Terms of Use
Welcome to our website. Evoke Pharma, Inc. (“Evoke”) owns, controls, and maintains this site for your information and education and as a service to the Internet community. By accessing the information or materials on this website or mobile application, you acknowledge certain of our intellectual property rights, and you accept, without limitation or qualification, to be bound by the Terms of Use set forth below that supersede any other agreement between you and Evoke covering our websites and mobile applications or their contents.
ATTENTION: PLEASE READ THESE TERMS OF USE CAREFULLY BEFORE USING THE WEBSITES OR MOBILE APPLICATIONS. BY USING THE WEBSITES OR MOBILE APPLICATIONS, INCLUDING ANY SERVICES PROVIDED ON OR THROUGH THEM, YOU INDICATE THAT YOU ACCEPT, WITHOUT LIMITATION OR QUALIFICATION, THESE TERMS OF USE. IF YOU DO NOT ACCEPT THESE TERMS OF USE, DO NOT USE THIS WEBSITE.
1. This website is for U.S. audiences only
Access to, and use of, our websites and mobile applications are subject to the Terms of Use. The websites and mobile applications were developed and are maintained by Evoke. This information is intended only for residents of the United States.
2. Medical information/conditions
The Site Content is provided for informational purposes only and should not be construed as medical, legal, financial, investment, or other professional advice or opinion. We do not offer personalized medical advice or patient-specific treatment advice. Only your doctor or other healthcare professional can determine if a product described on this website is appropriate for you. Use of this website is not a substitute for a call or visit to, or consultation with, your physician or healthcare professional. You should not rely on our websites and mobile applications or any other service offered by or through our websites and mobile applications for medical diagnosis or treatment. YOU SHOULD NEVER DISREGARD OR DELAY SEEKING MEDICAL ADVICE BECAUSE OF SOMETHING THAT YOU HAVE SEEN OR HEARD ON OUR WEBSITES AND MOBILE APPLICATIONS. PLEASE CONSULT WITH YOUR DOCTOR, OR OTHER QUALIFIED HEALTHCARE PROFESSIONAL, BEFORE USING ANY PRODUCT DISCUSSED ON OUR WEBSITES AND MOBILE APPLICATIONS.
3. Use of information
You may freely browse and use our websites and mobile applications, but you may only access, download, or use information from our websites and mobile applications, including any text, images, audio, and video (the “Information”) for your own noncommercial use. You may not modify, distribute, transmit, reuse, repost, or otherwise use the information for any commercial purpose without written permission from Evoke. You must retain and reproduce every copyright notice or other proprietary rights notice contained in any Information you download. Unless otherwise noted, you should assume that everything you see or read on our websites and mobile applications is copyrighted and may not be used except as provided in these Terms and Conditions or in the text on the website and mobile application without written permission from Evoke. Except as otherwise permitted in this paragraph, Evoke neither warrants nor represents that your use of materials displayed on our websites and mobile applications will not infringe rights of third parties not owned by or affiliated with Evoke. Except for the preceding limited authorization, no license to or right in the information, or any copyright of Evoke or any other party is granted or conferred to you.
4. No resale of service
The content on our websites and mobile applications is protected by copyright, trademark, database, and other intellectual property rights. We hereby grant you a non-exclusive, non-transferable, and revocable license to use our websites and mobile applications for personal use only and subject to these Terms of Use. You must not copy, transmit, modify, distribute, make available to the public, or create any derivative works from any of the content that you find on our websites and mobile applications for commercial purposes without first obtaining our consent to do so.
5. Proprietary rights
You acknowledge and agree that our websites and mobile applications and any necessary software provided through it and used in connection with it (“Software”) may contain proprietary and confidential information that is protected by applicable intellectual property and other laws. You further acknowledge and agree that content contained in sponsor advertisements or information presented to you through the website or advertisers is protected by copyrights, trademarks, service marks, patents, or other proprietary rights and laws. Except as expressly authorized by us or our advertisers, you agree not to modify, rent, lease, loan, sell, distribute or create derivative works based on the website or the software, in whole or in part. Software, if any, that is made available to download from the website, excluding software that may be made available by end-users through the website, is the copyrighted work of Evoke or its suppliers. Your use of the software is governed by the terms of the end-user license agreement, if any, that accompanies or is included with the software (“License Agreement”). You may not install or use any Software that is accompanied by or includes a License Agreement unless you first agree to the License Agreement terms.
