ZEMBRACE SYMTOUCH Rx
Generic Name and Formulations:
Sumatriptan (as succinate) 3mg/0.5mL; soln for SC inj.
Promius Pharma, LLC
Indications for ZEMBRACE SYMTOUCH:
Acute treatment of migraine with or without aura.
Limitations Of use:
Confirm diagnosis; reconsider if no response after treatment. Not for prevention of migraine attacks.
≥18yrs: 3mg by SC inj. Reevaluate if no response. Max cumulative dose: 12mg in 24hrs with each dose separated by at least 1hr. May also be given at least 1hr following another sumatriptan product.
<18yrs: not recommended.
Ischemic coronary artery disease (CAD) (eg, angina, history of MI, silent ischemia). Coronary artery vasospasm (including Prinzmetal's angina). Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders. History of stroke or TIA. History of hemiplegic or basilar migraine. Peripheral vascular disease. Ischemic bowel disease. Uncontrolled hypertension. Within 24hrs of ergot-type drugs (eg, methysergide, dihydroergotamine) or other 5-HT1 agonists. During or within 2 weeks of an MAO-A inhibitor. Severe hepatic impairment.
Avoid excessive use. Exclude underlying neurologic or cardiovascular disease, supervise 1st dose, and consider monitoring ECG in patients with multiple risk factors (eg, increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD). Monitor BP, cardiovascular function in long-term intermittent use. Discontinue if serious arrhythmias or cerebrovascular events occur or if serotonin syndrome is suspected. Peripheral or GI vascular ischemia and infarction following other 5-HT1 agonists. History, or risk of seizures. Elderly. Pregnancy (Cat.C). Nursing mothers (avoid nursing for 12 hours after treatment).
Selective 5-HT1B/1D receptor agonist.
Ergotamines, other 5-HT1 agonists, MAO-A inhibitors: see Contraindications. Increased risk of serotonin syndrome with SSRIs, SNRIs, tricyclics, or MAO inhibitors.
Inj site reactions, tingling, dizziness/vertigo, warm/hot/burning sensation, feeling of heaviness/tightness, pressure sensation, flushing, numbness; medication overuse headache; rare: serious cardiac and cerebrovascular events (including fatalities), vision loss, hypertensive crisis, hypersensitivity reactions.
Single-dose autoinjector (prefilled)—4