you enter that information or that we may offer to you in the future. Additionally, you may change your communications preferences (such as to opt-out of communications you requested previously) by using the opt-out link provided in our electronic communications or by contacting us at ComplianceOffice@Lupin.com.

Our online resources that use tracking technologies, such as cookies, to remember your personal preferences and selections, enable you to choose whether you want us to use such technologies to remember you, or to provide additional services to you, by checking or un-checking options provided during registration, or at the time that you enter Personal Data inform forms or data fields. If you leave one of our websites without becoming a registered user, we may use cookies in conjunction with third parties to service advertisements to your computer or other electronic device to remind you about our website that you had previously visited. Our online resources do not limit non-identifiable uses of tracking technologies for individual users. Individual users can control the use of certain tracking technologies, such as cookies, through most Internet browsers. Some Internet browsers enable you to limit or disable the use of cookies for individual websites. Other browsers allow you to select cookie settings for all websites that you visit. If you are concerned about the use of cookie technology, please see our Cookie Policy section for more information about cookies and how you can control them. If you would like to exercise your choice of tracking for advertisement purposes, you can use the pop-up banner on Company websites where available.

You may choose to receive optional marketing email and other communications from us by signing up for or subscribing to these communications on our websites and other online resources. If you do not wish to receive optional email communications, you may opt-out by visiting the website or other online resources where you subscribed, where available, and update your email communication selections, or you may follow the unsubscribe or opt-out instructions in the email communications you receive from us. You also may optout by contacting us at ComplianceOffice@Lupin.com. If you do not with for us to confirm where you have read certain email communications we have sent you, you may opt of of email communications tracking by opting out of receiving those email communications altogether.

NON-DISCLOSURE OF INFORMATION

Personal Data about you will be accessible to Lupin, including its subsidiaries, divisions and groups worldwide, and to individuals and organizations that use Personal Data solely for and at the direction of us. Lupin may transfer your data to one of its databases outside your country of domicile. We will ensure that such data transfers are adequately protected.

Uses and disclosures of Personal Data by external individuals and organizations acting on our behalf are governed by agreements that require Personal Data to be protected appropriately. Personal Data about you will only be used and disclosed by us and individuals and organizations working on our behalf, in a manner consistent with this Pledge, other applicable privacy notices, data, with accessed controlled as needed and as explicitly permitted or required by applicable laws, rules and regulations.

Lupin will not sell, share, or otherwise distribute your Personal Data to third parties except as described in this Pledge and other applicable privacy notices. However, circumstances may arise where we may, for business reasons, decide to reorganize or divest our business through sale, merger or acquisition. In these circumstances, Personal Data may be shared with actual or prospective purchasers. We will obtain written assurances that Personal Data will be protected appropriately in these circumstances.

We reserve the right to disclose Personal Data about you for reporting to government authorities, to parties in relevant legal proceedings as authorized by the presiding court or tribunal and otherwise to the extent required of explicitly authorized by applicable law. Otherwise, Personal Data about you will not be shared without your permission.

YOUR RIGHTS: ACCESS, CORRECT & DELETE

Subject to certain limitations such as (a) exceptions permitted by applicable law and (b) verification of your identity, you may exercise the following rights with regard to your Personal Data.

To gain access to Personal Data about you collected online, and to keep it accurate, complete and current, or to request deletion, you may contact us at ComplianceOffice@Lupin.com. In some cases, where we are required to retain information by law or regulation, or to continue to manage a service you have requested, or to ensure that we honor your preferences, or for other necessary business purposes, we may not be able to delete certain Personal Data about you. Where offered, you also may update Personal Data about your online by modifying information that you previously have entered into forms or data fields on our websites. Where permitted by law, our ability to access and correct Personal Data will be limited where access and correction would: inhibit our ability to comply with a legal or ethical obligation, inhibit our ability to investigate, make or defend legal claims, result in disclosure of Personal Data about a third party, result in breach of a contract or disclosure of trade secrets or other proprietary business information belonging to us or a third party.

COOKIE POLICY

Lupin Inc. ("Lupin") uses cookies to improve the experience for visitors to our Websites, including Websites that can be accessed through our mobile applications. This Cookie Policy ("Policy") supports Lupin's Pledge on Privacy ("Pledge") by providing more detail about the types of cookies and similar technologies that our Websites, web applications and other online services use (collectively, "Websites") and how you can control cookies on your computer or mobile device.

