Mirabegron

What is Mirabegron?

• Mirabegron (Myrbetriq) is a beta-3 adrenergic agonist, used alone or in combination with solifenacin (Vesicare) to treat overactive bladder.
• It is also used to treat neurogenic detrusor overactivity in children 3 years of age and older.

Mirabegron

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What are the uses of this medicine?

Mirabegron (Myrbetriq) is a prescription medicine that can be used alone or with solifenacin succinate to treat adults with the following symptoms due to a condition called overactive bladder (OAB):

• Urge urinary incontinence: a strong need to urinate with leaking or wetting accidents
• Urgency: a strong need to urinate right away
• Frequency: urinating often

In Children:

• Myrbetriq tablets is a prescription medicine used to treat children 3 years of age and older weighing at least 77 pounds (35 kg), with a condition called neurogenic detrusor overactivity (NDO).
• Myrbetriq Granules is a prescription medicine used to treat children 3 years of age and older with a condition called neurogenic detrusor overactivity (NDO).

How does this medicine work?

• Mirabegron (mir" a beg' ron) is a synthetic beta-3 adrenergic agonist which binds to receptors in the bladder that causes relaxation of the detrusor smooth muscle and results in an increase in the bladder capacity.
• Mirabegron has been evaluated as therapy of the overactive bladder syndrome, a condition marked by urgency, frequency, nocturia and incontinence that occurs most commonly in older women.
• Other therapies of overactive bladder include anticholinergics, but these are only partially effective and can have troublesome side effects, particularly in the elderly.
• In several short term clinical trials, mirabegron was found to increase voided volume and decrease episodes of incontinence and urinary frequency modestly.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• are allergic to mirabegron or any of the ingredients.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Especially tell your doctor if you take:

• anticoagulants ('blood thinners) such as warfarin (Coumadin, Jantoven); desipramine (Norpramin)
• digoxin (Lanoxin)
• flecainide (Tambocor)
• other medications for overactive bladder such as darifenacin (Enablex), fesoterodine (Toviaz), oxybutynin ( Glenique, Oxytrol), solifenacin (VESIcare), tolterodine (Detrol), and trospium
• propafenone (Rhythmol)
• metoprolol (Lopressor, Toprol, in Dutoprol)
• thioridazine

Is this medicine FDA approved?

• Mirabegron was approved for use in the United States in 2012 as treatment of overactive bladder with symptoms of urgency, incontinence and frequency. Mirabegron is available as 25 and 50 mg extended release tablets under the brand name Myrbetriq.

How should this medicine be used?

• Myrbetriq and Myrbetriq Granules are two different products and they are not substitutable on a milligram-per-milligram basis. Select the recommended product (Myrbetriq or Myrbetriq Granules) based on the indication and patient’s weight. Do not combine Myrbetriq and Myrbetriq Granules to achieve the total dose. A recommended dosage for Myrbetriq Granules for adults has not been determined.

Recommended dosage:

Recommended Dosage for Adult Patients with overactive bladder (OAB): Myrbetriq Monotherapy:

• The recommended starting dosage of Myrbetriq is 25 mg orally once daily.
• If needed, increase to the maximum dosage of Myrbetriq 50 mg orally once daily after 4 to 8 weeks.

Myrbetriq Combination Therapy with Solifenacin Succinate:

• The recommended starting dosage for combination treatment is Myrbetriq 25 mg orally once daily and solifenacin succinate 5 mg orally once daily.
• If needed, increase to the maximum dosage of Myrbetriq 50 mg orally once daily after 4 to 8 weeks.

Recommended Dosage for Pediatric Patients Aged 3 Years and Older with neurogenic detrusor overactivity (NDO):

• Pediatric Patients weighing less than 35 kg: Use Myrbetriq Granules: The recommended starting dose of Myrbetriq Granules is weight-based and administered as an extended-release oral suspension once daily.
• After 4 to 8 weeks, increase to the lowest effective dose without exceeding the maximum recommended dose.

Pediatric Patients weighing 35 kg or more: Use Myrbetriq or Myrbetriq Granules:

• The recommended starting dosage of Myrbetriq is 25 mg orally once daily.
• After 4 to 8 weeks, the Myrbetriq dose may be increased to 50 mg orally once daily.
• The recommended starting dosage of Myrbetriq Granules, administered as an extended-release oral suspension, is 6 mL (48 mg) orally once daily.
• After 4 to 8 weeks, increase to a maximum dosage of Myrbetriq Granules 10 mL (80 mg) orally once daily.

Administration:

• Mirabegron comes as an extended-release (long-acting) tablet and as an extended-release suspension to take by mouth.

Myrbetriq tablets:

• Take Myrbetriq tablets exactly as your doctor tells you to take it.
• You should take 1 Myrbetriq tablet 1 time a day.
• If your doctor prescribes Myrbetriq tablets and solifenacin succinate together, you should take 1 Myrbetriq tablet and 1 solifenacin succinate tablet at the same time, 1 time a day.
• You should take Myrbetriq tablets with water and swallow the tablet whole.
• Do not chew, break, or crush the tablet.
• Adults can take Myrbetriq tablets with or without food.
• Adults can take Myrbetriq tablets and solifenacin succinate together with or without food.
• Children should take Myrbetriq tablets with food.
• If you miss a dose of Myrbetriq tablets, 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 tablets, call your doctor or go to the nearest hospital emergency room right away.

