FROVA®
This product information is intended for U.S. residents only.
FROVA (frovatriptan succinate) is indicated for the acute treatment of migraine attacks with or without aura in adults. FROVA is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. The safety and effectiveness of FROVA have not been established for cluster headache, which is present in an older, predominantly male population.
The symptoms of migraines are often severe and disabling and can be accompanied by nausea, vomiting and sensitivity to light and sound. Migraines can last hours or even days.
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- Important Safety Information
- FROVA® (frovatriptan succinate) tablets is indicated for the acute treatment
of migraine attacks with or without aura in adults. FROVA is not intended for the
prophylactic therapy of migraine or for use in the management of hemiplegic or basilar
migraine. The safety and effectiveness of FROVA have not been established for cluster
headache, which is present in an older, predominantly male population.
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FROVA should only be used when a clear diagnosis of migraine has been established.
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As with other drugs in this class, FROVA should not be given to patients with ischemic
heart disease (eg, angina pectoris, history of myocardial infarction, or documented
silent ischemia), or to patients who have symptoms or findings consistent with ischemic
heart disease, coronary artery vasospasm, including Prinzmetal’s variant angina,
or other significant underlying cardiovascular disease.
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FROVA should not be given to patients with cerebrovascular syndromes including (but
not limited to) strokes of any type, as well as transient ischemic attacks.
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FROVA should not be given to patients with peripheral vascular disease including
(but not limited to) ischemic bowel disease.
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FROVA should not be given to patients with uncontrolled hypertension.
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It is strongly recommended that FROVA not be given to patients in whom unrecognized
coronary artery disease (CAD) is predicted by the presence of risk factors unless
a cardiovascular evaluation provides satisfactory clinical evidence that the patient
is reasonably free of coronary artery and ischemic myocardial disease or other significant
underlying cardiovascular disease.
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It is strongly recommended that patients who are intermittent long-term users of
5-HT agonists, including FROVA, and who have or acquire risk factors
predictive of CAD, undergo periodic cardiovascular evaluation as they continue to
use FROVA.
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The development of a potentially life-threatening serotonin syndrome may occur with
triptans, including FROVA treatment, particularly during combined use with selective
serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors
(SNRIs). If concomitant treatment with FROVA and an SSRI (eg, fluoxetine, paroxetine,
sertraline, fluvoxamine, citalopram, escitalopram) or SNRI (eg, venlafaxine, duloxetine)
is clinically warranted, careful observation of the patient is advised, particularly
during treatment initiation and dose increases.
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The most common side effects associated with the use of FROVA are dizziness, fatigue,
paresthesia, flushing, headache, dry mouth, hot or cold sensation, skeletal pain,
chest pain, and dyspepsia.
- Please see the Full Prescribing Information for FROVA.
FROVA® is a registered trademark of Vernalis Development Limited
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