TOSYMRA delivers the efficacy of an injection in a well-tolerated nasal spray1,2

The most common adverse reactions (≥5% and > placebo) with sumatriptan injection (6 mg) were tingling, dizziness/vertigo, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, flushing, feeling of tightness, and numbness.

6-month safety data demonstrates that TOSYMRA is generally well tolerated2

TOSYMRA, with Intravail® technology, effectively delivers sumatriptan intranasally. It may be an alternative for patients who cannot tolerate oral treatments.

In an open-label, repeat-dose study designed to assess the safety and tolerability of TOSYMRA in 167 adult patients who collectively reported 2211 migraines,2

Low rates of triptan-related AEs were reported

3292 doses of TOSYMRA were administered2,3

Reported triptan-related TEAEs chart
  • A 2.9% triptan-related TEAE rate was demonstrated (94 events out of 3292 individual doses)3
  • 5 patients (3%) discontinued due to adverse events3

TEAE=treatment-emergent adverse event.

*Most common triptan-related TEAEs occurring in ≥1% of patients: dizziness, nausea, chest discomfort, paresthesia, feeling hot, feeling jittery, muscle tightness, and vomiting.

Low rates of dysgeusia in the 6-month open-label safety study2

  • 21% of patients (n=35) experienced dysgeusia
    • The majority of cases were mild (30/35)2
    • No severe cases of dysgeusia were reported2
    • The per-dose percentage of dysgeusia was 7% (232 cases out of 3292 individual doses)2,5
  • In addition to dysgeusia, other common adverse reactions reported with TOSYMRA over the course of 6 months in the open-label trial were application site reactions (36%) and throat irritation (5%)

Each patient has a distinct migraine experience

Meet Bill: Patient with a Busy Lifestyle

Age 40
Profession Flight Attendant
Background

Bill has traditionally suffered from 3 migraines per month. However, due to his high-stress job, the frequency of his migraines has almost doubled. He now experiences between 4 to 6 moderate-to-severe migraines per month. Bill’s migraines are rapid in onset, and the severity of each migraine typically builds within 20 minutes.

Current/Previous Treatment

Bill has tried both oral and nasal triptans. Bill experienced a slower onset of pain relief than he needed, forcing him to lie down for approximately 2 hours.

Chief Complaint

Bill lives a busy lifestyle and requires a fast, effective, and tolerable migraine medication that won’t interfere with his schedule.

Bill Needs
  • A treatment option that fits his busy schedule
  • A rapid and effective treatment option for migraine pain
  • A treatment option that he tolerates well
Meet Bill: Patient with a busy lifestyle Not an actual patient.

References: 1. TOSYMRA [package insert]. Maple Grove, MN: Upsher-Smith Laboratories, LLC; 2019. 2. Munjal S, Brand-Schieber E, Allenby K, Spierings ELH, Cady RK, Rapoport AM. A multicenter, open-label, long-term safety and tolerability study of DFN-02, an intranasal spray of sumatriptan 10 mg plus permeation enhancer DDM, for the acute treatment of episodic migraine. J Headache Pain. 2017;18(1):313. 3. Halvorsen MB, Zachman MB, Munjal S, Rapoport AM. Triptan-Related Adverse Events in a Multicenter, Open-label, Long-Term, Safety Study of DFN-02 (Tosymra™; an Intranasal Spray of Sumatriptan 10 mg Plus Permeation Enhancer DDM), for the Acute Treatment of Migraine. Presented at: PAINWeek 2019; September 3-7, 2019; Las Vegas, NV. 4. Data on file. Upsher-Smith Laboratories, Maple Grove, MN. 5. Halvorsen MB, Zachman MB, Munjal S, Rapoport AM. Dysgeusia Rates in a Multicenter, Open-label, Long-Term, Safety Study of DFN-02 (Tosymra™; an Intranasal Spray of Sumatriptan 10 mg Plus Permeation Enhancer DDM), for the Acute Treatment of Migraine. Presented at: PAINWeek 2019; September 3-7, 2019; Las Vegas, NV.

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

There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of sumatriptan. Some of these reactions occurred in patients without known CAD. TOSYMRA, like other 5-HT1 agonists, may cause coronary artery vasospasm. Perform a cardiovascular evaluation in triptan-naive patients who have multiple cardiovascular risk factors prior to receiving TOSYMRA. For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first dose of TOSYMRA in a medically supervised setting and performing an ECG immediately following administration. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of TOSYMRA.

Life-threatening disturbances of cardiac rhythm, leading to death in some cases, have been reported within a few hours following the administration of 5-HT1 agonists. Discontinue TOSYMRA if any of these cardiovascular disturbances occur.

Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT1 agonists, and some have resulted in fatalities. Discontinue TOSYMRA if these occur.

Sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck, and jaw commonly occur after treatment with sumatriptan injection and are usually non-cardiac in origin.

TOSYMRA may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction, splenic infarction, and Raynaud’s syndrome.

Overuse of acute migraine drugs may lead to medication overuse headache. Detoxification of patients and treatment of withdrawal symptoms may be necessary.

Serotonin syndrome may occur with TOSYMRA, particularly during co-administration with selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, tricyclic antidepressants, and MAO inhibitors. Discontinue TOSYMRA if serotonin syndrome is suspected.

Significant elevation in blood pressure, including hypertensive crisis, has been reported on rare occasions in patients treated with 5-HT1 agonists, including patients without a history of hypertension. Monitor blood pressure in patients treated with TOSYMRA.

Seizures have been reported following administration of sumatriptan. Some have occurred in patients with either a history of seizures or concurrent conditions predisposing to seizures. TOSYMRA should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold.

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.

This safety information is not comprehensive. Please refer to the TOSYMRA full Prescribing Information, Patient Information, and Instructions for Use. You can also visit www.upsher-smith.com or call 1-888-650-3789.

You are encouraged to report suspected adverse reactions to Upsher-Smith Laboratories, LLC at 1-855-899-9180 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

INDICATION AND USAGE

TOSYMRA is indicated for the acute treatment of migraine with or without aura in adults.

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 TOSYMRA, reconsider the diagnosis before TOSYMRA is administered to treat any subsequent attacks.
  • TOSYMRA is not indicated for the preventive treatment of migraine.
  • TOSYMRA is not indicated for the treatment of cluster headache.
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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 or transient ischemic attack or history of hemiplegic or basilar migraine
  • Peripheral vascular disease
  • Ischemic bowel disease
  • Uncontrolled hypertension
  • Recent (i.e., within 24 hours) use of ergotamine-containing medication, ergot-type medication, or another 5-HT1 agonist
  • Concurrent or recent (within 2 weeks) use of a monoamine oxidase (MAO)-A inhibitor
  • Known hypersensitivity to sumatriptan (angioedema and anaphylaxis seen)
  • Severe hepatic impairment

There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of sumatriptan. Some of these reactions occurred in patients without known CAD. TOSYMRA, like other 5-HT1 agonists, may cause coronary artery vasospasm. Perform a cardiovascular evaluation in triptan-naive patients who have multiple cardiovascular risk factors prior to receiving TOSYMRA. For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first dose of TOSYMRA in a medically supervised setting and performing an ECG immediately following administration. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of TOSYMRA.

Life-threatening disturbances of cardiac rhythm, leading to death in some cases, have been reported within a few hours following the administration of 5-HT1 agonists. Discontinue TOSYMRA if any of these cardiovascular disturbances occur.

Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT1 agonists, and some have resulted in fatalities. Discontinue TOSYMRA if these occur.

Sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck, and jaw commonly occur after treatment with sumatriptan injection and are usually non-cardiac in origin.

TOSYMRA may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction, splenic infarction, and Raynaud’s syndrome.

Overuse of acute migraine drugs may lead to medication overuse headache. Detoxification of patients and treatment of withdrawal symptoms may be necessary.

Serotonin syndrome may occur with TOSYMRA, particularly during co-administration with selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, tricyclic antidepressants, and MAO inhibitors. Discontinue TOSYMRA if serotonin syndrome is suspected.

Significant elevation in blood pressure, including hypertensive crisis, has been reported on rare occasions in patients treated with 5-HT1 agonists, including patients without a history of hypertension. Monitor blood pressure in patients treated with TOSYMRA.

Seizures have been reported following administration of sumatriptan. Some have occurred in patients with either a history of seizures or concurrent conditions predisposing to seizures. TOSYMRA should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold.

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.

This safety information is not comprehensive. Please refer to the TOSYMRA full Prescribing Information, Patient Information, and Instructions for Use. You can also visit www.upsher-smith.com or call 1-888-650-3789.

You are encouraged to report suspected adverse reactions to Upsher-Smith Laboratories, LLC at 1-855-899-9180 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

INDICATION AND USAGE

TOSYMRA is indicated for the acute treatment of migraine with or without aura in adults.

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 TOSYMRA, reconsider the diagnosis before TOSYMRA is administered to treat any subsequent attacks.
  • TOSYMRA is not indicated for the preventive treatment of migraine.
  • TOSYMRA is not indicated for the treatment of cluster headache.