Frovatriptan

Frovatriptan binds with high affinity to 5-HT 1B/1D receptors. The therapeutic activity of frovatriptan is thought to be due to the agonist effects at the 5-HT 1B/1D receptors on intracranial blood vessels (including the arterio-venous anastomoses) and sensory nerves of the trigeminal system which result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release.

• Frovatriptan succinate tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use • Use only if a clear diagnosis of migraine has been established.ICD-10: G43.909

• Frovatriptan succinate tablets are contraindicated in patients with: • Ischemic coronary artery disease (CAD) (e.g., angina pectoris, history of myocardial infarction, or documented silent ischemia), or coronary artery vasospasm, including Prinzmetal’s angina [see Warnings and Precautions ( 5.1 )]. • Wolff-Parkinson-White Syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see Warnings and Precautions ( 5.2 )].contraindicated

Dosing Information The recommended dose is a single tablet of frovatriptan succinate (frovatriptan 2.5 mg) taken orally with fluids. If the migraine recurs after initial relief, a second tablet may be taken, providing there is an interval of at least 2 hours between doses. The total daily dose of frovatriptan succinate tablets should not exceed 3 tablets (3 × 2.5 mg per 24-hour period). There is no evidence that a second dose of frovatriptan succinate tablets is effective in patients who do not respond to a first dose of the drug for the same headache. The safety of treating an average of more than 4 migraine attacks in a 30-day period has not been established. • 1 tablet taken with fluids. Second tablet may be taken 2 hours after initial dose if headache recurs following initial relief. Total dose not to exceed 3 tablets in any 24-hour period ( 2 )

• Myocardial ischemia/infarction or Prinzmetal’s angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors ( 5.1 ) • Arrhythmias: Discontinue frovatriptan succinate if occurs ( 5.2 ) • Chest/throat/neck/jaw pain, tightness, pressure, or heaviness: Generally not associated with myocardial ischemia; evaluate high risk patients for coronary artery disease ( 5.3 ) • Cerebral hemorrhage, subarachnoid hemorrhage, and stroke: Discontinue frovatriptan succinate if occurs ( 5.4 ) • Gastrointestinal ischemic reactions and peripheral vasospastic reactions: Discontinue frovatriptan succinate if occurs (5.5) • Medication overuse headache: Detoxification may be necessary ( 5.6 ) • Serotonin syndrome: Discontinue frovatriptan succinate if occurs ( 5.7 , 7.3 ) 5.1 Myocardial Ischemia, Myocardial Infarction, and Prinzmetal’s Angina Frovatriptan succinate tablets are contraindicated 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 frovatriptan. Some of these reactions occurred in patients without known CAD. Frovatriptan 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 (e.g., increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving frovatriptan.

The following serious adverse reactions are described elsewhere in other sections of the labeling: • Myocardial Ischemia, Myocardial Infarction, and Prinzmetal’s Angina [see Warnings and Precautions ( 5.1 )] • Arrhythmias [see Warnings and Precautions ( 5.2 )] • Chest, Throat, Neck, and/or Jaw Pain/Tightness/Pressure [see Warnings and Precautions ( 5.3 )] • Cerebrovascular Events [see Warnings and Precautions ( 5.4 )] • Other Vasospasm Reactions [see Warnings and Precautions ( 5.5 )] • Medication Overuse Headache [see Warnings and Precautions ( 5.6 )] • Serotonin Syndrome [see Warnings and Precautions ( 5.7 )] • Increases in Blood Pressure [see Warnings and Precautions ( 5.8 )] • Hypersensitivity Reactions [see Contraindications ( 4 ) and Warnings and Precautions ( 5.8 )] • Most common adverse reactions (≥2% and >placebo) were dizziness, headache, paresthesia, dry mouth, dyspepsia, fatigue, hot or cold sensation, chest pain, skeletal pain, and flushing ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Frovatriptan was evaluated in four randomized, double-blind, placebo-controlled, short-term trials.

• Pregnancy: Based on animal data, may cause fetal harm ( 8.1 ) 8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of frovatriptan 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 [see Animal Data] . In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The reported rate of major birth defects among deliveries to women with migraine ranged from 2.2% to 2.9% and the reported rate of miscarriage was 17%, which were similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data have suggested that women with migraines may be at increased risk of preeclampsia during pregnancy.

Metabolism

The pharmacokinetics of frovatriptan are similar in migraine patients and healthy subjects. Absorption Mean maximum blood concentrations (C max ) in patients are achieved approximately 2 to 4 hours after administration of a single oral dose of frovatriptan 2.5 mg.

The elimination half-life of frovatriptan is 26 hours [ see Clinical Pharmacology ( 12.3 ) ]. Therefore, monitoring of patients after overdose with frovatriptan should continue for at least 48 hours or while symptoms or signs persist. There is no specific antidote to frovatriptan. It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of frovatriptan.

