ZEMBRACE SymTouch at a glance

  • The sumatriptan you know, now available in an autoinjector in a 3 mg dose1
  • May be appropriate for your patients with acute migraine1
  • Migraine pain relief in as little as 10 minutes (17% vs 5% for placebo)1
  • Administered using a single-dose, prefilled autoinjector pen1,2
    • Concealed, thin-walled, 29-gauge needle3,4
    • Smallest needle available in a sumatriptan autoinjector4

A simple approach, because every episode is different

Since patient responses to treatment aren’t always predictable, individualized management of migraine is recommended.5 ZEMBRACE SymTouch is an injectable alternative for your patients with episodes where a nonoral treatment may be appropriate. ZEMBRACE SymTouch is indicated in adults for the treatment of acute migraine with or without aura.

Consider all treatment options for each episode

  • ZEMBRACE SymTouch can be an appropriate option for acute migraine patients who may not be getting relief from all types of attacks with their current treatment regimen 1
    • It’s a therapy that skips the stomach—ideal for patients experiencing gastrointestinal distress and in need of fast relief, regardless of where they are when their symptoms start1
  • Migraine pain relief in as little as 10 minutes (17% vs 5% for placebo). Nearly half of patients (47%) achieved migraine relief within 30 minutes and the majority of patients (60%) felt relief from migraine pain within 2 hours1

Fast relief from migraine pain1

Proportion of patients with migraine relief by time and incidence with a 3 mg dose of sumatriptan injection (N=30)1

Percentage of Migraine Relief in Patients ZEMBRACE 3mg Dose Percentage Graph

ZEMBRACE SymTouch is designed with patients in mind

The only prefilled 3 mg sumatriptan autoinjector, ZEMBRACE SymTouch utilizes a thin-walled, concealed 29 gauge needle—the smallest needle in a sumaptripan autoinjector.1,3,4

ZEMBRACE SymTouch may be dosed up to 4 times daily (up to 12 mg daily total) with doses spaced a minimum of one hour apart.

  • Single-use and disposable with a compact design, ZEMBRACE SymTouch can be carried anywhere your patients may be when they need fast migraine relief—and it requires no refrigeration (store at room temperature)1*

Simple two-step injection process4,6 †

Two Step
*Store between 20°C and 25°C (68°F and 77°F). Excursions permitted between 15°C and 30°C (59°F and 86°F). NOTE: Do not refrigerate ZEMBRACE SymTouch. Should be stored at room temperature.

In a human-factors study, 100% of patients were able to safely and effectively administer the injection after receiving either written or verbal instructions.2

Bar Graph

See the Instructions for Use video to find out just how easy the ZEMBRACE SymTouch autoinjector is to use!

†As with all injection medications, the injection site must be properly cleaned. The device should be properly disposed of immediately after use.

ZEMBRACE SymTouch safety profile

In a single-attack parallel group study, 77% of patients injecting sumatriptan 3 mg experienced an adverse reaction (placebo, 55%). Most adverse events were injection site reactions: sumatriptan 6 mg (59%) versus placebo (24%).1

Proportion of patients who experienced adverse events with a 3 mg dose of sumatriptan injection1

Bar Graph
  • ZEMBRACE SymTouch is contraindicated in patients with:
    • Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal’s angina
    • Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders
    • History of stroke or transient ischemic attack (TIA) or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke
    • Peripheral vascular disease
    • Ischemic bowel disease
    • Uncontrolled hypertension
    • Recent (ie, within 24 hours) use of ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine 1 (5-HT1) agonist
    • Concurrent administration of an MAO-A inhibitor or recent (within 2 weeks) use of an MAO-A inhibitor
    • Known hypersensitivity to sumatriptan (angioedema and anaphylaxis seen)
    • Severe hepatic impairment
  • There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of sumatriptan injection
  • Life-threatening disturbances of cardiac rhythm, including ventricular tachycardia and ventricular fibrillation leading to death, have been reported within a few hours following the administration of 5-HT1 agonists
  • Sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck, and jaw commonly occur after treatment with sumatriptan injection and are usually non-cardiac in origin
  • Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT1 agonists, and some have resulted in fatalities
  • Reports of transient and permanent blindness and significant partial vision loss have been reported with the use of 5-HT1 agonists
  • Overuse of acute migraine drugs (e.g., ergotamine, triptans, opioids, combination of these drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache)
  • Serotonin syndrome may occur with ZEMBRACE SymTouch injection, particularly during co-administration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and MAO inhibitors. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea)
  • Significant elevation in blood pressure, including hypertensive crisis with acute impairment of organ systems, has been reported on rare occasions in patients treated with 5-HT1 agonists, including patients without a history of hypertension
  • Anaphylactic reactions have occurred in patients receiving sumatriptan. Such reactions can be life threatening or fatal
  • Seizures have been reported following administration of sumatriptan
  • Indications for Use
    • ZEMBRACE SymTouch is indicated for the acute treatment of migraine with or without aura in adults
  • Limitations of Use
    • Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with ZEMBRACE SymTouch, reconsider the diagnosis before ZEMBRACE SymTouch is administered to treat any subsequent attacks
    • ZEMBRACE SymTouch injection is not indicated for the prevention of migraine attacks

