Frova® (Frovatriptan Succinate)

Frova® (frovatriptan succinate) is a selective 5-HT1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine, with or without aura, in adults who have a clear migraine diagnosis. It is taken by mouth for the relief of migraine severity, from moderate or severe pain to mild or no pain.

Frova is generally well tolerated and is usually effective within 2 to 3 hours. It is intended to reduce acute migraine symptoms, as it will only treat a migraine that has already begun. It should not to be used as a prophylactic therapy to prevent the onset of migraine.

Overuse of acute migraine drugs can cause medication overuse headaches. Overuse is considered dosing on 10 or more days per month for 3 months or longer. Symptoms of overuse may need to be treated and detoxification from migraine medications may be required.

What are the ingredients in Frova?

The active ingredient in Frova is frovatriptan succinate.

How does Frova work?

Frova works by binding with 5-HT1B/1D receptors on blood vessels in the brain. It narrows the blood vessels (constriction) in the brainstem. It also reduces the inflammatory substances in the body that can trigger head pain, nausea, sensitivity to light and sound, and other migraine symptoms. Frova works best if it is taken as soon as migraine symptoms appear.

What are the possible side effects of Frova?

Many clinical trials evaluated the safety and efficacy of Frova. The most common side effects experienced by those taking Frova include:

• Dizziness
• Feeling weak, drowsy, or tired
• Headache (other than a migraine headache)
• Numbness or tingling in the fingers and toes (paresthesia)
• Dry mouth
• Flushing (warm red skin or face)
• Feeling hot or cold in the extremities
• Pain or tight feeling in the chest, throat, jaw, or neck
• Nausea or indigestion
• Skeletal pain in joints or bones
• Pressure or heavy feeling in any part of your body

This is not an exhaustive list of all potential side effects of Frova. Patients should talk to their doctor about what to expect with treatment with Frova. If you notice any new or worsening side effects when taking Frova, contact your doctor or healthcare provider immediately.

Things to note about Frova

Before starting Frova talk with your doctor if you:

• Have a history of hypersensitivity to frovatriptan succinate
• Have a history of coronary artery disease (CAD), angina or heart attacks
• Have a history of high blood pressure or high cholesterol
• Have a history of hemiplegic or basilar migraine
• Have a history of stroke, transient ischemic attacks (TIAs), or circulatory problems
• Have a history of ischemic bowel disease
• Are a female who has gone through menopause
• Are a man over 40
• Are overweight, smoke, or have diabetes
• Have taken ergot-containing medication or triptans within the 24 hours prior to Frova
• Take anti-depressant medicines including selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), or tricyclic antidepressants (TCAs)
• Have severe hepatic (liver) impairment
• Are pregnant or planning to get pregnant, as there is limited information on the use of Frova in pregnancy. It should be used only if the potential benefit of Frova therapy exceeds risk to the fetus.

Individuals with the above conditions should be monitored closely while taking Frova.

If there is no response to the first migraine attack treated with Frova, a physician should reconsider the migraine diagnosis prior to using the medication in any subsequent attacks.

A cardiovascular evaluation should be performed on patients who have never taken a triptan medication but who have multiple cardiovascular risk factors (e.g., increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) before starting Frova. For those with a cardiac history, the first dose of Frova should be administered in a medically supervised setting, and an electrocardiogram (ECG) should be performed immediately following the dose.

Keep track of when you have migraine and when you take Frova so you can monitor its effectiveness, and communicate with your doctor about how the medication is working for you.

You should begin no medication or supplement without first checking with your health care provider and should let them know of any other prescriptions, OTCs, and herbals you are taking to ensure there are no interactions.

Because Frova can cause dizziness, weakness, and drowsiness, do not drive a car, use machinery, or do anything requiring you to be fully alert when taking this medication.

For additional details, read the full prescribing information of Frova.