Terms of Service

Please read these Terms of Service carefully. By using the Services (as defined below), you agree to this Agreement. We recommend that you print a copy of this Agreement for future reference. We retain the right to make changes, as outlined below. This Agreement is between you and Janssen Pharmaceuticals, Inc. concerning your use of the SPRAVATOTreatmentCenter.com site located at https://www.spravatotreatmentcenter.com, or the mobile software application in connection with which you are accessing this Agreement.

THIS WEBSITE OR APPLICATION IS NOT INTENDED FOR USE BY PERSONS UNDER THEAGE OF 13. IF YOU ARE UNDER 13 YEARS OLD, YOU MAY NOT USE THIS WEBSITE OR APPLICATION OR PROVIDE THE COMPANY WITH ANY PERSONALLY IDENTIFIABLE INFORMATION. IF YOU ARE 13 OR OLDER BUT NOT OF LEGAL AGE TO ENTER INTO A CONTRACT, YOU SHOULD REVIEW THESE TERMS AND CONDITIONS WITH YOUR PARENT OR GUARDIAN TO MAKE SURE THAT YOU AND YOUR PARENT OR GUARDIAN UNDERSTAND THESE TERMS AND CONDITIONS. IF THIS SITE INCLUDES THE ABILITY TO PURCHASE PRODUCTS OR SERVICES, IN ORDER TO UTILIZE THE PURCHASING FUNCTION, YOU MUST BE THE AGE OF MAJORITY IN YOUR STATE.

1. Our Right to Make Changes. We may change this Agreement from time to time for valid reasons (e.g., to reflect a change in the law) by notifying you of such changes by any reasonable means and by making available a revised Agreement through the Services. Any such changes will not apply to any dispute between you and us arising prior to the date on which we posted the revised Agreement incorporating such changes or otherwise notified you of such changes. Your use of the Services following any changes will constitute your acceptance of such changes. The “Last Updated” legend above indicates when this Agreement was last changed.
To the extent permitted by applicable law, we may, at any time and without liability, modify or discontinue all or part of the Services for valid reasons (e.g., to reflect changes in the relevant laws, to protect the security of the site or mobile software application, or to implement reasonable technical adjustments and improvements); charge, modify, or waive any fees required to use the Services where reasonably necessary; or offer opportunities to some or all users, at our sole discretion. We will seek to notify you by reasonable means of (i) any modifications that will have a material adverse effect on the use of the Services, taken as a whole; and (ii) any material increase in the fees charged by us to use the Services.

2. Information Submitted Through the Services. Your submission of information through the Services is governed by our Privacy Policy, including our Cookie Policy, located here. You confirm that any information you provide is accurate and complete, and that you will update it as needed by contacting us here. We will have no liability arising from your failure to provide accurate information.

3. Jurisdictional Issues. The Services may not be appropriate or available for use in some jurisdictions. Any use of the Services is at your own risk, and you must comply with all applicable laws, rules, and regulations in doing so. We may limit the availability of the Services at any time, in whole or in part, to any person or geographic area that we choose, in our sole discretion, for valid reasons (e.g., to comply with relevant laws and regulatory requirements, to protect the security of the site or mobile software application or to implement reasonable technical adjustments).

4. Acceptable Use and Rules of Conduct. You must not: Post, transmit or otherwise make available through or in connection with the Services any materials that are or may be: (a) threatening, harassing, degrading, hateful, intimidating, or otherwise fail to respect the rights and dignity of others; (b) defamatory, libelous or fraudulent; (c) obscene, indecent, pornographic or otherwise objectionable; or (d) protected by copyright, trademark, trade secret, right of publicity or privacy or any other proprietary right, without the express prior written consent of the applicable owner.


  • Post, transmit or otherwise make available through or in connection with the Services any virus, worm, Trojan horse, Easter egg, time bomb, spyware or other computer code, file or program that is or is potentially harmful or invasive or intended to damage or hijack the operation of, or to monitor the use of, any hardware, software or equipment (each, a “Virus”).

  • Use the Services for any commercial purpose, including use for your commercial purposes or any commercial purposes that will benefit you in any way.

  • Use the Services for any purpose that is fraudulent or otherwise unlawful.

  • Collect information about users of the Services in any way, including through reverse engineering.

  • Interfere with the operation of the Services or the servers or networks used to make the Services available, including by hacking or defacing any portion of the Services, or violate any requirement or policy of such servers or networks.

  • Restrict or inhibit any other person from using the Services.

  • Reproduce, modify, adapt, translate, create derivative works of, sell, rent, lease, loan, timeshare, distribute or otherwise exploit any portion of (or any use of) the Services except as expressly authorized under this Agreement, without our express prior written consent.

  • Reverse engineer, decompile or disassemble any portion of the Services, except where such restriction is expressly prohibited by applicable law.