For any Software not accompanied by a License Agreement, we grant you a personal, non-transferable, and non-exclusive right and license to use the object code of the software on a single computer; provided that you do not (and do not allow any third party to) copy, modify, create a derivative work of, reverse engineer, reverse assemble, or otherwise try to discover any source code, sell, assign, sublicense, grant a security interest in, or otherwise transfer any right in the software. You agree not to modify the software in any manner or form or to use modified versions of the software, including (without limitation) to obtain unauthorized access to the service. You agree not to access the service by any means other than through the interface that is provided by us for use in accessing the service. Any rights not expressly granted herein are reserved.
6. User-provided ideas
Evoke does not accept or consider unsolicited ideas submitted through or in connection with our websites and mobile applications. Notwithstanding the foregoing, you agree that any feedback, information, suggestions, ideas, or materials (e.g., text, photographs, caricatures, illustrations, designs, icons, articles, audio clips, and video clips, etc.) you submit through, or in connection with, our websites and mobile applications (each, an “idea”) will not be subject to any use or disclosure restrictions and will be considered non-confidential by us. By providing ideas to us, you agree that we shall have, at no charge, a non-exclusive, transferable, royalty-free, perpetual, irrevocable, worldwide right and license to reproduce, distribute, display, perform, and create derivative works of such ideas and to use, make, offer for sale, sell, and import products containing or based on such ideas. We shall be free to use and disseminate such ideas on an unrestricted basis for any purpose. Also, we do not control ideas posted or otherwise transmitted via our websites and mobile applications by others, and we do not guarantee the accuracy, integrity, or quality of such ideas. Any communications you send to our websites and mobile applications or otherwise to Evoke by electronic means, except for personally identifiable information as defined in the Evoke Privacy policies, shall be deemed to be nonconfidential.
7. Privacy
We are committed to protecting your personal information. For more information on how your personal data will be used, please review our Privacy Policies.
8. Disclaimer of warranties
The Site Content is for your general education only and is not intended to provide advice or guidance or to be used for any commercial purpose. The identification or description of products or services of Evoke or third parties on our websites and mobile applications is for informational purposes only. It does not constitute a representation, warranty, guarantee, endorsement, or recommendation of such products and services. Although we have tried to provide accurate information on our websites and mobile applications, we assume no responsibility for the accuracy of the Site Content. In particular, we may not update our websites and mobile applications on a daily or other regular basis. As such, the Site Content may be out of date or include omissions or other errors. We may update or change the Site Content at any time without notice.
ALL SITE CONTENT IS PROVIDED “AS IS” AND “AS AVAILABLE” WITHOUT WARRANTY OF ANY KIND. TO THE MAXIMUM EXTENT PERMITTED BY LAW, EVOKE, ITS AFFILIATES, AND ITS COLLABORATORS DISCLAIM ALL WARRANTIES, EXPRESS OR IMPLIED, REGARDING THE WEBSITE AND THE SITE CONTENT THEREIN, INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT OF THIRD-PARTY RIGHTS.
We make no warranty that our websites and mobile applications will meet your requirements; that our websites and mobile applications will be uninterrupted, timely, secure, or error-free; that messages or requests will be delivered; that defects will be corrected; or that our websites and mobile applications are free of viruses or other harmful components. We make no warranty regarding any goods or services purchased or obtained through our websites and mobile applications, or any transactions entered into through our websites and mobile applications. You assume the entire risk as to the results and performance of our websites and mobile applications and any goods or services purchased therefrom.
9. Limitation of liability
You agree to indemnify, defend, and hold harmless Evoke, its subsidiaries, affiliates, directors, officers, employees, agents, consultants, business partners, and assigns of same, from and against any loss, costs, expenses (including reasonable attorneys’ fees and expenses), claims, damages, and liabilities related to, or associated with your use of our websites and mobile applications and any hyperlinked websites and mobile applications or based on any reliance upon the information contained therein and any violation of these Terms of Use by you. Applicable law may not allow the exclusion or limitation of incidental or consequential damages, so the above limitation or exclusion may not apply to you.
10. Use of our websites and mobile applications
You agree not to do any of the following while visiting or using our websites and mobile applications or any services provided by or through our websites and mobile applications:
- Impersonate or misrepresent your affiliation with any person or entity;
- Except as expressly permitted by the rules of our websites and mobile applications, post or transmit any unsolicited advertising, promotional materials, junk mail, spam, or any other form of solicitation on our websites and mobile applications or through the services;
- Post or transmit any information or material that is defamatory, offensive, indecent, obscene, or unlawful;
- Post or transmit any information or software that contains a virus, Trojan horse, worm, or other harmful components;
- Violate any applicable law or regulation, including, without limitation, any local, state, provincial, national, or international law, any export control laws, or any regulations promulgated by any state or federal authority;
- Access or use password-protected, secure or non-public areas of our websites and mobile applications without authorization; or
- Frame, repackage, or otherwise re-distribute any portion of our websites and mobile applications.
