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APO-FROVATRIPTAN is a brand name for Frovatriptan, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: APO-FROVATRIPTAN (frovatriptan tablets) is indicated for the acute treatment of migraine attacks with or without aura in adults. APO-FROVATRIPTAN is not intended for the prophylactic therapy of migraine or for the use in the management of hemiplegic, ophthalmoplegic or basilar migraine (see
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • APO-FROVATRIPTAN is recommended only for the acute treatment of migraine attacks, and should not be used prophylactically. 3 Pharmacokinetics). • The safety of treating an average of more than 4 migraine attacks in a 30 day period has not been established.
• In patients with mild to moderate controlled hypertension, patients should be treated cautiously (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular, Effects on Blood Pressure). 2 Recommended Dose and Dosage Adjustment General The recommended dosage of APO-FROVATRIPTAN is a single tablet for migraine headache with or without aura.
5 mg per day). If the headache recurs after initial relief, a second dose may be taken between 4 and 24 hours after the first dose. For a given attack, if a patient has no response to the first dose of APO-FROVATRIPTAN, the diagnosis of migraine should be reconsidered before administration of a second dose.
There is no evidence that a second dose of frovatriptan is effective in patients who do not respond to a first dose of the drug for the same headache (see 7 WARNINGS AND PRECAUTIONS, Neurologic, Cerebrovascular Events and Fatalities with 5-HT1 Agonists).
Pediatrics (< 18 years old) APO-FROVATRIPTAN (Frovatriptan Tablets) Page 6 of 35 Health Canada has not authorized an indication for pediatric use. 3 Pharmacokinetics). 3 Pharmacokinetics). APO-FROVATRIPTAN is contraindicated in patients with severe hepatic impairment (Child-Pugh grade C) due to the absence of clinical data (see 2 CONTRAINDICATIONS).
3 Pharmacokinetics). 4 Administration It is recommended that APO-FROVATRIPTAN be taken orally with fluids. Patients should be advised to read the Patient Medication Information before taking APO-FROVATRIPTAN.
1 Adverse Reaction Overview Serious cardiac events, including some that have been fatal, have occurred following the use of other 5-HT1 agonists. These events are extremely rare and most have been reported in patients with risk factors predictive of CAD.
Events reported have included coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia and ventricular fibrillation (see 2 CONTRAINDICATIONS, and 7 WARNINGS AND PRECAUTIONS, Cardiovascular).
Among more than 3000 patients with migraine who participated in premarketing clinical trials of frovatriptan tablets, no deaths or serious cardiac events related to the use of frovatriptan tablets were reported. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
Among 1554 patients treated with frovatriptan tablets in four placebo-controlled studies (Trials 1, 3, 4 and 5 in Table 2), only 1% (16) of the patients withdrew because of the treatment-emergent adverse events. 5 mg at an incidence rate of ≥1% and more than 1% more often than placebo, in the first attack in the four placebo-controlled trials.
APO-FROVATRIPTAN (Frovatriptan Tablets) Page 14 of 35 Frovatriptan tablets are generally well tolerated. The incidence of adverse events in clinical trials did not increase when up to 2 doses were used within 24 hours. The majority of adverse events were mild or moderate and transient.
The incidence of adverse events in the four placebo- controlled clinical trials was not affected by gender, age or concomitant medications commonly used by migraine patients. There were insufficient data to assess the impact of race on the incidence of adverse events.
, Cardiovascular, Effects on Blood Pressure). 2 Recommended Dose and Dosage Adjustment General The recommended dosage of APO-FROVATRIPTAN is a single tablet for migraine headache with or without aura. 5 mg per day). If the headache recurs after initial relief, a second dose may be taken between 4 and 24 hours after the first dose.
For a given attack, if a patient has no response to the first dose of APO-FROVATRIPTAN, the diagnosis of migraine should be reconsidered before administration of a second dose. There is no evidence that a second dose of frovatriptan is effective in patients who do not respond to a first dose of the drug for the same headache (see 7 WARNINGS AND PRECAUTIONS, Neurologic, Cerebrovascular Events and Fatalities with 5-HT1 Agonists).
