About SUMAVEL® DosePro®

SUMAVEL® DosePro® delivers on clinical response

Fast pain relief can start within 10 minutes

(16% of patients vs. 4% placebo)1

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

Patients with pain relief and relief of migraine symptoms2*

  • 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 episodes

* Two randomized, double blind, placebo-controlled clinical trials (N=1104) in patients experiencing acute migraine with moderate or severe pain evaluated the efficacy and safety of SQ sumatriptan 6mg vs placebo. The primary endpoint in the clinical trials was pain relief at 2 hours. Headache or Pain Relief was defined as a reduction in pain from severe or moderately severe to mild or no headache. Patients may have received an additional injection of the assigned treatment 1 hour after the initial injections2.

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

Dosing and Administration

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

If side effects are dose limiting, a lower dose (4mg) may be used for the acute treatment of migraines. For treatment of cluster headaches, the efficacy of lower dose (4mg) has not been established.

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

  • 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.

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. 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; 2014 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.

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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.
© 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)