Migraine and headache:

Indications for: TOSYMRA

Acute treatment of migraine with or without aura.

Limitations of Use:

Confirm diagnosis; reconsider if no response after treatment. Not for prevention of migraine attacks. Not for treatment of cluster headache.

Adult Dosage:

≥18yrs: 10mg as single spray in one nostril. Reevaluate if no response. Max cumulative dose: 30mg in 24hrs with each dose separated by at least 1hr. May also be given at least 1hr following another sumatriptan product.

Children Dosage:

<18yrs: not recommended.

TOSYMRA Contraindications:

Ischemic coronary artery disease (CAD) (eg, angina, history of MI, silent ischemia). 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 TIA. History of hemiplegic or basilar migraine. Peripheral vascular disease. Ischemic bowel disease. Uncontrolled hypertension. Within 24hrs of ergo-type drugs (eg, methysergide, dihydroergotamine) or other 5-HT1 agonists. During or within 2 weeks of an MAO-A inhibitor. Severe hepatic impairment.

TOSYMRA Warnings/Precautions:

Avoid excessive use. Exclude underlying neurologic or cardiovascular disease, supervise 1st dose, and consider monitoring ECG in patients with multiple risk factors (eg, increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD). Monitor BP, cardiovascular function in long-term intermittent use. Discontinue if serious arrhythmias or cerebrovascular events occur or if serotonin syndrome is suspected. Medication overuse headache. Peripheral or GI vascular ischemia and infarction following other 5-HT1 agonists. History, or risk of seizures. Elderly. Pregnancy. Nursing mothers: avoid for 12hrs after treatment.

TOSYMRA Classification:

Selective 5-HT1B/1D receptor agonist.

TOSYMRA Interactions:

Ergotamines, other 5-HT1 agonists, MAO-A inhibitors: see Contraindications. Increased risk of serotonin syndrome with SSRIs, SNRIs, tricyclics, or MAO inhibitors.

Adverse Reactions:

Tingling, dizziness/vertigo, flushing, warm/hot/burning sensation, feeling of heaviness/tightness, pressure sensation, numbness, application site reaction, dysgeusia, throat irritation; rare: serious cardiac and cerebrovascular events (including fatalities), vision loss, hypertensive crisis, hypersensitivity reactions.

Generic Drug Availability:


How Supplied:

Nasal spray (single dose)—6