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Brand Name

Frovatriptan

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FDA approval date: March 11, 2016

Classification: Serotonin-1b and Serotonin-1d Receptor Agonist

Form: Tablet

What is Frovatriptan?

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. If a patient has no response for the first migraine attack treated with frovatriptan succinate tablets, reconsider the diagnosis of migraine before frovatriptan succinate tablets are administered to treat any subsequent attacks., Frovatriptan succinate tablets are not indicated for the prevention of migraine attacks., Safety and effectiveness of frovatriptan succinate tablets have not been established for cluster headache. Frovatriptan succinate is a serotonin receptor agonist indicated for the acute treatment of migraine with or without aura in adults Limitations of Use, Use only after a clear diagnosis of migraine has been established , Not indicated for the prophylactic therapy of migraine , Not indicated for the treatment of cluster headache

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Brand Information

Frovatriptan (Frovatriptan succinate)

1INDICATIONS AND USAGE

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. If a patient has no response for the first migraine attack treated with frovatriptan succinate tablets, reconsider the diagnosis of migraine before frovatriptan succinate tablets are administered to treat any subsequent attacks.
Frovatriptan succinate tablets are not indicated for the prevention of migraine attacks.
Safety and effectiveness of frovatriptan succinate tablets have not been established for cluster headache.

2DOSAGE AND ADMINISTRATION

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 x 2.5 mg per 24-hour period).

There is no evidence that a second dose of frovatriptan succinate tablets are 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.

3DOSAGE FORMS AND STRENGTHS

Frovatriptan succinate tablets, 2.5 mg are supplied as white to off-white, round shaped, biconvex, film-coated tablets, debossed with ‘A5’ on one side and plain on other side.

4CONTRAINDICATIONS

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
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 a higher risk of stroke
Peripheral vascular disease
Ischemic bowel disease
Uncontrolled hypertension
Recent use (i.e. within 24 hours) of another 5-HT
Hypersensitivity to frovatriptan succinate (angioedema and anaphylaxis seen)

5ADVERSE REACTIONS

The following serious adverse reactions are described elsewhere in other sections of the labeling:

Myocardial Ischemia, Myocardial Infarction, and Prinzmetal’s Angina
Arrhythmias
Chest, Throat, Neck, and/or Jaw Pain/Tightness/Pressure
Cerebrovascular Events
Other Vasospasm Reactions
Medication Overuse Headache
Serotonin Syndrome
Increases in Blood Pressure
Hypersensitivity Reactions

5.1Clinical 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 succinate was evaluated in four randomized, double-blind, placebo-controlled, short-term trials. These trials involved 2,392 patients (1,554 on frovatriptan 2.5 mg and 838 on placebo). In these short-term trials, patients were predominately female (88%) and Caucasian (94%) with a mean age of 42 years (range 18 to 69). The treatment-emergent adverse events that occurred most frequently following administration of frovatriptan 2.5 mg (i.e

Table 1 lists treatment-emergent adverse events reported within 48 hours of drug administration that occurred with frovatriptan 2.5 mg at an incidence of

Table 1: Adverse Reactions Reported within 48 Hours (Incidence Patients in Four Pooled Placebo-Controlled Migraine Trials

The incidence of adverse events in clinical trials did not increase when up to 3 doses were used within 24 hours. The incidence of adverse events in 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.

Other Events Observed in Association with the Administration of frovatriptan succinate

The incidence of frequently reported adverse events in four placebo-controlled trials is presented below. Events are further classified within body system categories. Frequent adverse events are those occurring in at least 1/100 patients.

Central and peripheral nervous system: dysesthesia and hypoesthesia.

Gastrointestinal: vomiting, abdominal pain and diarrhea.

Body as a whole: pain.

Psychiatric: insomnia and anxiety.

Respiratory: sinusitis and rhinitis.

Vision disorders: vision abnormal.

Skin and appendages: sweating increased.

Hearing and vestibular disorders: tinnitus.

Heart rate and rhythm: palpitation.

