Setting Patient Expectations
for the SUMAVEL® DosePro® Experience

Train patients on proper use and instruct them to read the patient labeling.

Sound and Experience

Upon administration, you will hear a click and feel a burst of air.

Site Reactions

A small droplet of blood might appear. Swelling, erythema, and bruising may occur.

Slight discomfort (pain, stinging/burning) may occur during administration.

No patients withdrew from clinical trials due to these effects.1

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.

Please see the full Prescribing Information.

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.

Please see the full Prescribing Information.

 

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:

  • 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.

Please see the full Prescribing Information.

 

References:
1. Brandes JL, Cady RK, Freitag FG, et al. Needle-free subcutaneous sumatriptan (Sumavel DosePro): bioequivalence and ease of use. Headache. 2009;49:1435-1444.

The information provided on this site is intended only for healthcare professionals in the United States.

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Rx Only

SUMAVEL® is a registered trademark of Endo International plc or one of its affiliates.
DosePro® is a registered trademark of Zogenix, Inc.
© 2017 Endo Pharmaceuticals Inc. All rights reserved. Malvern, PA 19355
Privacy/Legal SD-05020/May 2017 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.
© 2017 Endo Pharmaceuticals Inc. All rights reserved. Malvern, PA 19355
Privacy/Legal SD-05020/May 2017 www.sumaveldosepro.com 1-800-462-ENDO (3636)