About ZEMBRACE SymTouch

ZEMBRACE SymTouch
at a glance

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The sumatriptan you know, available in an autoinjector in a 3 mg dose1

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60% of patients
experienced pain
relief
2 hours after administration
(vs 21% for placebo)1

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Migraine pain relief in
as little as 10 minutes
(17% vs 5% for placebo)1

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An easy-to-use
treatment option that
can be carried anywhere

A powerful and
well-tolerated approach

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

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

Most adverse events were injection site reations: sumatriptan 6 mg (59%) versus placebo (24%)1

  • 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

Designed with
patients in mind

Simple two-step injection process2-3*

In a human-factor study, 100% of patients were able to correctly use the ZEMBRACE SymTouch pen3‡
*As with all injection medications, the injection site must be properly cleaned. The device should be properly disposed of immediately after use. 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. Using a simulated injection.

Instructions for use

See the video below to find out just how easy ZEMBRACE SymTouch is to use.

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IMPORTANT SAFETY INFORMATION

ZEMBRACE SymTouch is contraindicated in patients with:
  • Ischemic Coronary Artery Disease (CAD) or coronary artery vasospasm (including Prinzmetal’s angina), Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders
  • Uncontrolled hypertension, history of stroke or transient ischemic attack (TIA) or history of hemiplegic or basilar migraine
  • Peripheral vascular disease
  • Ischemic bowel disease
  • Recent (i.e., within 24 hours) use of ergotamine-containing medication, ergot derivatives, or another 5-HT1 agonist
  • Concurrent or recent (within 2 weeks) use of an MAO-A inhibitor
  • Known hypersensitivity to sumatriptan
  • 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. Life-threatening disturbances of cardiac rhythm leading to death in some cases, have been reported within a few hours following the administration of 5-HT1 agonists. 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 any of these events occur.

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 consider periodic follow up. 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.

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. 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. Discontinue ZEMBRACE SymTouch if serotonin syndrome is suspected or hypertensive crisis is observed.

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. Please see Patient Information, Instructions For Use and Full Prescribing Information for ZEMBRACE SymTouch at www.ZEMBRACE.com.

You are encouraged to report negative side effects of prescription drugs. 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 SymTouch Prescribing Information, Promius Pharma, March 2017. 2. ZEMBRACE SymTouch. Instructions for Use. Princeton, NJ: Promius Pharma; 2017. 3. Brand-Schieber E, Munjal S, Kumar R, Andre A, Valladao W, Ramirez M. Human factors validation study of 3 mg sumatriptan autoinjector, for migraine patients. Medical Devices: Evidence and Research. 2016;9:131-137.

IMPORTANT SAFETY INFORMATION

ZEMBRACE SymTouch is contraindicated in patients with:
  • Ischemic Coronary Artery Disease (CAD) or coronary artery vasospasm (including Prinzmetal’s angina), Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders
  • Uncontrolled hypertension, history of stroke or transient ischemic attack (TIA) or history of hemiplegic or basilar migraine
  • Peripheral vascular disease
  • Ischemic bowel disease
  • Recent (i.e., within 24 hours) use of ergotamine-containing medication, ergot derivatives, or another 5-HT1 agonist
  • Concurrent or recent (within 2 weeks) use of an MAO-A inhibitor
  • Known hypersensitivity to sumatriptan
  • 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. Life-threatening disturbances of cardiac rhythm leading to death in some cases, have been reported within a few hours following the administration of 5-HT1 agonists. 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 any of these events occur.

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 consider periodic follow up. 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.

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. 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. Discontinue ZEMBRACE SymTouch if serotonin syndrome is suspected or hypertensive crisis is observed.

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. Please see Patient Information, Instructions For Use and Full Prescribing Information for ZEMBRACE SymTouch at www.ZEMBRACE.com.

You are encouraged to report negative side effects of prescription drugs. 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.