Privacy Policy

Effective October 19, 2020

ATHENA BIOSCIENCE PRIVACY POLICY

PLEASE READ THIS PRIVACY POLICY CAREFULLY. IT CONTAINS IMPORTANT INFORMATION REGARDING OUR COLLECTION AND USE OF YOUR PERSONAL INFORMATION, AND YOUR CONSENT TO OUR DOING SO IN REGARD TO THE SERVICES WE MAY PROVIDE.

This Privacy Policy (“Policy”) explains how Athena Bioscience LLC and its subsidiaries, affiliates and successors (collectively, “Athena”) collect, handle and use your Personal Information, including in regard to Athena’s various products, services, websites and applications (collectively, “Services”). For the purposes of this Policy, “Personal Information” means any information related to an individual, whether given online or offline, including information that Athena collects directly, is collected on Athena’s behalf, or is otherwise directed to Athena.

Please read this Policy carefully before using or engaging Athena’s Services or submitting any Personal Information. By accessing, using and otherwise benefiting from Athena’s Services, you consent to the collection, use and disclosure of your Personal Information in accordance with this Policy. While this Policy may address or reference certain Services, nothing stated in this Policy constitutes a promise, covenant or other undertaking by Athena that it will provide some or any Services, whether now or in the future. Also, while this Policy may outline certain categories of Personal Information that Athena might collect, nothing in this Policy is intended as a statement as to which Personal Information Athena does collect.

Information We Collect

Athena collects Personal Information that you choose to give, including through various registrations, applications and surveys, and in regard to inquiries you submit and purchases you make. You may provide Personal Information directly to Athena, or to third party services, platforms, and others from whom Athena may then acquire it. For example, you may give your name, contact, health, insurance, financial, and other information in connection with a promotion, or a copay savings or patient assistance or patient support program. Athena may also gather Personal Information through your interactions with Athena and its affiliated websites, like www.AthenaBioscience.com,  http://www.QDOLO.com/, and http://www.FIBRICOR.com, where Athena may learn your IP address, your navigation preferences, and browsing tools and programs.

Athena may supplement an individual’s Personal Information with information obtained from other sources. For example, Athena may use third party information to verify a healthcare professional’s licensure. Or Athena might cross reference your Personal Information with various demographic, financial and other information to build, design, evaluate, launch, and improve Athena’s Services. If you submit Personal Information relating to other people, you represent that you have the authority to do so and to permit us to use the information in accordance with this Policy.

How We Collect Information

Athena collects Personal Information in various way and through multiple channels, including from the following:

  • Directly from individuals;
  • Our websites and, to the extent applicable, mobile applications;
  • Athena’s business partners and vendors, third party service providers, and data brokers;
  • Public databases, social media platforms, and third-party sites and services;
  • Contract research organizations and clinical trial investigators;
  • Individuals enrolled in clinical trials or otherwise participating in research;
  • Online or paper applications for patient support, compassionate use, and expanded access programs;
  • Healthcare professionals;
  • Government agencies, regulatory authorities, or public records;
  • Patient groups and associations; and
  • Industry groups and associations.

Personal Information That We May Collect – General Public

Athena collects a broad range of Personal Information related to individuals, including although not limited to the following:

  • Contact information and contact preferences, including name, email address, mailing address, telephone number, and emergency contacts;
  • Biographical and demographic information, like date of birth, age, gender, ethnicity, marital status, and sexual orientation;
  • Health and medical information, including physical and mental health conditions, diagnoses, treatments for medical conditions, genetic information, family medical history, and medications you may be taking (including dosage, timing, and frequency);
  • Information regarding parents or legal guardians;
  • Financial information;
  • Usernames and passwords an individual may use to establish an account related to Athena’s Services;
  • Social media handle or digital or electronic signatures;
  • Your photograph;
  • Publicly available information;
  • Internet activity, like your browsing and search history and information concerning your interactions with Athena’s Services and advertisements;
  • Inferences drawn from Personal Information in creating a profile that reflects your preferences, pertinent characteristics, motivations, wants and needs; and
  • Adverse event reports and information and complaints concerning Athena’s Services.