  • Remove any copyright, trademark or other proprietary rights notice from the Services.

  • Incorporate any portion of the Services into any product or service, without our express prior written consent.

  • Systematically download and store Services content.

  • Use any robot, spider, site search/retrieval application or other manual or automatic device to retrieve, index, “scrape,” “data mine” or otherwise gather Services’ content, or reproduce or circumvent the navigational structure or presentation of the Services, without our express prior written consent. Notwithstanding the foregoing, and subject to compliance with any instructions posted in the robots.txt file located in the root directory of the Services, we grant to the operators of public search engines permission to use spiders to copy materials from the Services for the sole purpose of (and solely to the extent necessary for) creating publicly available, searchable indices of such materials, but not caches or archives of such materials. We reserve the right to revoke such permission either generally or in specific cases, at any time and without notice.

You are responsible for obtaining, maintaining and paying for all hardware, telecommunications and other services needed for you to use the Services.

5. Products. The Services may make available listings, descriptions and images of goods or services or related coupons or discounts (collectively, “Products”), as well as references and links to Products. We attempt to describe the items available on the website or application as accurately as possible, and depict the most up-to-date product packaging available. We make no warranties or representations as to the completeness, accuracy, reliability, validity or timeliness of such listings, descriptions or images (including any features, specifications and prices contained therein) or that product packaging depicted will match the actual Product that you receive. Such information and the availability of any Product are subject to change at any time without notice. If a Product is not as described when you receive it, or the packaging on the site does not match the Product you receive, your sole remedy is to return the Product to us in unused and undamaged condition in accordance with our Returns Policy, which is listed on the website under Customer Service.

6. Registration. You may need to register to use the Services. We may reject, or require that you change, any user name, password or other information that you provide. Your user name and password are for your personal use only. You are solely responsible for maintaining the confidentiality of your credentials and for restricting access to your mobile device, computer, and/or other means of accessing this website or application. We are not responsible for any use of your credentials caused by your failure to keep them confidential. Solely you are responsible for all activities that occur under your account, either with or without your knowledge. You must promptly notify us of any unauthorized use of your credentials or account of which you become aware. We recommend that, to the extent you access this website or application via a mobile device, you password protect said device.

7. Profiles and Forums. You may be permitted to make available certain information or materials (each, a “Submission”) in connection with the Services, including on profile pages or interactive features. We have no control over and are not responsible for any use or misuse by any third party of Submissions or for your interactions with other users. Users are ultimately responsible for their own actions. If you choose to make your personal or other information publicly available through the Services, you do so at your own risk.

8. Our Right to Use Submissions. You own your Submissions. For each Submission, you grant to us a worldwide, royalty-free, fully paid-up, non-exclusive, perpetual, irrevocable, transferable and fully sublicensable (through multiple tiers) license, without additional consideration to you or any third party, to reproduce, distribute, perform and display (publicly or otherwise), create derivative works of, adapt, modify, store and otherwise use, analyze and exploit such Submission and to contact you about such Submission, including your name and location, in any format or media now known or hereafter developed, and for any purpose (including promotional purposes, such as testimonials, and advertising in connection with pictures/videos).
In addition, if you provide to us any ideas, proposals or suggestions (“Feedback”), we will deem such Feedback a Submission. You agree that Feedback is not confidential and that your provision of it is gratuitous, unsolicited and without restriction and does not place us under any obligation in respect of such Feedback.
You confirm that (a) you have all rights necessary to grant the licenses in this section, (b) your Submissions are complete and accurate, and (c) your Submissions and your provision of them to us are not fraudulent or otherwise in breach of any applicable law or any right of any third party. You further irrevocably waive (and consent to us performing any acts or omissions in relation to your Submissions and associated materials that may be inconsistent with) any “moral rights” or other rights with respect to attribution of authorship or integrity of materials regarding your Submission that you may have under any applicable law.

9. Monitoring Use of the Service. We may (but have no obligation to) monitor, evaluate, alter or remove Submissions before or after they appear on the Services or analyze your access to or use of the Services, including analytics gathered from data that you submit through the website or application. We retain the right to use analytics gathered from the submitted data as part of overall analytics analysis. We may disclose information regarding either your access to or use of the Services, the circumstances surrounding the transmission of Submissions, and personal information regarding users who make Submissions available, in each case, in accordance with applicable law or a request by a court or law enforcement or other governmental authority, or otherwise in accordance with our Privacy Policy.

10. Your Right to Use the Services. Subject to your compliance with, and solely for the duration of, this Agreement: (a) you may view one copy of the website on any single device, solely for your personal, non-commercial use; (b) we permit you, on a limited, non-exclusive, revocable, non-transferable, non-sublicensable basis, to install and use the website or application on a device that you own or control, solely for your personal, non-commercial use. The application is licensed (not sold) to you. If you fail to comply with this Agreement, you must immediately cease using the App and delete it from your device. You are responsible for keeping your device secure and protecting it appropriately.

