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

Ubrelvy will not prevent a migraine headache.

It is not known if Ubrelvy is safe and effective in children.

You should not take Ubrelvy if you are taking medicines known as strong CYP3A4 Inhibitors, such as:

• ketoconazole
• clarithromycin
• itraconazole

Ask your healthcare provider if you are not sure if you are taking any of these medicines. Your healthcare provider can tell you if it is safe to take Ubrelvy with other medicines.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

Before taking this medicine

Many drugs can interact and cause dangerous effects. Some drugs should not be used together with Ubrelvy. Your doctor may change your treatment plan if you also use:

• nefazodone;

• an antibiotic - clarithromycin, telithromycin;

• antifungal medicine - itraconazole, ketoconazole; or

• antiviral medicine to treat HIV/AIDS - indinavir, nelfinavir, ritonavir, saquinavir.

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

• liver disease; or

• kidney disease.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether Ubrelvy will harm an unborn baby. However, having migraine headaches during pregnancy may cause complications such as diabetes or 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.

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

Take Ubrelvy exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take this medicine with or without food. Avoid grapefruit or grapefruit juice.

After taking Ubrelvy: If your headache does not completely go away, or goes away and comes back, you may take a second tablet if it has been at least 2 hours since your first dose. If your symptoms have not improved, contact your doctor before taking any more tablets.

You should not take a second tablet within 24 hours if you have consumed a grapefruit product, or if you also take any of the following medications:

• ciprofloxacin;

• cyclosporine;

• fluconazole;

• fluvoxamine; or

• verapamil.

Call your doctor if you have more than 8 headaches in one month (30 days). Tell your doctor if this medicine seems to stop working as well in treating your migraine attacks.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Migraine:

Initial dose: 50 to 100 mg orally, once
-After 2 hours, a second dose may be taken if needed
Maximum dose: 200 mg in 24-hour period

Comments:
-The safety of treating more than 8 migraines in a 30-day period is unknown.

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

Many drugs can interact and cause dangerous effects. Some drugs should not be used together with Ubrelvy. Your doctor may change your treatment plan if you also use:

• nefazodone;

• an antibiotic - clarithromycin, telithromycin;

• antifungal medicine - itraconazole, ketoconazole; or

• antiviral medicine to treat HIV/AIDS - indinavir, nelfinavir, ritonavir, saquinavir.

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

• liver disease; or

• kidney disease.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether Ubrelvy will harm an unborn baby. However, having migraine headaches during pregnancy may cause complications such as diabetes or 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.

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

Since Ubrelvy is used when needed, it does not have a daily dosing schedule. Do not take more than 200 milligrams in a 24-hour period. Do not use this medicine to treat more than 8 headaches per month.

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

Grapefruit may interact with ubrogepant and lead to unwanted side effects. You should not take a second Ubrelvy tablet within 24 hours after consuming grapefruit or grapefruit juice.

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

Common Ubrelvy side effects may include:

• nausea; or

• drowsiness.

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.

Tell your doctor about all your current medicines. Many drugs can interact with ubrogepant, especially:

• curcumin (also called turmeric);

• cyclosporine;

• eltrombopag;

• fluconazole;

• fluvoxamine;

• phenytoin;

• St. John's wort;

• an antibiotic - ciprofloxacin, rifampin;

• a barbiturate - butabarbital, phenobarbital, secobarbital; or

• heart or blood pressure medicine - carvedilol, quinidine, verapamil.

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