Information That We May Collect – Healthcare Professionals

If you are a healthcare professional, Athena may also collect the following information:

  • Professional credentials, educational and professional history, institutional and government affiliations, and information included on a résumé, curriculum vitae or other form;
  • Work experience, education, and languages spoken;
  • Information about the Athena Services, including programs and products which you have interacted;
  • Your interactions with Athena, prescribing preferences (including for Athena products), and agreements you may have executed with Athena; and
  • Publicly available information about your practice, like licensure, certifications, disciplinary history, litigation, regulatory work and proceedings, and the like.

How We Use Personal Information

Athena uses Personal Information in the regular course of business for its own internal purposes. While Athena’s various uses for Personal Information can be broad, generally they include the following:

  • Operation and improvement of Athena’s business and operations;
  • Delivery, design, use, launch, evaluation, and improvement of Athena’s Services;
  • Processing, completion and fulfillment of your transaction requests with Athena, both directly and in regard to any third-party service providers;
  • Provision of customer service and support;
  • Responding to your requests and inquiries;
  • Establishing and maintaining communications with you;
  • Designing, targeting, and improving Athena’s marketing programs and campaigns;
  • Providing you with promotional and educational messaging and literature, newsletters, articles, alerts, announcements, invitations, and other information about Athena’s products and brands, and also in regard to health topics and disease states;
  • Applications for Athena Services (including their provision and completion), Athena’s assessment of your eligibility for any of Athena’s Services, and Athena’s renewal of any of its Services;
  • Fulfillment of security, processing, compliance, and regulatory requirements; and
  • Compilation of statistics and data for analysis of Athena’s sites and business.

Content Sharing, Third-Party Applications, and Your Personal Information

Athena’s websites and other Services may allow you to share content with others. In that event, Athena will gain access to and use of both your Personal Information and that of the person with whom you share Athena’s content. Under this circumstance, you represent to Athena that you have the right to share that other person’s Personal Information. Further, Athena may provide access to third party applications, like social media widgets and associated tools and buttons. Any use of third-party sharing functionality is subject to separate and independent privacy policies and terms of service. While Athena recommends you read these privacy policies and terms of service carefully, Athena is not responsible for third party applications, widgets, websites or operations, or the uses to which they may put your Personal Information.

How and With Whom We May Share Personal Information

Athena may share and disclose your Personal Information as follows:

  • Internally and with its affiliates, including any subsidiaries or parent companies. When done, this type of sharing is for the uses and purposes stated in this Policy. If Athena sells, transfers or assigns one of its business units or divisions, an affiliate, or an asset to an acquiring company, your Personal Information may be part of that transaction, and subject to the privacy policies of the acquiring company. You acknowledge that the acquiring company’s policies may be materially different that those stated in this Policy.
  • With third party contractors, vendors, companies and individuals who perform services relevant to Athena and its business, including the Services. Examples of third parties with whom Athena may share Personal Information include credit card processors, customer support specialists, marketing and data analytics firms, email and SMS/texting services, webhosting and website design vendors, logistic and order fulfillment companies, distributors and licensees of Athena, and co-promotion and contract marketing organizations. In these instances, Athena shall share only that portion of Personal Information necessary to the work or service in question and will undertake reasonable efforts to ensure all Personal Information is protected from subsequent use or disclosure except as may otherwise be agreed or legally permitted.
  • Whenever legally required, when necessary or appropriate in ensuring compliance with applicable regulations and law, within a judicial proceeding, under court order or civil or criminal investigatory or other government request, in response to legal process, or to protect the safety, rights, or property of our customers, the public, Athena or others.
  • In the form of aggregated or de-identified data that is not personally identifiable to third parties for any purpose.

How We Collect Personal Information Online

Athena and the third parties who may provide services to Athena, including in regard to the Services, may collect Personal Information using cookies, tracking pixels, web beacons and other software, applications and technologies. Athena may utilize this Personal Information to better understand, customize and improve user experiences with Athena’s Services, including websites and other offerings, and to better manage and target advertising and enhanced personalization and functionality.

Accordingly, Athena’s Services may collect information that could be Personal Information and personally identifiable, including in regard to your visits, without you actively submitting such information. As part of your use of a Athena website or application, your internet browser automatically transmits some Personal Information, including website URL and browser type and version that your computer or device is utilizing. Passive information collection technologies can make your use of Athena’s websites easier by allowing Athena to provide better and more customized services based on consumer preferences, compile statistics and analyze trends. Information collected by these passive information technologies cannot generally be used to identify you without additional information. The decision to deactivate these passive sharing technologies may impede or prohibit the proper functioning of Athena’s websites and applications.

