frovatriptan (Rx)

Brand and Other Names:Frova, Migard
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Dosing & Uses

AdultPediatricGeriatric

Dosage Strengths

tablet

  • 2.5mg

Migraine

Indicated for acute treatment of migraine headache

2.5 mg PO at onset; may repeat after 2 hr if migraine recurs; not to exceed 7.5 mg/day

No evidence that a second dose is effective if no response seen with first dose for same headache

Safety and efficacy for treating more than 4 migraine attacks in 30-day period not established

Renal Impairment

Dose adjustment not necessary

Hepatic Impairment

Mild to moderate hepatic impairment: Dose adjustment not necessary

Severe hepatic impairment: Safety and efficacy not established

Safety and efficacy not established

Migraine: See adult dosing

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Interactions

Interaction Checker

and frovatriptan

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Adverse Effects

            1-10%

            Chest pain (>2%)

            Frequency Not Defined

            Dizziness

            Fatigue

            Flushing

            Headache

            Hot or cold sensation

            Paresthesia

            Somnolence

            Dyspepsia

            Nausea

            Xerostomia

            Skeletal pain

            Myocardial infarction and coronary artery vasospasm in patients with CAD risk factors (extremely rare)

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            Warnings

            Contraindications

            Ischemic coronary artery disease (CAD) (eg., angina pectoris, history of myocardial infarction, or documented silent ischemia), or 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 (TIA), or history of hemiplegic or basilar migraine because these patients are at higher risk of stroke

            Peripheral vascular disease

            Ischemic bowel disease

            Uncontrolled hypertension

            Recent use (ie, within 24 hr) of another 5-HT1 agonist, an ergotamine containing or ergot-type medication such as dihydroergotamine (DHE) or methysergide

            Hypersensitivity to frovatriptan succinate (angioedema and anaphylaxis seen)

            Cautions

            Clear diagnosis of migraine headache must be established

            Chest discomfort and jaw or neck tightness reported infrequently following intranasal administration (relatively common following SC injection)

            Sensations of pain, tightness, pressure, and heaviness reported in chest, throat, neck, and jaw after treatment and are usually non-cardiac in origin; however, perform a cardiac evaluation if these patients are at high cardiac risk; contraindicated in patients with CAD and those with Prinzmetal’s angina

            Overuse of acute migraine drugs (eg, ergotamine, triptans, opioids, or combination of these drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache); medication overuse headache may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks; detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary

            Significant elevation in blood pressure, including hypertensive crisis with acute impairment of organ systems, reported on rare occasions in patients treated with 5-HT1 agonists, including patients without a history of hypertension; monitor blood pressure in patients receiving therapy; contraindicated in patients with uncontrolled hypertension

            There have been reports of reactions, including anaphylaxis and angioedema, in patients receiving therapy; such reactions can be life threatening or fatal; in general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens; therapy is contraindicated in patients with a history of hypersensitivity reaction to drug

            Serotonin syndrome

            • Serotonin syndrome may occur particularly during co-administration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and monoamine oxidase (MAO) inhibitors [
            • Serotonin syndrome symptoms may include mental status changes (eg, agitation, hallucinations, coma), autonomic instability (eg, tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (eg, hyperreflexia, incoordination), and/or gastrointestinal symptoms (eg, nausea, vomiting, diarrhea)
            • The onset of symptoms usually occurs within minutes to hours of receiving a new or a greater dose of a serotonergic medication; discontinue therapy if serotonin syndrome is suspected

            Vasospasm reactions

            • Therapy may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction (presenting with abdominal pain and bloody diarrhea), splenic infarction, and Raynaud’s syndrome
            • In patients who experience symptoms or signs suggestive of a vasospastic reaction following the use of any 5-HT1 agonist, rule out a vasospastic reaction before administering therapy
            • Reports of transient and permanent blindness and significant partial vision loss reported with use of 5-HT1 agonists; since visual disorders may be part of a migraine attack, a causal relationship between these events and the use of 5-HT1 agonists have not been clearly established

            Cerebrovascular events

            • Cerebral hemorrhage, subarachnoid hemorrhage, stroke, and other cerebrovascular events reported in patients treated with 5-HT1 agonists; some have resulted in fatalities
            • In a number of cases, it appears possible that the cerebrovascular events were primary, the agonist having been administered in the incorrect belief that the symptoms experienced were a consequence of migraine, when they were not
            • Before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with symptoms atypical of migraine, other potentially serious neurological conditions need to be excluded; therapy is contraindicated in patients with a history of stroke or TIA

            Arrhythmias

            • Life-threatening disturbances of cardiac rhythm including ventricular tachycardia and ventricular fibrillation leading to death reported within a few hours following administration of 5-HT1 agonists
            • Discontinue therapy if these disturbances occur; therapy is contraindicated in patients with Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders

            Myocardial ischemia, infarction, and Prinzmetal’s angina

            • Not for use in patients with ischemic or vasospastic CAD
            • There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of therapy; some of these reactions occurred in patients without known CAD
            • Therapy may cause coronary artery vasospasm (Prinzmetal’s angina), even in patients without a history of CAD
            • 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) prior to receiving therapy
            • Do not administer therapy if there is evidence of CAD or coronary artery vasospasm
            • For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administrating first dose in a medically-supervised setting and performing an electrocardiogram (ECG) immediately following administration
            • For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of drug
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            Pregnancy & Lactation

            Pregnancy

            There are no adequate data on developmental risk associated with use in pregnant women; in animal studies, frovatriptan produced developmental toxicity (embryofetal lethality, fetal abnormalities, and decreased embryofetal growth) when administered to pregnant rats and rabbits at doses greater than those used clinically

            Published data have suggested that women with migraines may be at increased risk of preeclampsia during pregnancy

            Lactation

            There are no data on presence of frovatriptan in human milk, effects of frovatriptan on breastfed infant, or effects of on milk production; in rats, oral dosing with frovatriptan resulted in levels of frovatriptan and/or its metabolites in milk up to four times higher than in plasma

            Developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from frovatriptan or underlying maternal condition

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Selective 5-HT1 receptor agonist in cranial arteries

            Causes vasoconstriction and reduces inflammation associated with antidronic neuronal transmission associated with relief of migraine

            Pharmacokinetics

            Half-life: 26 hr

            Peak plasma time: 2-4 hr

            Metabolism: CYP1A2

            Distribution: 4.2 L/kg (male); 3 L/kg (female)

            Protein binding: 15%

            Bioavailability: 20% (male); 30% (female)

            Excretion: Feces (62%); urine (32%)

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.