This site is intended for US healthcare providers

    Terms of Use

    PERSERIS is a registered trademark of Indivior UK Ltd. ("Indivior" or "we," "us") or its affiliated companies.

    YOUR ACCESS TO AND USE OF THIS SITE, WWW.PERSERISHCP.COM (THE "SITE"), ARE SUBJECT TO THE FOLLOWING TERMS OF USE (the "Terms"). BY VIEWING THIS SITE, YOU AGREE TO THESE TERMS. IF YOU DO NOT AGREE TO ITS TERMS, DO NOT VIEW THIS SITE.

    1. Modification of the terms

      Indivior reserves the right to change these Terms from time to time as it deems necessary, and will post such changes and their effective date within the current terms of use on this Site. Any changes to these Terms will be effective after the date on which the revised Terms are posted.

    2. Eligibility

      In order to use the Site, you must be 18 years of age and fully able and competent to enter into the terms, conditions, obligations, affirmations, representations and warranties set forth in the Terms and to abide by and comply with the Terms. You represent that you meet the eligibility requirements in this Section and that you are over the age of 18, as the Site is not intended for use by anyone under 18.

    3. Privacy Notice

      Your privacy is important to Indivior. Indivior's Privacy Policy is hereby incorporated into the Terms by reference. All information Indivior collects on this Site is subject to our Privacy Policy located at https://www.perserishcp.com/privacy-policy. Please read it carefully for information relating to Indivior's collection, use, and disclosure of your personal information.

    4. Applicable law and venue

      These Terms are governed by the laws of the Commonwealth of Virginia, without regard to its rules regarding conflicts of law.

      By using this Site, you agree that all litigation arising from or related to this Site shall be instituted and maintained only in the Circuit Court of the County of Henrico, Virginia, or in the United States District Court for the Eastern District of Virginia, Richmond Division, and you irrevocably waive any objection that you may have at any time to the laying of venue in any suit, action or proceeding arising out of or related hereto brought in any such court, irrevocably waive any claim that any such suit, action or proceeding brought in any such court has been brought in an inconvenient forum, and irrevocably waive the right to object, with respect to any such suit, action or proceeding brought in any such court, that such court does not have jurisdiction over you.

    5. Site access

      USE OF THIS SITE IS NOT AUTHORIZED IN ANY JURISDICTION THAT DOES NOT GIVE EFFECT TO ALL PROVISIONS OF THESE TERMS, INCLUDING WITHOUT LIMITATION, THIS PARAGRAPH. THESE TERMS APPLY ONLY TO YOUR USE OF THIS SPECIFIC SITE. INDIVIOR OPERATES OTHER WEBSITES THAT ARE COVERED BY THEIR OWN TERMS OF USE AS SPECIFIED IN THOSE WEBSITES.

      You may browse this Site for personal information. However, you may not copy, distribute, modify, transmit or revise the contents of this Site without written permission of Indivior. Neither title nor intellectual property rights are transferred to you or any third-party through the use or access to this Site; rather, all rights, title, and interest in and to all aspects of this site remain the sole property of Indivior or its affiliates.

    6. No warranties

      This Site, its Content and access are provided on an "AS IS" basis. INDIVIOR, AND ITS AFFILIATES, TO THE FULLEST EXTENT PERMITTED BY LAW, DISCLAIMS ALL WARRANTIES, EITHER EXPRESS OR IMPLIED, STATUTORY OR OTHERWISE, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT OF THIRD-PARTIES' RIGHTS, TITLE, OR FITNESS FOR A PARTICULAR PURPOSE, OR WARRANTIES ARISING BY COURSE OF DEALING OR CUSTOM OF TRADE. Specifically, Indivior and its affiliates make no representations or warranties regarding the (i) accuracy, completeness, currency or timeliness of the Content, (ii) links provided on or through the use of this Site or (iii) the quality and security of the Site, or inability to access the Content or Site, including whether they will be free of viruses, unauthorized code or other harmful components.

    7. Medical information

      The Content is offered for informational and educational purposes only, and is not intended to be a substitute for medical advice, diagnosis or treatment. We do not offer or give medical advice, nor do we provide medical or diagnostic services. Use of this Site does not create a doctor/patient relationship between you and Indivior or its affiliates. Instead, the Content is intended to support, not replace, the relationship that exists between you and your physician. You should not act upon this information without seeking professional advice and counsel.

