Zembrace SymTouch 3 mg/.5mL

Sumatriptan Succinate · SOLUTION · Tonix Medicines, Inc.

No Recall HistoryCurrently in Shortage

Plain English

Zembrace SymTouch is a solution containing sumatriptan succinate at 3 mg/.5mL, taken subcutaneous. Manufactured by Tonix Medicines, Inc..

Key Facts

Brand Name: Zembrace SymTouch
Generic Name: Sumatriptan Succinate
NDC Code (Product): 70792-809
Manufacturer: Tonix Medicines, Inc.
Strength: 3 mg/.5mL
Dosage Form: SOLUTION
Route: SUBCUTANEOUS
Marketing Status
Application #: NDA208223
Marketing Start: 07/01/2023

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective1,149 reports

headache732 reports

migraine644 reports

nausea559 reports

product dose omission issue538 reports

fatigue478 reports

product quality issue428 reports

off label use400 reports

pain364 reports

product complaint348 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE ZEMBRACE SymTouch is indicated for the acute treatment of migraine with or without aura in adults. ZEMBRACE SymTouch is a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for: Acute treatment of migraine with or without aura in adults. ( 1 ) Limitations of Use : Use only if a clear diagnosis of migraine has been established. ( 1 ) Not indicated for the prophylactic therapy of migraine. ( 1 ) 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.

Dosage & Administration

2 DOSAGE AND ADMINISTRATION For subcutaneous use only. ( 2.1 ) Acute treatment of migraine: 3 mg Single dose. ( 2.1 ) Maximum dose in a 24-hour period: 12 mg. Separate doses by at least 1 hour. ( 2.1 ) 2.1 Dosing Information The recommended dose of ZEMBRACE SymTouch is 3 mg injected subcutaneously. The maximum cumulative injected dose that may be given in 24 hours is 12 mg, with doses of ZEMBRACE SymTouch separated by at least 1 hour. ZEMBRACE SymTouch may also be given at least 1 hour following a dose of another sumatriptan product. 2.2 Administration Using ZEMBRACE SymTouch ZEMBRACE SymTouch is available as a prefilled, ready-to-use, single dose, disposable auto-injector containing 3 mg sumatriptan. With ZEMBRACE SymTouch, the needle penetrates approximately ¼ inch (6 mm). The injection is intended to be given subcutaneously. Do not administer by any other route. Instruct patients on the proper use of ZEMBRACE SymTouch and direct them to use injection sites with an adequate skin and subcutaneous thickness to accommodate the length of the needle.

Contraindications

4 CONTRAINDICATIONS ZEMBRACE SymTouch injection 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 [see Warnings and Precautions (5.1) ] . Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see Warnings and Precautions (5.2) ] . 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 [see Warnings and Precautions (5.4) ] . Peripheral vascular disease [see Warnings and Precautions (5.5) ] . Ischemic bowel disease [see Warnings and Precautions (5.5) ] . Uncontrolled hypertension [see Warnings and Precautions (5.8) ] . Recent (i.e., within 24 hours) use of ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine1 (5-HT 1 ) agonist [see Drug Interactions (7.1 , 7.3) ] . Concurrent administration of an MAO-A inhibitor or recent (within 2 weeks) use of an MAO-A inhibitor [see Drug Interactio…

Drug Interactions

7 DRUG INTERACTIONS 7.1 Ergot-Containing Drugs Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Because these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and ZEMBRACE SymTouch within 24 hours of each other is contraindicated. 7.2 Monoamine Oxidase-A Inhibitors MAO-A inhibitors increase systemic exposure by 2-fold. Therefore, the use of ZEMBRACE SymTouch injection in patients receiving MAO-A inhibitors is contraindicated [see Clinical Pharmacology (12.3) ] . 7.3 Other 5-HT 1 Agonists Because their vasospastic effects may be additive, coadministration of ZEMBRACE SymTouch injection and other 5-HT 1 agonists (e.g., triptans) within 24 hours of each other is contraindicated. 7.4 Selective Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors and Serotonin Syndrome Cases of serotonin syndrome have been reported during coadministration of triptans and SSRIs, SNRIs, TCAs, and MAO inhibitors [see Warnings and Precautions (5.7) ] .

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: Myocardial ischemia, myocardial infarction, and Prinzmetal's angina [see Warnings and Precautions (5.1) ] Arrhythmias [see Warnings and Precautions (5.2) ] Chest, throat, neck, and/or jaw pain/tightness/pressure [see Warnings and Precautions (5.3) ] Cerebrovascular events [see Warnings and Precautions (5.4) ] Other vasospasm reactions [see Warnings and Precautions (5.5) ] Medication overuse headache [see Warnings and Precautions (5.6) ] Serotonin syndrome [see Warnings and Precautions (5.7) ] Increase in blood pressure [see Warnings and Precautions (5.8) ] Hypersensitivity reactions [see Contraindications (4) , Warnings and Precautions (5.9) ] Seizures [see Warnings and Precautions (5.10) ] 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Tonix Medicines, Inc. at 1-888-869-7633 (1-888-TNXPMED) or FDA at 1-800-FDA-1088 or w…

Frequently Asked Questions

What is Zembrace SymTouch used for?

Zembrace SymTouch contains Sumatriptan Succinate. It is a solution taken subcutaneous. Consult your doctor for specific uses.

Is Zembrace SymTouch a controlled substance?

Zembrace SymTouch is not classified as a controlled substance by the DEA.

What is the generic name for Zembrace SymTouch?

The generic name for Zembrace SymTouch is Sumatriptan Succinate. There are 12 other brand versions of Sumatriptan Succinate.

What is the NDC code for Zembrace SymTouch 3 mg/.5mL?

The NDC (National Drug Code) for Zembrace SymTouch 3 mg/.5mL is 70792-809, listed by Tonix Medicines, Inc..

Product NDC

70792-809

Package NDC

70792-809-38

Other Sumatriptan Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)