11. Company’s Proprietary Rights. We and our suppliers own the Services, which are protected by proprietary rights and laws, including all of our brand names, trademarks and service marks and any associated logos. All trade names, trademarks, service marks and logos (collectively, “Marks”) on the Services not owned by us are the property of their respective owners. You may not use our Marks in connection with any product or service that is not ours or in any manner that is likely to cause confusion. Nothing contained in the Services should be construed as granting any right to use any Marks without the express prior written consent of the owner.

12. Third Party Materials; Links. The Services may allow access to third-party information, products, services and other materials, including Submissions (collectively, “Third Party Materials”), and including any access via links. We do not control or endorse, and are not responsible for, any Third Party Materials. We have no obligation to monitor Third Party Materials, and we may block or disable access to any Third Party Materials at any time. Your access or use of Third Party Materials is at your own risk and is subject to any additional terms, conditions and policies applicable to such materials.

13. Disclaimer of Warranties. To the fullest extent permitted under applicable law, the Services are made available to you on an "As Is," "Where Is" and "Where Available" basis, without any warranties or conditions of any kind, whether express, implied, or statutory. We disclaim all warranties with respect to the Services to the fullest extent permissible under applicable law, including the warranties of merchantability, fitness for a particular purpose, non-infringement, and title.
To the fullest extent permissible under applicable law, and subject to any applicable terms and conditions or policies applicable to the use of third party materials as set out in Section 13, third party materials are made available to you on an "As Is," "Where Is" and "Where Available" basis, without any warranties of any kind, whether express or implied. We disclaim all warranties with respect to third party materials.
Without limiting the generality of the foregoing, to the fullest extent permissible under applicable law, we make no representation or warranty that the Services will be secure, that any user name, password or other security measure that you may use or allow others to use in connection with the Services will prevent unauthorized access to your Services account or related information, or that your Services Account or related information will not be accessed or misused by any third party.
All disclaimers of any kind in this agreement (including in this section and elsewhere in this Agreement) are made for the benefit of both Company and its affiliates and their respective shareholders, Stockholders, directors, officers, employees, affiliates, agents, representatives, licensors, suppliers and service providers, and their respective successors and assigns (collectively, the "Company Parties").
While we take reasonable steps to try to maintain the timeliness, integrity and security of the Services, we cannot guarantee that they are or will remain updated, complete, correct or secure, or that access to them will be uninterrupted. The Services may include inaccuracies, errors and materials that conflict with this Agreement. Additionally, third parties may make unauthorized alterations to the Services. If you become aware of any such alteration, contact us at domaincentral@its.jnj.com with a description of such alteration and its location on the Services.

14. Limitation of Liability. Nothing in this Agreement restricts, excludes or modifies or purports to restrict, exclude or modify any mandatory statutory consumer rights under applicable law.
With respect to any conditions, warranties or guarantees that cannot be excluded under applicable statutes, to the extent permitted by applicable law, our liability is limited (at our option) to the resupply or refund of the cost of the relevant portion of the Services.
To the fullest extent permitted under applicable law: (a) we will not be liable for any indirect, incidental, consequential, special, exemplary or punitive damages of any kind, or losses that were not reasonably foreseeable to you or us at the time you agreed to this Agreement, in each case arising out of or in connection with the Services or this Agreement, and under any contract, tort (including negligence), strict liability or other theory (collectively, "Indirect Losses"). Loss or damage is foreseeable if either it is obvious that it will happen or if, at the time the contract was made, both you and we knew it might happen.
without limiting the foregoing, we will not be liable for Indirect Losses of any kind resulting from your use of or inability to use the Services or from any Products or Third Party Materials, including from any Virus that may be transmitted in connection therewith.
the Company Parties do not exclude or limit in any way our liability to you where it would be unlawful to do so. this includes liability for death or personal injury caused by our negligence or the negligence of our employees, agents or subcontractors, for gross negligence or willful behavior, or for fraud or fraudulent misrepresentation.
Our maximum aggregate liability for all damages, losses and causes of action arising out of or in connection with the Services or this Agreement, whether in contract, tort (including negligence) or otherwise, will not exceed the greater of (a) the total amount, if any, paid by you to us to use the Services; and (b) ten United States dollars ($10).
All limitations of liability of any kind in this Agreement (including in this section and elsewhere in this Agreement) are made for the benefit of both Company and the Company Parties.
With respect to any conditions, warranties or guarantees that cannot be excluded under statute, to the extent permitted under applicable law, our liability is limited (at our option) to the resupply or refund of the cost of relevant services.


