ZEMBRACE SymTouch at a glance

Powerful!

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

Fast!

Provides migraine pain relief in as little as 10 minutes (17% for sumatriptan 3 mg vs 5% for placebo).1

Simple!

Features a discreet, compact design with a SIMPLE TWO-STEP injection process.2,3*

Easy to Use!

A treatment option that can be carried anywhere.

*Please see complete Instructions for Use. As with all injection medications, be sure that the injection site is properly cleaned and that the used needle is properly disposed of immediately after use.

A powerful and well-tolerated approach

Proportion of patients with migraine pain relief by time 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

Proportion of subjects with migraine relief by time and by sumatriptan dose in a clinical study1*

*In a single-attack, parallel-group design study, 6 different doses of sumatriptan injection (n=30 each group) were compared with placebo (n=62). After a single 3 mg dose, ZEMBRACE SymTouch was bioequivalent to IMITREX subcutaneous injection.

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Incidences of Adverse Reactions by Sumatriptan Dose1*

 

*In a single-attack, parallel-group design study, 6 different doses of sumatriptan injection (n=30 each group) were compared with placebo (n=62).

The most common adverse event was injection site reactions: sumatriptan 6 mg (59%) versus placebo (24%)1

Contraindications

  • 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-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

Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina

  • There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of sumatriptan injection

Arrhythmias

  • 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

Chest, Throat, Neck, and/or Jaw Pain/Tightness/Pressure

  • 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

Cerebrovascular Events

  • Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT1 agonists, and some have resulted in fatalities

Vasospasm Reactions

  • Reports of transient and permanent blindness and significant partial vision loss have been reported with the use of 5-HT1 agonists

Medication Overuse Headache

  • 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

  • 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)

Increase in Blood Pressure

  • 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

  • Anaphylactic reactions have occurred in patients receiving sumatriptan. Such reactions can be life threatening or fatal

Seizures

  • Seizures have been reported following administration of sumatriptan

Adverse Events

Table 1: Adverse Reactions in Pooled Placebo-Controlled Trials in Patients with Migraine (Studies 2 and 3)

*Includes injection site pain, stinging/burning, swelling, erythema, bruising, bleeding.

Indications 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 injection is not indicated for the prevention of migraine attacks

Designed with patients in mind

A non-oral treatment option that features a SIMPLE TWO-STEP injection process that bypasses the stomach1-3*

In a human-factors study, 100% of patients were able to correctly use the ZEMBRACE SymTouch pen 3‡

*Please see complete Instructions for Use. As with all injection medicines, be sure that the injection site is properly cleaned and that the used needle is 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.1
Using a simulated injection.


Instructions for Use

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

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