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.
Interactions
Appears to be metabolized principally via CYP1A2.
Does not inhibit CYP1A2, 2C9, 2C19, 2D6, 2E1, or 3A4 or MAO isoenzymes in vitro; does not induce drug metabolizing enzymes. Pharmacokinetic interaction with drugs metabolized by these isoenzymes unlikely.
Drugs Affecting Hepatic Microsomal Enzymes
Potential pharmacokinetic interaction (increased plasma frovatriptan concentrations) with concomitant use of CYP1A2 inhibitors; however, effects not considered clinically relevant.
Possible increased plasma concentrations of frovatriptan
No dosage adjustment required
Pharmacokinetics
Absorption
Bioavailability
Incompletely absorbed from GI tract; absolute bioavailability of 20 and 30% in males and females, respectively.
Peak plasma concentrations attained approximately 2–4 hours after oral administration.
Food
Food does not affect bioavailability but may delay time to peak plasma concentration by 1 hour.
Distribution
Extent
Distributes into cellular fraction of blood, principally erythrocytes (approximately 60% reversibly bound).
Animal studies indicate limited capacity to cross blood-brain barrier.
Distributed into milk in rats; not known whether distributed into milk in humans.
Plasma Protein Binding
Approximately 15%.
Elimination
Metabolism
Appears to be metabolized principally via CYP1A2 to numerous metabolites, including desmethyl frovatriptan, which exhibits lower affinity for 5-HT1B/1D receptors compared with frovatriptan.
Elimination Route
Excreted in urine (32%) and feces (62%) as unchanged drug and metabolites.
Half-life
Approximately 26 hours.
Special Populations
In patient with mild to moderate hepatic impairment, AUC is twofold higher than in healthy individuals; pharmacokinetics not studied in patients with severe hepatic impairment.
In geriatric patients, AUC is 1.5- to 2-fold higher than in younger adults; half-life and time to peak plasma concentrations unchanged.
Stability
Storage
Oral
Tablets
25°C (may be exposed to 15–30°C). Protect from moisture and light.
Actions
Binds with high affinity to 5-HT1B and 5-HT1D receptors.
Precise mechanism of action not established; may ameliorate migraine through selective constriction of certain intracranial blood vessels, inhibition of neuropeptide release, and reduced transmission in trigeminal pain pathway.
Advice to Patients
Importance of immediately informing clinician if tightness, pain, pressure, or heaviness in chest, throat, jaw, or neck occurs and of not taking frovatriptan again until evaluated by clinician.
Importance of taking frovatriptan exactly as prescribed.
Importance of providing patient a copy of manufacturer’s patient information.
Risk of dizziness or fatigue; importance of exercising caution when driving or operating machinery.
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal supplements, as well as any concomitant illnesses (e.g., cardiovascular disease).
Importance of informing patients of risk of serotonin syndrome with concurrent use of frovatriptan and an SSRI or SNRI. Importance of seeking immediate medical attention if symptoms of serotonin syndrome develop.
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.
Importance of informing patients of other important precautionary information. (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 09/2009. For the most current and up-to-date pricing information, please visit www.drugstore.com. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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