About Cluster Headaches

An estimated half a million Americans may have Cluster Headaches

Almost 80% of them may be misdiagnosed1*

*Data from the United States Cluster Headache Survey, an Internet-based survey conducted in 2008, involving 1134 patients with cluster headache
†Data from an Internet-based survey of 789 respondents

Cluster headaches and migraines may share some of the same symptoms

In a survey, a number of migraine symptoms have also been reported to occur in patients experiencing cluster headache

The occurence of these migraine symptoms in cluster may be responsible for the high number of misdiagnoses

SUMAVEL® DosePro® provided fast pain relief to cluster headache patients

Cluster headache patients achieving pain relief within 15 minutes3*

n = Number of headaches treated

Significant headache relief within 10 or 15 minutes. In 2 separate studies, significantly more patients achieved headache relief (no/mild pain) with sumatriptan injection than patients taking placebo, 49% vs 10-25% (P<0.05) at 10 minutes and 74-75% vs 26-35% (P<0.05) at 15 minutes3*.

*The efficacy of sumatriptan injection in the acute treatment of cluster headache was demonstrated in 2 randomized, double-blind, placebo-controlled, 2-period crossover trials. Patients aged 21 to 65 years were enrolled and were instructed to treat a moderate to very severe headache within 10 minutes of onset. Pain-free response was defined as a reduction in headache severity to no pain. Headache relief was defined as a reduction in headache severity to mild or no pain3.

INDICATION and Usage

SUMAVEL® DosePro® (sumatriptan injection) is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache.

Limitations of Use:

  • Use only if a clear diagnosis of migraine or cluster headache has been established.
  • If a patient has no response to the first migraine attack treated with SUMAVEL® DosePro®, reconsider the diagnosis of migraine before SUMAVEL® DosePro® is administered to treat any subsequent attacks.
  • SUMAVEL® DosePro® is not indicated for the prevention of migraine attacks.
IMPORTANT SAFETY INFORMATION about SUMAVEL® DosePro®

SUMAVEL® DosePro® is contraindicated in patients with:

  • Ischemic coronary artery disease (CAD) (e.g. 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, transient ischemic attack (TIA) because these patients are at a higher risk of stroke
  • History of hemiplegic or basilar migraine
  • Peripheral vascular disease
  • Ischemic bowel disease
  • Uncontrolled hypertension
  • Recent use (i.e., within 24 hours) of another 5-HT1 agonist, and ergotamine-containing or ergot-type medication such as dihydroergotamine (DHE) or methysergide
  • Concurrent use of an MAO-A inhibitor or recent (within 2 weeks) use of an MAO-A inhibitor
  • Hypersensitivity to SUMAVEL® DosePro® (angioedema and anaphylaxis seen)

There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of SUMAVEL® DosePro®. SUMAVEL® DosePro® may cause coronary artery vasospasm (Prinzmetal’s angina). These types of reactions have occurred in some patients without known CAD.

For triptan-naïve patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administrating the first SUMAVEL® DosePro® dose in a medically-supervised setting and performing an electrocardiogram (ECG) immediately following SUMAVEL® DosePro® administration. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of SUMAVEL® DosePro®.

Life-threatening arrhythmias have been reported within a few hours following the administration of 5-HT1 agonists. Discontinue SUMAVEL® DosePro® if these disturbances occur.

Sensations of tightness, pain, pressure, and heaviness have been reported in the chest, throat, neck, and jaw after treatment with SUMAVEL® DosePro® and are usually non-cardiac in origin.

Cerebrovascular events, some fatal; non-coronary vasospastic reactions such as peripheral or gastrointestinal vascular ischemia and Raynaud’s syndrome; and increases in blood pressure have been reported in patients treated with 5-HT1 agonists. Monitor blood pressure in patients treated with SUMAVEL® DosePro®.

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 SUMAVEL® DosePro® particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and monoamine oxidase (MAO) inhibitors. Discontinue SUMAVEL® DosePro® if serotonin syndrome is suspected.

In controlled clinical trials with sumatriptan injection, the 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.

INDICATION and Usage

SUMAVEL® DosePro® (sumatriptan injection) is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache.

Limitations of Use:

IMPORTANT SAFETY INFORMATION about SUMAVEL® DosePro®

 

SUMAVEL® DosePro® is contraindicated in patients with:

  • Ischemic coronary artery disease (CAD) (e.g. 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, transient ischemic attack (TIA) because these patients are at a higher risk of stroke
  • History of hemiplegic or basilar migraine
  • Peripheral vascular disease
  • Ischemic bowel disease
  • Uncontrolled hypertension
  • Recent use (i.e., within 24 hours) of another 5-HT1 agonist, and ergotamine-containing or ergot-type medication such as dihydroergotamine (DHE) or methysergide
  • Concurrent use of an MAO-A inhibitor or recent (within 2 weeks) use of an MAO-A inhibitor
  • Hypersensitivity to SUMAVEL® DosePro® (angioedema and anaphylaxis seen)

There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of SUMAVEL® DosePro®. SUMAVEL® DosePro® may cause coronary artery vasospasm (Prinzmetal’s angina). These types of reactions have occurred in some patients without known CAD.

For triptan-naïve patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administrating the first SUMAVEL® DosePro® dose in a medically-supervised setting and performing an electrocardiogram (ECG) immediately following SUMAVEL® DosePro® administration. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of SUMAVEL® DosePro®.

Life-threatening arrhythmias have been reported within a few hours following the administration of 5-HT1 agonists. Discontinue SUMAVEL® DosePro® if these disturbances occur.

Sensations of tightness, pain, pressure, and heaviness have been reported in the chest, throat, neck, and jaw after treatment with SUMAVEL® DosePro® and are usually non-cardiac in origin.

Cerebrovascular events, some fatal; non-coronary vasospastic reactions such as peripheral or gastrointestinal vascular ischemia and Raynaud’s syndrome; and increases in blood pressure have been reported in patients treated with 5-HT1 agonists. Monitor blood pressure in patients treated with SUMAVEL® DosePro®.

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 SUMAVEL® DosePro® particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and monoamine oxidase (MAO) inhibitors. Discontinue SUMAVEL® DosePro® if serotonin syndrome is suspected.

In controlled clinical trials with sumatriptan injection, the 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.

 

References:
1. Rozen TD, Fishman RS. Cluster headache in the United States of America: demographics, clinical characteristics, triggers, suicidality, and personal burden. Headache. 2012; 52(1):99-113. 2. Klapper JA, Klapper A, Voss T. The misdiagnosis of cluster headache: a nonclinic, population-based, Internet survey. Headache. 2000;40(9):730-735. 3. SUMAVEL® DosePro® [package insert]. Malvern, PA: Endo Pharmaceuticals Inc.; 2014.

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SUMAVEL® is a registered trademark of Endo International plc or one of its affiliates.
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© 2016 Endo Pharmaceuticals Inc. All rights reserved. Malvern, PA 19355
Privacy/Legal SD-03314(1)/March 2016 www.sumaveldosepro.com 1-800-462-ENDO (3636)

Rx Only
SUMAVEL® is a registered trademark of Endo International plc or one of its affiliates.
DosePro® is a registered trademark of Zogenix, Inc.
© 2016 Endo Pharmaceuticals Inc. All rights reserved. Malvern, PA 19355
Privacy/Legal SD-03313(1)/March 2016 www.sumaveldosepro.com 1-800-462-ENDO (3636)