Generic Name: frovatriptan (FROE-va-TRIP-tan)
Brand Name: Frova
Frova is used for:
Treating acute migraine headache with or without aura (flashing lights, wavy lines, dark spots) in adults. It should not be used to prevent migraines.
Frova is a serotonin 5-HT1 receptor agonist ("triptan"). It works by narrowing the blood vessels in the brain and, thereby, reducing pressure and pain in the brain. A migraine headache is thought to be caused by widened blood vessels exerting pressure on the brain.
Do NOT use Frova if:
- you are allergic to any ingredient in Frova
- you have a history of ischemic heart disease (eg, angina, heart attack), coronary artery disease (CAD), other moderate to severe heart problems, brain blood vessel disease (eg, stroke, transient ischemic attack), or other blood vessel disease (eg, Raynaud syndrome, ischemic bowel disease)
- you have uncontrolled high blood pressure
- you have certain types of migraines (eg, hemiplegic, basilar)
- you are taking an ergot alkaloid (eg, ergotamine) or have taken another 5-HT1 receptor agonist (eg, sumatriptan, rizatriptan) within the past 24 hours
- you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the past 14 days
- you are taking sibutramine
Contact your doctor or health care provider right away if any of these apply to you.
Before using Frova:
Some medical conditions may interact with Frova. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have history of liver or kidney problems, seizures (eg, epilepsy), heart problems, other types of headaches (eg, cluster headaches), shortness of breath, chest pain, heart attack, stroke, or irregular heartbeat, or if a family member has had heart disease
- if you have high blood pressure, high cholesterol, diabetes, or if you smoke
- if you are a woman past menopause or you have had a hysterectomy
- if you are a man over 40 years old
- if you are very overweight
Some MEDICINES MAY INTERACT with Frova. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), serotonin norepinephrine reuptake inhibitors (SNRIs) (eg, duloxetine), or sibutramine because the risk of a serious side effect called serotonin syndrome may be increased. Symptoms of serotonin syndrome may include mental or mood changes, hallucinations, fast heartbeat, fever, loss of coordination, muscle spasms, increased sweating, nausea, vomiting, or diarrhea
- Beta-blockers (eg, propranolol) or MAOIs (eg, phenelzine) because they may increase the risk of Frova's side effects
- Ergot alkaloids (eg, ergotamine) or another 5-HT1 receptor agonist (eg, sumatriptan or rizatriptan) because the actions and side effects of Frova or these medicines may be increased when taken together
This may not be a complete list of all interactions that may occur. Ask your health care provider if Frova may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Frova:
Use Frova as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Frova. Talk to your pharmacist if you have questions about this information.
- Take Frova by mouth with or without food.
- Take a single dose of Frova with fluids as soon as migraine symptoms appear. A second dose may be taken if there is only a partial response or symptoms of the migraine return. However, do not take it sooner than 2 hours following the first dose. Do not take a second dose if your symptoms do not get better after your first dose. Do not take more than 3 tablets in a 24-hour period.
- If you miss a dose of Frova and you still have a headache, follow your doctor's dosing instructions. Contact your doctor if you are unsure of what to do if you miss a dose. Do not take Frova more often than prescribed. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Frova.
Important safety information:
- Frova may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Frova with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Frova may cause dizziness or fainting. If dizziness occurs, sit or stand up slowly.
- If Frova does not stop or decrease the severity of your migraine attack or if your symptoms become worse, check with your doctor.
- Frova is intended to relieve acute migraine headaches. Do not use it to prevent or reduce the number of attacks you experience. Use Frova only to treat an actual migraine attack. If you have a headache that is different from your usual migraine attacks, check with your doctor before using Frova.
- Overuse of Frova can cause your headache to become worse. Do NOT take more than the recommended dose or use more often than prescribed without checking with your doctor.
- Rarely, serious heart problems (eg, heart attack, irregular heartbeat) have been reported within a few hours of using Frova. Contact your doctor at once if fast or irregular heartbeat; chest, jaw, or neck pain or numbness; numbness of an arm or leg; severe stomach pain, dizziness, or vomiting; fainting; or vision changes occur. Discuss any questions or concerns with your doctor.
- Serotonin syndrome is a possibly fatal syndrome that can be caused by Frova. Your risk may be greater if you take Frova with certain other medicines (eg, SSRIs, SNRIs). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; loss of coordination; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.
- Tell your doctor or dentist that you take Frova before you receive any medical or dental care, emergency care, or surgery.
- Lab tests, including heart function tests, may be performed while you use Frova. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Frova with caution in the ELDERLY; they may be more sensitive to its effects.
- Frova is not recommended for use in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Frova while you are pregnant. It is not known if Frova is found in breast milk. If you are or will be breast-feeding while you use Frova, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Frova:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Dizziness; drowsiness; dry mouth; fatigue; flushing; headache; hot or cold sensations; indigestion; numbness or tingling in the arms, legs, hands, or feet.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody diarrhea; bone or joint pain; confusion, slurred speech, or changes in vision; hallucinations; irregular or rapid heartbeat; loss of coordination; mental or mood changes (eg, agitation); muscle spasms; one-sided weakness; pain or unusual coldness in feet, legs, hands, or arms; pain, tightness, pressure, and heaviness in the chest, throat, neck, or jaw; pale or blue-colored fingers or toes; persistent numbness or tingling in the arms, legs, hands, or feet; seizures; severe stomach pain; sudden severe dizziness, fainting, headache, or vomiting; sudden shortness of breath.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; severe dizziness; unusually fast or irregular heartbeat.Proper storage of Frova:
Store Frova at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Frova out of the reach of children and away from pets.
- If you have any questions about Frova, please talk with your doctor, pharmacist, or other health care provider.
- Frova is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Frova or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. 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 Frova. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Frova. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Frova.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. 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 this medicine. 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 your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.