15. Third Party Claims. If we are sued by a third party as a result of your breach of this Agreement or your infringement of any third-party right, then, to the fullest extent permitted by applicable law, you will be responsible for all liabilities, damages, judgments, awards, losses, costs, expenses and fees (including attorneys' fees) incurred by the Company Parties.

16. Termination. You may stop using the Services, and thereby terminate this Agreement, at any time. We may terminate or suspend your use of the Services if you do not comply with this Agreement, engage in any fraud or abuse, or if you or anyone using your account makes any misrepresentation to us. Where reasonable under the circumstances, we will provide you with at least twenty-four (24) hours’ prior notice of termination or suspension, provided that if we reasonably believe that you have materially breached this Agreement, we may immediately terminate or suspend you. Upon any termination or suspension, your right to use the Services will immediately cease, and we may, without liability to you or any third party, immediately deactivate or delete your user name, password and account, and all associated materials, without obligation to provide further access to such materials. The Preamble and Sections 2-10, 12-17, and 20-24 shall survive any expiration or termination of this Agreement.

17. Governing Law; Jurisdiction. Unless otherwise prescribed by local law, this Agreement is governed by and shall be construed in accordance with the laws of New Jersey, USA, without regard to its principles of conflicts of law, and regardless of your location. All disputes between you and us arising out of or related to the Services or this Agreement, whether based in contract, tort, statute, fraud, misrepresentation or any other legal theory and including non-contractual disputes or claims, will be subject to the exclusive jurisdiction of the federal and state courts located in New Jersey, USA, and you waive any jurisdictional, venue or inconvenient forum objections to such courts. 

18. Filtering. Parental control protections (such as computer hardware, software or filtering services) are commercially available that may assist you in limiting access to material that may be harmful to or inappropriate for minors. Information identifying current providers of such protections (which we do not endorse) is available from https://en.wikipedia.org/wiki/Comparison_of_content-control_software_and_providers.

19. Information or Complaints. If you have a question or complaint regarding the Services, please send an e-mail to domaincentral@its.jnj.com. You may also contact us by using the “Contact Us” link provided on the site. California residents may reach the Complaint Assistance Unit of the Division of Consumer Services of the California Department of Consumer Affairs by mail at 1625 North Market Blvd., Sacramento,CA 95834, or by telephone at (916) 445-1254 or (800) 952-5210.

20. Copyright Infringement Claims. If you believe in good faith that materials available on the Services infringe your copyright, you may write to us by mail, e-mail or fax and request that we remove such material or block access to it. Please be precise about the identity and location of the allegedly infringing materials. If you believe in good faith that someone has wrongly filed a notice of copyright infringement against you, you may send us a written counter-notice. Notices and counter-notices must be sent as follows: by e-mail to Domaincentral@its.jnj.com; or by fax to 732-524-6341. In the United States, the Company’s Agent for complaints related to the Digital Millennium Copyright Act (DMCA) is as follows:

Trademark Law Department

Johnson & Johnson

One Johnson & Johnson Plaza

New Brunswick, NJ 08933

Email: DomainCentral@its.jnj.com

Phone: 732-524-3245

This contact information may also be used to contact us about copyright infringement claims in jurisdictions outside of the United States.

21. Export Controls. The Services are subject to U.S. export controls restrictions. We will not knowingly make the Services available to you if you are, and you confirm that you are not, (a) located in, or a resident or a national of, any country subject to a U.S. government embargo or trade sanction (currently Cuba, Iran, Sudan, Syria, and the Crimea region of Ukraine)
(see http://www.treasury.gov/resource-center/sanctions/Programs/Pages/Programs.aspx for more information on U.S. sanctions); or (b) on any of the U.S. government lists of restricted end users (for example, including the “Specially Designated Nationals” list available at
http://www.treasury.gov/resource-center/sanctions/SDN-List/Pages/default.aspx).

22. Forward-Looking Statements. Statements appearing on the Services that concern us, our affiliates or our and their management and that are not historical facts are “Forward-Looking Statements.” Forward-Looking Statements are only predictions, and actual future events may differ materially from those discussed in any Forward-Looking Statement. Various external factors and risks affect our operations, markets, products, services and prices. These factors and risks are described in our current annual report filed with the SEC and in other filings we make with the SEC. You can access our most recent SEC filings via the SEC EDGAR system located at www.sec.gov, or you may obtain these filings directly from us at no charge. We disclaim any obligation or responsibility to update, revise or supplement any Forward-Looking Statement or any other statements appearing on the Services.