Evoke may, at its sole discretion, take any action we deem necessary, including, but not limited to, termination of access to our websites and mobile applications if we believe a user’s conduct or content fails to conform to the terms and conditions provided in these Terms of Use or may create liability for Evoke, our affiliates, partners, suppliers, or other users. Evoke will not be liable to you or any third-party as a result of such termination and modification. The terms and conditions provided in the Terms of Use will survive any such termination and modification.
11. Technologically harmful materials
We will not be liable for any loss or damage caused by a distributed denial-of-service attack, viruses, or other technologically harmful material that may infect your computer equipment, computer programs, data, or other proprietary material due to your use of our website or to your downloading of any material posted on it, or on any website linked to it.
12. Links to other sites
Links to third-party sites may be provided for the interest or convenience of visitors to our websites and mobile applications but are not an endorsement of those sites. We will try to inform you when you are leaving this site that the terms of use and Privacy Policy of the third-party site may be different than ours; however, Evoke accepts no liability for the accuracy or legality of the content on any third-party sites. Evoke accepts no liability regarding the third party’s privacy practices.
13. Reservation
Any rights not expressly granted in our websites and mobile applications are reserved to us. If any provision of these Terms of Use is held to be invalid or unenforceable, such provision shall be struck, and the remaining provisions shall be enforced.
14. Trademarks
Product names and the Evoke logos and product and service names are trademarks of Evoke Pharma, Inc. (the “Marks”). Without our prior permission, you agree not to display or use in any manner the Marks. Other logos, product, and service names are the property of their respective owners, as may be indicated on the website.
15. Variations
We may revise these Terms of Use at any time by amending this page. You are expected to check this page from time to time to take notice of any changes we have made, as they are binding on you. Some of the provisions contained in these Terms of Use may also be superseded by provisions or notices published elsewhere on our website.
16. Your concerns
If you have any concerns about the material that appears on our websites and mobile applications, please contact us.
Thank you for visiting our website.
These Terms and Conditions were last updated on September 2, 2020.
Indication and Important Safety Information
INDICATION
Gimoti® (metoclopramide) nasal spray is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.
Limitations of Use
GIMOTI is not recommended for use in pediatric patients, in patients with moderate or severe hepatic impairment, in patients with moderate or severe renal impairment, or in patients concurrently using strong CYP2D6 inhibitors.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: TARDIVE DYSKINESIA
- Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. The risk of developing TD increases with duration of treatment and total cumulative dosage.
- Discontinue GIMOTI in patients who develop signs or symptoms of TD. In some patients, symptoms may lessen or resolve after metoclopramide is stopped.
- Avoid treatment with metoclopramide (all dosage forms and routes of administration) for longer than 12 weeks because of the increased risk of developing TD with longer-term use.
CONTRAINDICATIONS
GIMOTI is contraindicated in patients with a history of TD or a dystonic reaction to metoclopramide; when the stimulation of gastrointestinal motility might be dangerous (eg, in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation); in patients with pheochromocytoma or other catecholamine-releasing paragangliomas (metoclopramide may cause a hypertensive/pheochromocytoma crisis, probably due to release of catecholamines from the tumor); in patients with epilepsy (metoclopramide may increase the frequency and severity of seizures); in patients with hypersensitivity to metoclopramide (reactions have included laryngeal and glossal angioedema and bronchospasm).
WARNING AND PRECAUTIONS
TARDIVE DYSKINESIA (TD): Metoclopramide can cause TD, a syndrome of potentially irreversible involuntary movements of the face or tongue, and sometimes of the trunk and/or extremities. The risk of developing TD and the likelihood that TD will become irreversible increases with the duration of treatment and the total cumulative dosage. The risk of developing TD is increased in the elderly, especially elderly women, and in patients with diabetes mellitus. Due to the risk of developing TD, avoid treatment with metoclopramide for longer than 12 weeks. GIMOTI is not recommended in geriatric patients as initial therapy. See Full Prescribing Information for switching geriatric patients on a stable dose of an alternative metoclopramide product to GIMOTI.
Other extrapyramidal symptoms (EPS): In addition to TD, metoclopramide may cause other EPS, parkinsonian symptoms, and motor restlessness. Advise patients to seek immediate medical attention if such symptoms occur and to discontinue GIMOTI.
