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HCP Patient Expectations

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Easy to use1: Needle-free delivery in 3 simple steps

 

 

  • 98% of patients correctly used SUMAVEL® DosePro® during migraine attacks on their first try following simple instructions1*

*Based on 52 patients in an open-label usability study.

 

For administration in abdomen or thigh only. Do not use if the tip of the device is tilted or broken off upon removal from packaging. Patients should be trained by a healthcare provider prior to first use.

 

 

Prepare patients for the SUMAVEL DosePro experience by setting expectations

 

Sound

  • There is a sound upon administration similar to the opening of a soda can

Site Sensation

  • Instruct patients that some discomfort may occur upon administration
     
  • Patients should be trained by a healthcare provider prior to first use and instructed to read the patient labeling with each refill

Site Reactions

  • Mild and transient bleeding, swelling, erythema, and bruising may occur
     
  • No patients withdrew from SUMAVEL DosePro clinical trials due to these effects

Sumatriptan

  • Typical triptan sensations include transient pain, tightness, pressure, and heaviness in the chest, throat, neck, and jaw
     
  • Well characterized by over 19 years of clinical experience2

 

Most Common Adverse Reactions: 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.

 

SUMAVEL DosePro should not be used within 24 hours of other ergotamine-containing or ergot-type medications or other 5-HT1 agonists and 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.

 

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. 2. Cady RK, Wendt JK, Kirchner JR, Sargent JD, Rothrock JF, Skaggs H Jr. Treatment of acute migraine with subcutaneous sumatriptan. JAMA. 1991;265:2831-2835.

The information in this section is intended for healthcare professionals in the United States and is not intended for the general public.

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