Sumatriptan

IMITREX injection is indicated in adults for the acute treatment of migraine, with or without aura, and the acute treatment of cluster headache. Limitations of Use • Use only if a clear diagnosis of migraine or cluster headache has been established. If a patient has no response to the first migraine or cluster headache attack treated with IMITREX injection, reconsider the diagnosis before IMITREX injection is administered to treat any subsequent attacks. • IMITREX injection is not indicated for the prevention of migraine or cluster headache attacks. IMITREX injection is a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for: • Acute treatment of migraine with or without aura in adults. • Acute treatment of cluster headache in adults. Limitations of Use • Use only if a clear diagnosis of migraine or cluster headache has been established.

Sumatriptan binds with high affinity to human cloned 5-HT 1B / 1D receptors. Sumatriptan presumably exerts its therapeutic effects in the treatment of migraine and cluster headaches through agonist effects at the 5-HT 1B / 1D receptors on intracranial blood vessels and sensory nerves of the trigeminal system, which result in cranial vessel constriction and inhibition of pro‑inflammatory neuropeptide release.

• For subcutaneous use only. • Acute treatment of migraine: single dose of 4 mg or 6 mg. • Acute treatment of cluster headache: single dose of 6 mg. • Maximum dose in a 24-hour period: 12 mg, separate doses by at least 1 hour. • The needle shield of the prefilled syringe contains dry natural rubber (a latex derivative) which may cause allergic reactions in latex-sensitive patients.

IMITREX injection is contraindicated in patients with: • Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or 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 transient ischemic attack (TIA) or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke [s ee Warnings and Precautions ]. • Peripheral vascular disease. • Ischemic bowel disease. • Uncontrolled hypertension.

• Myocardial ischemia/infarction and Prinzmetal’s angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors. • Arrhythmias: Discontinue IMITREX if occurs. • Chest/throat/neck/jaw pain, tightness, pressure, or heaviness: Generally not associated with myocardial ischemia, evaluate for coronary artery disease in patients at high risk. • Cerebral hemorrhage, subarachnoid hemorrhage, and stroke: Discontinue IMITREX if occurs. • Gastrointestinal ischemic reactions and peripheral vasospastic reactions: Discontinue IMITREX if occurs. • Medication overuse headache: Detoxification may be necessary. • Serotonin syndrome: Discontinue IMITREX if occurs. • Seizures: Use with caution in patients with epilepsy or a lowered seizure threshold.

The following serious adverse reactions are described below and elsewhere in the labeling: • Myocardial ischemia, myocardial infarction, and Prinzmetal’s angina • Arrhythmias • Chest, throat, neck, and/or jaw pain/tightness/pressure • Cerebrovascular events • Other vasospasm reactions • Medication overuse headache • Serotonin syndrome • Increase in blood pressure • Hypersensitivity reactions • Seizures Most common adverse reactions (≥5% and >placebo) were injection site reactions, tingling, dizziness/vertigo, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, flushing, feeling of tightness, and numbness.

Ergot-Containing Drugs Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Because these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and IMITREX injection within 24 hours of each other is contraindicated.

Store between 2° and 30°C (36° and 86°F). Protect from light.