Uses
Vascular Headaches
Acute treatment of migraine attacks with or without aura.
Not recommended for management of hemiplegic or basilar migraine or for prophylaxis of migraine.
Safety and efficacy not established for management of cluster headaches.
Dosage and Administration
Administration
Oral Administration
Administer orally with fluids without regard to meals.
Dosage
Available as frovatriptan succinate; dosage is expressed in terms of frovatriptan.
Adults
Vascular Headaches
Migraine
Oral
2.5 mg as a single dose. Higher dosages provide no additional benefit but may increase risk of adverse effects.
If headache recurs, additional doses may be administered at intervals of ≥2 hours, up to a maximum dosage of 7.5 mg in any 24-hour period.
If patient does not respond to first dose, additional doses are unlikely to provide benefit for the same headache.
Prescribing Limits
Adults
Vascular Headaches
Migraine
Oral
Maximum 7.5 mg in any 24-hour period.
Safety of treating an average of >4 headaches per 30-day period has not been established.
Special Populations
Dosage in Hepatic Impairment
No dosage adjustment required in patients with mild to moderate hepatic impairment; not studied in patients with severe hepatic impairment.
Cautions
Contraindications
- Known or suspected ischemic heart disease (e.g., angina pectoris, history of MI, documented silent ischemia).
- Coronary artery vasospasm (e.g., Prinzmetal variant angina).
- Other serious underlying cardiovascular disease (e.g., uncontrolled hypertension).
- Cerebrovascular syndromes (e.g., stroke syndrome, TIAs).
- Peripheral vascular ischemia (e.g., ischemic bowel disease).
- Hemiplegic or basilar migraine.
- Treatment within previous 24 hours with another 5-HT1 receptor agaonist or an ergot alkaloid. (See Specific Drugs under Interactions.)
- Known hypersensitivity to frovatriptan or any ingredient in the formulation.
Warnings/Precautions
Warnings
Use only in patients in whom a clear diagnosis of migraine has been established.
If first migraine attack treated with frovatriptan fails to respond to the drug, reconsider diagnosis before administering frovatriptan to treat subsequent attacks.
Cardiac Effects
Risk of myocardial ischemia and/or infarction, coronary vasospasm, life-threatening cardiac rhythm disturbances, and death with use of 5-HT1 receptor agonists.
Use not recommended in patients with known or suspected ischemic or vasospastic heart disease or in patients in whom unrecognized CAD is likely (e.g., postmenopausal women; men >40 years of age; patients with risk factors such as hypertension, hypercholesterolemia, smoking, obesity, diabetes, or family history of CAD) unless there is satisfactory evidence from prior cardiovascular evaluation that patient does not have CAD, ischemic heart disease, or other underlying cardiovascular disease.
Administer initial dose to patients with risk factors for CAD who have completed satisfactory cardiovascular evaluation under medical supervision (e.g., in clinician’s office, possibly followed by ECG) unless patient previously received the drug.
Periodic cardiovascular evaluation recommended in patients with risk factors for CAD if receiving intermittent long-term therapy.
Patients with symptoms suggestive of angina after receiving frovatriptan should be evaluated for presence of CAD or predisposition to Prinzmetal variant angina before receiving additional doses.
Cerebrovascular Events
Possible cerebral or subarachnoid hemorrhage, stroke, and other cerebrovascular events, sometimes fatal, with use of 5-HT1 receptor agonists.
Risk of certain cerebrovascular events (e.g., stroke, hemorrhage, TIA) may be increased in patients with migraine.
Other Cardiovascular or Vasospastic Effects
Peripheral vascular ischemia and colonic ischemia with abdominal pain and bloody diarrhea reported with use of 5-HT1 receptor agonists. Further evaluation recommended if signs or symptoms of decreased arterial flow (e.g., ischemic colitis, Raynaud’s phenomenon) occur following administration.
Substantial increases in BP, including hypertensive crises, reported rarely with 5-HT1 receptor agonists in patients with or without history of hypertension; transient increases in BP observed following administration of recommended dosage of frovatriptan (2.5 mg) in geriatric patients.
Increases in mean pulmonary artery pressure observed following administration of a 5-HT1 receptor agonist to patients with suspected CAD who were undergoing cardiac catheterization.
Serotonin Syndrome
Potentially life-threatening serotonin syndrome reported during concurrent therapy with 5-HT1 receptor agonists (“triptans”) and SSRIs or selective serotonin- and norepinephrine-reuptake inhibitors (SNRIs). Symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile BP, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or GI symptoms (e.g., nausea, vomiting, diarrhea). (See Specific Drugs under Interactions.)
General Precautions
Ocular Effects
Possible accumulation of frovatriptan and/or its metabolites in melanin-rich tissues (e.g., eye) over time, resulting in potential toxicity in these tissues with extended use.
Specific Populations
Pregnancy
Category C.
Lactation
Distributed into milk in rats; not known whether distributed into milk in humans. Caution advised if frovatriptan is used.
Pediatric Use
Safety and efficacy not established in children <18 years of age; use not recommended.
Geriatric Use
Insufficient experience in patients ≥65 years of age to determine whether they respond differently than younger adults. (See Special Populations under Pharmacokinetics.)
Hepatic Impairment
Use with caution in patients with mild to moderate hepatic impairment. (See Special Populations under Pharmacokinetics.)
Not studied in patients with severe hepatic impairment.
Common Adverse Effects
Dizziness, fatigue, headache, paresthesia, flushing, dry mouth, hot or cold sensation, skeletal pain, dyspepsia, chest pain, somnolence, nausea.
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