Version May 2024
Migraine, moderate to severe, acute treatment:
Note: Do not use within 24 hours of an ergotamine preparation or a different triptan. Limit use to <10 days per month to avoid medication-overuse headache. Administration early in the course of a migraine attack, at the first sign of pain, may improve response to treatment. When attack is complicated by severe nausea or vomiting, a non-oral medication may be more effective (AHS [Ailani 2021]).
Oral: 2.5 mg as a single dose; if symptoms persist or return, may repeat dose after ≥2 hours. Maximum: 2.5 mg/dose; 5 mg per 24 hours (AHS [Pringsheim 2016]; Ryan 2002; Savi 2011; manufacturer's labeling).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
No dosage adjustment necessary.
Mild to moderate impairment: No dosage adjustment necessary.
Severe impairment: Use with caution (has not been studied).
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Cardiovascular: Flushing (4%), hot or cold flashes (3%), chest pain (2%), palpitations (1%)
Central nervous system: Dizziness (8%), fatigue (5%), headache (4%), paresthesia (4%), drowsiness (≥2%), anxiety (1%), dysesthesia (1%), hypoesthesia (1%), insomnia (1%), pain (1%)
Dermatologic: Diaphoresis (1%)
Gastrointestinal: Xerostomia (3%), nausea (≥2%), dyspepsia (2%), abdominal pain (1%), diarrhea (1%), vomiting (1%)
Neuromuscular & skeletal: Musculoskeletal pain (3%)
Ophthalmic: Visual disturbance (1%)
Otic: Tinnitus (1%)
Respiratory: Rhinitis (1%), sinusitis (1%)
<1%, postmarketing, and/or case reports: Abnormal dreams, abnormal gait, abnormal lacrimation, abnormal reflexes, agitation, amnesia, anaphylactoid reaction, anaphylaxis, anorexia, arthralgia, ataxia, back pain, bradycardia, bullous rash, change in bowel habits, cheilitis, chest tightness, confusion, conjunctivitis, constipation, dehydration, depersonalization, depression, dysgeusia, dysphagia, dyspnea, ECG changes, emotional lability, epistaxis, eructation, esophageal spasm, euphoria, eye pain, fever, flatulence, gastroesophageal reflux disease, hiccups, hyperacusis, hyperesthesia, hypersensitivity reaction (including angioedema), hypertonia, hyperventilation, hypocalcemia, hypoglycemia, hypotonia, increased thirst, involuntary muscle movements, jaw tightness, lack of concentration, laryngitis, leg pain, malaise, mouth edema, myalgia, myasthenia, myocardial infarction, nervousness, nocturia, osteoarthritis, otalgia, peptic ulcer, personality disorder, pharyngitis, polyuria, pruritus, purpura, renal pain, rigors, salivary gland pain, seizure, sialorrhea, significant cardiovascular event, speech disturbance, stomatitis, syncope, tachycardia, tightness in chest and throat, tongue paralysis, toothache, tremor, urinary frequency, urine abnormality, vertigo, weakness
Ischemic coronary artery disease (eg, angina pectoris, history of MI, documented silent ischemia); coronary artery vasospasm, including Prinzmetal's angina; Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders; history of stroke, transient ischemic attack, or history of hemiplegic migraine or migraine with brainstem aura; peripheral vascular disease; ischemic bowel disease; uncontrolled hypertension; recent use (within 24 hours) of another 5-HT1 agonist, an ergotamine containing or ergot-type medication (eg, dihydroergotamine, methysergide); hypersensitivity to frovatriptan or any component of the formulation.
Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Canadian labeling: Additional contraindications (not in US labeling): Cardiac arrhythmias (especially tachycardia) or valvular heart disease, significant underlying cardiovascular disease (eg, congenital heart disease, atherosclerotic disease); management of ophthalmoplegic migraine; severe hepatic impairment.
Concerns related to adverse effects:
• Anaphylactic/Anaphylactoid reactions: Anaphylaxis, anaphylactoid, and hypersensitivity reactions (including angioedema) have occurred; may be life-threatening or fatal. Use is contraindicated in patients with known hypersensitivity to frovatriptan.
