For your patients who require a fast-acting, easy-to-use acute migraine treatment option that bypasses the stomach

TOSYMRA delivers the efficacy of an injectable in a nasal spray1

The efficacy of TOSYMRA nasal spray is based on relative bioavailability of TOSYMRA compared to a 4-mg Imitrex®
(sumatriptan) subQ injection in healthy adults1

Proportion of patients with migraine relief* by time1

Data from the 4-mg dose arm (n=30) of a sumatriptan subQ dose-ranging, single-attack study (N=242).1

Proportion of patients with migraine relief by time.

*Migraine relief was defined as the reduction of moderate or severe pain to no or mild pain after dosing without use of rescue medication.1

Sumatriptan injection also has been shown to relieve photophobia, phonophobia, nausea, and vomiting associated with migraine attacks1

An open-label, repeat-dose study assessed the safety and tolerability of TOSYMRA in 167 adult patients diagnosed with episodic migraine with or without aura.2 A post hoc analysis evaluated the change in the number of migraine headache days and hours at month 6 compared to month 1.3

Patients receiving TOSYMRA, who experienced a migraine in both month 1 and 6 (n=105), achieved a statistically significant reduction in mean number of3

Day Icon

MIGRAINE HEADACHE DAYS

2.3 DAYS’ REDUCTION 

Mean migraine headache days in month 6 was 3.2, a decrease of 2.3 days from month 1 (P<.001)

Time Icon

MIGRAINE HEADACHE HOURS

10.9 HOURS’ REDUCTION 

Mean number of migraine hours in month 6 was 10.6, a 10.9-hour reduction from month 1 (P<.001)

In the open-label, repeat-dose study of TOSYMRA, the most common treatment-emergent AEs were application site pain, dysgeusia, application site reaction, upper respiratory tract infection, nasopharyngitis, and sinusitis.2

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

Each patient has a distinct migraine experience

Meet Linda: Can’t find relief

Age 35
Profession Customer Service Agent
Background

Linda has suffered from migraines for several years; recently, however, the intensity has increased. Prior to this point, Linda had approximately 1 to 2 moderate migraines per week, but the pain associated with these migraines has worsened over time. Linda's migraine attacks can happen at any time, and the typical onset can take approximately 30 to 45 minutes.

Current/Previous Treatment

Linda tried oral triptans, but she did not experience the relief she needed, especially as the migraines progressed in severity. To try to manage the pain, Linda added nonsteroidal anti-inflammatory drugs (NSAIDs) to her treatment regimen.

Chief Complaint

Linda has cycled through multiple oral therapies and has yet to find an option that is consistently effective and works fast enough to relieve her migraine attacks. She likes the idea of a fast-acting medication, but has never been comfortable with the idea of self injections.

Linda Needs
  • A non-oral and non-injectable fast-acting treatment option
  • A treatment that Linda can tolerate well
Meet Linda: Patient who can’t find relief 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):31. 3. Halvorsen MB, Zachman MB, Munjal S, Rapoport AM. Evaluation of the Number of Migraine Headache Days and Hours 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.