23. Other Important Terms. This Agreement does not, and shall not be construed to, create any partnership, joint venture, employer-employee, agency or franchisor-franchisee relationship between you and us. This Agreement is between you and us. Except as set forth in Sections 14, 15 and 24, no other person shall have any rights to enforce any of the terms of this Agreement. If any provision of this Agreement is found to be unlawful, void or for any reason unenforceable, that provision will be deemed severable from this Agreement and will not affect the validity and enforceability of any remaining provision. You may not assign, transfer or sublicense any or all of your rights or obligations under this Agreement without our prior written consent. We may assign, transfer or sublicense any or all of our rights or obligations under this Agreement without restriction. No waiver by either party of any breach or default under this Agreement will be deemed to be a waiver of any preceding or subsequent breach or default. Any heading, caption or section title contained herein is for convenience only, and in no way defines or explains any section or provision. All terms defined in the singular shall have the same meanings when used in the plural, where appropriate and unless otherwise specified. Any use of the term “including” or variations thereof in this Agreement shall be construed as if followed by the phrase “without limitation.” This Agreement, including any terms and conditions incorporated herein, is the entire agreement between you and us relating to the subject matter of this Agreement, and, in the absence of fraud, supersedes any and all prior or contemporaneous written or oral agreements or understandings between you and us relating to such subject matter. Notices to you (including notices of changes to this Agreement) may be made via posting to the Services or by e-mail (including in each case via links), or by regular mail. Without limitation, a printed version of this Agreement and of any notice given in electronic form shall be admissible in judicial or administrative proceedings based upon or relating to this Agreement to the same extent and subject to the same conditions as other business documents and records originally generated and maintained in printed form. Neither party will be responsible for any failure to fulfill any obligation due to any cause beyond its control.

24. Terms Required by Apple. In addition to your agreement with the foregoing terms and conditions, and notwithstanding anything to the contrary herein, the following provisions apply with respect to your use of any version of the application compatible with the iOS operating system of Apple Inc. (“Apple”). Apple is not a party to this Agreement and does not own and is not responsible for the application. Apple is not providing any warranty for the application except, if applicable, to refund the purchase price for it. Apple is not responsible for maintenance or other support services for the application and shall not be responsible for any other claims, losses, liabilities, damages, costs or expenses with respect to the application, including any third-party product liability claims, claims that the application fails to conform to any applicable legal or regulatory requirement, claims arising under consumer protection or similar legislation, and claims with respect to intellectual property infringement. Any inquiries or complaints relating to the use of the application, including those pertaining to intellectual property rights, must be directed to Company in accordance with the “Information or Complaints” section above. The license you have been granted herein is limited to a non-transferable license to use the application on an Apple-branded product that runs Apple’s iOS operating system and is owned or controlled by you, or as otherwise permitted by the Usage Rules set forth in Apple’s App Store Terms of Service. In addition, you must comply with the terms of any third-party agreement applicable to you when using the application, such as your wireless data service agreement. Apple and Apple’s subsidiaries are third-party beneficiaries of this Agreement and, upon your acceptance of the terms and conditions of this Agreement, will have the right (and will be deemed to have accepted the right) to enforce this Agreement against you as a third-party beneficiary thereof; notwithstanding the foregoing, Company’s right to enter into, rescind or terminate any variation, waiver or settlement under this Agreement is not subject to the consent of any third party.

25. Open Source Font License. Copyright 2010, 2012 Adobe Systems Incorporated (http://www.adobe.com/), with Reserved Font Name ‘Source’. All Rights Reserved. Source is a trademark of Adobe Systems Incorporated in the United States and/or other countries.

This Font Software is licensed under the SIL Open Font License, Version 1.1.

This license is copied below, and is also available with a FAQ at: http://scripts.sil.org/OFL

SIL OPEN FONT LICENSE Version 1.1 - 26 February 2007

PREAMBLE

The goals of the Open Font License (OFL) are to stimulate worldwide development of collaborative font projects, to support the font creation efforts of academic and linguistic communities, and to provide a free and open framework in which fonts may be shared and improved in partnership with others.

The OFL allows the licensed fonts to be used, studied, modified and redistributed freely as long as they are not sold by themselves. The fonts, including any derivative works, can be bundled, embedded, redistributed and/or sold with any software provided that any reserved names are not used by derivative works. The fonts and derivatives, however, cannot be released under any other type of license. The requirement for fonts to remain under this license does not apply to any document created using the fonts or their derivatives.

DEFINITIONS

"Font Software" refers to the set of files released by the Copyright Holder(s) under this license and clearly marked as such. This may include source files, build scripts and documentation.

"Reserved Font Name" refers to any names specified as such after the copyright statement(s).

"Original Version" refers to the collection of Font Software components as distributed by the Copyright Holder(s).

"Modified Version" refers to any derivative made by adding to, deleting, or substituting—in part or in whole—any of the components of the Original Version, by changing formats or by porting the Font Software to a new environment.

"Author" refers to any designer, engineer, programmer, technical writer or other person who contributed to the Font Software.