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IMPORTANT SAFETY INFORMATION

ZEMBRACE SymTouch is contraindicated in patients with:
  • Ischemic Coronary Artery Disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal’s angina
  • Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders
  • History of stroke or transient ischemic attack (TIA) or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke
  • Peripheral vascular disease
  • Ischemic bowel disease
  • Uncontrolled hypertension
  • Recent (i.e., within 24 hours) use of ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine1 (5-HT1) agonist
  • Concurrent administration of an MAO-A inhibitor or recent (within 2 weeks) use of an MAO-A inhibitor
  • Known hypersensitivity to sumatriptan (angioedema and anaphylaxis seen)
  • Severe hepatic impairment

There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of sumatriptan injection. Some of these reactions occurred in patients without known CAD. 5-HT1 agonists, including ZEMBRACE SymTouch, may cause coronary artery vasospasm (Prinzmetal’s angina), even in patients without a history of CAD.

Perform a cardiovascular evaluation in triptan-naive patients who have multiple cardiovascular risk factors prior to receiving ZEMBRACE SymTouch. For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first dose of ZEMBRACE SymTouch in a medically supervised setting and performing an electrocardiogram (ECG) immediately following ZEMBRACE SymTouch. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of ZEMBRACE SymTouch.

Life-threatening disturbances of cardiac rhythm, including ventricular tachycardia and ventricular fibrillation leading to death, have been reported within a few hours following the administration of 5-HT1 agonists. Discontinue ZEMBRACE SymTouch if these disturbances occur.

Sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck, and jaw commonly occur after treatment with sumatriptan injection and are usually non-cardiac in origin. However, perform a cardiac evaluation if these patients are at high cardiac risk.

Cerebrovascular events including cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT1 agonists, and some have resulted in fatalities. Discontinue ZEMBRACE SymTouch if a cerebrovascular event occurs.

ZEMBRACE SymTouch may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction, splenic infarction, and Raynaud’s syndrome.

Overuse of acute migraine drugs may lead to exacerbation of headache (medication overuse headache). Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms may be necessary.

Serotonin syndrome may occur with ZEMBRACE SymTouch, particularly during co-administration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and MAO inhibitors. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Discontinue ZEMBRACE SymTouch if serotonin syndrome is suspected.

Significant elevation in blood pressure, including hypertensive crisis with acute impairment of organ systems, has been reported on rare occasions in patients treated with 5-HT1 agonists, including patients without a history of hypertension. Monitor blood pressure in patients treated with ZEMBRACE SymTouch.

Seizures have been reported following administration of sumatriptan. Some have occurred in patients with either a history of seizures or concurrent conditions predisposing to seizures. ZEMBRACE SymTouch should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold.

Most common adverse reactions (≥5% and > placebo) were injection site reactions, tingling, dizziness/vertigo, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, flushing, feeling of tightness, and numbness.

These are not all the side effects associated with ZEMBRACE SymTouch. Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions For Use). Please see Patient Information, Instructions For Use and Prescribing Information for ZEMBRACE SymTouch. To report SUSPECTED SIDE EFFECTS, call Promius Pharma at 1‑888‑966‑8766 or contact the FDA at 1-800-FDA-1088 (1‑800‑332‑1088) or online at http://www.fda.gov/Safety/MedWatch