      Any statements made in this Site about products have not been evaluated by the United States Food and Drug Administration. They are not intended to diagnose, treat, cure or prevent any condition or disease.

      We do not endorse any specific tests, products, procedures, opinions, or other information that may be mentioned or described in this Site. If you rely on any Content obtained by you on or through this Site, you do so solely at your own risk. You are solely responsible for compliance with the laws and regulations applicable to your place or country of residence and accessing this Site from any country where its content does not comply with its laws and regulations is prohibited.

    8. Limitation of liability, Damages

      YOU AGREE THAT INDIVIOR AND ITS AFFILIATES SHALL NOT BE LIABLE TO YOU OR ANYONE ELSE FOR ANY LOSS OR INJURY CAUSED IN WHOLE OR IN PART BY RELYING UPON, USING, OR INTERPRETING THE CONTENT OR ANY OTHER INFORMATION OBTAINED THROUGH USE OF THIS SITE. IN NO EVENT WILL INDIVIOR OR ITS AFFILIATES BE LIABLE TO YOU OR ANYONE ELSE FOR ANY INCIDENTAL, CONSEQUENTIAL, INDIRECT, SPECIAL OR EXEMPLARY DAMAGES OR LOST PROFITS ARISING OUT OF THE USE OR INABILITY TO USE THE CONTENT, THE SITE OR ANY OTHER INFORMATION OBTAINED THROUGH THE SITE, EVEN IF INDIVIOR, ITS AFFILIATES, ITS LICENSORS, AGENTS OR REPRESENTATIVES KNOW OR HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. THESE EXCLUDED DAMAGES INCLUDE, BUT ARE NOT LIMITED TO, MEDICAL, LEGAL AND ACCOUNTING MALPRACTICE DAMAGE CLAIMS OR AWARDS, PAIN AND SUFFERING, PERSONAL INJURY/WRONGFUL DEATH, LOSS OF INCOME, LOSS OF CONSORTIUM, BUSINESS INTERRUPTION, MEDICAL BILLS, DAMAGES FOR LOSS OF DATA, LOSS OF PROGRAMS, AND/OR COST OF PROCUREMENT OF SUBSTITUTE SERVICES OR SERVICE INTERRUPTIONS. INDIVIOR'S AND ITS AFFILIATES' CUMULATIVE LIABILITY TO YOU OR ANY OTHER PARTY FOR ANY LOSS OR DAMAGES RESULTING FROM ANY CLAIMS, DEMANDS, OR ACTIONS ARISING OUT OF OR RELATING TO THE SITE, THE CONTENT OR THESE TERMS OF USE SHALL NOT EXCEED FIVE DOLLARS ($5.00). SOME STATES DO NOT ALLOW THE EXCLUSION OR LIMITATION OF INCIDENTAL DAMAGES, OR LIMITATIONS UPON HOW LONG AN IMPLIED WARRANTY LASTS, SO THE ABOVE LIMITATIONS OR EXCLUSIONS MAY NOT APPLY TO YOU. IN NO EVENT SHALL INDIVIOR OR ITS AFFILIATES BE LIABLE FOR ANY PERSONAL INJURY, INCLUDING DEATH, CAUSED BY YOUR USE OR MISUSE OF THIS SITE OR THE CONTENT. Any claims made by you in connection with your use of this Site or the Content must be brought within one (1) year of the date on which the event giving rise to such action occurred. All remedies set forth in these Terms are exclusive and are limited to those expressly provided for in these Terms.

    9. Links and third-party websites

      Any link (including a hyperlink, button or referral device of any kind) used on this Site is provided for your use and convenience. The appearance of a link on this Site does not constitute an endorsement, recommendation or certification by us, nor should the presence of a link in any way be construed as a suggestion that any third-party website has any relationship with us. We do not endorse the content on any third-party websites. We are not responsible for the content of linked third-party websites or third-party advertisements, and do not make any representations regarding their content or accuracy. We do not knowingly link to websites that may infringe on valid and existing trademarks, service marks, copyrights or patents. Your use of third-party websites is at your own risk and subject to the terms and conditions of use for such websites.

