SOLOSEC - CONSUMER HEALTH DATA PRIVACY STATEMENT
Effective Date: 03/18/2024
You care about the protection of your Consumer Health Data - and so do we. At Lupin Pharmaceutical, Inc. (USA) ("Lupin"), we work to maintain the privacy and data security of all Consumer Health Data we collect or receive from you, including when you use our websites at www.solosec.com and https://www.solosechcp.com/ (together, the "Website").
This Consumer Health Data Privacy Statement ("Statement") applies to the Consumer Health Data of residents of the State of Washington and the State of Nevada that Lupin collects, uses or shares, including when you visit the Website or otherwise interact with us. Please read this Statement carefully. Should you have any questions about this Statement or how we handle Consumer Health Data, please contact us at complianceandethicsoffice@lupin.com.
We may modify this Statement at any time. All changes will be effective immediately upon posting to the Website. Material changes will be conspicuously posted on the Website or otherwise communicated to you.
IF YOU PROVIDE CONSUMER HEALTH DATA WITH REGARD TO OUR PHARMACOVIGILANCE PROGRAM, PLEASE SEE OUR PHARMACOVIGILANCE PRIVACY STATEMENT WHICH DESCRIBES HOW WE COLLECT, USE AND SHARE CONSUMER HEALTH DATA YOU PROVIDE IN CONNECTION WITH THAT PROGRAM.
THIS CONSUMER HEALTH DATA PRIVACY STATEMENT APPLIES SOLELY TO WASHINGTON AND NEVADA CONSUMERS. PLEASE SEE OUR WEBSITE PRIVACY STATEMENT FOR GENERAL INFORMATION ABOUT HOW WE COLLECT USE AND SHARE PERSONAL INFORMATION.
1. What is Consumer Health Data?
Consumer Health Data is personal information linked or reasonably linkable to a consumer and that identifies the consumer's past, present, or future physical or mental health status ("Consumer Health Data") as defined under Washington's My Health My Data Act.
2. What Consumer Health Data Do We Collect?
The types of Consumer Health Data we collect include:
- Contact information including your name, phone number, email address, and home address
- Health conditions, treatment, diseases, or diagnosis
- Diagnoses or diagnostic testing, treatment, or medication
- Bodily functions, vital signs, symptoms, or measurements
- Use or purchase of prescribed medication
- Diagnoses, treatment, or medication
- Data that identifies a consumer seeking healthcare services including the purchase of medication
- Information regarding possible adverse events associated with the use of our pharmaceutical products
- Genetic Data
3. Why We Collect Consumer Health Data?
Where you have provided us with your express consent or to the extent necessary to provide you a product or service you have requested, we will collect your Consumer Health Data for the following purposes:
- For Customer Service reasons:
- To respond to your requests including requests for information about our products
- To provide you the ability to download a savings card for Solosec
- To operate our business and to communicate with you:
- To determine the suitability of certain products or programs
- To improve our products
- To perform market research on our products and product developments, in which case the data will be pseudonymized to prevent your identification
- To administer our contracts with service providers
- For the security of our Website
- To meet our legal and regulatory obligations:
- Management of adverse events, including investigating the adverse event and contacting you or a person reporting on your behalf for further information on the adverse event that you have reported or was reported on your behalf as required under 21 CFR 314.80 entitled “Post Marketing Reporting on Adverse Drug Experiences”
- Monitor and report on product safety and quality
- Administration and legal maintenance of product registries (where required under applicable laws)
- Provision of reports to authorities with respect to the safety of our products
- Responding to court orders, subpoenas or other legal processes with which we are required to comply
- Complying with legal, regulatory, and other requirements under applicable U.S. federal and state laws
4. What are the Sources of the Consumer Health Data We Collect?
We may collect Consumer Health Data described in Section 2 of this Statement (a) from you when you contact us for a customer service request; (b) when we receive a report of an adverse event from you or an individual reporting on your behalf and (c) from sources as otherwise described in our Pharmacovigilance Privacy Statement.
5. How Do We Share Consumer Health Data?
Categories of Consumer Health Data We Share
We may share any of the types of Consumer Health Data described in Section 2 of this Statement with Lupin Affiliates and third parties.
Categories of Third Parties and Affiliates with Whom We Share Consumer Health Data
We may share Consumer Health Data with the following categories of third-party recipients:
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Affiliates. We enable other Lupin related entities access to Consumer Health Data on a limited basis. For example, we share common data information systems to comply with good pharmacovigilance practices and our obligations under international, federal and state laws.
Lupin related entities with access to your Consumer Health Data include Lupin Ltd, Lupin Inc., Lupin Research, Inc., Novel Laboratories, Inc., Hormosan Pharma GmbH, Lupin Europe GmbH, Lupin Healthcare (UK) Ltd. and Lupin Atlantis Holdings SA. You may contact any of these entities by sending an email to complianceandethicsoffice@lupin.com. By contacting us, you understand that you may share and we may collect your health information as part of your communication with us. - Processors. We may disclose Consumer Health Data to third parties that process your Consumer Health Data on our behalf. For example, you may provide your Consumer Health Data to the processor that operates our call center; the processor that provides our email services; the processor that services our pharmacovigilance report database; or our processor that supports the security of our Website.
- Government agencies. As described in this Statement and our Pharmacovigilance Privacy Statement, we may be required to disclose Consumer Health Data to law enforcement or other government agencies when we believe doing so is necessary to comply with applicable law or respond to valid legal process.
