Reyvow is a serotonin (5-HT) 1F receptor agonist.

Reyvow is used in adults to treat migraine headaches with or without aura.

Reyvow will only treat and will not prevent migraine headache.

Reyvow is a federally controlled substance (CV) because it contains lasmiditan that can be a target for people who abuse prescription medicines or street drugs.

Keep this medicine in a safe place to protect it from theft. Never give your Reyvow to anyone else, because it may harm them. Selling or giving away Reyvow is against the law. Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.

Do not take more than one dose in a 24-hour period.

For at least 8 hours after taking Reyvow, do not drive and avoid other hazardous activity.

Take Reyvow exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Reyvow may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

Take Reyvow soon as you notice headache symptoms.

Swallow the tablet whole and do not crush, chew, or break it.

Do not take more than one dose in a 24-hour period.

You may take this medicine with or without food.

Never use more than your recommended dose. Overuse of migraine headache medicine can make headaches worse. Tell your doctor if the medicine seems to stop working as well in treating your migraine attacks.

Call your doctor if your headache does not go away completely, or if you have more than 4 headaches in one month (30 days).

Store at room temperature away from moisture and heat.

Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Usual Adult Dose for Migraine:

Initial dose: 50 mg, 100 mg, or 200 mg orally once
Maximum dose: 1 dose per day

Comments:
-This drug should not be taken unless the patient can wait 8 hours or more before driving or operating machinery.
-No more than 1 dose should be taken in 24 hours; a second dose has not been shown to be effective for the same migraine attack.
-The safety of treating an average of more than 4 migraine attacks in a 30-day period has not been established.
-This drug is not indicated for the prevention of migraine attacks.

Use: For the acute treatment of migraine with or without aura.

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

• an allergy to lasmiditan;

• liver disease;

• slow heartbeats;

• high blood pressure; or

• drug addiction.

Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. These medicines may interact with lasmiditan and cause a serious condition called serotonin syndrome.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of lasmiditan on the baby.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether lasmiditan will harm an unborn baby. However, having migraine headaches during pregnancy may cause complications such as eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of treating migraines may outweigh any risks to the baby.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Since Reyvow is used once when needed, it does not have a daily dosing schedule. Call your doctor if your migraine symptoms do not improve after using this medicine.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

After taking Reyvow, do not drive for at least 8 hours, and avoid other hazardous activity. Your reactions could be impaired, and you may not realize the extent of that impairment.

Drinking alcohol with this medicine can cause side effects.

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

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common Reyvow side effects may include:

• dizziness, drowsiness;

• feeling tired; or

• numbness or tingling.

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.

Using Reyvow with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Many drugs may interact with lasmiditan. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.