Some of Athena’s service providers and vendors may use their own cookies on Athena’s websites and applications. Although Athena may not have direct access to or control over these third-party cookies, this Policy nonetheless governs the use of these cookies. Athena may also permit social media companies to put “widgets” on Athena’s websites, which have the potential to track you across multiple websites. Athena does not have control over the privacy policies or practices of these social media companies.

When Consent Required

Whenever Athena relies on consent for the fair and lawful processing of Personal Information, Athena will provide you the opportunity to consent before any subject Personal Information is collected. In these instances, your consent may be given through your authorized representative, including legal guardian, agent, or holder of a power of attorney. Although you may give consent, you are entitled to withdraw that consent at any time, although you acknowledge in such circumstance that you may lose essential functionality for any website or application to which that consent applied.

How We Safeguard Personal Information

Athena employs a combination of technical, administrative and procedural measures to safeguard Personal Information from unauthorized access or use. No measure, however, can be entirely effective. Accordingly, Athena cannot represent, warrant, covenant or guaranty that any Personal Information is and will remain secure from all theft, loss, or unauthorized access or use, or that the measures that Athena may use always be effective. Users are responsible for maintaining the secrecy of their own passwords. If you believe that your interaction with Athena or any Athena Services are no longer secure, please immediately notify Athena at info@AthenaBioscience.com.

Retention Period

Athena will retain your Personal Information for as long as needed or as permitted, subject to such minimum retention periods as may be legally mandated or otherwise required or as advised by counsel.

International Norms and Requirements 

Athena’s Services, including websites, are controlled and operated from the United States of America, and concern Services only intended for the benefit and consumption of persons within that territory. Accordingly, neither Athena nor the Athena’s Services are subject to the laws or jurisdiction of any state, country or territory other than that of the United States. Any information you provide to Athena through the Services may be stored and processed, transferred between and accessed from the United States and other countries which may not guarantee the same level of protection of personal data as the one in which you reside.

Children’s Privacy

Athena does not direct its Services, including websites, to minors. Athena does not knowingly collect personal data from minors.

State Law Access and Deletion Rights

Residents in some states, like California, may have a right know certain Personal Information that Athena has collected on them, to know how that information is used, and to request that Athena delete and otherwise not sell their Personal Information (collectively “State Protections”). If these State Protections exist and are in force, they are qualified and may be subject to regulatory and legal obligations and requirements that prohibit Athena from fulfilling a request for disclosure or deletion. In some cases, Athena may need to collect additional information to honor a request arising under State Protections, including for the purpose of verifying your identity. Once honored, you acknowledge that State Protections may prohibit your ability to use or access Athena’s Services. If you have a request arising under State Protections, please contact info@AthenaBioscience.com.

Your Options

You have choices in regard to how and if we communicate with you. For example, you may choose not to receive marketing email communications from Athena by clicking the “Unsubscribe” link in our advertising emails. If you have any questions about this Policy, or if you are a California resident and would like to ask us to refrain from sharing your personal information with certain of our affiliates and other third parties for their marketing purposes, or to submit an data access or data deletion request, please contact us at info@AthenaBioscience.com.

Modifications to Policy

Athena may update, amend, modify or restate (collectively “modify”) this Policy from time to time and at any time without prior notice. Any modification is effective when posted to the applicable Athena Services, including websites and applications. This Policy was last updated as of the effective date first stated above. Please periodically review this page for the latest information on Athena’s privacy practices as any modified Policy will control the use of any Personal Information from that date forward.

Questions or Concerns

Any questions or concerns regarding Athena’s handling or use of Personal Information or about this Policy, please email info@AthenaBioscience.com.

Any requests to opt-out of future communications or Services from Athena, please email info@AthenaBioscience.com.

Alternatively, you may send a written letter or request to: Athena Bioscience LLC, 244 E Washington Street, Suite 203, Athens, Georgia 30601; or you can call 1-833-284-3622.

