Important Facts About MYRBETRIQ® (mirabegron extended-release tablets) Rx Only

Active Ingredient

Myrbetriq (mirabegron extended-release tablets) 25 mg, 50 mg

Purpose

Overactive Bladder (OAB) Symptoms Treatment

Uses

Myrbetriq (meer-beh-trick) is a prescription medication used to treat adults with the following symptoms due to a condition called overactive bladder: ■ Urge urinary incontinence: a strong need to urinate with leaking or wetting accidents ■ Urgency: a strong need to urinate right away ■ Frequency: urinating often

Warnings

Do not take Myrbetriq if you are allergic to mirabegron or any of the ingredients in Myrbetriq. See the end of this summary for a complete list of ingredients in Myrbetriq.

Serious Side Effects

■ increased blood pressure–you and your doctor should check your blood pressure while you are taking Myrbetriq. Call your doctor if you have increased blood pressure

■ inability to empty your bladder (urinary retention)–tell your doctor right away if you are unable to empty your bladder ■ angioedema–myrbetriq may cause an allergic reaction with swelling of the lips, face, tongue, or throat with or without difficulty breathing. Stop using Myrbetriq and go to the nearest hospital emergency room right away.

Tell your doctor about all of your medical conditions, including:

■ liver problems or kidney problems ■ very high uncontrolled blood pressure ■ trouble emptying your bladder or you have a weak urine stream ■ if you are pregnant or plan to become pregnant. It is not known if Myrbetriq will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. ■ if you are breastfeeding or plan to breastfeed. It is not known if Myrbetriq passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take Myrbetriq.

Myrbetriq may affect the way other medicines work, and other medicines may affect how Myrbetriq works. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Tell your doctor if you take: ■ thioridazine (Mellaril™ or Mellaril-s™) ■ flecainide (Tambocor®) ■ propafenone (Rythmol®) ■ digoxin (Lanoxin®) solifenacin succinate (Vesicare®)

Most Common Side Effects

high blood pressure ■ pain or swelling of the nose or throat (nasopharyngitis) ■ urinary tract infection ■ headache

Tell your doctor if you have any side effect that bothers you or that does not go away, or if you have swelling of the face, lips, tongue or throat, hives, skin rash, or itching while taking Myrbetriq.

These are not all the possible side effects of Myrbetriq. For more information, ask your doctor or pharmacist. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Directions

■ Take Myrbetriq exactly as your doctor tells you to take it ■ Take 1 Myrbetriq tablet 1 time a day ■ Take Myrbetriq with water and swallow the tablet whole ■ Do not chew, break, or crush the tablet ■ You can take Myrbetriq with or without food If you miss a dose of Myrbetriq, take it as soon as possible. If it has been more than 12 hours since taking the last dose of Myrbetriq tablets, skip that dose and take the next dose at the usual time ■ If you take too much Myrbetriq, call your doctor or go to the nearest hospital emergency room right away

Keep Myrbetriq and all medicines out of the reach of children.

Inactive Ingredients

Butylated hydroxytoluene, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, polyethylene oxide, red ferric oxide (25 mg Myrbetriq tablet only), and yellow ferric oxide.

For more information about Myrbetriq, talk to your health care provider.

Myrbetriq® and Vesicare® are registered trademarks of Astellas Pharma Inc.

All other trademarks are the property of their respective owners.

©2021 Astellas Pharma US, Inc. 057-4598-PM 4/21