5.2Postmarketing Experience

The following adverse reactions were identified during post approval use of frovatriptan succinate. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Central and peripheral nervous system: Seizure.

6OVERDOSAGE

The elimination half-life of frovatriptan is 26 hours

7DESCRIPTION

Frovatriptan succinate tablets contain frovatriptan succinate, a selective 5-hydroxy-tryptamine

The molecular formula is C

Frovatriptan succinate is a white to off-white powder that is soluble in water.

Each frovatriptan succinate tablet for oral administration contains 3.91 mg frovatriptan succinate, equivalent to 2.5 mg of frovatriptan base. Each tablet also contains following inactive ingredients: anhydrous lactose, hypromellose, lactose monohydrate, polyethylene glycol, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium starch glycolate, titanium dioxide and triacetin.

8CLINICAL STUDIES

The efficacy of frovatriptan succinate in the acute treatment of migraine headaches was demonstrated in four randomized, double-blind, placebo-controlled, short-term outpatient trials. In these trials, patients received doses of frovatriptan from 0.5 mg to 40 mg. In these controlled short-term trials, patients were predominately female (88%) and Caucasian (94%) with a mean age of 42 years (range 18 to 69). Patients were instructed to treat a moderate to severe headache. Headache response, defined as a reduction in headache severity from moderate or severe pain to mild or no pain, was assessed for up to 24 hours after dosing. The associated symptoms nausea, vomiting, photophobia, and phonophobia were also assessed. Maintenance of response was assessed for up to 24 hours post dose. In two of the trials a second dose of frovatriptan succinate was provided after the initial treatment, to treat recurrence of the headache within 24 hours. Other medication, excluding other 5-HT

In all four placebo-controlled trials, the percentage of patients achieving a headache response 2 hours after treatment was significantly greater for those taking frovatriptan 2.5 mg compared to those taking placebo (Table 2).

Lower doses of frovatriptan (1 mg or 0.5 mg) were not effective at 2 hours. Higher doses (5 mg to 40 mg) of frovatriptan showed no added benefit over 2.5 mg but did cause a greater incidence of adverse events.

Table 2: Percentage of Patients with Headache Response (Mild or No Headache) 2 Hours Following Treatment

The estimated probability of achieving an initial headache response by 2 hours following treatment is depicted in Figure 1.

Figure 1: Estimated Probability of Achieving Initial Headache Response Within 2 Hours

Figure 1 shows a Kaplan-Meier plot of the probability over time of obtaining headache response (no or mild pain) following treatment with frovatriptan 2.5 mg or placebo. The probabilities displayed are based on pooled data from the four placebo-controlled trials described in Table 2. Patients who did not achieve a response were censored at 24 hours.

In patients with migraine-associated nausea, photophobia, and phonophobia at baseline there was a decreased incidence of these symptoms in frovatriptan succinate treated patients compared to placebo.

The estimated probability of patients taking a second dose or other medication for their migraine over the 24 hours following the initial dose of study treatment is summarized in Figure 2.

Figure 2: Estimated Probability of Patients Taking a Second Dose or Other Medication for Migraine Over the 24 Hours Following the Initial Dose of Study Treatment

Figure 2 is a Kaplan-Meier plot showing the probability of patients taking a second dose or other medication for migraine over the 24 hours following the initial dose of study medication based on the data from the four placebo-controlled trials described in Table 2. The plot includes those patients who had a response to the initial dose and those who did not. The protocols did not permit remedication within 2 hours of the initial dose.

Efficacy was unaffected by a history of aura; gender; age, or concomitant medications commonly used by migraine patients.

9HOW SUPPLIED/STORAGEAND HANDLING

Frovatriptan Succinate Tablets,

They are available as follows:

Carton of 9 Tablets: NDC 69238-1539-9

(Packages of 9 unit doses, 1 card of 9 tablets each)

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Protect from moisture.

10PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Myocardial Ischemia and/or Infarction, Prinzmetal’s Angina, Other Vasospastic Reactions, and Cerebrovascular Events

Inform patients that frovatriptan succinate may cause serious cardiovascular adverse reactions such as myocardial infarction or stroke, which may result in hospitalization and even death. Although serious cardiovascular reactions can occur without warning symptoms, instruct patients to be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and instruct them to ask for medical advice when observing any indicative sign or symptoms. Instruct patients to seek medical advice if they have symptoms of other vasospastic reactions

Hypersensitivity Reactions

Inform patients that anaphylactic reactions have occurred in patients receiving frovatriptan succinate. Inform patients that such reactions can be life threatening or fatal and to seek immediate medical attention if they have anaphylactic symptoms. In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens

Medication Overuse Headache

Inform patients that use of drugs to treat acute migraines for 10 or more days per month may lead to an exacerbation of headache, and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary)

Serotonin Syndrome

Inform patients about the risk of serotonin syndrome with the use of frovatriptan succinate or other triptans, particularly during combined use with SSRIs, SNRIs, TCAs, and MAO inhibitors

Pregnancy

Advise patients to notify their healthcare provider if they become pregnant during treatment or plan to become pregnant

Lactation

Inform patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed

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11Patient Information

Frovatriptan Succinate (froe” va trip’ tan sux’ i nate) Tablets

What is the most important information I should know about frovatriptan succinate tablets?

Frovatriptan succinate tablets can cause serious side effects, including:

Heart attack and other heart problems. Heart problems may lead to death. Stop taking frovatriptan succinate tablets and get emergency medical help right away if you have any of the following symptoms of a heart attack:

discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw, or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded

Frovatriptan succinate tablets are not for people with risk factors for heart disease unless a heart exam is done and shows no problem. You have a higher risk for heart disease if you:

What are frovatriptan succinate tablets?

Frovatriptan succinate tablets are a prescription medicine used to treat migraine headaches with or without aura in adults.

Frovatriptan succinate tablets are not used to treat other types of headaches.

Frovatriptan succinate tablets are not used to prevent or decrease the number of migraine headaches.

It is not known if frovatriptan succinate tablets are safe and effective to treat cluster headaches.

It is not known if frovatriptan succinate tablets are safe and effective in children under 18 years of age.

Who should not take frovatriptan succinate tablets?

Do not take frovatriptan succinate tablets if you have:

heart problems, a history of heart problems, or problems with the electrical system of your heart.
had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation.
had hemiplegic migraines or basilar migraines. If you are not sure if you have had these types of migraines, ask your healthcare provider.
narrowing of blood vessels to your legs, arms, or stomach (peripheral vascular disease).

injury to your bowel (intestine) due to poor blood circulation (ischemic bowel disease).

uncontrolled high blood pressure.
taken any of the following medicines in the last 24 hours:

almotriptan (AXERT
eletriptan (RELPAX
naratriptan (AMERGE
rizatriptan (MAXALT
sumatriptan (IMITREX
sumatriptan and naproxen (TREXIMET
zolmitriptan (ZOMIG
ergotamine or ergotamine-type medicines (CAFERGOT

Ask your healthcare provider if you are not sure if your medicine is listed above.

an allergy to frovatriptan or any of the ingredients in frovatriptan succinate tablets. See the end of this leaflet for a complete list of ingredients in frovatriptan succinate tablets.

What should I tell my doctor before taking frovatriptan succinate tablets?

Before taking frovatriptan succinate tablets, tell your doctor about all of your medical conditions, including if you:

have high blood pressure.
have high cholesterol.
have diabetes.
have liver problems.
smoke.
are overweight.
have heart disease or a family history of heart disease or stroke.

have any allergies.

are pregnant or plan to become pregnant. It is not known if frovatriptan succinate tablets can harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if frovatriptan succinate passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take frovatriptan succinate tablets.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Frovatriptan succinate tablets and certain other medicines can affect each other, causing serious side effects.

Especially tell your doctor if you take:

ergotamine or triptan medicine
opioid pain medicine
antidepressant medicines called:

selective serotonin reuptake inhibitors (SSRIs)

serotonin norepinephrine reuptake inhibitors (SNRIs)
tricyclic antidepressants (TCAs)
monoamine oxidase inhibitors (MAOIs)

Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine.

How should I take frovatriptan succinate tablets?

Certain people should take their first dose of frovatriptan succinate tablet in their doctor’s office or in another medical setting. Ask your doctor if you should take your first dose in a medical setting.
Take frovatriptan succinate tablets exactly as your doctor tells you.
Take frovatriptan succinate tablets by mouth with fluids.
If you do not get any relief from your headache after your first frovatriptan succinate tablet, do not take a second tablet without first talking with your doctor.
If your headache comes back or you only get some relief from your headache, you may take a second frovatriptan succinate tablet if it has been at least 2 hours after the first tablet.
Do not take more than 3 frovatriptan succinate tablets in a 24-hour period.
It is not known if it is safe to take frovatriptan succinate tablets for more than 4 headaches in 30 days.
If you take too much frovatriptan succinate tablets, call your doctor or go to the nearest hospital emergency room right away.
You should write down when you have headaches and when you take frovatriptan succinate tablets so you can talk with your doctor about how frovatriptan succinate tablets are working for you.

What should I avoid while taking frovatriptan succinate tablets?

Frovatriptan succinate tablets can cause dizziness, weakness, or drowsiness. If you have these symptoms do not drive a car, use machinery, or do anything where you need to be alert.

What are the possible side effects of frovatriptan succinate tablets?

Frovatriptan succinate tablets can cause serious side effects.

See

Stroke. Stop taking frovatriptan succinate tablets and get emergency medical help right away if you have any of the following symptoms of a stroke:

Changes in color or sensation in your fingers and toes (Raynaud’s syndrome).

Stomach and intestinal problems (gastrointestinal and colonic ischemic events). Symptoms of gastrointestinal and colonic ischemic events include:

Problems with blood circulation to your legs and feet (peripheral vascular ischemia). Symptoms of peripheral vascular ischemia include:

Medication overuse headache. Some people who use too many frovatriptan succinate tablets may have worse headaches (medication overuse headache). If your headaches get worse, your doctor may decide to stop your treatment with frovatriptan succinate tablets.

Serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using frovatriptan succinate tablets, especially if frovatriptan succinate tablets are used with anti-depressant medicines called SSRIs, SNRIs, TCAs, and MAOIs. Call your doctor right away if you have any of the following symptoms of serotonin syndrome:

Increased blood pressure.

Allergic reactions. Call your doctor or get emergency medical help right away if you have symptoms of an allergic reaction, including:

The most common side effects of frovatriptan succinate tablets are:

These are not all the possible side effects of frovatriptan succinate tablets. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store frovatriptan succinate tablets?

Store frovatriptan succinate tablets at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F).
Protect frovatriptan succinate tablets from moisture.
Throw away (discard) after expiration date printed on the carton.

Keep frovatriptan succinate tablets and all medicines out of the reach of children.

General information about the safe and effective use of frovatriptan succinate tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use frovatriptan succinate tablets for a condition for which it was not prescribed. Do not give frovatriptan succinate tablets to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your doctor or pharmacist for information about frovatriptan succinate tablets that is written for health professionals.

What are the Ingredients in frovatriptan succinate tablets?

Active Ingredient: frovatriptan succinate

Inactive Ingredients: anhydrous lactose, hypromellose, lactose monohydrate, polyethylene glycol, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium starch glycolate, titanium dioxide and triacetin.

For more information, go to www.amneal.com or call 1-877-835-5472.

All trademarks are the property of their respective owners.

This Patient Information has been approved by the U.S. Food and Drug Administration.

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Rev. 09-2019-02

12PRINCIPAL DISPLAY PANEL

NDC 69238-1539-9

Frovatriptan Succinate Tablets, 2.5 mg

Rx Only

Carton of 9 Tablets

Amneal Pharmaceuticals LLC