HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use TOSYMRA safely and effectively. See full prescribing information forTOSYMRA.
TOSYMRA(sumatriptan)nasal spray
Initial U.S. Approval: 1992
INDICATIONS AND US AGE
TOSYMRA is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated forthe acute treatment of migraine with or without aura in adults
Limitations of Use:
Use only if a clear diagnosis of migraine has been established (1)

Not indicated for the preventive treatment of migraine (1)

Not indicated for the treatment of cluster headache (1)

DOSAGE AND ADMINIS TRATION
Single dose of 10 mg of nasal spray (2)
Maximum dose in a 24-hour period: 30 mg; separate doses by at leastone hour (2)
DOSAGE FORMS AND S TRENGTHS
Nasal Spray, 10 mg (3)
CONTRAINDICATIONS
History of coronary artery disease or coronary vasospasm(4)
Wolff-Parkinson-White syndrome or other cardiac accessory conductionpathway disorders (4)
History of stroke, transient ischemic attack, or hemiplegic or basilarmigraine (4)
Peripheral vascular disease (4)
Ischemic bowel disease (4)
Uncontrolled hypertension (4)
Recent (within 24 hours) use of another 5-HT1 agonist (e.g., anothertriptan) or of an ergotamine-containing medication (4)
Concurrent or recent (past 2 weeks) use of monoamine oxidase-Ainhibitor (4)
Hypersensitivity to sumatriptan (angioedema and anaphylaxis seen) (4)
Severe hepatic impairment (4)
WARNINGS AND PRECAUTIONS
Myocardial ischemia/infarction and Prinzmetal’s angina: Perform cardiaceva luation in patients with multiple cardiovascular risk factors (5.1)
Arrhythmias: Discontinue TOSYMRA if occurs (5.2)
Chest/throat/neck/jaw pain, tightness, pressure, or heaviness:Generallynot associated with myocardial ischemia; eva luate for coronary arterydisease in patients at high risk (5.3)
Cerebral hemorrhage, subarachnoid hemorrhage, and stroke:
Discontinue TOSYMRA if occurs (5.4)
Gastrointestinal ischemia and reactions, peripheral vasospastic reactions:
Discontinue TOSYMRA if occurs (5.5)
Medication overuse headache:Detoxification may be necessary (5.6)
Serotonin syndrome: Discontinue TOSYMRA if occurs (5.7)
Increase in blood pressure: Hypertensive crisis can occur (5.8)
Hypersensitivity reactions: Angioedema and anaphylaxis can occur (5.9)
Seizures: Use with caution in patients with epilepsy or a lowered seizurethreshold (5.10)
Local irritation: Burning and abnormal taste can occur (5.11)
ADVERS E REACTIONS
Most common adverse reactions (≥5% and > placebo) with sumatriptaninjection were tingling, dizziness/vertigo, warm/hot sensation, burningsensation, feeling of heaviness, pressure sensation, flushing, feeling oftightness, and numbness (6.1)
Additional common adverse reactions with TOSYMRA include applicationsite reactions, dysgeusia, and throat irritation. (6.1)
To report SUSPECTED ADVERS E REACTIONS, contact PromiusPharma, LLC. at 1-888-966-8766 or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.
US E IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, may cause fetal harm (8.1)
See 17 for PATIENT COUNSELING INFORMATION and FDAapprovedpatient labeling.
Date: 1/2019
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE 7.4 Selective Serotonin Reuptake Inhibitors/Se