QDOLO (tramadol hydrochloride) Oral Solution 5mg/1ml C-IV IMPORTANT SAFETY INFORMATION

WARNING: RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, and MISUSE; RISK EVALUATION and MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF TRAMADOL and OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

  • Ensure accuracy when prescribing, dispensing, and administering QDOLO. Dosing errors due to confusion between mg and mL can result in accidental overdose and death.
  • QDOLO exposes users to the risks of addiction, abuse and misuse, which can lead to overdose and death.
  • The FDA has required a REMS for all opioid analgesics.
  • Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially during initiation or following a dose increase.
  • Accidental ingestion of QDOLO, especially by children, can result in a fatal overdose of tramadol.
  • Life-threatening respiratory depression and death have occurred in children who received tramadol. Some of the reported cases followed tonsillectomy and/or adenoidectomy; in at least one case, the child had evidence of being an ultra-rapid metabolizer of tramadol due to a CYP2D6 polymorphism.
  • QDOLO is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid the use of QDOLO in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of tramadol.
  • Prolonged use of QDOLO, during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
  • The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with tramadol are complex. Use of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with QDOLO requires careful consideration of the effects on the parent drug, tramadol, and the active metabolite, M1.
  • Concomitant use of opioids with benzodiazepines or other central nervous system depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.

INDICATION

QDOLO is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve QDOLO for use in patients for whom alternative treatment options (e.g., non-opioid analgesics):

  • Have not been tolerated or are not expected to be tolerated.
  • Have not provided adequate analgesia or are not expected to provide adequate analgesia.

DOSAGE AND ADMINISTRATION

  • Ensure accuracy when prescribing, dispensing, and administering QDOLO to avoid dosing errors due to confusion between mg and mL which could result in accidental overdose and death. Ensure the proper dose is communicated and dispensed.
  • When writing prescriptions, include both the total dose in mg and the total dose in volume.
  • Instruct patients on how to measure and take the correct dose of QDOLO and to use extreme caution when measuring the dose.
  • Strongly advise patients to always use a calibrated oral syringe or other oral dosing device, with metric units of measurements (i.e., mL), to correctly measure the prescribed amount of medication.
  • Inform patients that oral dosing devices may be obtained from their pharmacy and to never use household teaspoons or tablespoons to measure QDOLO.
  • Do not use QDOLO concomitantly with other tramadol-containing products.
  • Do not administer QDOLO at a dose exceeding 400 mg (80 mL) per day.
  • Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
  • Initiate the dosing regimen for each patient individually, taking into account the patient’s severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse.
  • Monitor patients closely for respiratory depression, especially within the first 24–72 hours of initiating therapy and following dosage increases with QDOLO and adjust the dosage accordingly.

CONTRAINDICATIONS

  • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
  • Known or suspected gastrointestinal obstruction, including paralytic ileus
  • Hypersensitivity to tramadol, any other component of this product or opioids
  • Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days

WARNINGS AND PRECAUTIONS

  • Serotonin Syndrome: May be life-threatening. Can occur with use of tramadol alone, with concomitant use of serotonergic drugs, with drugs that impair metabolism of serotonin or tramadol.
  • Risk of Seizure: Can occur at the recommended dose of tramadol. Concomitant use with other drugs may increase seizure risk. Risk may increase in patients with epilepsy, a history of seizures, and in patients with a recognized risk for seizures.
  • Risk of Suicide: Do not prescribe for suicidal or addiction-prone patients.
  • Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off the opioid.
  • Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration.
  • Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of QDOLO in patients with circulatory shock.
  • Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression. Avoid use of QDOLO in patients with impaired consciousness or coma.

ADVERSE REACTIONS

The most common adverse events (≥15.0%) in patients were dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting and pruritus.

To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch or Athena Bioscience, LLC at 1-833-874-2664.

See Full Prescribing Information for all adverse reactions associated with QDOLO.

DRUG INTERACTIONS

QDOLO use with Agonist/Antagonist and Partial Agonist Opioid Analgesics should be avoided as it may reduce analgesic effect of QDOLO or precipitate withdrawal symptoms.

See Full Prescribing Information for all drug interactions associated with QDOLO.

SPECIAL POPULATIONS

Pregnancy and Lactation: May cause fetal harm; breastfeeding is not recommended.

See Full Prescribing Information for use in specific populations associated with QDOLO.

Please see the accompanying Full Prescribing Information