Ubrelvy

Ubrelvy tablets are used to treat migraine headaches in adults, that are with or without aura. Ubrelvy works by blocking a protein called CGRP in the nerve endings that are involved in pain and migraines, this helps reduce pain and migraine symptoms. Ubrelvy is from the CGRP inhibitor class of medicines and is a prescription medicine.

• Ubrelvy is used when you have a migraine headache; it is not used to prevent a migraine headache.

The Ubrelvy dose is 50mg to 100 mg at the start of the migraine, then after 2 hours, a second dose may be taken if needed.

Ubrelvy (ubrogepant) received FDA approval on December 23, 2019, for the acute treatment of migraine with or without aura in adults. They are available as Ubrelvy 100mg tablets and Ubrelvy 50mg tablets.

There is no generic Ubrelvy available.

Ubrelvy's active ingredient is ubrogepant; some people call this the Ubrelvy generic name.

Ubrelvy (ubrogepant) works by blocking the activity of calcitonin gene-related peptide (CGRP), a protein that plays a key role in migraine attacks.

Ubrelvy mechanism of action involves binding to CGRP receptors and preventing CGRP from triggering inflammation, dilation of blood vessels, and pain in the brain. By inhibiting CGRP, Ubrelvy helps reduce migraine symptoms such as headache, nausea, and sensitivity to light and sound. It is unlike some traditional migraine treatments, which constrict blood vessels. Ubrelvy specifically targets this pathway without causing vascular side effects.

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.

The cost of prescription drugs varies depending on your insurance plan and which pharmacy you use. Refer to our Ubrelvy price guide page for more information about the cost.

You may also be eligible for a Ubrelvy savings card, Ubrelvy coupon or Ubrelvy copay card. Ask your doctor or pharmacist if you qualify.

Hypersensitivities or allergies. Do not use Ubrelvy if you have a history of serious hypersensitivity to ubrogepant or any inactive ingredients. Reactions have included anaphylaxis, dyspnea, and facial or throat edema.

Hypertension (high blood pressure). This medicine may cause new-onset or worsening of pre-existing hypertension to occur. Contact your doctor if you have an increase in blood pressure.

Raynaud’s phenomenon. New-onset or worsening of pre-existing Raynaud’s phenomenon has occurred when taking this medication. Contact your doctor if your fingers or toes feel numb, cool, or painful, or change color from pale, to blue, to red.

Medicine interactions. 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.

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.

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

Pregnancy

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. There is a pregnancy registry for women who take this medicine. Talk to your doctor or call 1-833-277-0206 to enroll.

Breastfeeding

Very small amounts of this medicine pass into breast milk. Talk to your doctor if you are breastfeeding or plan to breastfeed.

Common Ubrelvy side effects may include nausea or sleepiness.

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

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.

Usual Adult Dose for Migraine: Take 50 mg to 100 mg orally once, then after 2 hours, a second dose may be taken if needed.Maximum dose: 200 mg in a 24-hour periodComments: The safety of treating more than 8 migraines in a 30-day period is unknown.

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.

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 Ubrelvy, 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.

Review the full Ubrelvy prescribing information here for more detailed information about this medicine. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about Ubrelvy for safe and effective use and does not take the place of talking to your doctor about your treatment.

Store at room temperature between 68ºF to 77ºF (20ºC to 25ºC).

Active ingredient: ubrogepant

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, mannitol, microcrystalline cellulose, polyvinylpyrrolidone vinyl acetate copolymer, sodium chloride, sodium stearyl fumarate, and vitamin E polyethylene glycol succinate.

Manufactured for: AbbVie Inc. North Chicago, IL 60064