PERMISSION & CONDITIONS

Permission is hereby granted, free of charge, to any person obtaining a copy of the Font Software, to use, study, copy, merge, embed, modify, redistribute, and sell modified and unmodified copies of the Font Software, subject to the following conditions:

1) Neither the Font Software nor any of its individual components, in Original or Modified Versions, may be sold by itself.

2) Original or Modified Versions of the Font Software may be bundled, redistributed and/or sold with any software, provided that each copy contains the above copyright notice and this license. These can be included either as stand-alone text files, human-readable headers or in the appropriate machine-readable metadata fields within text or binary files as long as those fields can be easily viewed by the user.

3) No Modified Version of the Font Software may use the Reserved Font Name(s) unless explicit written permission is granted by the corresponding Copyright Holder. This restriction only applies to the primary font name as presented to the users.

4) The name(s) of the Copyright Holder(s) or the Author(s) of the Font Software shall not be used to promote, endorse or advertise any Modified Version, except to acknowledge the contribution(s) of the Copyright Holder(s) and the Author(s) or with their explicit written permission.

5) The Font Software, modified or unmodified, in part or in whole, must be distributed entirely under this license, and must not be distributed under any other license. The requirement for fonts to remain under this license does not apply to any document created using the Font Software.

TERMINATION

This license becomes null and void if any of the above conditions are not met.

DISCLAIMER

THE FONT SOFTWARE IS PROVIDED "AS IS", WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT OF COPYRIGHT, PATENT, TRADEMARK, OR OTHER RIGHT. IN NO EVENT SHALL THE COPYRIGHT HOLDER BE LIABLE FOR ANY CLAIM, DAMAGES OR OTHER LIABILITY, INCLUDING ANY GENERAL, SPECIAL, INDIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGES, WHETHER IN AN ACTION OF CONTRACT, TORT OR OTHERWISE, ARISING FROM, OUT OF THE USE OR INABILITY TO USE THE FONT SOFTWARE OR FROM OTHER DEALINGS IN THE FONT SOFTWARE.

Indication
SPRAVATO™ (esketamine) CIII Nasal Spray is indicated, in conjunction with an oral antidepressant (AD), for the treatment of treatment-resistant depression (TRD) in adults.

SPRAVATO™ is not approved as an anesthetic agent. The safety and effectiveness of SPRAVATO™ as an anesthetic agent have not been established.

Important Safety Information

WARNING: SEDATION, DISSOCIATION; ABUSE AND MISUSE; and SUICIDAL THOUGHTS AND BEHAVIORS

See full prescribing information for complete boxed warning

  • Risk for sedation and dissociation after administration. Monitor patients for at least two hours after administration (5.1, 5.2).
  • Potential for abuse and misuse. Consider the risks and benefits of using SPRAVATO™ prior to use in patients at higher risk of abuse. Monitor for signs and symptoms of abuse and misuse (5.3).
  • SPRAVATO™ is only available through a restricted program called the SPRAVATO™ REMS (5.4).
  • Increased risk of suicidal thoughts and behaviors in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. SPRAVATO™ is not approved for use in pediatric patients (5.5).

CONTRAINDICATIONS
SPRAVATO™ is contraindicated in patients with:

  • Aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial and peripheral arterial vessels) or arteriovenous malformation
  • History of intracerebral hemorrhage
  • Hypersensitivity to esketamine, ketamine, or any of the excipients


WARNINGS AND PRECAUTIONS

Sedation: In clinical trials, 49% to 61% of SPRAVATO™-treated patients developed sedation and 0.3% of SPRAVATO™-treated patients experienced loss of consciousness.

Because of the possibility of delayed or prolonged sedation, patients must be monitored by a healthcare provider for at least 2 hours at each treatment session, followed by an assessment to determine when the patient is considered clinically stable and ready to leave the healthcare setting.

Closely monitor for sedation with concomitant use of SPRAVATO™ with CNS depressants [see Drug Interaction (7.1)].

SPRAVATO™ is available only through a restricted program under a REMS.

Dissociation: The most common psychological effects of SPRAVATO™ were dissociative or perceptual changes (including distortion of time, space and illusions), derealization and depersonalization (61% to 75% of SPRAVATO™-treated patients developed dissociative or perceptual changes). Given its potential to induce dissociative effects, carefully assess patients with psychosis before administering SPRAVATO™; treatment should be initiated only if the benefit outweighs the risk.

Because of the risks of dissociation, patients must be monitored by a healthcare provider for at least 2 hours at each treatment session, followed by an assessment to determine when the patient is considered clinically stable and ready to leave the healthcare setting.

SPRAVATO™ is available only through a restricted program under a REMS.

