Mirabegron

Mirabegron is a prescription medication used to treat an Overactive Bladder (OAB).

• Mirabegron is available under the following different brand names: Myrbetriq. 

Adult and pediatric dosage

Tablet, extended-release

• 25mg
• 50mg

Pediatric dosage

• Granules for extended-release oral suspension
• 8mg/mL after reconstitution 

Overactive Bladder

Adult dosage

Monotherapy

• 25 mg orally once daily
• 25 mg dose is typically effective within 8 weeks
• May increase to 50 mg orally once daily based on individual efficacy and tolerability
• Combination with muscarinic antagonist
• Combination regimen: 25 mg orally once daily plus solifenacin succinate 5 mg orally once daily
• May increase mirabegron to 50 mg orally once daily after 4-8 weeks based on individual efficacy and tolerability

Neurogenic Detrusor Overactivity

Pediatric dosage

• Children younger than 3 years of age: Safety and efficacy not established
• Children 3 years or older, weight less than 35 kg:
  • Granules for oral suspension
  • 11 kg to less than 22 kg: 24 mg (3mL) orally once daily initially; may increase to maximum of 48 mg/day (6 mL)
  • 22 kg to less than 35 kg: 32 mg (4mL) orally once daily initially; may increase to maximum of 64 mg/day (8 mL)
• Children 3 years or older, weight more than 35 kg:
  • Tablets: 25 mg orally once daily initially; may increase to maximum of 50 mg/day after 4-8 weeks
  • Granules for oral suspension: 48 mg (6 mL) orally once daily initially; may increase to maximum of 80 mg/day (10mL) after 4-8 weeks

Dosage Considerations – Should be Given as Follows: 

• See "Dosages."

Common side effects of Mirabegron include:

• painful urination, 
• increased blood pressure, 
• sinus pain, 
• sore throat, 
• constipation, 
• headache, 
• dry mouth, and
• fast heartbeats

Serious side effects of Mirabegron include:

• hives, 
• difficulty breathing, 
• swelling of the face, lips, tongue, or throat, 
• pain or burning during urination, 
• severe headache, 
• blurred vision, and
• pounding in the neck or ears

Rare side effects of Mirabegron include:

• none 

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them.  Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Mirabegron has severe interactions with no other drugs.
• Mirabegron has serious interactions with the following drugs:
  • metoclopramide intranasal
  • ozanimod
• Mirabegron has moderate interactions with at least 59 other drugs.
• Mirabegron has minor interactions with the following drugs:
  • benazepril

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drugs interactions. Therefore, before using this drug, tell your doctor or pharmacist of all the drugs you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Contraindications

• Hypersensitivity 

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Mirabegron?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Mirabegron?”

Cautions

• Angioedema of the face, lips, tongue, and/or larynx reported; may occur after the first dose or following multiple doses; promptly discontinue and initiate appropriate therapy to ensure a patent airway
• Increased blood pressure
  • May increase blood pressure (BP); monitor BP periodically, especially in hypertensive patients
  • Not recommended for use in severe uncontrolled hypertensive patients (ie, systolic BP greater than or equal to 180 mm Hg and/or diastolic BP greater than or equal to 110 mm Hg for adults; systolic and/or diastolic BP over 99th percentile plus 5 mm Hg for age, sex, and stature for children)
  • BP increases may be larger in children aged 3 to over 12 years compared with adolescents
  • Drug interactions overview
• Moderate CYP2D6 inhibitor
  • Sensitive CYP2D6 substrates
  • Appropriate monitoring is recommended and dose adjustment may be necessary for narrow therapeutic index CYP2D6 substrates
• Digoxin
  • Modify dose
  • Coadministration of digoxin 0.25 mg with a combination of solifenacin 5 mg and mirabegron 50 mg increased digoxin AUC and peak plasma concentration by ~10% and 14%, respectively
  • Consider initiating lowest dose for digoxin; monitor serum digoxin concentrations and titrate digoxin dose to obtain desired clinical effect
• Concomitant antimuscarinic drugs
  • Use with caution
  • Urinary retention may occur with bladder outlet obstruction or with concomitant antimuscarinic therapy

Pregnancy and Lactation

• There are no studies with the use in pregnant women to inform drug-associated risk for birth defects or miscarriage
• There is no information on the presence of mirabegron in human milk, the effects on the breastfed child, or the effects on milk production
• Mirabegron-related material was present in rat milk and in the stomach of nursing pups following administrations of a single 10 mg/kg oral dose of 14C-labeled mirabegron to lactating rats