Introduction and Scope
How We Receive Your Information
We may receive your information when:
- you provide it directly to us, for example, through our Website, at an event or conference, while participating in a webinar we host or sponsor, or by email, phone, or one of our partners;
- we collect your information from publicly available platforms such as LinkedIn;
- our customers (including their employees, contractors, and other representatives of the company) provide it to us;
- we receive it from other companies within our corporate group;
- our service providers provide it to us;
- we purchase lists of individuals who might be interested in becoming customers of ours; or
- when a friend of yours or one of our partners or customers refers you to us, and in doing so, provides your information to us.
Categories of Information We Receive
We may receive, collect, or process the following types of information:
- biographical and demographic information, such as your first and last name, date of birth, age, gender, ethnicity, and marital status;
- health and medical information (such as information about physical and mental health conditions and diagnoses, treatments for medical conditions, genetic information, family medical history, and medications you may take, including the dosage, timing, and frequency) we collect in connection with conducting research, providing patient support programs, distributing and marketing our products, and tracking adverse event reports; employment information, such as the name, address, and contact information of your employer. If you are a healthcare professional, we may also collect professional credentials, educational and professional history, institutional and government affiliations, and information included on a resume or curriculum vitae (such as work experience, education, and languages spoken); contact information and contact preferences, such as your email address and postal address;
- publicly available information; adverse event information;
- automatically collected information, such as your IP address, location, device information, identifiers, mobile network information, browser type, and similar information; and
- any other information you choose to provide to us.
How We Use Your Information
We may process your information for the purposes of:
- providing you with our products and services;
- marketing our products and services to you;
- enabling the use of our products and services;
- responding to your requests or questions, or otherwise communicating with you;
- sending you email marketing communications about our products, services, or businesses that we think may interest you;
- enforcing any applicable terms;
- administering and maintaining the security of our customers, Website, and business; and
- complying with any legal, security, processing, and regulatory obligations.
How We Share Your Information with Third Parties
Corporate Family. We may also share your information with our subsidiaries, affiliates, and other entities within our corporate family.
Legal Reasons. We may share your information to the extent required by law, or if we have a good-faith belief that we need to disclose it in order to (a) protect and defend the rights, property, or safety of Evoke, our employees, other users of the Services, or the public; (b) enforce any applicable terms; (c) as required by a legally valid request from a competent governmental authority and/or to comply with official investigations or legal proceedings (whether initiated by governmental/law enforcement officials, or private parties); or (d) respond to claims that any content violates the rights of third parties.
Sale or Merger. We may also share your information if we sell or transfer all or some of our company’s business interests, assets, or both, or in connection with a corporate restructuring.
Aggregate Data. We reserve the right to use, transfer, sell, and share aggregated, anonymous data for any legal business purpose. Such data does not identify you or any other individual person.
Cookies and Tracking
We use session and persistent cookies. Session cookies are deleted when you close your browser. Persistent cookies may remain even after you close your browser, but always have an expiration date. Most of the cookies placed on your device through our Website are first-party cookies, since they are placed directly by us. Other parties, such as Google, may also set their own (thirdparty) cookies through our Services. Please refer to the policies of these third parties to learn more about the way in which they collect and process information about you.
If you would prefer not to accept cookies, you can change the setup of your browser to reject all or some cookies. Note, if you reject certain cookies, you may not be able to use all of our Website’s features. For more information, please visit https://www.aboutcookies.org/.
Analytics. We use Google Analytics, a web analytics tool that helps us understand how users engage with our Website and allows us to understand traffic patterns to help us improve the design of our Website, the products we make, and the services we offer. Like many services, Google Analytics uses first-party cookies to track user interactions, as in our case, where they are used to collect information about how users use our Website. This information is used to compile reports and to help us improve our Website. Our reports disclose website trends without identifying individual visitors.
You can opt out of Google Analytics without affecting how you visit our Website. For more information on opting out of being tracked by Google Analytics across all websites you use, visit this Google page: https://tools.google.com/dlpage/gaoptout.
Do Not Track. You may also set your browser to send a Do Not Track (DNT) signal. For more information, please visit https://allaboutdnt.com/. Please note that our Website does not have the capability to respond to “Do Not Track” signals received from web browsers.
California law permits users in California to request certain details about how their information is shared with third parties for direct marketing purposes. California users may, under certain circumstances, request and obtain certain information regarding our disclosure, if any, of personal information to third parties for their direct marketing purposes. If this applies, you may obtain the categories of personal information shared and the names and addresses of all third parties that received personal information for their direct marketing purposes during the immediately prior calendar year (e.g., requests made in 2020 will receive information about 2019 sharing activities). You may contact us using the Contact information, below, to send us such requests.
Please note that any information you send to us electronically, while using the Website or otherwise interacting with us, may not be secure when it is transmitted to us. We recommend that you do not use unsecure channels to communicate sensitive or confidential information to us. Please be aware though, that despite our best efforts, no security measures are perfect or impenetrable, and we cannot guarantee “perfect security.” Any information you send us through any means is transmitted at your own risk.
Privacy of Children
We do not seek or knowingly collect any information about children under 13 years of age. If we become aware that we have unknowingly collected information about a child under 13 years of age, we will make commercially reasonable efforts to delete such information from our database.
If you are the parent or guardian of a child under 13 years of age who has provided us with their information, you may contact us using the below information to request that it be deleted.
Changes to this Policy
If we make any material change to this Policy, we will post the revised Policy to the Website. We will also update the Effective Date. By continuing to use our Website after we post any of these changes, you accept the modified Policy.
If you have any questions about this Policy or our processing of your information, please contact us at:
420 Stevens Avenue, Suite 370
Solana Beach, CA
Indication and Important Safety Information
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.
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.
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.
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.
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.