About SUMAVEL® DosePro®

SUMAVEL® DosePro® delivers on clinical response

Fast pain relief can start within 10 minutes.1*

(49% of patients achieved 10-minute pain relief*, vs. 25% for placebo)2†

SUMAVEL® DosePro® relieves photophobia, phonophobia, nausea, and vomiting associated with migraine episodes.2†

Patients with pain relief and relief of migraine symptoms after 1 and 2 hours of treatment2†‡

  • 81-82% of patients were nausea free at 2 hours vs 56-63% for placebo (P<0.05)2
  • SUMAVEL® DosePro® relieves photophobia, phonophobia, nausea, and vomiting associated with migraine episodes2

* Complete relief was defined as a reduction in headache severity to no pain.1

† The efficacy of SUMAVEL® DosePro® was evaluated in 2 multi-center, randomized, double blind, placebo-controlled clinical trials in patients (N=1104) with acute migraine (with or without aura). Patients aged 21 to 65 years were enrolled and instructed to treat a moderate to very severe headache within 10 minutes of onset with a dose of 6 mg SUMAVEL® DosePro®. Headache relief was defined as a reduction in headache severity to mild or no headache.

‡ Pain-free response was defined as a reduction in headache severity to no pain.2

§ A successful outcome in terms of clinical disability was defined prospectively as ability to work mildly impaired or ability to work and function normally.

|| Patients may have received an additional injection of the assigned treatment 1 hour after the initial injections.2

Dosing and Administration

The maximum single recommended dose for SUMAVEL® DosePro® for the acute treatment of migraines or cluster headaches is 6mg given subcutaneously (under the skin).

The maximum cumulative injected dose that may be given in 24 hours is 12mg, with doses of SUMAVEL® DosePro® separated by at least one hour. SUMAVEL® DosePro® may be given at least one hour following dose of another sumatriptan product. A second dose should only be considered if some response to the first dose was observed.2

Snap the tip off firmly

Flip the green lever down to get it ready

Pinch your stomach or thigh and PRESS against your skin to deliver the medicine

Self-administration to sites on the abdomen or the thigh with an adequate subcutaneous thickness to accommodate penetration of sumatriptan injection into the subcutaneous space. Administration should not be made within 2 inches of the navel. SUMAVEL® DosePro® is not to be administered to other areas of the body, including the arm.

  • 98% of patients correctly used SUMAVEL® DosePro® on their first try during migraine attacks by following the Instructions for Use3
    • Based on 52 patients in an open-label usability study
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. Cady RK, Wendt JK, Kirchner JR, Sargent JD, Rothrock JF, Skaggs H. Treatment of acute migraine with subcutaneous sumatriptan. JAMA. 1991;265:2831-2835 2. SUMAVEL® DosePro® [package insert]. Malvern, PA: Endo Pharmaceuticals Inc. 3. 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)