Frovatriptan Succinate

Frovatriptan succinate tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use

• Use only if a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with frovatriptan succinate tablets, reconsider the diagnosis of migraine before frovatriptan succinate tablets are administered to treat any subsequent attacks.
• Frovatriptan succinate tablets are not indicated for the prevention of migraine attacks.
• Safety and effectiveness of frovatriptan succinate tablets have not been established for cluster headache. Frovatriptan succinate is a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults ( 1 ) Limitations of Use
• Use only after a clear diagnosis of migraine has been established ( 1 )
• Not indicated for the prophylactic therapy of migraine ( 1 )
• Not indicated for the treatment of cluster headache ( 1 )

Frovatriptan succinate tablets are contraindicated in patients with:

• Ischemic coronary artery disease (CAD) (e.g., angina pectoris, history of myocardial infarction, or documented silent ischemia), or coronary artery vasospasm, including Prinzmetal’s angina [see Warnings and Precautions ( 5.1 )].
• Wolff-Parkinson-White Syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see Warnings and Precautions ( 5.2 )].
• History of stroke, transient ischemic attack (TIA), or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke [see Warnings and Precautions ( 5.4 )].
• Peripheral vascular disease [see Warnings and Precautions ( 5.5 )].
• Ischemic bowel disease [see Warnings and Precautions ( 5.5 )].
• Uncontrolled hypertension [see Warnings and Precautions ( 5.8 )].
• Recent use (i.e., within 24 hours) of another 5-HT 1 agonist, an ergotamine containing or ergot-type medication such as dihydroergotamine (DHE) or methysergide [see Drug Interactions ( 7.1 , 7.2 )].
• Hypersensitivity to frovatriptan succinate tablets (angioedema and anaphylaxis seen) [see Warnings and Precautions ( 5.9 )].
• History of coronary artery disease or coronary artery vasospasm ( 4 )
• Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders ( 4 )
• History of stroke, transient ischemic attack, or hemiplegic or basilar migraine ( 4 )