INDICATION AND USAGE

ZEMBRACE SymTouch is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use:
  • Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with ZEMBRACE SymTouch, reconsider the diagnosis before ZEMBRACE SymTouch is administered to treat any subsequent attacks.
  • ZEMBRACE SymTouch is not indicated for the prevention of migraine attacks.
References: 1. Zembrace Prescribing Information, Promius Pharma, Jan 2016. 2. IAA report #1502 on file, Feb 2015. 3. US Food and Drug Administration NDA # 208223. Dr. Reddy's Laboratories. Princeton, NJ: January 2016. 4. Memo – Confirmation of Needle Gauge of Sumatriptan Syringes (PFS). Promius Pharma, March 2016. 5. Matchar DB, Young WB, Rosenberg JH, et al. Evidence-based guidelines for migraine headache in the primary care setting: pharmacological management of acute attacks. https://evidencebasedpractice.osumc.edu/Documents/Guidelines/MigrainePrimaryCare.pdf. Accessed February 22, 2016. 6. ZEMBRACE SymTouch. Instructions for Use. Princeton, NJ: Promius Pharma; 2016.

IMPORTANT SAFETY INFORMATION

ZEMBRACE SymTouch is contraindicated in patients with:
  • Ischemic Coronary Artery Disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal’s angina
  • Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders
  • History of stroke or transient ischemic attack (TIA) or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke
  • Peripheral vascular disease
  • Ischemic bowel disease
  • Uncontrolled hypertension
  • Recent (i.e., within 24 hours) use of ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine1 (5-HT1) agonist
  • Concurrent administration of an MAO-A inhibitor or recent (within 2 weeks) use of an MAO-A inhibitor
  • Known hypersensitivity to sumatriptan (angioedema and anaphylaxis seen)
  • Severe hepatic impairment

There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of sumatriptan injection. Some of these reactions occurred in patients without known CAD. 5-HT1 agonists, including ZEMBRACE SymTouch, may cause coronary artery vasospasm (Prinzmetal’s angina), even in patients without a history of CAD.

Perform a cardiovascular evaluation in triptan-naive patients who have multiple cardiovascular risk factors prior to receiving ZEMBRACE SymTouch. For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first dose of ZEMBRACE SymTouch in a medically supervised setting and performing an electrocardiogram (ECG) immediately following ZEMBRACE SymTouch. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of ZEMBRACE SymTouch.

Life-threatening disturbances of cardiac rhythm, including ventricular tachycardia and ventricular fibrillation leading to death, have been reported within a few hours following the administration of 5-HT1 agonists. Discontinue ZEMBRACE SymTouch if these disturbances occur.

Sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck, and jaw commonly occur after treatment with sumatriptan injection and are usually non-cardiac in origin. However, perform a cardiac evaluation if these patients are at high cardiac risk.

Cerebrovascular events including cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT1 agonists, and some have resulted in fatalities. Discontinue ZEMBRACE SymTouch if a cerebrovascular event occurs.

ZEMBRACE SymTouch may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction, splenic infarction, and Raynaud’s syndrome.

Overuse of acute migraine drugs may lead to exacerbation of headache (medication overuse headache). Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms may be necessary.

Serotonin syndrome may occur with ZEMBRACE SymTouch, particularly during co-administration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and MAO inhibitors. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Discontinue ZEMBRACE SymTouch if serotonin syndrome is suspected.

Significant elevation in blood pressure, including hypertensive crisis with acute impairment of organ systems, has been reported on rare occasions in patients treated with 5-HT1 agonists, including patients without a history of hypertension. Monitor blood pressure in patients treated with ZEMBRACE SymTouch.

Seizures have been reported following administration of sumatriptan. Some have occurred in patients with either a history of seizures or concurrent conditions predisposing to seizures. ZEMBRACE SymTouch should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold.

Most common adverse reactions (≥5% and > placebo) were injection site reactions, tingling, dizziness/vertigo, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, flushing, feeling of tightness, and numbness.

These are not all the side effects associated with ZEMBRACE SymTouch. Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions For Use). Please see Patient Information, Instructions For Use and Prescribing Information for ZEMBRACE SymTouch. To report SUSPECTED SIDE EFFECTS, call Promius Pharma at 1‑888‑966‑8766 or contact the FDA at 1-800-FDA-1088 (1‑800‑332‑1088) or online at http://www.fda.gov/Safety/MedWatch

ZEMBRACE SymTouch is indicated for the acute treatment of migraine with or without aura in adults.

Limitations of Use:
  • Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with ZEMBRACE SymTouch, reconsider the diagnosis before ZEMBRACE SymTouch is administered to treat any subsequent attacks.
  • ZEMBRACE SymTouch is not indicated for the prevention of migraine attacks.