ONTRALFY (tizanidine)

Privacy Policy

Effective November 10, 2025

ROSEMONT PHARMACEUTICALS, LLC 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 Rosemont Pharmaceuticals, LLC and its subsidiaries, affiliates and successors (collectively, “Rosemont”) collect, handle and use your Personal Information, including in regard to Rosemont’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 Rosemont collects directly, is collected on Rosemont’s behalf, or is otherwise directed to Rosemont.

Please read this Policy carefully before using or engaging Rosemont’s Services or submitting any Personal Information. By accessing, using and otherwise benefiting from Rosemont’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 Rosemont 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 Rosemont might collect, nothing in this Policy is intended as a statement as to which Personal Information Rosemont does collect.

Information We Collect

Rosemont 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 Rosemont, or to third party services, platforms, and others from whom Rosemont 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. Rosemont may also gather Personal Information through your interactions with Rosemont and its affiliated websites where Rosemont may learn your IP address, your navigation preferences, and browsing tools and programs.

Rosemont may supplement an individual’s Personal Information with information obtained from other sources. For example, Rosemont may use third party information to verify a healthcare professional’s licensure. Or Rosemont might cross reference your Personal Information with various demographic, financial and other information to build, design, evaluate, launch, and improve Rosemont’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

Rosemont 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;
  • Rosemont’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

Rosemont 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 Rosemont’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 Rosemont’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 Rosemont’s Services.

Information That We May Collect – Healthcare Professionals

If you are a healthcare professional, Rosemont 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 Rosemont Services, including programs and products which you have interacted;
  • Your interactions with Rosemont, prescribing preferences (including for Rosemont products), and agreements you may have executed with Rosemont; 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

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

  • Operation and improvement of Rosemont’s business and operations;
  • Delivery, design, use, launch, evaluation, and improvement of Rosemont’s Services;
  • Processing, completion and fulfillment of your transaction requests with Rosemont, 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 Rosemont’s marketing programs and campaigns;
  • Providing you with promotional and educational messaging and literature, newsletters, articles, alerts, announcements, invitations, and other information about Rosemont’s products and brands, and also in regard to health topics and disease states;
  • Applications for Rosemont Services (including their provision and completion), Rosemont’s assessment of your eligibility for any of Rosemont’s Services, and Rosemont’s renewal of any of its Services;
  • Fulfillment of security, processing, compliance, and regulatory requirements; and
  • Compilation of statistics and data for analysis of Rosemont’s sites and business.

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

Rosemont’s websites and other Services may allow you to share content with others. In that event, Rosemont will gain access to and use of both your Personal Information and that of the person with whom you share Rosemont’s content. Under this circumstance, you represent to Rosemont that you have the right to share that other person’s Personal Information. Further, Rosemont 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 Rosemont recommends you read these privacy policies and terms of service carefully, Rosemont 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

Rosemont 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 Rosemont 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 Rosemont and its business, including the Services. Examples of third parties with whom Rosemont 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 Rosemont, and co-promotion and contract marketing organizations. In these instances, Rosemont 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, Rosemont 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

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

Accordingly, Rosemont’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 Rosemont 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 Rosemont’s websites easier by allowing Rosemont 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 Rosemont’s websites and applications.

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

When Consent Required

Whenever Rosemont relies on consent for the fair and lawful processing of Personal Information, Rosemont 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

Rosemont 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, Rosemont 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 Rosemont may use always be effective. Users are responsible for maintaining the secrecy of their own passwords. If you believe that your interaction with Rosemont or any Rosemont Services are no longer secure, please immediately notify Rosemont at info@rosemontpharmaceuticals.com.

Retention Period

Rosemont 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

Rosemont’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 Rosemont nor the Rosemont’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 Rosemont 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

Rosemont does not direct its Services, including websites, to minors. Rosemont 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 Rosemont has collected on them, to know how that information is used, and to request that Rosemont 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 Rosemont from fulfilling a request for disclosure or deletion. In some cases, Rosemont 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 Rosemont’s Services. If you have a request arising under State Protections, please contact info@rosemontpharmaceuticals.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 Rosemont 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@rosemontpharmaceuticals.com.

Modifications to Policy

Rosemont 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 Rosemont 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 Rosemont’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 Rosemont’s handling or use of Personal Information or about this Policy, please email info@rosemontpharmaceuticals.com.

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

Alternatively, you may send a written letter or request to: Rosemont Pharmaceuticals, LLC, 6035 Ponders Court, Suite C, Greenville, SC 29615; or you can call (762) 847-0420.