Myrbetriq Granules:

• You or your child should take Myrbetriq Granules exactly as the doctor tells you to take it.
• You or your child should take Myrbetriq Granules by mouth 1 time a day.
• You or your child should take Myrbetriq Granules with food.
• You or your child should take Myrbetriq Granules immediately after preparation (see the steps below). Do not save the dose for later use.
• If you or your child misses a dose of Myrbetriq Granules, take or give it as soon as possible. If it has been more than 12 hours since the last dose of Myrbetriq Granules, skip that dose and take or give the next dose at the usual time.
• If you or your child takes too much Myrbetriq Granules, call your doctor or go to the nearest hospital emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Extended-release tablets: 25 mg and 50 mg
• extended-release oral suspension: 8 mg/mL of mirabegron after reconstitution

This medicine is available in fallowing brand namesː

• Myrbetriq
• Myrbetriq Granules

What side effects can this medication cause?

The most common side effects of this medicine include:

In Adults with Overactive Bladder:

The most common side effects of Myrbetriq tablets include:

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

The most common side effects of Myrbetriq tablets, when used with solifenacin succinate, include:

• dry mouth
• urinary tract infection
• constipation
• fast heartbeat

In Children with Neurogenic Detrusor Overactivity:

The most common side effects of Myrbetriq tablets and Myrbetriq Granules include:

• urinary tract infection
• pain or swelling of the nose or throat (nasopharyngitis)
• constipation
• headache

Myrbetriq tablets and Myrbetriq Granules may cause serious side effects, including:

• increased blood pressure
• urinary retention
• angioedema

What special precautions should I follow?

• Myrbetriq/Myrbetriq Granules can increase blood pressure in adult or pediatric patients. Periodic blood pressure determinations are recommended, especially in hypertensive patients. Myrbetriq/Myrbetriq Granules is not recommended for use in patients with severe uncontrolled hypertension. Periodically monitor blood pressure, especially in hypertensive patients. Myrbetriq/Myrbetriq Granules are not recommended in patients with severe uncontrolled hypertension.
• In patients taking Myrbetriq, urinary retention has been reported to occur in patients with bladder outlet obstruction (BOO) and in patients taking muscarinic antagonist medications for the treatment of OAB. Inform patients and/or their caregivers that Myrbetriq may cause urinary retention in adult patients with bladder outlet obstruction and in patients taking muscarinic antagonist medications for the treatment of OAB. Advise patients to contact their physician if they experience these effects while taking Myrbetriq
• Angioedema of the face, lips, tongue, and/or larynx has been reported with Myrbetriq/Myrbetriq Granules. Inform patients and/or their caregivers that Myrbetriq/Myrbetriq Granules may cause angioedema. Advise patients and/or their caregivers to promptly discontinue Myrbetriq/Myrbetriq Granules and seek medical attention if angioedema associated with the upper airway swelling occurs as this may be life-threatening.
• Advise patients to report their use of any other prescription or nonprescription medications or dietary supplements because co-administration with Myrbetriq/Myrbetriq Granules may require a dose adjustment and/or increased monitoring of these drugs.\
• Instruct patients and/or their caregivers to take any missed doses as soon as they remember, unless more than 12 hours have passed since the missed dose. If more than 12 hours have passed, the missed dose can be skipped and the next dose should be taken at the usual time.
• It is not known if Myrbetriq tablets or Myrbetriq Granules passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take Myrbetriq tablets or Myrbetriq Granules.
• Mirabegron has not been implicated in causing liver enzyme elevations or clinically apparent acute liver injury.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• palpitations
• increased pulse rate
• increased systolic blood pressure

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Treatment for overdosage should be symptomatic and supportive. In the event of overdosage, pulse rate, blood pressure and ECG monitoring is recommended.

Can this medicine be used in pregnancy?

• There are no studies with the use of Myrbetriq/Myrbetriq Granules in pregnant women or adolescents to inform a drug-associated risk of major birth defects, miscarriages, or adverse maternal or fetal outcomes.
• It is not known if Myrbetriq tablets or Myrbetriq Granules will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.

Can this medicine be used in children?

• It is not known if Myrbetriq tablets and Myrbetriq Granules to treat NDO, are safe and effective in children under 3 years of age.

What are the active and inactive ingredients in this medicine?

Myrbetriq tablets:

• Active ingredient: mirabegron
• 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.

Myrbetriq Granules:

• Active ingredient: mirabegron
• Inactive ingredients: acesulfame potassium, diluted hydrochloric acid, ethylparaben, hypromellose, magnesium stearate, mannitol, methylparaben, silicon dioxide, simethicone, sodium polystyrene sulfonate, and xanthan gum.

Who manufactures and distributes this medicine?

Marketed and Distributed by:

• Astellas Pharma US, Inc.
• Northbrook, IL

• Myrbetriq and VESIcare are registered trademarks of Astellas Pharma Inc.

What should I know about storage and disposal of this medication?

• Store Myrbetriq tablets at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep the bottle closed.
• Throw away (discard) medicine that is out of date or no longer needed.
• Store Myrbetriq Granules at room temperature between 68°F to 77°F (20°C to 25°C).
• Use Myrbetriq Granules within 28 days (4 weeks) after the date the pharmacist prepares the suspension. The pharmacist will write the expiration date on the bottle. Throw away (discard) any unused medicine after the expiration date.

Urologic agents

• Overactive bladder syndrome agents - darifenacin, fesoterodine, flavoxate, hyoscyamine, mirabegron, oxybutynin, solifenacin, tolterodine, trospium

• Dailymed label info on Mirabegron
• FDA Mirabegron

Mirabegron Resources
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