• Cardiac events: Coronary artery vasospasm, transient ischemia, myocardial infarction, ventricular tachycardia/fibrillation, cardiac arrest, and death have been reported with 5-HT1 agonist administration; some events have occurred within a few hours of administration. Discontinue if these events occur. Patients who experience sensations of chest pain/pressure/tightness or symptoms suggestive of angina following dosing should be evaluated for coronary artery disease or Prinzmetal's angina before receiving additional doses; if dosing is resumed and similar symptoms recur, monitor with ECG. Use is contraindicated in patients with ischemic or vasospastic CAD and Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders.
• Cerebrovascular events: Cerebral/subarachnoid hemorrhage and stroke (some fatal) have been reported with 5-HT1 agonist administration. Use is contraindicated in patients with a history of stroke or transient ischemic attack.
• Elevated BP: Significant elevation in BP, including hypertensive crisis with acute impairment of organ systems, has also been reported on rare occasions in patients with and without a history of hypertension. Monitor BP; use is contraindicated in patients with uncontrolled hypertension.
• Headaches: Acute migraine agents (eg, triptans, opioids, ergotamine, or a combination of the agents) used for ≥10 days per month may lead to worsening of headaches (medication overuse headache); withdrawal treatment may be necessary in the setting of overuse.
• Vasospasm-related events: Peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction, splenic infarction, and Raynaud syndrome have been reported with 5-HT1 agonist administration.
• Visual effects: Partial vision loss and blindness (transient and permanent) have been reported with use of 5-HT1 agonists; a causal relationship between these events and 5-HT1 agonist administration has not been clearly determined.
Disease-related concerns:
• Coronary artery disease: Should not be given to patients who have risk factors for CAD (eg, hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of CAD, menopause, male >40 years of age) without adequate cardiac evaluation. Use is contraindicated if there is evidence of CAD or coronary artery vasospasm. Patients with suspected CAD should have cardiovascular evaluation to rule out CAD before considering use; if cardiovascular evaluation is “satisfactory,” first dose should be given in the health care provider's office (consider ECG monitoring). Periodic evaluation of cardiovascular status should be done in all patients.
• Hepatic impairment: Use with caution in severe impairment (has not been studied).
Concurrent drug therapy issues:
• Serotonin syndrome: Symptoms of agitation, confusion, hallucinations, hyper-reflexia, myoclonus, shivering, and tachycardia may occur with concomitant proserotonergic drugs (eg, SSRIs/SNRIs or triptans) or agents which reduce frovatriptan's metabolism. Concurrent use of serotonin precursors (eg, tryptophan) is not recommended. If concomitant administration with SSRIs is warranted, monitor closely, especially at initiation and with dose increases. Discontinue frovatriptan if serotonin syndrome is suspected.
Special populations:
• Older adult: Blood pressure was increased to a greater extent in elderly subjects than in younger subjects.
Other warnings/precautions:
• Appropriate use: Only indicated for treatment of acute migraine; not indicated for prevention of migraine or treatment of cluster headache. If a patient does not respond to the first dose, the diagnosis of migraine should be reconsidered; rule out underlying neurologic disease in patients with atypical headache, migraine (with no prior history of migraine), or inadequate clinical response to initial dosing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Frova: 2.5 mg
Generic: 2.5 mg
Yes
Tablets (Frova Oral)
2.5 mg (per each): $171.09
Tablets (Frovatriptan Succinate Oral)
2.5 mg (per each): $72.28 - $72.35
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Frova: 2.5 mg
Generic: 2.5 mg
Administer orally with fluids as soon as symptoms appear.
Migraine, moderate to severe, acute treatment: Acute treatment of migraine with or without aura in adults.
