Company: Dr. Reddy�s Laboratories Ltd.
Treatment for: Migraine
Zembrace SymTouch (sumatriptan) is a selective 5-HT1B/ID receptor agonist in a prefilled, ready-to-use, single-dose disposable autoinjector for the treatment of acute migraine episodes, with or without aura.
ZEMBRACE SymTouch 3 mg/0.5 mL Injection contains sumatriptan as the succinate salt and is supplied as a clear, colorless to pale yellow, sterile, nonpyrogenic solution in a prefilled, ready-to-use, single dose, disposable auto-injector unit (NDC # 67857-809-37).
Each carton contains 4 units (NDC # 67857-809-38) and a Patient Information and Instructions for Use leaflet.
16.2 Storage and Handling
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).
Protect from light These highlights do not include all the information needed to use ZEMBRACE� SymTouch� safely and effectively. See full prescribing information for ZEMBRACE� SymTouch�.
ZEMBRACE� SymTouch� (sumatriptan succinate) Injection, for
subcutaneous use
Initial U.S. Approval: 1992
RECENT MAJOR CHANGES
Warnings and Precautions (5.9) 06/2019
INDICATIONS AND USAGE
ZEMBRACE SymTouch is a serotonin (5-HT1B/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)
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)
DOSAGE FORMS AND STRENGTHS
Injection: 3-mg prefilled, ready-to use, single-dose disposable autoinjector. (3)
CONTRAINDICATIONS
History of coronary artery disease or coronary vasospasm (4)
Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders (4)
History of stroke, transient ischemic attack, or hemiplegic or basilar migraine (4)
Peripheral vascular disease (4)
Ischemic bowel disease (4)
Uncontrolled hypertension (4)
Recent (within 24 hours) use of another 5-HT1 agonist (e.g., another triptan) or of an ergotamine-containing medication (4)
Concurrent or recent (past 2 weeks) use of monoamine oxidase-A inhibitor (4)
Hypersensitivity to sumatriptan (angioedema and anaphylaxis seen) (4)
Severe hepatic impairment (4)
WARNINGS AND PRECAUTIONS
Myocardial ischemia/infarction and Prinzmetal�s angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors. (5.1)
Arrhythmias: Discontinue ZEMBRACE SymTouch if occurs. (5.2)
Chest/throat/neck/jaw pain, tightness, pressure, or heaviness: Generally not associated with myocardial ischemia; evaluate for coronary artery disease in patients at high risk. (5.3)
Cerebral hemorrhage, subarachnoid hemorrhage, and stroke: Discontinue ZEMBRACE SymTouch if occurs. (5.4)
Gastrointestinal ischemia and reactions, peripheral vasospastic reactions: Discontinue ZEMBRACE SymTouch if occurs. (5.5)
Medication overuse headache: Detoxification may be necessary. (5.6)
Serotonin syndrome: Discontinue ZEMBRACE SymTouch if occurs. (5.7)
Seizures: Use with caution in patients with epilepsy or a lowered seizure threshold. (5.10)
ADVERSE REACTIONS
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 Promius Pharma, LLC. at 1-888-966-8766 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, may cause fetal harm. (8.1)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 6/2019