    10. Your use of the Site

      Neither Indivior nor its affiliates is under any obligation to respond to messages posted to this Site, nor need we provide any compensation for any such communication. If you post any information or material to this Site you are responsible for such information or material and the consequences of their posting. If you choose to post material, you agree to do so solely for lawful purposes and in compliance with all applicable laws. You expressly agree that we have no responsibility for or control over the information, creations, data or material you may post to this Site. We make no representation that your use of this Site will comply with applicable laws or that they were designed to comply with the applicable laws. For example, many states regulate physician advertising and you are responsible for ensuring that your use of the Site complies with laws applicable to you. You also expressly agree that you will not post any material that: (1) is defamatory, libelous, abusive, or obscene, including, without limitation, material which encourages conduct that would constitute a criminal offense, give rise to civil liability or otherwise violate any applicable local, state, federal, or international law; (2) infringes on the copyright or any other proprietary right of a third-party; (3) would invade the privacy of any other person; (4) is intended to advertise to or solicit others without our express permission; (5) constitutes charity solicitations, chain letters or pyramid schemes; (6) contains a virus, worm, Trojan horse, time bomb, or any other harmful program or component; or (7) does not generally pertain to the designated topic or theme of the Site. You further expressly agree that you will not: (a) after receiving warning, continue to post material which we have advised you not to post; (b) create a false identity or forged email address or header, or otherwise attempt to mislead others as to the identity of the sender or the origin of the message; (c) post, generate or disseminate so-called "spam" or mass-mailings; (d) harvest or otherwise collect information about others, including email addresses, without their consent; (e) interfere with or disrupt networks connected to the Site, or used for purposes of delivering the Content (or violate the regulations, policies or procedures of such networks); (f) attempt to gain unauthorized access to restricted areas of the Site, other accounts, computer systems or networks connected to the Site, through password mining or any other means; or (g) interfere with another user's use and enjoyment of the Site.

    11. No monitoring

      We do not and are not responsible for screening or monitoring material posted by you or any other person or entity. If notified by one of our Users of any material that is alleged not to conform to the terms of these Terms of Use, we may investigate the allegation and determine in our sole discretion to remove or request the removal of the material. We reserve the right to remove material that is abusive, illegal, disruptive, or that otherwise fails to conform to these Terms of Use. We reserve the right to edit or delete any material posted on our Site, regardless of whether such material violates these standards for content. We have no liability or responsibility to you or any other person or entity for performance or nonperformance of the screening activities set forth above.

      We further do not represent, warrant or guarantee the truthfulness, accuracy, or reliability of any of the material posted by others on the Site. We also do not endorse any opinions expressed by others on the Site. YOU ACKNOWLEDGE THAT ANY RELIANCE ON CONTENT POSTED BY OTHERS ON THE SITE, AND YOUR USE OF THAT CONTENT, IS AT YOUR OWN RISK.

    12. Intellectual property rights

      You hereby grant to Indivior a non-exclusive, worldwide, royalty-free, perpetual license, with right to sublicense, to reproduce, distribute, transmit, create derivative works of, publicly display and publicly perform and otherwise exploit any materials and other information you submit to the Site by all means and in any media now known or hereafter developed for any use or purpose.

    13. Digital Millennium Copyright Act Compliance.

      If You are a copyright owner or an agent thereof, and believe that any third-party content on the Site infringes upon Your copyrights, You may submit a notification pursuant to the Digital Millennium Copyright Act ("DMCA") by providing our Copyright Agent with the following information in writing (see 17 U.S.C § 512(c)(3) for further detail).

      (i) A physical or electronic signature of a person authorized to act on behalf of the owner of an exclusive right that is allegedly infringed;

      (ii) Identification of the copyrighted work claimed to have been infringed, or, if multiple copyrighted works on the Site are covered by a single notification, a representative list of such works from the Site;

      (iii) Identification of the material that is claimed to be infringing or to be the subject of infringing activity and that is to be removed or access to which is to be disabled, and information reasonably sufficient to permit Indivior to locate the material;

      (iv) Information reasonably sufficient to permit Indivior to contact the complaining party, such as an address, telephone number, and, if available, an electronic mail address at which the complaining party may be contacted;

      (v) A statement that the complaining party has a good faith belief that use of the material in the manner complained of is not authorized by the copyright owner, its agent, or the law; and

      (vi) A statement that the information in the notification is accurate, and under penalty of perjury, that the complaining party is authorized to act on behalf of the owner of an exclusive right that is allegedly infringed.

