See Migraine Differently

Episodic variability

Migraines can vary. Sufferers experience migraine headaches that differ from episode to episode. The attacks’ onset speed can change, and so can the severity of the symptoms a patient may experience. In addition to head pain, a patient can experience 1 or more of the following symptoms during each attack:

Nausea
Vomiting
Sensitivity to sound, light, or smell
Visual aura
Tingling or numbness

Different migraine attacks may call for different treatments

Ask your patients: When it comes to their migraines…

Different Types Migraine Attacks
Different Types Migraine Attacks
Different Types Migraine Attacks

Evidence to support stratified care

Guidelines encourage different approaches to treating varying migraine attacks

US Headache Consortium general principles of management1

  • Patients and physicians should decide on treatment plan together
  • Treatments should be individualized for every migraine episode
  • Treatment choice should be based on many factors

Stratified care provides significantly better clinical outcomes both within and across migraine episodes2,a

Headache Response (Mild or No Pain)

Stratified Care with Zembrace Efficacy in Acute Migraine Treatment graph

Approaches to migraine treatment

a Stratified care: initial treatment selected based on severity of migraine episode:
- Physicians use headache-related disability to determine severity of illness
- Increases likelihood that appropriate treatment will be selected first

Stratification using treatment delivery routes

Because every migraine is different: Consider all options

Survey Graphic 1
Survey Graphic 2
Survey Graphic 3

Guidelines and professional organizations also recommend non-oral administration of medication for patients with time to peak disability of <1 hour and those who wake up with headache6

Are non-oral routes underutilized?

Sumatriptan Administration Routes Percentage Chart

Sumatriptan is most commonly administered by 3 different routes: by mouth (oral), by injection under the skin (subcutaneous), and by nasal spray (intranasal). Currently, oral medications are heavily favored by doctors when treating their migraine patients.4

Choice of migraine treatment is based on many factors, including: frequency and severity of attacks, the presence and degree of temporary disability, and the profile of associated symptoms such as nausea or vomiting.1


IMPORTANT SAFETY INFORMATION

ZEMBRACE SymTouch is contraindicated in patients with:
  • Ischemic Coronary Artery Disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) 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 (TIA) or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke
  • Peripheral vascular disease
  • Ischemic bowel disease
  • Uncontrolled hypertension
  • Recent (i.e., within 24 hours) use of ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine1 (5-HT1) agonist
  • Concurrent administration of an MAO-A inhibitor or recent (within 2 weeks) use of an 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 injection. Some of these reactions occurred in patients without known CAD. 5-HT1 agonists, including ZEMBRACE SymTouch, may cause coronary artery vasospasm (Prinzmetal’s angina), even in patients without a history of CAD.

Perform a cardiovascular evaluation in triptan-naive patients who have multiple cardiovascular risk factors prior to receiving ZEMBRACE SymTouch. For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first dose of ZEMBRACE SymTouch in a medically supervised setting and performing an electrocardiogram (ECG) immediately following ZEMBRACE SymTouch. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of ZEMBRACE SymTouch.

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 agonists. Discontinue ZEMBRACE SymTouch if these disturbances 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. However, perform a cardiac evaluation if these patients are at high cardiac risk.

Cerebrovascular events including cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT1 agonists, and some have resulted in fatalities. Discontinue ZEMBRACE SymTouch if a cerebrovascular event occurs.

ZEMBRACE SymTouch 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 exacerbation of 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 ZEMBRACE SymTouch, particularly during co-administration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and MAO inhibitors. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Discontinue ZEMBRACE SymTouch if serotonin syndrome is suspected.

Significant elevation in blood pressure, including hypertensive crisis with acute impairment of organ systems, 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 ZEMBRACE SymTouch.

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. ZEMBRACE SymTouch 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) were injection site reactions, tingling, dizziness/vertigo, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, flushing, feeling of tightness, and numbness.

