SUMAVEL DOSEPRO Rx

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SUMAVEL DOSEPRO

Migraine and headache
Only 4 drugs may be compared at once

Generic Name and Formulations:

Sumatriptan (as succinate) 4mg/0.5mL, 6mg/0.5mL; needle-free delivery system; soln for SC inj.

Select therapeutic use:

Indications for SUMAVEL DOSEPRO:

Acute treatment of migraine or cluster headaches.

Limitations Of use:

Confirm diagnosis; reconsider if no response after treatment. Not for prevention of migraine attacks.

Adult:

≥18yrs: Cluster headache: one (6mg) DosePro SC to the abdomen or thigh only. Migraine: may use one (4mg) or (6mg) DosePro SC to the abdomen or thigh only. Reevaluate if no response. May repeat after 1 hour; max 12mg in 24 hours.

Children:

<18yrs: not recommended.

Contraindications:

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.

Warnings/Precautions:

Avoid excessive use. Exclude underlying cardiovascular disease, supervise 1st dose, and consider monitoring ECG in patients with multiple cardiovascular risk factors (eg, increased age, diabetes, hypertension, smokers, 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 vascular or colonic ischemia following other 5-HT1 agonists. History, or risk of seizures. Severe hepatic impairment: not recommended. Instruct patients on use of DosePro. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:

Ergotamines, other 5-HT1 agonists, MAO-A inhibitors: see Contraindications. Increased risk of serotonin syndrome with SSRIs, SNRIs, tricyclics, or MAO inhibitors.

Pharmacological Class:

Selective 5-HT1B/1D receptor agonist.

Adverse Reactions:

Inj site reactions, tingling, dizziness/vertigo, warm/hot or burning sensation, feeling of heaviness or tightness, pressure sensation, flushing, numbness, tight feeling in head, chest or jaw/nasal cavity/sinuses discomfort, drowsiness/sedation, headache; rare: serious cardiac and cerebrovascular events (including fatalities), hypertension, vision loss, hypersensitivity reactions.

How Supplied:

Single-dose units (prefilled)—6

SUMAVEL DOSEPRO 6 pens of 6mg/0.5ml cartons (Qty:1)

appx. price $1035.00