Adult Dosing

Acute treatment of migraine attacks with or without aura

• Start 2.5 mg PO as a single dose; if the headache recurs, take another dose at least 2 hrs after the first dose
• Max: 7.5 mg/day

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Acute treatment of migraine attacks with or without aura in adults

• Hypersensitivity to any of the ingredients of the product
• Ischemic heart disease, coronary artery vasospasm
• Significant underlying cardiovascular disease
• Cerebrovascular syndromes
• Peripheral vascular disease
• Uncontrolled hypertension
• Hemiplegic or basilar migraine
• Ischemic bowel disease
• Use within 24 hrs of treatment with ergotamine-containing or ergot-type medication
• Use of frovatriptan in conjunction, or within 24 hrs of treatment, with other 5-HT1 agonists (triptans)

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Mild-moderate impairment: No dose adjustments
• Severe impairment: Dose adjustments not defined

See Supplemental Patient Information

• Use only where a clear diagnosis of migraine has been established
• Frovatriptan should not be given when risk factors for CAD are present (e.g. hypertension, hypercholesterolemia, diabetes, strong family history of CAD, smoking, obesity, female with surgical or physiological menopause, male >40 years of age)
• Cardiovascular events may occur in patients without any cardiac history or coronary artery disease. Because of the possibility of coronary vasospasm, patients with signs or symptoms suggestive of angina should be evaluated for the presence of CAD or a predisposition to Prinzmetal’s variant angina before receiving additional doses; monitor ECG if dosing is resumed or symptoms recur
• Serious adverse cardiac events, including acute myocardial infarction, life-threatening disturbances of cardiac rhythm and death may occur within a few hours of frovatriptan administration
• Cerebral hemorrhage, subarachnoid hemorrhage, stroke, and other cerebrovascular events have been reported and some events resulted to be fatal. Patients with acute migraine may be at increased risk of certain cerebrovascular events (e.g., stroke, hemorrhage, transient ischemic attack)
• Occasional increases in blood pressure have been reported; contraindicated in patients with uncontrolled hypertension
• Peripheral vascular ischemia and colonic ischemia with abdominal pain and bloody diarrhea may occur during therapy
• Potentially life-threatening serotonin syndrome may occur during co-administration with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)

Cautions: Use cautiously in

• Hepatic impairment
• Cardiac disease risk

Supplemental Patient Information

• Caution patients about the risk of serotonin syndrome with the use of frovatriptan, especially when taken concomitantly with SSRIs or SNRIs
• Advise patients to promptly notify their physician if they become pregnant or intend to become pregnant during therapy; also advise them to report their physician if they are breastfeeding or plan to breastfeed
• Caution patients against driving vehicle or operating machinery, as frovatriptan may cause dizziness or fatigue

Frova interacts with :

	Cafergot
	D.H.E. 45
	Dihydroergotamine
	Ergomar
	Ergotamine
	Methysergide
	Migranal
	Sansert
	Smoking

Pregnancy Category:C

Breastfeeding: Safety unknown. No published data exists with frovatriptan during breastfeeding. However, due to its long half-life, a short-acting alternative drug may be preferred for nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 10 January 2011). Manufacturer advises caution while administering to a nursing woman.

• CNS: Dizziness, paresthesias, headache, dysesthesia, hypoesthesia, insomnia, anxiety, stroke, cerebral hemorrhage, subarachnoid hemorrhage, serotonin syndrome
• GI: Dry mouth, dyspepsia, vomiting, abdominal pain, diarrhea, taste perversion, intestinal ischemia
• DERM: Flushing, hot or cold sensation, increased sweating
• CV: Palpitation, severe hypertension, MI, coronary vasospasm, transient myocardial ischemia, ventricular tachycardia, ventricular fibrillation, life-threatening arrhythmias, hypertensive crisis, peripheral vascular ischemia, chest pain/pressure/tightness
• MUSC: Bone and joint pain, neck pain/pressure/tightness
• EENT: Abnormal vision, tinnitus, jaw pain/pressure/tightness
• RESP: Sinusitis, rhinitis
• MISC: Fatigue

• 5-HT receptor agonist (vasoconstrictor agent); binds with high affinity to human 5-HT1B and 5-HT1D receptors leading to cranial blood vessel constriction and inhibits excessive dilation of these vessels in migraine
• Absorbed 20% in males and 30% in females following oral administration
• Mostly metabolized by the liver; CYP450: 1A2 substrate
• Urine: 32%; feces: 62%
• Half-life: 26 hrs

US Trade Name(s)

• Frova

US Availability

Frova

• TABS: 2.5 mg

Canadian Trade Name(s)

• Frova

Canadian Availability

Frova

• TABS: 2.5 mg

UK Trade Name(s)

• Migard

UK Availability

Migard

• TABS: 2.5 mg

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Analgesics

Antimigraine Agents

Triptans (5-HT1 Receptor Agonists)

Neurologic

Antimigraine Agents

Triptans (5-HT1 Receptor Agonists)

Pricing data from www.DrugStore.com in U.S.A.

• Frova 2.5 MG TABS [Box] (ENDO PHARMACEUTICALS)
  9 mg = $299.99
  27 mg = $883.97

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Frova 2.5 MG Oral Tablet

Ingredient(s): Frovatriptan

Imprint: E;2;5

Color(s): White

Shape: Round

Size (mm): 8.00

Score: 1

Inactive Ingredient(s): lactose / cellulose, microcrystalline / silicon dioxide / sodium starch glycolate type a potato / magnesium stearate / hypromellose / polyethylene glycol 3000 / triacetin / titanium dioxide

Drug Label Author:
Endo Pharmaceuticals

DEA Schedule:
Non-Scheduled

Drug Name: Frova 2.5 MG Oral Tablet

Ingredient(s): Frovatriptan

Imprint: E;2;5

Color(s): White

Shape: Round

Size (mm): 8.00

Score: 1

Inactive Ingredient(s): lactose / cellulose, microcrystalline / silicon dioxide / sodium starch glycolate type a potato / magnesium stearate / hypromellose / polyethylene glycol 3000 / triacetin / titanium dioxide

Drug Label Author:
STAT RX USA LLC

DEA Schedule:
Non-Scheduled