These are not all the side effects associated with ZEMBRACE SymTouch. Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions For Use). Please see Patient Information, Instructions For Use and Prescribing Information for ZEMBRACE SymTouch. To report SUSPECTED SIDE EFFECTS, call Promius Pharma at 1‑888‑966‑8766 or contact the FDA at 1-800-FDA-1088 (1‑800‑332‑1088) or online at http://www.fda.gov/Safety/MedWatch

INDICATION AND USAGE

ZEMBRACE SymTouch 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 ZEMBRACE SymTouch, reconsider the diagnosis before ZEMBRACE SymTouch is administered to treat any subsequent attacks.
  • ZEMBRACE SymTouch is not indicated for the prevention of migraine attacks.
References: 1. Matchar DB, Young WB, Rosenberg JH, et al. Evidence-based guidelines for migraine headache in the primary care setting: pharmacological management of acute attacks. https://evidencebasedpractice.osumc.edu/Documents/Guidelines/MigrainePrimaryCare.pdf. Accessed February 22, 2016. 2. Lipton RB, Stewart WF, Stone AM, Láinez MJA, Sawyer JPC. Stratified care vs step care strategies for migraine. JAMA. 2000;284:2599–2605. 3. Bigal M, Rapoport A, Aurora S, Sheftell F, Tepper S, Dahlof C. Satisfaction with current migraine therapy: experience from 3 centers in US and Sweden. Headache. 2007;47(4):475-479. 4. Migraine Patient Survey. Slide Player. http://player.slideplayer.com/3/1372890/#. Accessed December 29, 2015. 5. Newman LC. Why triptan treatment can fail: focus on gastrointestinal manifestations of migraine. Headache. 2013;53(1):11-16. 6. Beithon J, Gallenberg M, Johnson K, et al. Institute for Clinical Systems Improvement. Diagnosis and Treatment of Headache. http://www.icsi.org/_asset/qwrznq/Headache.pdf. Updated January 2013. 7. IMS Healthcare, Inc. IMS Xponent Plantrak. December 2014 to November 2015.

IMPORTANT SAFETY INFORMATION

ZEMBRACE SymTouch is contraindicated in patients with:
  • Ischemic Coronary Artery Disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) 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 (TIA) or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke
  • Peripheral vascular disease
  • Ischemic bowel disease
  • Uncontrolled hypertension
  • Recent (i.e., within 24 hours) use of ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine1 (5-HT1) agonist
  • Concurrent administration of an MAO-A inhibitor or recent (within 2 weeks) use of an 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 injection. Some of these reactions occurred in patients without known CAD. 5-HT1 agonists, including ZEMBRACE SymTouch, may cause coronary artery vasospasm (Prinzmetal’s angina), even in patients without a history of CAD.

Perform a cardiovascular evaluation in triptan-naive patients who have multiple cardiovascular risk factors prior to receiving ZEMBRACE SymTouch. For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first dose of ZEMBRACE SymTouch in a medically supervised setting and performing an electrocardiogram (ECG) immediately following ZEMBRACE SymTouch. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of ZEMBRACE SymTouch.

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 agonists. Discontinue ZEMBRACE SymTouch if these disturbances 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. However, perform a cardiac evaluation if these patients are at high cardiac risk.

Cerebrovascular events including cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT1 agonists, and some have resulted in fatalities. Discontinue ZEMBRACE SymTouch if a cerebrovascular event occurs.

ZEMBRACE SymTouch 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 exacerbation of 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 ZEMBRACE SymTouch, particularly during co-administration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and MAO inhibitors. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Discontinue ZEMBRACE SymTouch if serotonin syndrome is suspected.

Significant elevation in blood pressure, including hypertensive crisis with acute impairment of organ systems, 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 ZEMBRACE SymTouch.

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. ZEMBRACE SymTouch 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) were injection site reactions, tingling, dizziness/vertigo, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, flushing, feeling of tightness, and numbness.

These are not all the side effects associated with ZEMBRACE SymTouch. Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions For Use). Please see Patient Information, Instructions For Use and Prescribing Information for ZEMBRACE SymTouch. To report SUSPECTED SIDE EFFECTS, call Promius Pharma at 1‑888‑966‑8766 or contact the FDA at 1-800-FDA-1088 (1‑800‑332‑1088) or online at http://www.fda.gov/Safety/MedWatch

ZEMBRACE SymTouch 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 ZEMBRACE SymTouch, reconsider the diagnosis before ZEMBRACE SymTouch is administered to treat any subsequent attacks.
  • ZEMBRACE SymTouch is not indicated for the prevention of migraine attacks.