• Mar 11, 2016ANDAANDA204730Glenmark Pharms Ltd
• Nov 6, 2018ANDAANDA211292Amneal Pharms Co
• Apr 6, 2022ANDAANDA213891Renata

1. 1Off Label Use24734%
2. 2Headache23932%
3. 3Drug Ineffective For Unapproved Indication22130%
4. 4Drug Ineffective19927%
5. 5Hypersensitivity19026%
6. 6Drug Intolerance18926%
7. 7Swelling Face18325%
8. 8Swollen Tongue18325%
9. 9Angioedema18125%
10. 10Dysphonia18024%
11. 11Migraine12217%
12. 12Product Use In Unapproved Indication10915%
13. 13Nausea9913%
14. 14Dyspnoea8512%
15. 15Diarrhoea7710%

The 10 most recently updated of 32 ClinicalTrials.gov registrations naming Frovatriptan as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Neck Rescue Access Comparison
  Enrolling by invitation · Interventional · 30 enrolled · Insel Gruppe AG, University Hospital Bern
  NCT07368179updated 2026-02-06
• Standard Versus Flexible Tip Bougie for Videolaryngoscopy
  Completed · Interventional · 160 enrolled · University Hospitals Coventry and Warwickshire NHS Trust
  NCT04973176updated 2025-05-13
• Management of Non-Organic Dysphonia in Adults.
  Recruiting · Interventional · 60 enrolled · Sohag University
  NCT06856785updated 2025-03-04
• Treatments of Migraine with Triptans in Individuals with Elevated Cardiovascular Risk and in Pregnant Women
  Completed · Observational · 68,419 enrolled · Mayo Clinic
  NCT05854992updated 2024-12-02
• Scheimpflug Versus Placido-disc System in Evaluation of Corneal Higher-Order Aberrations
  Not yet recruiting · Observational · 36 enrolled · Assiut University
  NCT06278220updated 2024-02-28
• Safety and Tolerability of Frovatriptan to Prevention of Menstrually Associated Migraine (MAM) Headaches
  Completed · Phase 3 · Interventional · 550 enrolled · Endo USA Inc., a Keenova Therapeutics Company
  NCT01035983updated 2024-01-02
• A Randomized Trial of Frovatriptan for the Intermittent Prevention of Menstrual Migraine
  Completed · Phase 3 · Interventional · 579 enrolled · Endo USA Inc., a Keenova Therapeutics Company
  NCT00644033updated 2024-01-02
• A Controlled Trial to Investigate the Efficacy and Safety of Frovatriptan to Prevent Menstrual Migraine
  Completed · Phase 3 · Interventional · 500 enrolled · Endo USA Inc., a Keenova Therapeutics Company
  NCT00475514updated 2024-01-02
• Pediatric Neck Rescue Access Comparison
  Completed · Interventional · 30 enrolled · Insel Gruppe AG, University Hospital Bern
  NCT05499273updated 2023-03-09
• The Comparison of the Success Rate of the Endotracheal Intubation Between the Stylet and the Frova With Acute Angled Videolaryngoscope
  Unknown · Interventional · 166 enrolled · Yonsei University
  NCT03962374updated 2022-12-06

Frequently asked questions

How does Frovatriptan work?

Frovatriptan binds with high affinity to 5-HT 1B/1D receptors. The therapeutic activity of frovatriptan is thought to be due to the agonist effects at the 5-HT 1B/1D receptors on intracranial blood vessels (including the arterio-venous anastomoses) and sensory nerves of the trigeminal system which result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release.

What is Frovatriptan used for?

According to FDA labeling, Frovatriptan carries indications including: Frovatriptan succinate tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use • Use only if a clear diagnosis of migraine has been established.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Frovatriptan?

Frovatriptan is classified as Selective serotonin (5HT1) agonists, Serotonin-1b and Serotonin-1d Receptor Agonist, Serotonin 1b Receptor Agonists, Serotonin 1d Receptor Agonists, Serotonin Agonists, Cerebral Arterial Vasoconstriction, Increased Central Nervous System Serotonin Activity.

What are the brand names for Frovatriptan?

Frovatriptan is marketed under brand names including Frova.

What are the contraindications for Frovatriptan?

Frovatriptan labeling lists contraindications including: Frovatriptan succinate tablets are contraindicated in patients with: • Ischemic coronary artery disease (CAD) (e.g., angina pectoris, history of myocardial infarction, or documented silent ischemia), or coronary artery vasospasm, including Prinzmetal’s angina [see Warnings and Precautions ( 5.1 )]. • Wolff-Parkinson-White Syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see Warnings and Precautions ( 5.2 )].. Always consult the full prescribing information and a clinician.