Cookies & Other Tracking Technologies.

What types of online tracking mechanisms do we use? We may use cookies, web beacons, pixel tags and other tracking technologies (collectively "Cookies") on our Website.

What are cookies and web beacons / pixel tags? A cookie is a small text file that our Website saves onto your computer or device when you use the Website that provides us certain information about your activities. Cookies allow the Website to remember your actions and preferences and recognize you or your browser. Web beacons / pixel tags are small graphics on a webpage that monitor your activity when viewing a webpage.

Why do we collect Cookies? We use Cookies to:

· make our Website function properly;

· provide personalized experiences;

· tailor our interactions with you;

· help with our marketing efforts;

· provide us with valuable data and statistics about the usage and effectiveness of our Website and to help us improve our Website; and

· help us improve our services.

What type of information do Cookies collect? The Cookies on our Website may collect information such as:

· IP addresses assigned to the computers and other devices you use;

· your internet service provider;

· device ID number;

· approximate geographic location;

· browser type;

· Website pages visited;

· Websites you access before and after visiting the Website, and

· data related to how and when you use the Website.

We may combine information from Cookies with Personal Data, including data obtained from third parties.

How long do Cookies last? A Cookie can either be a "session" Cookie or a "persistent" Cookie. Session Cookies exist only for so long as you are visiting the applicable Website and are typically deleted when you exit your web browser. Persistent Cookies exist for a set period of time, for example, up to several months or years. Each time you visit a Website that has implemented a persistent Cookie, the persistent Cookie is renewed and that Cookie will remain active until its predetermined expiration date. You can manually delete persistent Cookies through your browser settings.

Flash cookies differ from other browser cookies regarding the amount and types of data collected and how the data is stored. Your browser will not remove and cannot manage Flash cookies in the same way as other Cookies. To learn about managing your Flash cookie settings, visit the Flash player settings page on Adobe's Website.

We are not responsible for third-party Cookies. Cookies may either be "first-party" or "third-party" Cookies. A first-party Cookie allows your web browser to talk to the actual Website that you are visiting (i.e. this Website). A third-party Cookie allows your web browser to talk to a third-party Website, such as the source of an ad that appears on the Website you are visiting or a third-party analytics provider. We do not have control over third-party Cookies. Third-party Cookies are not governed by this Policy.

How do you manage Cookies or opt-out? Most browsers automatically accept cookies. You can disable this function by changing your browser settings, but disabling cookies may impact your use and enjoyment of the Website. Not all features or functions of the Website may work properly if you disable Cookies. You cannot disable all Cookies, such as Cookies that are essential to the functioning of the Website.

Analytics. We use Google Analytics or similar services to collect and process information about your use of the Site. The service providers set cookies and then your web browser will automatically send data. The service providers uses this data to provide us with reports that we use to improve the Website's structure and content. We may implement additional add-on services to Analytics, such as Demographics and Interest Reporting. Demographics and Interest Reporting uses Cookies to collect data about our Website traffic by tracking users across Websites and across time to provide us with analytics on our user base.

Online Behavioral Advertising. We use third parties to provide internet-based advertising services. These services collect data about your interactions with the Site and other Websites to send you targeted advertisements for goods and services. The data collected may be associated with your Personal Information. These advertisements may appear on the Site and on other Websites and may be sent to you via email.

We use Google Ads or equivalent service providers to serve ads across various Websites. These service providers use Cookies to collect data about your visits to the Site to generate targeted advertisements to you on other Websites that you visit. To opt-out of this type of advertising, to customize your ad preferences, or to limit the collection or use of such data, visit their settings page and follow their personalization and opt-out instructions. Opting out will not affect your use of the Site.

To change your preferences with respect to certain online ads and to obtain more information about third-party ad networks and online behavioral advertising, visit National Advertising Initiative Consumer opt-out page or the Digital Advertising Alliance Self-Regulatory Program. Changing your settings with individual browsers or ad networks will not necessarily carry over to other browsers or ad networks. As a result, depending on the opt-outs you request, you may still see our ads.

YOUR CALIFORNIA PRIVACY RIGHTS

If you are a California resident, California law may provide you with additional rights regarding our use of your personal information. California's "Shine the Light" law (Civil Code Section § 1798.83) permits users of our Website that are California residents to request certain information regarding our disclosure of personal information to third parties for their direct marketing purposes. To make such a request, please send an email to ComplianceOffice@Lupin.com or write to us at: 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108.