IMPORTANT SAFETY INFORMATION

Indications and Usage1:

ONTRALFY® (tizanidine oral solution) is a central alpha-2-adrenergic agonist indicated for the treatment of spasticity in adults. (1)

CONTRAINDICATIONS:

ONTRALFY is contraindicated in patients:

  • taking strong CYP1A2 inhibitors [see Drug Interactions (7.1)]
  • with a history of hypersensitivity to tizanidine or the ingredients in ONTRALFY. Symptoms have included anaphylaxis and angioedema [see Warnings and Precautions (5.5)]

WARNINGS AND PRECAUTIONS:

Hypotension

ONTRALFY is an α2-adrenergic agonist that can produce hypotension [see Adverse Reactions (6.1) and Drug Interactions (7.5)]. Syncope has been reported in patients treated with tizanidine in the postmarketing setting. The risk of hypotension may be minimized by dose titration; monitoring for signs and symptoms of hypotension prior to dosage increase may minimize the risks associated with hypotension. In addition, patients moving from a supine to fixed upright position may be at increased risk for hypotension and orthostatic effects.

Monitor for hypotension when ONTRALFY is used in patients receiving concurrent antihypertensive therapy. It is not recommended that ONTRALFY be used with other α2-adrenergic agonists. Clinically significant hypotension (decreases in both systolic and diastolic pressure) has been reported with concomitant administration of tizanidine and strong CYP1A2 inhibitors [see Clinical Pharmacology (12.3)]. Therefore, concomitant use of ONTRALFY with strong CYP1A2 inhibitors is contraindicated [see Contraindications (4) and Drug Interactions (7.1)]. (5.1)

Liver Injury

ONTRALFY may cause hepatocellular liver injury. Liver function test abnormality and hepatotoxicity have been observed with tizanidine, the active moiety of ONTRALFY [see Adverse Reactions (6.1, 6.2)]. Monitoring of aminotransferase levels is recommended at baseline and 1 month after maximum dose is achieved, or if hepatic injury is suspected [see Dosage and Administration (2.1) and Use in Specific Populations (8.7)]. (5.2)

Sedation

ONTRALFY can cause sedation, which may interfere with everyday activity. In the multiple dose studies of tizanidine, the prevalence of patients with sedation peaked following the first week of titration and then remained stable for the duration of the maintenance phase of the study [see Adverse Reactions (6.1)]. The CNS depressant effects of ONTRALFY with alcohol and other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants) may be additive [see Drug Interactions (7.4)]. Monitor patients who take ONTRALFY with another CNS depressant for symptoms of excess sedation. (5.3)

Hallucinosis/Psychotic-Like Symptoms

Tizanidine use has been associated with hallucinations. Formed, visual hallucinations or delusions were reported in 5 of 170 patients (3%) in two North American controlled clinical studies of tizanidine. Most of the patients were aware that the events were unreal. One patient developed psychosis in association with the hallucinations. One patient among these 5 continued to have problems for at least 2 weeks following discontinuation of tizanidine. Hallucinations have also been reported with tizanidine use in the postmarketing setting. Consider discontinuing ONTRALFY in patients who develop hallucinations. (5.4)

Hypersensitivity Reactions

ONTRALFY can cause anaphylaxis. Signs and symptoms of hypersensitivity, including respiratory compromise, urticaria, and angioedema of the throat and tongue, have been reported. ONTRALFY is contraindicated in patients with a history of hypersensitivity reactions to tizanidine [see Contraindications (4)]. (5.5)

Withdrawal Adverse Reactions

ONTRALFY can cause withdrawal adverse reactions, which include rebound hypertension, tachycardia, and hypertonia. To minimize the risk of these reactions, particularly in patients who have been receiving high doses of ONTRALFY (20 to 28 mg daily) for long periods of time (9 weeks or more) or who may be on concomitant treatment with narcotics, the ONTRALFY dosage should be decreased slowly [see Dosage and Administration (2.5)]. (5.6)

ADVERSE REACTIONS:

The following clinically significant adverse reactions are described elsewhere in other sections of the prescribing information:

  • Hypotension [see Warnings and Precautions (5.1)]
  • Liver Injury [see Warnings and Precautions (5.2)]
  • Sedation [see Warnings and Precautions (5.3)]
  • Hallucinosis/Psychotic-Like Symptoms [see Warnings and Precautions (5.4)]
  • Hypersensitivity Reactions [see Warnings and Precautions (5.5)]
  • Withdrawal Adverse Reactions [see Warnings and Precautions (5.6)]

The most common adverse reactions (in greater than 10% of patients taking tizanidine) were dry mouth, somnolence/sedation, asthenia (weakness, fatigue and/or tiredness), and dizziness. (6.1)