Abuse and Misuse: SPRAVATO™ contains esketamine, a Schedule III controlled substance (CIII), and may be subject to abuse and diversion. Assess each patient’s risk for abuse or misuse prior to prescribing and monitor all patients for the development of these behaviors or conditions, including drug-seeking behavior, while on therapy. Individuals with a history of drug abuse or dependence are at greater risk; therefore, use careful consideration prior to treatment of individuals with a history of substance use disorder and monitor for signs of abuse or dependence.

SPRAVATO™ is available only through a restricted program under a REMS.

SPRAVATO™ Risk Evaluation and Mitigation Strategy (REMS): is available only through a restricted program called the SPRAVATO™ REMS because of the risks of serious adverse outcomes from sedation, dissociation, and abuse and misuse.

Important requirements of the SPRAVATO™ REMS include the following:

  • Healthcare settings must be certified in the program and ensure that SPRAVATO™ is:
    • Healthcare settings must be certified in the program and ensure that SPRAVATO™ is:
    • Pharmacies must be certified in the REMS and must only dispense SPRAVATO™ to healthcare settings that are certified in the program.
  • Pharmacies must be certified in the REMS and must only dispense SPRAVATO™ to healthcare settings that are certified in the program.


Further information, including a list of certified pharmacies, is available at www.SPRAVATOrems.com or 1-855-382-6022.

Suicidal Thoughts and Behaviors in Adolescents and Young Adults: In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included adult and pediatric patients, the incidence of suicidal thoughts and behaviors in patients age 24 years and younger was greater than in placebo-treated patients. SPRAVATO™ is not approved in pediatric (<18 years of age) patients.

There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied.

Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing SPRAVATO™ and/or the concomitant oral antidepressant, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.

Increase in Blood Pressure: SPRAVATO™ causes increases in systolic and/or diastolic blood pressure (BP) at all recommended dosages. Increases in BP peak approximately 40 minutes after SPRAVATO™ administration and last approximately 4 hours.

Approximately 8% to 17% of SPRAVATO™-treated patients experienced an increase of more than 40 mmHg in systolic BP and/or 25 mmHg in diastolic BP in the first 1.5 hours after administration at least once during the first 4 weeks of treatment. A substantial increase in blood pressure could occur after any dose administered even if smaller blood pressure effects were observed with previous administrations. SPRAVATO™ is contraindicated in patients for whom an increase in BP or intracranial pressure poses a serious risk (e.g., aneurysmal vascular disease, arteriovenous malformation, history of intracerebral hemorrhage). Before prescribing, patients with other cardiovascular and cerebrovascular conditions should be carefully assessed to determine whether the potential benefits of SPRAVATO™ outweigh its risk.

Assess BP prior to administration of SPRAVATO™. In patients whose BP is elevated prior to SPRAVATO™ administration (as a general guide: >140/90 mmHg), a decision to delay SPRAVATO™ therapy should be taken into account to balance the benefit and risk in individual patients.

BP should be monitored for at least 2 hours after SPRAVATO™ administration. Measure blood pressure around 40 minutes post-dose and subsequently as clinically warranted until values decline. If BP remains high, promptly seek assistance from practitioners experienced in BP management. Refer patients experiencing symptoms of a hypertensive crisis (e.g., chest pain, shortness of breath) or hypertensive encephalopathy (e.g., sudden severe headache, visual disturbances, seizures, diminished consciousness or focal neurological deficits) immediately for emergency care.

Closely monitor blood pressure with concomitant use of SPRAVATO™ with psychostimulants or monoamine oxidase inhibitors (MAOIs) [see Drug Interactions (7.2, 7.3)].

In patients with history of hypertensive encephalopathy, more intensive monitoring, including more frequent blood pressure and symptom assessment, is warranted because these patients are at increased risk for developing encephalopathy with even small increases in blood pressure.

Cognitive Impairment

Short-Term Cognitive Impairment: In a study in healthy volunteers, a single dose of SPRAVATO™ caused cognitive performance decline 40 minutes post-dose. SPRAVATO™-treated subjects required a greater effort to complete the cognitive tests at 40 minutes post-dose. Cognitive performance and mental effort were comparable between SPRAVATO™ and placebo at 2 hours post-dose. Sleepiness was comparable after 4 hours post-dose.

Long-Term Cognitive Impairment: Long-term cognitive and memory impairment have been reported with repeated ketamine misuse or abuse. No adverse effects of SPRAVATO™ nasal spray on cognitive functioning were observed in a one-year open-label safety study; however, the long-term cognitive effects of SPRAVATO™ have not been evaluated beyond one year.

Impaired Ability to Drive and Operate Machinery: Before SPRAVATO™ administration, instruct patients not to engage in potentially hazardous activities requiring complete mental alertness and motor coordination, such as driving a motor vehicle or operating machinery, until the next day following a restful sleep. Patients will need to arrange transportation home following treatment with SPRAVATO™.

