Rimegepant is a prescription medicine used by adults to treat migraines (with or without aura) when they occur and also to prevent episodic migraines. Rimegepant works to reduce migraine symptoms of headache, nausea, vomiting, light sensitivity and sound sensitivity, by blocking CGRP receptors. This medicine may reduce the number of monthly migraine days when taken to prevent episodic migraines.

Rimegepant is an orally disintegrating tablet (ODT) that dissolves in the mouth without the need to take it with a glass of water. Because the tablet dissolves in the mouth it is absorbed into the bloodstream quickly, with the highest blood concentrations reached after one and a half hours.

It is not known if it is safe to take rimegepant ODT for more than 15 migraine headaches in 30 days.

Rimegepant ODT can be taken 1 time each day as needed. You should not take more than 1 tablet in 24 hours.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

If you take too much rimegepant ODT, go to the nearest emergency room right away.

Use rimegepant ODT exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Call your doctor if your symptoms do not improve, or if you have more than 15 headaches in one month (30 days).

Remove an orally disintegrating tablet from the package only when you are ready to take the medicine.

• Use dry hands when opening the blister pack.

• Peel back the foil covering of one blister and gently remove the orally disintegrating tablet (ODT). Do not push the ODT through the foil.

• As soon as the blister is opened, remove the ODT and place on the tongue; alternatively, the ODT may be placed under the tongue.

• The ODT will disintegrate in saliva so that it can be swallowed without additional liquid.

• Swallow several times as the tablet dissolves.

• Take the ODT immediately after opening the blister pack. Do not store the ODT outside the blister pack for future use.

Store at cool room temperature, away from moisture and heat.

Usual Adult Dose for Migraine:

75 mg orally
Maximum dose: 75 mg in a 24-hour period

Comments:
-This drug is not for the preventive treatment of migraine.
-The safety of treating more than 15 migraines in a 30-day period is unknown.

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

Place on tongue (or under tongue) and allow to disintegrate in saliva and swallow; additional liquid is not necessary. Do not take more than 1 dose in 24-hours.

You should not use rimegepant if you are allergic to it.

To make sure rimegepant is safe for you, tell your doctor if you have ever had:

• liver disease; or

• kidney disease (or if you are on dialysis).

It is not known whether rimegepant will harm an unborn baby. However, having migraine headaches may cause complications during pregnancy such as 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.

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

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

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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

An allergic reaction can be severe, and may occur days after you have taken this medicine.

Common rimegepant side effects may include nausea.

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.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

If you use any of the following medicines, avoid taking rimegepant within 48 hours after you last took the other medicine:

• aprepitant;

• erythromycin;

• fluconazole; or

• heart or blood pressure medicine - diltiazem, verapamil.

This list is not complete and many other drugs may interact with rimegepant. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor.

You should keep a headache diary by writing down when you have headaches and when you take rimegepant.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.