- Parties to a Business Transaction. We may disclose Consumer Health Data in connection with a sale of all or a portion of our business, a merger, financing, acquisition, bankruptcy, dissolution, or a transfer, divestiture, or sale of all or a portion of our business or assets.
6. My Health My Data Rights
Under the State of Washington My Health My Data Act, Washington residents and natural persons whose Consumer Health Data is collected in the State of Washington may have the following rights, subject to verification, exceptions, and limitations:
Right to Confirm/Access/Know
Up to twice annually, you have the right to (a) confirm whether we are collecting, sharing, or selling your Consumer Health Data, and (b) access such Consumer Health Data, including a list of all third parties and affiliates with whom we have shared or sold Consumer Health Data and an active email address or other online mechanisms that you may use to contact these third parties.
Right to Delete
You have the right to request deletion of your Consumer Health Data held by us and our affiliates, processors, contractors, and other third parties.
Right to Withdraw
Your Consent/Opt-Out You may withdraw any consent you have provided for the Selling or Sharing of your Consumer Health Data at any time.
Right to Non-Discrimination
You have the right to not to receive discriminatory treatment as a result of your exercise of your rights conferred by the Washington My Health My Data Act.
How to Exercise Your Rights
You may submit your rights request to us by contacting us at any of the following:
- Phone: +1 844-815-3731
- Email: complianceandethicsoffice@lupin.com
- Webform: https://www.lupin.com/US/your-privacy-choices/
If you have any questions or wish to appeal any refusal to take action in response to a rights request, contact us at complianceandethicsoffice@lupin.com. We will respond to any request to appeal within the period required by law.
By contacting us, you understand that you may share and we may collect your health information as part of your communication with us.
APPEAL PROCESS
Right to Seek and Appeal.
If you disagree with our refusal to take action on your request to exercise your Washington Consumer Health Data privacy rights, you have the right to ask us to reconsider. You may submit your request to us by:
- Phone: +1 844- 815- 3731
- Email: complianceandethicsoffice@lupin.com
- Webform: https://www.lupin.com/US/your-privacy-choices/
By contacting us, you understand that you may share and we may collect your health information as part of your communication with us.
Appeal Timeframe.
Once we receive your request, we will acknowledge and start processing your request. Within 45 days of receiving your request, we will inform you in writing of any action taken or not taken in response to an appeal of your request, including a written explanation of the reasons for our decision.
If we deny your appeal, you can raise a concern or lodge a complaint by contacting the Washington State Attorney General at www.atg.wa.gov/file-complaint.
7. Nevada Supplement to Consumer Health Data Privacy Statement
This Supplement applies to Nevada consumers. It contains additional information as required under Nevada law with regard to how we process consumer health data of Nevada residents.
Purposes & Manner of Processing.
We collect, use, process and share Consumer Health Data for the purposes and in the manners described in Sections 2 and 3 of our Consumer Health Data Privacy Statement.
Review & Revision of Consumer Health Data.
You may submit a request to review and revise your Consumer Health Data, using any of the methods set forth in our Consumer Health Data Privacy Statement. We will respond to your requests in accordance with applicable law, but in any event within 45 days after receiving your request. We have the right to extend the time for our response an additional 45 days if permitted under applicable law.
Third Party Collection of Consumer Health Data.
We do not use cookies, web beacons, pixels, or other online trackers on our website.
Changes to this Supplement.
We will notify you before making any changes to our privacy practices with respect to your Consumer Health Data by posting an updated notice on this Consumer Health Data Privacy Statement and updating the effective date.
Indication
SOLOSEC® (secnidazole) 2 g oral granules is an antimicrobial agent indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older and trichomoniasis in patients 12 years of age and older. Since trichomoniasis is a sexually transmitted disease, treat sexual partners of infected patients with the same dose and at the same time to prevent reinfection.
Dosage and Administration
SOLOSEC is a single-dose therapy for oral use. The entire contents of SOLOSEC packet should be sprinkled onto applesauce, yogurt or pudding and consumed once within 30 minutes without chewing or crunching the granules. SOLOSEC is not intended to be dissolved in any liquid. Avoid consumption of alcoholic beverages and preparations containing ethanol or propylene glycol during treatment with SOLOSEC and for at least 2 days after completing therapy.
Important Safety Information
- SOLOSEC is contraindicated in patients with a history of hypersensitivity to secnidazole or other nitroimidazole derivatives and in patients with Cockayne syndrome.
- Vulvovaginal candidiasis may develop with SOLOSEC and require treatment with an antifungal agent.
- Potential risk of carcinogenicity is unknown and has not been studied in patients. Carcinogenicity has been seen in rodents chronically treated with nitroimidazole derivatives, which are structurally related to secnidazole. Chronic use should be avoided.
- Breastfeeding is not recommended. Patients should discontinue breastfeeding for 96 hours after administration of SOLOSEC.
- Most common adverse reactions observed in clinical trials (incidence ≥2%) were vulvovaginal candidiasis, headache, nausea, dysgeusia, vomiting, diarrhea, abdominal pain, and vulvovaginal pruritus.
- In patients with Cockayne syndrome, after initiation of systemic use of metronidazole, another nitroimidazole agent, cases of severe irreversible hepatotoxicity/acute liver failure (including cases of fatal outcomes) have been reported.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also contact Lupin Pharmaceuticals, Inc. at 1-844-SOLOSEC (1-844-765-6732).
Click here for full Prescribing Information.