Menstrually associated migraines (short-term prevention)
Allegro: Brand name for frovatriptan [Germany], but also the brand name for fluticasone [Israel]
Allegro [Germany] may be confused with Allegra and Allegra-D brand names for fexofenadine and fexofenadine/pseudoephedrine, respectively, in the [US, Canada, and multiple international markets]
Substrate of CYP1A2 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Bromocriptine: May enhance the adverse/toxic effect of Serotonin 5-HT1D Receptor Agonists (Triptans). Management: Consider alternatives to this combination when possible. If combined, monitor for increased bromocriptine and triptan toxicities. Risk D: Consider therapy modification
Droxidopa: Serotonin 5-HT1D Receptor Agonists (Triptans) may enhance the hypertensive effect of Droxidopa. Risk C: Monitor therapy
Ergot Derivatives (Vasoconstrictive CYP3A4 Substrates): Serotonin 5-HT1D Receptor Agonists (Triptans) may enhance the vasoconstricting effect of Ergot Derivatives (Vasoconstrictive CYP3A4 Substrates). Risk X: Avoid combination
Monoamine Oxidase Inhibitors: Serotonin 5-HT1D Receptor Agonists (Triptans) may enhance the serotonergic effect of Monoamine Oxidase Inhibitors. This could result in serotonin syndrome. Monoamine Oxidase Inhibitors may increase the serum concentration of Serotonin 5-HT1D Receptor Agonists (Triptans). Risk X: Avoid combination
Serotonergic Agents (High Risk): Serotonin 5-HT1D Receptor Agonists (Triptans) may enhance the serotonergic effect of Serotonergic Agents (High Risk). This could result in serotonin syndrome. Management: Monitor for signs and symptoms of serotonin syndrome/serotonin toxicity (eg, hyperreflexia, clonus, hyperthermia, diaphoresis, tremor, autonomic instability, mental status changes) when these agents are combined. Risk C: Monitor therapy
Serotonin 5-HT1D Receptor Agonists (Triptans): May enhance the vasoconstricting effect of other Serotonin 5-HT1D Receptor Agonists (Triptans). Risk X: Avoid combination
Food does not affect frovatriptan bioavailability.
Outcome data following maternal use of frovatriptan during pregnancy are limited in comparison to other 5-HT1B/1D agonists (triptans) (Spielmann 2018).
Triptans relieve migraine pain by selectively binding to serotonin receptors, resulting in vasoconstriction of cranial arteries. Although the effects on uterine blood flow have not been evaluated, one case report suggests excessive use of a triptan may cause placental hypoperfusion (ACOG 2022; Viard 2021).
Treatment for migraine headaches in pregnant patients should be individualized (AHS [Ailani 2021]). Triptans are not the preferred initial treatment for acute migraine headache in pregnant patients (ACOG 2022). Until additional data are available, frovatriptan is not the preferred triptan when first-line therapy is ineffective. Triptans should be avoided in pregnant patients with cardiac disease or hypertension (ACOG 2022; CHS [Worthington 2013]).
It is not known if frovatriptan is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. Treatment for migraine headaches in lactating patients should be individualized (AHS [Ailani 2021]). Withholding breastfeeding for 24 hours after the maternal dose will minimize infant exposure via breast milk. The decision to withhold breastfeeding following a dose of frovatriptan should be part of a shared decision-making process (ACOG 2022).
Headache severity, blood pressure, signs/symptoms suggestive of angina; perform a cardiovascular evaluation in triptan-naïve patients who have multiple cardiovascular risk factors (eg, increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD), monitor ECG with first dose in patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation and consider periodic cardiovascular evaluation in such patients if they are intermittent long-term users; signs/symptoms of serotonin syndrome and hypersensitivity reactions.
Selective agonist for serotonin (5-HT1B and 5-HT1D receptors) in cranial arteries; causes vasoconstriction and reduces sterile inflammation associated with antidromic neuronal transmission correlating with relief of migraine.
Distribution: Male: 4.2 L/kg; Female: 3 L/kg
Protein binding: ~15%
Metabolism: Primarily hepatic via CYP1A2
Bioavailability: Male: ~20%; Female: ~30%
Half-life elimination: ~26 hours
Time to peak: 2-4 hours
Excretion: Feces (62%); urine (32%)
Hepatic function impairment: In patients with mild (Child-Pugh class 5 to 6) to moderate (Child-Pugh class 7 to 9) hepatic function impairment, AUC increased 2 times that of healthy subjects.
Older adult: AUC was 1.5- to 2-fold higher in elderly subjects.
Sex: Bioavailability was higher and systemic exposure was approximately 2-fold greater in females than males.
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