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Zembrace and SymTouch are registered trademarks of Tonix Medicines, Inc. All other marks are property of their respective owners.
© 2024 Tonix Medicines, Inc., Chatham, NJ 07928

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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/paresthesia.

This safety information is not comprehensive. Please refer to the Zembrace SymTouch full Prescribing Information, Patient Information, and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-650-3789.

You are encouraged to report suspected adverse reactions to Tonix Medicines, Inc. at 1-888-869-7633 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

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.

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