Sumavel(TM) DosePro(TM) (sumatriptan injection) Approved by FDA for Acute Migraine and Cluster Headache: First Product Featuring Novel DosePro Needle-Free Deliv...(graine or cluster headache should be rec...)

Important Safety Information

Sumavel DosePro is contraindicated in patients with ischemic heart disease or those with symptoms consistent with ischemic heart disease. It should not be administered to patients with cerebrovascular syndromes, peripheral vascular disease or in patients with uncontrolled hypertension. Very rarely, serious cardiac adverse events 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.

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 selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors SNRIs or MAO inhibitors. Sumavel DosePro should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

The most common adverse events observed in controlled clinical trials with sumatriptan injection were injection site reactions, atypical sensations (such as feelings of tingling, warm/hot sensations), dizziness and flushing. Most side effects lasted for only a short time. In clinical trials comparing the safety and tolerability of Sumavel DosePro to sumatriptan injection, most injection site reactions resolved spontaneously, with no apparent difference between Sumavel DosePro and sumatriptan needle injection.

About DosePro technology

The DosePro technology is an easy-to-use, pre-filled drug delivery system designed to enable self-administration of single doses of liquid drug formulations, subcutaneously, without a needle. The DosePro technology has undergone more
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