Indication/Limitations of Use

TOSYMRA^® (sumatriptan) nasal spray is indicated for the acute treatment of migraine with or without aura in adults. TOSYMRA should only be used where a clear diagnosis of migraine has been established. TOSYMRA is not indicated for the prevention of migraine attacks or for the treatment of cluster headache.

Important Safety Information

 TOSYMRA is contraindicated in patients with:

• Ischemic coronary artery disease (CAD) 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, transient ischemic attack (TIA), or hemiplegic or basilar migraine
• Peripheral vascular disease
• Ischemic bowel disease
• Uncontrolled hypertension
• Recent (ie, within 24 hours) use of ergotamine-containing or ergot-type medication, or another 5-hydroxytryptamine₁(5-HT₁) agonist
• Concurrent or recent (within 2 weeks) use of a monoamine oxidase-A (MAO-A) inhibitor
• Hypersensitivity to sumatriptan (angioedema and anaphylaxis seen)
• Severe hepatic impairment

WARNINGS AND PRECAUTIONS

• Myocardial ischemia/infarction, Prinzmetal’s angina: These events may occur even in patients without known cardiovascular disease. Perform cardiac evaluation in triptan-naive patients with multiple risk factors and, if satisfactory, administer the first dose of TOSYMRA in a medically supervised setting
• Arrhythmias: 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 Discontinue TOSYMRA if these disturbances occur
• Sensations of chest/throat/neck/jaw pain, tightness, pressure, or heaviness: Commonly occur after treatment with 5-HT₁ agonists and are usually noncardiac in origin. Perform a cardiac evaluation in patients with cardiac risk
• Cerebrovascular events: Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT₁ agonists, and some have resulted in fatalities. Discontinue TOSYMRA if a cerebrovascular event occurs. Before treating headaches in patients not previously diagnosed with migraine or in patients who present with atypical symptoms, exclude other potentially serious neurological conditions
• Other vasospasm reactions: 5-HT₁ agonists, including TOSYMRA, may cause noncoronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction, splenic infarction, and Raynaud’s syndrome. In patients who experience symptoms or signs suggestive of a vasospastic reaction following the use of any 5-HT₁ agonist, rule out a vasospastic reaction before using TOSYMRA
• Medication overuse headache: Overuse of acute migraine drugs may lead to exacerbation 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 triptans, including TOSYMRA, particularly during co-administration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and MAO inhibitors. The onset of symptoms usually occurs within minutes to hours of receiving a new or greater dose of a serotonergic medication. Discontinue TOSYMRA if serotonin syndrome is suspected
• Increase in blood pressure: Significant elevation in blood pressure, including hypertensive crisis with acute impairment of organ systems, has been reported in patients treated with 5-HT₁ Monitor blood pressure in patients treated with TOSYMRA
• Hypersensitivity reactions: Hypersensitivity reactions, including angioedema and anaphylaxis, have occurred in patients receiving sumatriptan. Such reactions can be life threatening or fatal. TOSYMRA is contraindicated in patients with a history of hypersensitivity reaction to sumatriptan
• Seizures: Seizures have been reported following administration of sumatriptan, with or without predisposing factors. TOSYMRA should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold
• Local irritation: Local irritative symptoms were reported in approximately 46% of patients with TOSYMRA in an open-label trial that allowed repeated use of TOSYMRA over the course of 6 months. The most common local irritative symptoms were application site reaction (eg, burning sensations in the nose), dysgeusia, and throat irritation. Approximately 0.5% of the cases were reported as severe

ADVERSE REACTIONS

The most common adverse reactions (≥5% and >placebo) with sumatriptan injection were tingling, dizziness/vertigo, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, flushing, feeling of tightness, and numbness. In an open-label study allowing repeated use of TOSMYRA nasal spray over 6 months, 46% of patients reported local irritative symptoms, the most common of which were application site reaction, dysgeusia, and throat irritation.

DRUG INTERACTIONS

• Ergot-containing drugs: Reported to cause prolonged vasoplastic reactions
• MAO-A inhibitors: Increase systemic exposure by 2-fold
• Other 5-HT₁ agonists: Vasoplastic effects may be additive
• SSRIs, SNRIs, TCAs, and MAO inhibitors: Serotonin syndrome has been reported

USE IN SPECIFIC POPULATIONS

Pregnancy: Disease-Associated Maternal and/or Embryo/Fetal Risk: Several studies have suggested that women with migraine may be at increased risk of preeclampsia during pregnancy.

Lactation: Sumatriptan is excreted in human milk following subcutaneous administration. There are no data on the effects of sumatriptan on a breastfed infant or the effects on milk production. Infant exposure can be minimized by avoiding breastfeeding for 12 hours after treatment with TOSYMRA.

Pediatric use: The safety and effectiveness in pediatric patients have not been established. TOSYMRA is not recommended for use in patients younger than 18 years of age.

Geriatric patients: Clinical trials of sumatriptan did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger patients. Dose selection for an elderly patient should usually start at the low end of the dosing range. A cardiovascular evaluation is recommended for geriatric patients who have other cardiovascular risk factors (eg, diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving TOSYMRA.

Please see additional information in the full Prescribing Information.  

To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.