      Indivior's designated Copyright Agent to receive notifications of claimed infringement is:

      Email: CopyrightAgent@Indivior.com
      Phone: 804-379-1090
      Fax: 804-379-1215

    14. Trademark use

      Indivior only purports to use names, logos or marks appearing in this site in those territories in which it or its affiliates are entitled to do so, whether by virtue of pending or registered trade marks, licenses, or otherwise. For the avoidance of doubt, Indivior does not purport to use any name, logo or mark in any territory in which it is not so entitled, and will not supply or offer to supply products and/or services bearing any such name, logo or mark into any such territory. The use of these trademarks or any other content on this site, except as provided in these terms of use or in the Site content, is strictly prohibited. All site content is Copyright © 2017 Indivior and/or its subsidiaries and affiliated companies. All rights reserved.

      In the event that any or any part of the terms contained in these terms of use shall be determined by any competent authority to be invalid, unlawful or unenforceable to any extent, such term shall to that extent be severed from the remaining terms which shall continue to be valid and enforceable to the fullest extent permitted by law.

    15. Assignment and Transfer

      We may assign this agreement, in whole or in part, at any time without notice to you. You may not assign this agreement or transfer any rights to use the Site.

    16. Contract Interpretation

      This is the entire agreement between you and Indivior for your use of the Site. It supersedes any prior agreements between you and Indivior regarding your use of the Site. All parts of this agreement apply to the maximum extent permitted by relevant law. If a court holds that we can't enforce a part of this agreement as written, we may replace those terms with similar terms to the extent enforceable under the relevant law, but the rest of this agreement won't change. The agreement's section titles are for reference only and have no legal effect.

    Please see full Prescribing Information and BOXED WARNING for PERSERIS.

    IMPORTANT SAFETY INFORMATION

    WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

    Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. PERSERIS is not approved for the treatment of patients with dementia-related psychosis and has not been studied in this population.

    INDICATIONS AND USAGE

    PERSERIS is indicated for the treatment of schizophrenia in adults.

    CONTRAINDICATIONS:

    PERSERIS is contraindicated in patients with a known hypersensitivity to risperidone, its metabolite, paliperidone, or to any of its components. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone or paliperidone.

    WARNINGS AND PRECAUTIONS

    Cerebrovascular Adverse Reactions: In trials of elderly patients with dementia-related psychosis, there was a significantly higher incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack), including fatalities, in patients treated with oral risperidone compared to placebo. PERSERIS is not approved for use in patients with dementia-related psychosis.

    Neuroleptic Malignant Syndrome, a potentially fatal symptom complex, has been reported with antipsychotic medications. Clinical manifestations include hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (see full Prescribing Information). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Management should include immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, intensive symptomatic treatment and medical monitoring, and treatment of any concomitant serious medical problems.

    Tardive Dyskinesia (TD): TD may develop in patients treated with antipsychotic drugs. The risk of developing TD and likelihood that it will become irreversible are believed to increase with treatment duration and total cumulative dose. Less commonly, TD can develop after relatively brief treatment periods at low doses. Elderly patients, especially elderly women, appear to be at increased risk, but it is impossible to predict which patients will develop TD. Therefore, PERSERIS should be prescribed in a manner that is most likely to minimize the occurrence of TD. Discontinue treatment if clinically appropriate.

    Metabolic Changes that may increase cardiovascular/cerebrovascular risk, have been associated with atypical antipsychotics (APs).

    • Hyperglycemia and Diabetes Mellitus (DM), in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, have been reported in patients treated with APs, including risperidone. Patients with DM who are started on atypical APs, including PERSERIS, should be monitored regularly for worsening of glucose control. Patients at risk for DM (e.g., obesity, family history of diabetes) who are starting treatment with atypical APs, including PERSERIS, should undergo fasting blood glucose (FBG) testing at the beginning of treatment and periodically while treated. Any patient treated with atypical APs, including PERSERIS, should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical APs, including PERSERIS, should undergo FBG testing. In some cases, hyperglycemia has resolved when risperidone was discontinued; however, some patients required continuation of antidiabetic treatment despite discontinuation of risperidone.

    • Dyslipidemia has been observed in patients treated with atypical APs.