Pediatrics (< 18 years old) APO-FROVATRIPTAN (Frovatriptan Tablets) Page 6 of 35 Health Canada has not authorized an indication for pediatric use. 3 Pharmacokinetics). 3 Pharmacokinetics). APO-FROVATRIPTAN is contraindicated in patients with severe hepatic impairment (Child-Pugh grade C) due to the absence of clinical data (see 2 CONTRAINDICATIONS).
3 Pharmacokinetics). 4 Administration It is recommended that APO-FROVATRIPTAN be taken orally with fluids. Patients should be advised to read the Patient Medication Information before taking APO-FROVATRIPTAN. 5 OVERDOSAGE There is no direct experience of any patient taking an overdose of frovatriptan tablets.
The maximum single dose of frovatriptan given to male and female patients with migraine was 40 mg (16 times the clinical dose) and the maximum single dose given to healthy male subjects was 100 mg (40 times the clinical dose) without significant adverse events.
As with other 5-HT1 receptor agonists, there is no specific antidote for frovatriptan. The elimination half-life of frovatriptan is 26 hours. Therefore, if an overdose occurs, the patient should be monitored closely for at least 48 hours and be given any necessary symptomatic treatment.
). The safety and effectiveness of frovatriptan tablets have not been established for cluster headache, which is present in an older, predominantly male, population. 5 Post-Market Adverse Reactions). 2 Geriatrics Geriatrics (≥ 65 years old): Because migraine occurs infrequently in the elderly, clinical experience with frovatriptan tablets is limited in such patients.
3 Pharmacokinetics, Special Populations and Conditions, Geriatrics). 2 CONTRAINDICATIONS APO-FROVATRIPTAN is contraindicated: • In patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. , atherosclerotic APO-FROVATRIPTAN (Frovatriptan Tablets) Page 5 of 35 disease, congenital heart disease); • In patients with severe or uncontrolled hypertension as APO-FROVATRIPTAN may increase blood pressure; • In patients with hemiplegic, ophthalmoplegic or basilar migraine; • Within 24 hours of treatment with another 5-HT1 agonist, or an ergot-type medication like dihydroergotamine; • In patients with severe hepatic impairment (Child-Pugh grade C) as there are no data available.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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5 mg n = 1554 (%) Frovatriptan 5 mg n=99 (%) Placebo n = 838 (%) Cardiac disorders Chest pain 2 3 1 Throat tightness 2 1 0 Gastrointestinal disorders Mouth dry 3 NR 1 Dyspepsia 2 3 1 General disorders Fatigue 5 4 2 Asthenia NR 4 1 Hot or cold sensation* 3 NR 2 Rigors NR 2 1 Dysesthesia 1 NR 0 Musculoskeletal and connective tissue disorders Skeletal pain 3 NR 2 Nervous system disorders Dizziness 8 NR 5 Headache 4 NR 3 Paresthesia 4 NR 2 Hypertonia NR 4 0 Psychiatric disorders Euphoria NR 2 0 Respiratory, thoracic and mediastinal disorders Rhinitis NR 3 1 Vascular disorders Flushing 4 NR 2 *The term “sensation” encompasses adverse events described as pain, discomfort, pressure, constriction, numbness and tingling.
APO-FROVATRIPTAN (Frovatriptan Tablets) Page 15 of 35 NR:
No incidence rates of ≥1% and 1% greater than placebo. Other Frequently Observed Events in Association with Frovatriptan Tablets In the list that follows, the incidence of other reported adverse events (frequent, minimum 1/100 patients) in the four placebo-controlled trials are presented.
The incidence of each adverse event is calculated as the number of patients reporting the event at least once divided by the number of patients who used frovatriptan tablets. All adverse events reported within 48 hours of drug administration in the first attack in the four placebo-controlled trials are included, except those already listed in Table 2, those too general to be informative, those not reasonably associated with the use of the drug and those which occurred at the same or a greater incidence in the placebo group.