Neuroleptic malignant syndrome (NMS): Metoclopramide may cause a potentially fatal symptom complex called NMS. Clinical manifestations of NMS include hyperpyrexia, muscle rigidity, altered mental status, and manifestations of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac arrhythmias). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Patients with such symptoms should be evaluated immediately. Avoid GIMOTI in patients receiving other drugs associated with NMS, including typical and atypical antipsychotics.
Depression: Depression has occurred in metoclopramide-treated patients with and without a history of depression. Symptoms have included suicidal ideation and suicide. Avoid GIMOTI use in patients with a history of depression.
Hypertension: Metoclopramide may elevate blood pressure and should be avoided in patients with hypertension or in patients taking monoamine oxidase inhibitors (MAOIs). Discontinue GIMOTI in any patient with a rapid rise in blood pressure.
Fluid Retention: Because metoclopramide produces a transient increase in plasma aldosterone, patients with cirrhosis or congestive heart failure may be at risk of developing fluid retention and volume overload. Discontinue GIMOTI if any of these adverse reactions occur.
Hyperprolactinemia: As with other dopamine-D2 receptor antagonists, metoclopramide elevates prolactin levels and may suppress pituitary gonadotropin secretion. This may inhibit reproductive function by impairing gonadal steroidogenesis in both female and male patients. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported with prolactin-elevating drugs, including metoclopramide.
Effects on the ability to drive and operate machinery: Metoclopramide may impair the mental and/or physical abilities required for the performance of hazardous tasks such as operating machinery or driving a motor vehicle. Concomitant use of CNS depressants or drugs associated with EPS may increase this effect (eg, alcohol, sedatives, hypnotics, opiates, and anxiolytics). Avoid GIMOTI or the interacting drug, depending on the importance of the drug to the patient.
ADVERSE REACTIONS
The most common adverse reactions in patients treated with GIMOTI are dysgeusia, headache, and fatigue. In patients receiving an equivalent oral dose of metoclopramide, the most common adverse reactions were restlessness, drowsiness, fatigue, and lassitude. Adverse reactions involving the nervous system occurred after stopping oral metoclopramide, including dizziness, nervousness, and headaches.
DRUG INTERACTIONS
Avoid concomitant use with antipsychotics, MAOIs, and central nervous system (CNS) depressants. Concomitant use with strong CYP2D6 inhibitors (eg, quinidine, bupropion, fluoxetine, paroxetine) is not recommended. Use with caution with dopaminergic agonists and drugs that increase dopamine concentration. Monitor for reduced therapeutic effect when used with drugs that may have opposing effects on gastrointestinal motility (eg, antiperistaltics, anticholinergics, opiates). Monitor patients receiving GIMOTI for increased blood glucose and adjust insulin dose regimen as needed.
USE IN SPECIFIC POPULATIONS
Pregnancy: Published studies do not report a consistent pattern or a consistently increased risk of pregnancy-related adverse outcomes with oral use of metoclopramide during pregnancy. There are potential risks to the neonate during delivery following exposure to metoclopramide in utero.
Lactation: Breastfed infants exposed to metoclopramide have experienced gastrointestinal adverse reactions, including intestinal discomfort and increased intestinal gas formation. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for GIMOTI and any potential adverse effects on the breastfed child from GIMOTI or from the underlying maternal condition.
Pediatric: Metoclopramide is not recommended for use in pediatric patients due to the risk of TD and other EPS as well as the risk of methemoglobinemia in neonates.
Geriatric: Elderly patients are more likely to have decreased renal function and may be more sensitive to the therapeutic or adverse effects of metoclopramide, especially older women. GIMOTI is not recommended as initial therapy.
Renal impairment: GIMOTI is not recommended in patients with moderate and severe renal impairment.
Hepatic impairment: GIMOTI is not recommended in patients with moderate or severe hepatic impairment.
NADH-cytochrome b5 reductase deficiency: Metoclopramide-treated patients with NADH-cytochrome b5 reductase deficiency are at an increased risk of developing methemoglobinemia and/or sulfhemoglobinemia.
CYP2D6 poor metabolizers: GIMOTI is not recommended in patients who are CYP2D6 poor metabolizers.
Please see complete Prescribing Information, including Boxed Warning, and Patient Information.
You may report side effects related to Evoke Pharma products by calling 1-833-4-GIMOTI (1-833-444-6684) or emailing GIMOTImedinfo@evokepharma.com. If you prefer to report side effects to the FDA, either visit www.FDA.gov/medwatch or call 1-800-FDA-1088.