    • Weight Gain has been observed with atypical AP use. Monitoring weight is recommended.

    Hyperprolactinemia: Risperidone elevates prolactin levels, and the elevation persists during chronic administration. Risperidone is associated with higher levels of prolactin elevation than other antipsychotic agents. Hyperprolactinemia may inhibit reproductive function in female and male patients. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating drugs. Long-standing hyperprolactinemia, when associated with hypogonadism, may lead to decreased bone density in females and males.

    Orthostatic Hypotension: Risperidone may induce orthostatic hypotension associated with dizziness, tachycardia, and in some patients, syncope. Use with particular caution in patients with known cardiovascular disease, cerebrovascular disease, and conditions which predispose patients to hypotension, and in the elderly and patients with renal or hepatic impairment. Monitor such patients and consider a dose reduction if hypotension occurs.

    Falls: Somnolence, postural hypotension, motor instability, and sensory instability have been reported with the use of antipsychotics, including PERSERIS, which may lead to falls, and consequently, fractures or other fall-related injuries. Assess the risk of falls when initiating treatment and recurrently during treatment.

    Leukopenia, Neutropenia, and Agranulocytosis have been reported with antipsychotic agents, including risperidone. In patients with a history of a clinically significant low white blood count (WBC) or a drug-induced leukopenia/neutropenia, perform a complete blood count frequently during the first few months of therapy. Consider discontinuation at the first sign of a clinically significant decline in WBC in the absence of other causative factors. Monitor patients with clinically significant neutropenia for fever or other symptoms/signs of infection and treat promptly if such symptoms/signs occur. Discontinue PERSERIS in patients with severe neutropenia (absolute neutrophil count <1000/mm3) and follow WBC until recovery.

    Potential for Cognitive and Motor Impairment: Risperidone may impair judgment, thinking, or motor skills. Caution patients about operating machinery, including automobiles, until they are reasonably certain PERSERIS does not affect them adversely.

    Seizures have been observed in risperidone studies in adults with schizophrenia. PERSERIS should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.

    Dysphagia: Esophageal dysmotility and aspiration can occur. Use cautiously in patients at risk for aspiration pneumonia.

    Priapism has been reported with other risperidone products. Severe priapism may require surgical intervention.

    Disruption of Body Temperature Regulation has been attributed to antipsychotic agents. Use with caution in patients who will be exposed to temperature extremes.

    Adverse Reactions:

    The most common adverse reactions in a clinical trial (≥ 5% and greater than placebo) were increased weight, constipation, sedation/somnolence, pain in extremity, back pain, akathisia, anxiety, and musculoskeletal pain. The most common injection site reactions (≥ 5%) were injection site pain and erythema. This is not a complete list of potential adverse events. Please see the full Prescribing Information for a complete list.

    DRUG INTERACTIONS

    • Carbamazepine and other strong CYP3A4 inducers decrease risperidone plasma concentration.

    • Fluoxetine, paroxetine, and other strong CYP2D6 inhibitors increase risperidone plasma concentration.

    • Use with other CNS drugs or alcohol may increase nervous system disorders.

    • PERSERIS may enhance hypotensive effects of hypotensive agents.

    • PERSERIS may antagonize the pharmacologic effects of dopamine agonists.

    USE IN SPECIFIC POPULATIONS

    Pregnancy: PERSERIS may cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. Advise patients to notify their healthcare professional if they become or intend to become pregnant during treatment with PERSERIS. Patients exposed to PERSERIS during pregnancy may be registered with the National Pregnancy Registry for Atypical Antipsychotics (1-866-961-2388 or http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/).

    Lactation: Infants exposed to risperidone through breastmilk should be monitored for excess sedation, failure to thrive, jitteriness, and extrapyramidal symptoms.

    Pediatric Use: Safety and effectiveness of PERSERIS have not been established in pediatric patients.

    Renal or Hepatic Impairment: Carefully titrate on oral risperidone up to at least 3 mg before initiating treatment with PERSERIS at a dose of 90 mg.

    To report pregnancy or side effects associated with taking PERSERIS, please call 1-877-782-6966.

    For more information about PERSERIS, see the full Prescribing Information including BOXED WARNING.

    To report SUSPECTED ADVERSE REACTIONS, contact Indivior Inc. at 1-877-782-6966 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.