Myrbetriq

Myrbetriq is a beta-3 receptor agonist that relaxes the muscles inside your bladder by activating certain proteins in your bladder. This way, your bladder will be able to hold more urine, which will allow you to go to the bathroom less frequently.

Follow all directions and drug information given by your doctor and read the FDA-approved product labeling, full Prescribing Information, patient information, instructions for use, and Medication Guide before using Myrbetriq. In addition, follow your doctor's instructions about any restrictions on food, beverages, or activities.

For the tablet, take one tablet once daily. It is used alone or with solifenacin succinate. Do not chew, break, or crush the tablet; swallow the tablet whole. Make sure that you take it with water. It is not a requirement to take the medication with food, though you can. Children, however, need to take Myrbetriq while eating.

If a dose is missed, take the missed dose as soon as you remember unless it is close to the time of your next dose, in which case skip this dose and start treatment again with the next dose at your normal time.

If you are taking the granules, take them with food at the same time each day. Make sure that you take the dose of Myrbetriq granules immediately after preparation.

The most frequent side effects of Myrbetriq include:

• High blood pressure
• Nasopharyngitis (common cold symptoms such as pain or swelling of the nose or throat)
• Urinary tract infection
• Headache
• Constipation
• Upper respiratory tract infection
• Tachycardia (increased heart rate)
• Dry mouth
• Nausea

Rarely, Myrbetriq may cause some serious side effects, including:

• Uncontrolled high blood pressure
• The risk of having difficulty emptying your bladder (urinary retention)
• Angioedema (unusual swelling of the lips, face, or throat)
• This may be life-threatening

This is not the full list of adverse reactions. Speak to your doctor about any questions you may have. Contact your healthcare professional for medical advice about any possible adverse effects that you have while taking Myrbetriq. You can report your adverse events to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• An allergy or have had an allergic reaction in the past to mirabegron or any ingredients in Myrbetriq
• Liver problems
• Kidney problems
• Renal impairment or failure
• Very high blood pressure (severe hypertension)
• A pregnancy, plan to become pregnant, or are breastfeeding
• A history of bladder issues (such as a blockage) or bladder pain

You should not take Myrbetriq if you are allergic to any of the active or inactive ingredients in the product.

Some people may start to notice improvement in their symptoms within a few weeks of starting Myrbetriq. However, the full benefits may take 4 to 8 weeks to become more noticeable.

Mirabegron is metabolized in the liver primarily by the CYP450 enzyme system, specifically CYP2D6. Drugs that affect this enzyme can influence how Myrbetriq works in your body:

• CYP2D6 Inhibitors (may increase mirabegron levels and the risk of side effects):
• Fluoxetine (an SSRI antidepressant)
• Paroxetine (another SSRI)
• Bupropion (used for depression, smoking cessation)
• Quinidine (used for heart arrhythmias)

CYP2D6 Inducers (may decrease the effectiveness of Myrbetriq):

• Rifampin (an antibiotic used for tuberculosis)
• Carbamazepine (used for epilepsy and mood disorders)

Myrbetriq comes in both mirabegron extended-release tablets and extended-release oral suspension. The tablets come in the following strengths:

• 25 mg
• 50 mg

The extended-release oral granules for suspension come in the following strength:

• 8 mg/mL of mirabegron after reconstitution.

For pediatric patients, dosage will depend on body weight.

Store Myrbetriq granules and tablets at room temperature. Make sure that you throw out the medication when it expires.

Myrbetriq (mirabegron) is manufactured by Astellas Pharma, a global pharmaceutical company

Currently, there is no generic available for Myrbetriq in the United States.

By working closely with your healthcare provider, you can find a safe and effective way to manage your condition while transitioning off Myrbetriq.

If you are pregnant or planning to become pregnant, you should not take Myrbetriq (mirabegron) unless advised to do so by your healthcare provider.

If you are breastfeeding, you should not take Myrbetriq (mirabegron) unless advised to do so by your healthcare provider.