Events are further classified within system organ classes and enumerated in order of decreasing frequency. Cardiac disorders: palpitation Ear and labyrinth disorders: tinnitus Eye disorders: abnormal vision General disorders and administration site conditions: pain Gastrointestinal disorders: vomiting, abdominal pain, diarrhea Nervous system disorders: hypoesthesia Psychiatric disorders: insomnia, anxiety Respiratory, thoracic and mediastinal disorders: sinusitis, rhinitis Skin and subcutaneous tissue disorders: sweating increased Long-Term Safety In a long-term, open-label study where patients were allowed to treat multiple migraine attacks with frovatriptan tablets for up to 1 year, 5% (26/496) patients discontinued due to treatment- emergent adverse events.
The adverse events which occurred within 48 hours of drug administration in this long-term open- label safety study were similar to those that occurred in the placebo-controlled trials. The most frequent adverse events were: nausea, dizziness, fatigue, somnolence, headache, dyspepsia, skeletal pain, flushing and paresthesia.
3 Less Common Clinical Trial Adverse Reactions In the list that follows, the incidence of infrequent (between 1/1000 and 1/100 patients) and rare (less than 1/1000 patients) reported adverse events in the four placebo-controlled trials are presented.
All adverse events reported within 48 hours of drug administration in the first attack in the four placebo-controlled trials are included, except those already listed in Table 2, those too general to be informative, those not reasonably associated with the use of the drug and those APO-FROVATRIPTAN (Frovatriptan Tablets) Page 16 of 35 which occurred at the same or a greater incidence in the placebo group.
Events are further classified within system organ classes and enumerated in order of decreasing frequency.
Blood and lymphatic system disorders:
Infrequent: epistaxis; Rare: purpura Cardiac disorders: Infrequent: tachycardia, abnormal ECG; Rare: bradycardia Ear and labyrinth disorders: […]
The effects of hemo- or peritoneal dialysis on blood concentrations of frovatriptan are unknown. 5" on the other side. The tablets are available in blisters of 6’s and 7’s unit dose and perforated and HDPE bottles of 30’s and 3500’s count.
7 WARNINGS AND PRECAUTIONS General APO-FROVATRIPTAN should only be used where a clear diagnosis of migraine has been established. Carcinogenesis and Mutagenesis See 16 NON-CLINICAL TOXICOLOGY. Cardiovascular Discomfort in the chest, neck, throat and jaw (including pain, tightness, pressure and heaviness) have been reported after treatment with frovatriptan tablets.
Because 5-HT1 agonists may cause coronary vasospasm, patients who experience signs or symptoms suggestive of angina following dosing should be evaluated for the presence of CAD or a predisposition to variant angina before receiving additional doses, and should be monitored electrocardiographically if dosing is resumed and similar symptoms recur.
Similarly, patients who experience other symptoms or signs suggestive of decreased arterial flow, such as ischemic bowel syndrome or Raynaud’s syndrome following APO-FROVATRIPTAN administration should be evaluated for atherosclerosis or predisposition to vasospasm (see 2 CONTRAINDICATIONS).
Non-Coronary Vasospastic Events: 5-HT1 agonists may cause vasospastic reactions other than coronary artery vasospasm. Extensive post-market experience has shown the use of another 5-HT1 agonist to be associated with rare occurrences of peripheral vascular ischemia and colonic ischemia with abdominal pain and bloody diarrhea.
APO-FROVATRIPTAN (Frovatriptan Tablets) Page 8 of 35 Cardiac Events and Fatalities with 5-HT1 Agonists: Serious adverse cardiac events including acute myocardial infarction, life-threatening disturbances of cardiac rhythm and death have been reported within a few hours following the administration of 5-HT1 agonists.
Considering the extent of use of 5-HT1 agonists in patients with migraine, the incidence of these events is extremely low. APO-FROVATRIPTAN should be discontinued if any cardiac disturbances occur.
Risk of Myocardial Ischemia and/or Infarction and other Adverse Cardiac Events:
Frovatriptan tablets have been associated with transient chest and/or neck pain and tightness which may resemble angina pectoris. Following the use of other 5-HT1 agonists, in rare cases, these symptoms have been identified as being the likely result of coronary vasospasm or myocardial ischemia.
Rare cases of serious coronary events or arrhythmia have occurred following use of other 5-HT1 agonists, and may therefore also occur with APO-FROVATRIPTAN. Because of the potential of this class of compounds (5-HT1B/1D agonists) to cause coronary vasospasm, […]