Ulcerative or Interstitial Cystitis: Cases of ulcerative or interstitial cystitis have been reported in individuals with long-term off-label use or misuse/abuse of ketamine. In clinical studies with SPRAVATO™ nasal spray, there was a higher rate of lower urinary tract symptoms (pollakiuria, dysuria, micturition urgency, nocturia, and cystitis) in SPRAVATO™-treated patients than in placebo-treated patients. No cases of esketamine-related interstitial cystitis were observed in any of the studies, which involved treatment for up to a year.

Monitor for urinary tract and bladder symptoms during the course of treatment with SPRAVATO™ and refer to an appropriate healthcare provider as clinically warranted.

Embryo-fetal Toxicity: SPRAVATO™ may cause fetal harm when administered to pregnant women. Advise pregnant women of the potential risk to an infant exposed to SPRAVATO™ in utero. Advise women of reproductive potential to consider pregnancy planning and prevention.

DRUG INTERACTIONS

CNS depressants (e.g., benzodiazepines, opioids, alcohol): Concomitant use may increase sedation. Closely monitor for sedation with concomitant use of CNS depressants.

Psychostimulants (e.g., amphetamines, methylphenidate, modafinil, armodafinil): Concomitant use may increase blood pressure. Closely monitor blood pressure with concomitant use of psychostimulants.

Monoamine oxidase inhibitors (MAOIs): Concomitant use may increase blood pressure. Closely monitor blood pressure with concomitant use of MAOIs.

USE IN SPECIFIC POPULATIONS

Pregnancy: SPRAVATO™ is not recommended during pregnancy. SPRAVATO™ may cause fetal harm when administered to pregnant women. Advise pregnant women of the potential risk to an infant exposed to SPRAVATO™ in utero. There are risks to the mother associated with untreated depression in pregnancy. If a woman becomes pregnant while being treated with SPRAVATO™, treatment with SPRAVATO™ should be discontinued and the patient should be counseled about the potential risk to the fetus.

Pregnancy Exposure Registry: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including SPRAVATO™, during pregnancy. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.

Lactation: SPRAVATO™ is present in human milk. Because of the potential for neurotoxicity, advise patients that breastfeeding is not recommended during treatment with SPRAVATO™.

Females and Males of Reproductive Potential: SPRAVATO™ may cause embryo-fetal harm when administered to a pregnant woman. Consider pregnancy planning and prevention for females of reproductive potential during treatment with SPRAVATO™.

Pediatric Use: The safety and effectiveness of SPRAVATO™ in pediatric patients have not been established.

Geriatric Use: Of the total number of patients in Phase 3 clinical studies exposed to SPRAVATO™, 12% were 65 years of age and older, and 2% were 75 years of age and older. No overall differences in the safety profile were observed between patients 65 years of age and older and patients younger than 65 years of age.

The mean esketamine Cmax and AUC values were higher in elderly patients compared with younger adult patients.

The treatment of TRD in geriatric patients was evaluated in a 4-week, randomized, double-blind study comparing flexibly-dosed intranasal SPRAVATO™ plus a newly initiated oral antidepressant compared to intranasal placebo plus a newly initiated oral antidepressant in patients ≥65 years of age. At the end of four weeks, there was no statistically significant difference between groups on the primary efficacy endpoint of change from baseline to Week 4 on the Montgomery-Åsberg Depression Rating Scale (MADRS).

Hepatic Impairment: SPRAVATO™-treated patients with moderate hepatic impairment may need to be monitored for adverse reactions for a longer period of time.

SPRAVATO™ has not been studied in patients with severe hepatic impairment (Child-Pugh class C). Use in this population is not recommended.

DRUG ABUSE AND DEPENDENCE

Controlled Substance: SPRAVATO™ contains esketamine hydrochloride, the (S)-enantiomer of ketamine and a Schedule III controlled substance under the Controlled Substances Act.

Abuse: Individuals with a history of drug abuse or dependence may be at greater risk for abuse and misuse of SPRAVATO™. Abuse is the intentional, non-therapeutic use of a drug, even once, for its psychological or physiological effects. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. Careful consideration is advised prior to use of individuals with a history of substance use disorder, including alcohol.

SPRAVATO™ may produce a variety of symptoms including anxiety, dysphoria, disorientation, insomnia, flashback, hallucinations, and feelings of floating, detachment and to be “spaced out.” Monitoring for signs of abuse and misuse is recommended.

ADVERSE REACTIONS

The most common adverse reactions with SPRAVATO™ plus oral AD (incidence ≥5% and at least twice that of placebo nasal spray plus oral AD) were dissociation, dizziness, nausea, sedation, vertigo, hypoesthesia, anxiety, lethargy, blood pressure increased, vomiting, and feeling drunk.

Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO™.

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