Zogenix Launches Improved Migraine Toolbox in Conjunction With National Migraine Awareness Month
The Migraine Toolbox reinforces the role of SUMAVEL® DosePro® Needle-free Delivery System (sumatriptan injection) in treating specific types of migraine attacks such as those that cause patients to wake up or throw up, or require a fast-acting backup plan when migraines come on suddenly or recur. A
The updated Migraine Toolbox, which is provided to patients by their physician, is more compact for easy storage and patient use. It contains several enhancements and important patient education materials, including:
- Upgraded carrying case for patient migraine treatments
- One sample dose of SUMAVEL DosePro
- Migraine journal for tracking migraine attacks and effectiveness of treatments
- Patient education materials, including SUMAVEL DosePro product brochure, key card to access an online video demonstrating the use of SUMAVEL DosePro, and a reminder card outlining how to use the product
Pharmacy convenience materials, including co-pay information and
$15product card to simplify pharmacy experience
In a survey of more than 1,500 people using SUMAVEL DosePro, 3 out of 4 patients would recommend other migraine sufferers talk to their doctor about SUMAVEL DosePro.2 Migraine pain relief can start within 10 minutes with SUMAVEL DosePro (16 percent of patients vs. 4 percent for placebo), with studies demonstrating that 82% of patients achieved pain relief at 2 hours (vs. 35 percent with placebo) and 64 percent of patients were pain free within 2 hours (vs. 15 percent with placebo)3.
In controlled clinical trials with sumatriptan injection, the most common adverse reactions were injection site reactions, tingling, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, feeling of tightness, numbness, feeling strange, tight feeling in head, flushing, tightness in chest, discomfort in nasal cavity/sinuses, jaw discomfort, dizziness/vertigo, drowsiness/ sedation and headache.
INDICATION and IMPORTANT LIMITATIONS
SUMAVEL DosePro (sumatriptan injection) is indicated for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache episodes.
SUMAVEL DosePro is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine and should not be administered intravenously. SUMAVEL DosePro should only be used where a clear diagnosis of migraine or cluster headache has been established. For a given attack, if a patient does not respond to the first dose of SUMAVEL DosePro, the diagnosis of migraine or cluster headache should be reconsidered before administration of a second dose.
IMPORTANT SAFETY INFORMATION
SUMAVEL DosePro is contraindicated in patients with uncontrolled hypertension, in patients with history, symptoms or signs of ischemic heart disease, coronary artery vasospasm, cerebrovascular or peripheral vascular disease including ischemic bowel disease and in patients with other significant underlying cardiovascular diseases or known hypersensitivity to sumatriptan. SUMAVEL DosePro should not be given to patients in whom unrecognized coronary artery disease is predicted by the presence of risk factors without a prior cardiovascular evaluation.
Serious cardiovascular events, including death, have been reported when taking sumatriptan, including patients with no findings of cardiovascular disease. Considering the extent of use of sumatriptan in patients with migraine, the incidence of these events is extremely low. Cerebrovascular events, some fatal, have been reported in patients treated with sumatriptan. In a number of cases, it appears possible that the cerebrovascular events were primary, sumatriptan having been administered in the incorrect belief the symptoms experienced were a consequence of migraine when they were not. It is important to advise patients not to administer SUMAVEL DosePro if a headache being experienced is atypical.
Do not use SUMAVEL DosePro and any ergotamine-containing or ergot-type medication within 24 hours of each other; do not use SUMAVEL DosePro and another 5-HT1 agonist (e.g. triptan) within 24 hours of each other (with the exception of a single dose of another sumatriptan product, provided the doses are separated by at least 1 hour). SUMAVEL DosePro is not generally recommended for use with MAO-A inhibitors. The development of a potentially life-threatening serotonin syndrome may occur with triptans, including treatment with SUMAVEL DosePro, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). SUMAVEL DosePro should be used during pregnancy only if the potential benefit justifies the potential risk.
In controlled clinical trials with sumatriptan injection, the most common adverse reactions were injection site reactions, tingling, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, feeling of tightness, numbness, feeling strange, tight feeling in head, flushing, tightness in chest, discomfort in nasal cavity/sinuses, jaw discomfort, dizziness/vertigo, drowsiness/sedation and headache.
For full prescribing information, go to http://www.zogenix.com/downloads/SV0468.0611_SDP_PI.pdf
For more information about SUMAVEL DosePro, please visit http://www.sumaveldosepro.com/.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and
SUMAVEL®, DosePro®, ReldayTM and ZohydroTM ER are trademarks of
Zack Kubow| The Ruth Group646.536.7020 | firstname.lastname@example.org Media Caitlin Cox| The Ruth Group646.536.7033 | email@example.com