DRUG INTERACTIONS:

Strong CYP1A2 Inhibitors

Concomitant use of ONTRALFY with strong cytochrome P450 1A2 (CYP1A2) inhibitors (e.g., fluvoxamine, ciprofloxacin) is contraindicated. Changes in pharmacokinetics of tizanidine when administered with a strong CYP1A2 inhibitor resulted in significantly decreased blood pressure, increased drowsiness, and increased psychomotor impairment [see Contraindications (4) and Clinical Pharmacology (12.3)]. (7.1)

Moderate or Weak CYP1A2 Inhibitors

Concomitant use of ONTRALFY with moderate or weak CYP1A2 inhibitors (e.g., zileuton, antiarrhythmics [amiodarone, mexiletine, propafenone, and verapamil], cimetidine, famotidine, oral contraceptives, acyclovir, and ticlopidine) should be avoided. If concomitant use is clinically necessary, and adverse reactions such as hypotension, bradycardia, or excessive drowsiness occur, reduce ONTRALFY dosage or discontinue ONTRALFY therapy [see Clinical Pharmacology (12.3)]. (7.2)

Oral Contraceptives

Concomitant use of ONTRALFY with oral contraceptives is not recommended. However, if concomitant use is clinically necessary and adverse reactions such as hypotension, bradycardia, or excessive drowsiness occur, reduce or discontinue ONTRALFY therapy [see Clinical Pharmacology (12.3)]. (7.3)

Alcohol and Other CNS Depressants

Alcohol increases the exposure of tizanidine after administration of ONTRALFY. This was associated with an increase in adverse reactions of tizanidine.

Concomitant use of ONTRALFY with CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may cause additive CNS depressant effects, including sedation. Monitor patients who take ONTRALFY with another CNS depressant for symptoms of excess sedation [see Clinical Pharmacology (12.3)]. (7.4)

α2-Adrenergic Agonists

Concomitant use of ONTRALFY with other α2-adrenergic agonists is not recommended because hypotensive effects may be cumulative [see Warnings and Precautions (5.1)]. (7.5) 

Antihypertensive Medications

Concomitant use of ONTRALFY with antihypertensive medications may cause additive hypotensive effects [see Warnings and Precautions (5.1)]. Monitor patients who take ONTRALFY with antihypertensive medications for hypotension. (7.6)

USE IN SPECIFIC POPULATIONS:

Pregnancy

There are no adequate data on the developmental risk associated with use of tizanidine in pregnant women. See Full Prescribing Information for animal data. (8.1)

Lactation

There are no data on the presence of tizanidine in human milk, the effects on the breastfed infant, or the effects on human milk production. Animal studies have reported the presence of tizanidine in the milk of lactating animals.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ONTRALFY and any potential adverse effects on the breastfed infant from ONTRALFY or from the underlying maternal condition. (8.2)

Females and Males of Reproductive Potential

There are no adequate and well-controlled studies in humans on the effect of ONTRALFY on female or male reproductive potential. Oral administration of tizanidine to male and female rats resulted in adverse effects on fertility [see Nonclinical Toxicology (13.1)]. (8.3)

Pediatric Use

Safety and effectiveness in pediatric patients have not been established. See Full Prescribing Information for juvenile animal toxicity data. (8.4)

Geriatric Use

Tizanidine is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (8.5)

Renal Impairment

In patients with renal insufficiency (creatinine clearance < 25 mL/min), clearance of tizanidine was reduced [see Clinical Pharmacology (12.3)]. In these patients, dosage reduction is recommended [see Dosage and Administration (2.3)]. Because the risk of adverse reactions to ONTRALFY may be greater in patients with impaired renal function, monitor these patients closely for the onset or increase in severity of common adverse reactions [see Adverse Reactions (6.1)]. (8.6)

Hepatic Impairment

ONTRALFY should be used with caution in patients with hepatic impairment. The influence of hepatic impairment on the pharmacokinetics of tizanidine has not been evaluated. Because tizanidine is extensively metabolized in the liver, hepatic impairment would be expected to have significant effects on pharmacokinetics of tizanidine [see Warnings and Precautions (5.2), and Clinical Pharmacology (12.3)]. In patients with hepatic impairment, dosage reduction is recommended [see Dosage and Administration (2.4)]. (8.7)

REFERENCES:
1. ONTRALFY Prescribing Information PI-TIZ-01-001. Rosemont Pharmaceuticals, LLC; 2025

This Important Safety Information does not include all the information needed to use ONTRALFY safely and effectively. Click here for Full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact Rosemont Pharmaceuticals, LLC at 1-844-638-2235 or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch