Frovatriptan

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Do not take frovatriptan if you:

• have uncontrolled high blood pressure
• have heart disease or a history of heart disease
• have hemiplegic or basilar migraine (if you are not sure about this, ask your doctor)
• have had a stroke
• have circulation (blood flow) problems
• have taken a similar drug (a serotonin receptor agonist) in the last 24 hours. These include sumatriptan (Imitrex), naratriptan (Amerge), zolmitriptan (Zomig), rizatriptan (Maxalt), eletriptan hydrobromide (Relpax),or almotriptan (Axert)
• have taken ergotamine type medicines in the last 24 hours. These include Bellergal, Cafergot, Ergomar, Wigraine, DHE 45, or Sansert
• have any allergic reaction to frovatriptan

Frovatriptan can cause dizziness, tiredness, and tingling feeling. If you have these symptoms do not drive a car, use machinery, or do anything where you need to be alert.

Since frovatriptan is used as needed, it does not have a daily dosing schedule. Call your doctor promptly if your symptoms do not improve after using frovatriptan.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using frovatriptan and call your doctor at once if you have:

• numbness or tingling and a pale or blue-colored appearance in your fingers or toes;

• pain, heaviness, or cold feeling in your legs;

• sudden and severe stomach pain and bloody diarrhea;

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), slurred speech;

• high levels of serotonin in the body--agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting; or

• dangerously high blood pressure--severe headache, blurred vision, pounding in your neck or ears, nosebleed, anxiety, confusion, severe chest pain, shortness of breath, irregular heartbeats, seizure.

Common side effects may include:

• mild headache (not a migraine);

• feeling too warm or too cold;

• dry mouth, upset stomach;

• bone or joint pain;

• numbness or tingling;

• dizziness, tired feeling; or

• flushing (warmth, redness, or tingly feeling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Taking frovatriptan while you are using certain other medicines can cause high levels of serotonin to build up in your body, a condition called "serotonin syndrome," which can be fatal. Tell your doctor if you also use:

• medicine to treat depression;

• medicine to treat a psychiatric disorder;

• a narcotic (opioid) medication; or

• medicine to prevent nausea and vomiting.

This list is not complete. Other drugs may interact with frovatriptan, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

You should not use frovatriptan if you are allergic to it, or if you have:

• severe or uncontrolled high blood pressure;

• past or present heart problems;

• history of coronary artery disease, heart attack, or stroke, including "mini-stroke";

• Wolff-Parkinson-White syndrome or other heart rhythm disorder;

• a blood vessel disorder or circulation problems that cause a lack of blood supply within the body; or

• a headache that seems different from your usual migraine headaches.

To make sure frovatriptan is safe for you, tell your doctor if you have:

• liver or kidney disease;

• high blood pressure, a heart rhythm disorder; or

• coronary heart disease (or risk factors such as diabetes, menopause, smoking, being overweight, having high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether frovatriptan passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Frovatriptan is not approved for use by anyone younger than 18 years old.

In the U.S.

• Frova

Available Dosage Forms:

• Tablet

Therapeutic Class: Antimigraine

Pharmacologic Class: Serotonin Receptor Agonist, 5-HT1

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling tired or weak.
• Headache.
• Dry mouth.
• Flushing.
• Feeling of warmth.
• Feeling of heaviness or pressure.
• Upset stomach.
• Bone or joint pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about frovatriptan, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about frovatriptan. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using frovatriptan.

Review Date: October 4, 2017

• It is used to treat migraine headaches.

Use frovatriptan as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Take with liquids as early as you can after the attack has started.
• If your headache comes back after the first dose, 1 more dose may be taken 2 hours after the first one.

What do I do if I miss a dose?

• This medicine is taken on an as needed basis. Do not take more often than told by the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling tired or weak.
• Headache.
• Dry mouth.
• Flushing.
• Feeling of warmth.
• Feeling of heaviness or pressure.
• Upset stomach.
• Bone or joint pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Refer to adult dosing.

Analgesics (Opioid): May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Monitor therapy

Antiemetics (5HT3 Antagonists): May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Monitor therapy

Anti-Parkinson Agents (Monoamine Oxidase Inhibitor): May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Management: Monitor for signs and symptoms of serotonin syndrome/serotonin toxicity if selegiline, rasagiline, or safinamide is combined with a serotonin modulator. Use of transdermal selegiline with serotonin modulators is contraindicated. Consider therapy modification

Antipsychotic Agents: Serotonin Modulators may enhance the adverse/toxic effect of Antipsychotic Agents. Specifically, serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotic Agents may enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Monitor therapy

Dapoxetine: May enhance the adverse/toxic effect of Serotonin Modulators. Avoid combination

Droxidopa: Serotonin 5-HT1D Receptor Agonists may enhance the hypertensive effect of Droxidopa. Monitor therapy

Ergot Derivatives: Serotonin 5-HT1D Receptor Agonists may enhance the vasoconstricting effect of Ergot Derivatives. Ergot Derivatives may enhance the vasoconstricting effect of Serotonin 5-HT1D Receptor Agonists. Exceptions: Nicergoline. Avoid combination

Linezolid: May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Management: Due to a risk of serotonin syndrome/serotonin toxicity, discontinue serotonin modulators 2 weeks prior to the administration of linezolid. If urgent initiation of linezolid is needed, discontinue serotonin modulators immediately and monitor closely. Consider therapy modification

Metaxalone: May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Monitor therapy

Methylene Blue: May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Avoid combination

Methylphenidate: May enhance the adverse/toxic effect of Serotonin Modulators. Specifically, the risk of serotonin syndrome or serotonin toxicity may be increased. Monitor therapy

Metoclopramide: Serotonin Modulators may enhance the adverse/toxic effect of Metoclopramide. This may be manifest as symptoms consistent with serotonin syndrome or neuroleptic malignant syndrome. Monitor therapy

Serotonin Modulators: May enhance the adverse/toxic effect of other Serotonin Modulators. The development of serotonin syndrome may occur. Exceptions: Nicergoline; Tedizolid. Monitor therapy

SUMAtriptan: Serotonin 5-HT1D Receptor Agonists may enhance the adverse/toxic effect of SUMAtriptan. Avoid combination

Tedizolid: May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Monitor therapy

TraMADol: Serotonin Modulators may enhance the adverse/toxic effect of TraMADol. The risk of seizures may be increased. TraMADol may enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Monitor therapy

In patients with mild (Child-Pugh class 5 to 6) to moderate (Child-Pugh class 7 to 9) hepatic function impairment, AUC increased 2 times that of healthy subjects.

Note: If the first dose is ineffective, diagnosis needs to be re-evaluated. The safety of treating >4 migraines/month has not been established.

Migraine: Oral:

U.S. labeling: Initial: 2.5 mg; if headache recurs, a second dose may be administered after 2 hours have elapsed since the first dose (maximum: 7.5 mg daily)

Canadian labeling: Initial: 2.5 mg; if headache recurs, a second dose may be administered after 4 hours have elapsed since the first dose (maximum: 5 mg daily)

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience dizziness, loss of strength and energy, dry mouth, flushing, sensation of warmth, feeling of heaviness, bone pain, or joint pain. Have patient report immediately to prescriber signs of serotonin syndrome (dizziness, severe headache, agitation, hallucinations, tachycardia, arrhythmia, flushing, tremors, sweating a lot, change in balance, severe nausea, or severe diarrhea), signs of severe cardiac abnormalities (chest, throat, neck, or jaw tightness, pain, pressure, or heaviness; break out in a cold sweat; shortness of breath; tachycardia; arrhythmia; or severe dizziness or passing out), signs of severe cerebrovascular disease (change in strength on one side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight), vision changes, severe nausea, severe vomiting, severe headache, constipation, diarrhea, severe abdominal pain, bloody diarrhea, weight loss, leg cramps, leg pain, sensation of cold, burning or aching in feet or toes, shortness of breath, or burning or numbness feeling (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

Applies to frovatriptan: oral tablet

General

The most commonly reported adverse events included dizziness, fatigue, paraesthesia, headache, and vascular flushing.[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity reactions including cutaneous disorders, angioedema, and anaphylactic reactions[Ref]

Cardiovascular

Common (1% to 10%): Flushing, chest discomfort
Uncommon (0.1% to 1%): Palpitations, tachycardia, peripheral coldness, hypertension, chest pain
Rare (0.01% to 0.1%): Bradycardia
Postmarketing reports: Myocardial infarction, coronary arteriospasm[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache, paresthesia, dysesthesia, hypoesthesia , somnolence
Uncommon (0.1% to 1%): Dysgeusia, tremor, disturbance in attention. lethargy, sedation, vertigo, involuntary muscle contractions
Rare (0.01% to 0.1%): Amnesia hypertonia hypotonia, hyporeflexia, movement disorder
Postmarketing reports: Seizure[Ref]

Psychiatric

Uncommon (0.1% to 1%): Anxiety, insomnia, confusional state, nervousness, agitation, depression, depersonalization
Rare (0.01% to 0.1%): Abnormal dreams, personality disorder[Ref]

Gastrointestinal

Common (1% to 10%): Dry mouth, dyspepsia, vomiting, nausea, abdominal pain, diarrhea
Uncommon (0.1% to 1%): Dysphagia, flatulence, constipation, anorexia, esophagospasm, increased salivation
Rare (0.01% to 0.1%): Change in bowel habits, chelitis, eructation, gastroesophageal reflux, hiccough, peptic ulcer, salivary gland pain, stomatitis, toothache, lip blister, lip pain , oral mucosal blistering, peptic ulcer, salivary gland pain[Ref]

Musculoskeletal

Common (1% to 10%): Skeletal pain
Uncommon (0.1% to 1%): Musculoskeletal stiffness, musculoskeletal pain, pain in extremity, back pain, arthralgia[Ref]

Respiratory

Common (1% to 10%): Throat tightness
Uncommon (0.1% to 1%): Rhinitis, sinusitis, pharyngolaryngeal pain
Rare (0.01% to 0.1%): Epistasis, hiccups, hyperventilation, respiratory disorder, throat irritation[Ref]

Ocular

Common (1% to 10%): Visual disturbance
Uncommon (0.1% to 1%): Eye pain, eye irritation, photophobia
Rare (0.01% to 0.1%): Night blindness[Ref]

Dermatologic

Common (1% to 10%): Hyperhidrosis
Uncommon (0.1% to 1%): Pruritus
Rare (0.01% to 0.1%): Erythema, piloerection, urticaria, purpura[Ref]

Other

Common (1% to 10%): Fatigue, hot or cold sensation, tinnitus
Uncommon (0.1% to 1%): Ear pain, ear discomfort, ear disorder, ear pruritus, hyperacusis, feeling hot temperature intolerance, asthenia, sluggishness, energy increased, malaise
Rare (0.01% to 0.1%): Pyrexia[Ref]

Genitourinary

Uncommon (0.1% to 1%): Increased micturition frequency, polyuria
Rare (0.01% to 0.1%): Nocturia, renal pain, abnormal urine analysis[Ref]

Metabolic

Uncommon (0.1% to 1%): Dehydration, thirst
Rare (0.01% to 0.1%): Hypoglycemia[Ref]

Hematologic

Rare (0.01% to 0.1%): Lymphadenopathy[Ref]

Hepatic

Rare (0.01% to 0.1%): Increased blood bilirubin[Ref]

Endocrine

Uncommon (0.1% to 1%): Breast tenderness[Ref]

Some side effects of frovatriptan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Data not available