SECURITY AND CONFIDENTIALITY

We use commercially reasonable technical and organizational measures to help secure Personal Data against loss, misuse, and alteration appropriate to the type of Personal Data processed. If a breach of your Personal Data occurs, we will notify you of the breach if required under applicable law.

YOU UNDERSTAND THAT NO DATA TRANSMISSION OVER THE INTERNET OR DEVICE CAN BE GUARANTEED TO BE 100% SECURE. WHILE WE STRIVE TO PROTECT PERSONAL DATA, WE DO NOT GUARANTEE THE SECURITY OF PERSONAL DATA AND YOU PROVIDE PERSONAL DATA AT YOUR OWN RISK.

RECORD RETENTION

We generally retain Personal Data for only as long as reasonably needed for the specific business purpose or purposes for which it was collected and the duration of your use of our websites. In some cases, we may be required to retain information for a longer period of time based on laws or regulations that apply to our business, such as applicable rules on statute of limitations or for other necessary business purposes. Where possible, we aim to anonymize the information or remove unnecessary identifiers from records that we may need to keep for periods beyond the original retention period.

LINKS TO OTHER SITES

This Website Privacy Pledge applies only to Lupin's websites. The Site may link to, or be linked to, websites not owned or controlled by us. We are not responsible for third-parties' privacy policies or practices. This Policy does not apply to any third-party websites or to any data that you provide to third parties. You should read the privacy policy for each website that you visit.

CONTACT

We aim to constantly improve the tools available to you to manage the data that you provide to us. We may update this policy periodically. We reserve the right to modify, add or remove portions of this Website Privacy Pledge at our discretion. If we decide to change this Pledge, we will post those changes at this site on our homepage so you always will know what information we gather, how we might use that information, and whether we will disclose it to anyone. Please refer to this page from time to time to review these and other new features or updates. This policy was last updated on May 4, 2020.

Terms of Use

Terms of Use

Please carefully read these Terms of Use and our Privacy Policy before using our Website. By using the Lupin Website, you agree to follow and be bound by these Terms of Use and our Privacy Policy without modification. In the case of any violation of these Terms of Use, Lupin reserves the right to seek all remedies available at law and in equity for such violation. Because we will continue to implement new technologies and improve the services and features we provide on our Website, this statement is subject to change without prior notice. For that reason, we encourage you to review this statement periodically. By using our Website, you agree to the Terms of Use in effect at that time.

Use of Website

The Lupin Website may contain other proprietary notices and copyright information, the terms of which must be observed and followed. Information on this Website may contain technical inaccuracies or typographical errors. Information may be changed or updated without notice. Lupin reserves the right to refuse service in its discretion, including, without limitation, if Lupin believes that customer conduct violates applicable law or is harmful to the interests of Lupin.

Submitted Information

No information or material provided to Lupin by you through our Website may contain vulgar, obscene, threatening or otherwise unlawful language or material. Lupin will not release your name or otherwise publicize the fact that you submitted materials or other information to us unless we obtain your permission to use your name or we are required to do so by law. Please review our Privacy Policy for a complete description of how we handle personal information submitted to us. Lupin Information Lupin has made a conscious effort to display and describe information about Lupin on the site accurately so that you can get a good idea of our business. Furthermore, Lupin is constantly improving its information. The materials on this Website are for your general educational information only. Lupin does not practice medicine or provide medical services or advice, and the information on this Website should not be considered medical advice. You should always rely on your health care professional for diagnosis and treatment.

Trademarks

Lupin's names and logos referenced on the Website are trademarks of Lupin in India and other countries and may not be used in connection with any product or service in any manner that is likely to cause confusion among customers or in any manner that disparages or discredits Lupin.

All other trademarks not owned by Lupin that appear on this Website are the property of their respective owners, who may or may not be affiliated with, connected to, or sponsored by Lupin. If you use the materials or trademarks on this Website in a way that is not clearly allowed by these Terms of Use, you are violating your agreement with us and may be violating copyright, trademark, and other laws. In that case, we automatically revoke your permission to use this Website. Title to the materials remains with us or with the authors of the materials contained on this Website. All rights not expressly granted are reserved.

Change to Term of Use

Lupin reserves the right to update the Terms of Use statement at any time. Any changes or updates will be effective immediately upon posting to this Website. Your use of this Website constitutes acceptance of our Terms of Use. If you do not agree to the terms, please exit from this Website immediately.

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