Savings and support through vitaCare Prescription Services
vitaCare Prescription Services is the only pharmacy for GIMOTI
To ensure that patients receive GIMOTI, you MUST send the prescription to
vitaCare Prescription Services—NOT a local pharmacy.
1. In your EHR, save:vitaCare Prescription Services
951 Yamato Road, Ste. 160
Boca Raton, FL 33431
2. ePrescribe the order to vitaCare Prescription Services
3. Tell your patient that they must speak with vitaCareto receive their medication, asking them to save 1-844-244-6684 as the contact “GIMOTI Pharmacy” in their phone
Alternatively, you can fax your patient’s prescription to 1-800-891-4320 or call it in to 1-844-2GIMOTI (1-844-244-6684).
If a prior authorization (PA) is required, you will likely need to answer a few questions about your patient in CoverMyMeds.
GIMOTI nasal spray may cost ≤$20
Gimoti (metoclopramide) nasal spray may cost only $0 for patients whose commercial
insurance covers GIMOTI, or $20 if it does not cover GIMOTI or they pay cash.*
97% of all patients pay ≤$20,
regardless of coverage.1,†
Patient assistance program
For patients who need financial assistance with GIMOTI, vitaCare may be able to help.
Contact 1-844-244-6684 for more information.
vitaCare Prescription Services contact information
FAQs on prescribing GIMOTI through vitaCare pharmacy
vitaCare Prescription Services (vitaCare) is a mail-order pharmacy wholly owned by GoodRx, Inc., and the only pharmacy for GIMOTI. To prescribe GIMOTI, simply save “vitaCare” (in Boca Raton, FL 33431, NCPDP #5728045) as a Favorite and link it to GIMOTI in your EHR system. vitaCare can work with you to verify your patient’s benefits, submit a PA (if required), and find the lowest out-of-pocket cost possible for your patient.
At this time, GIMOTI is available only through vitaCare Prescription Services. If you do not send the prescription to vitaCare, your patient cannot receive GIMOTI.
By taking a moment to answer a few questions to complete the PA process for GIMOTI, you will be advocating for your new patients and those taking oral medications who may still be experiencing symptoms. The PA process determines your patients’ coverage to get them the medication they need at the lowest out-of-pocket cost available.
vitaCare Prescription Services will send you an eFax, with instructions on how to submit the PA in CoverMyMeds. Most often, it just asks for the patient’s:
- Relevant medical history (eg, failed lifestyle and treatment options; persistent, refractory, or intractable nausea or vomiting; inability to ingest medicines; malabsorption; and/or ER visits/hospitalizations)
- Prior patient experience with GIMOTI, if applicable
Please submit the completed PA within 3 business days after receiving the eFax. If you need assistance, give vitaCare a call at 1-844-244-6684, and they will help you out.
vitaCare Prescription Services can usually verify benefits for patients within the same day. If a PA is required, vitaCare will send you an eFax, with instructions on how to quickly submit the PA in CoverMyMeds. Once you submit the completed PA form within 3 business days after receiving the eFax, the plan will likely send you its coverage decision within a few days (although some plans may take longer).
vitaCare Prescription Services will send you an eFax containing the PA’s key code. Simply enter this code into your CoverMyMeds account to access the PA. If you cannot find the PA, try switching your CMM filters from Active to Active and Archived. If you still cannot find it, give vitaCare a call at 1-844-244-6684, and they will quickly help you out.
If the PA is denied, you can still advocate for your patient by completing a Letter of Medical Necessity form, which vitaCare Prescription Services will send to you through CoverMyMeds. Alternatively, you can use this Letter of Medical Necessity sample as a guide while referring to this checklist. Important: Eligible patients pay $0 if their commercial insurance covers GIMOTI, but patients can still get it for $20 if the PA is denied.
In certain cases, plans maintain narrower pharmacy networks to limit costs. While Evoke Pharma actively works with those plans to include vitaCare Prescription Services in their network, vitaCare may still be able to find savings options for patients covered by commercial insurance.
Numerous fee-for-service and managed-care plans for Medicare and Medicaid patients cover GIMOTI. Many plans currently require a PA, though we are actively working with states and Medicaid and Medicare plans to improve coverage. Government-insured patients are not usually eligible for manufacturer savings programs by law, but vitaCare Prescription Services can work with you to submit a tier exception in these cases and significantly lower your patient’s out-of-pocket costs.
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.