mirabegron (Rx)

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Brand and Other Names:Myrbetriq

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet, extended-release

  • 25mg
  • 50mg
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Overactive Bladder

Indicated for overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency

25 mg PO qDay

25 mg dose is typically effective within 8 weeks

May increase to 50 mg PO qDay based on individual efficacy and tolerability

Dosage Modifications

Renal impairment

  • Severe (CrCl 15-29 mL/min): Not to exceed 25 mg/day
  • ESRD: Not recommended

Hepatic impairment

  • Moderate (Child-Pugh B): Not to exceed 25 mg/day
  • Severe (Child Pugh C): Not recommended

Safety and efficacy not established

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Interactions

Interaction Checker

and mirabegron

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Elevated BP occurring predominantly in patients with preexisting hypertension (7-11%)

            1-10%

            Dry mouth (3-9%)

            Nasopharyngitis (3-4%)

            UTI (3-6%)

            Headache (2-4%)

            Influenza (2-3%)

            Constipation (2-3%)

            Dizziness (2%)

            Arthralgia (2%)

            Cystitis (2%)

            Back pain (1-3%)

            Sinusitis (1-3%)

            URTI (1-2%)

            Arthralgia (1-2%)

            Diarrhea (1-2%)

            Tachycardia (1-2%)

            Fatigue (1%)

            Abdominal pain (0-1%)

            Reports of neoplasms (0-1%)

            <1%

            Cardiac disorders (eg, palpitations, elevated BP)

            Eye Disorders (eg, glaucoma, blurry vision)

            GI disorders (eg, dyspepsia, gastritis, abdominal distension)

            Rhinitis

            Elevations in GGT, AST, ALT, LDH

            Renal and urinary disorders (eg, nephrolithiasis, bladder pain)

            Reproductive system disorders (eg, vulvovaginal pruritis, vaginal infection)

            Skin and subcutaneous tissue disorders (eg, urticaria, leukocytoclastic vasculitis, rash, pruritus, purpura, lip edema)

            Stevens-Johnson syndrome associated with increased serum ALT, AST and bilirubin

            Postmarketing Reports

            Urinary retention

            Angioedema of the face, lips, tongue, and larynx, with or without respiratory symptoms

            Nausea

            Pruritus

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            Warnings

            Contraindications

            Hypersensitivity

            Cautions

            May increase blood pressure; monitor blood pressure periodically, especially in hypertensive patients; not recommended for use in severe uncontrolled hypertensive patients

            Urinary retention may occur with bladder outlet obstruction or with concomitant antimuscarinic therapy; administer with caution in these patients

            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

            Appropriate monitoring is recommended and dose adjustment may be necessary for narrow therapeutic index CYP2D6 substrates

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: Unknown whether distributed in breast milk; excretion in breast milk possible; discontinue nursing or the drug taking into account the importance of the drug to the mother

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Beta-3 adrenergic receptor agonist which causes relaxation of the detrusor smooth muscle of the urinary bladder and increases bladder capacity

            Absorption

            Bioavailability: 29% for 25 mg dose, 35% for 50 mg dose

            Peak Plasma Time: 3.5 hr

            Peak Plasma Concentration: ~3-fold increase from 50 mg dose to 100 mg dose

            AUC: ~2.5-fold increase from 50 mg dose to 100 mg dose

            Distribution

            Protein Bound: 71%

            Vd: 1670 L

            Metabolism

            Via multiple pathways including dealkylation, (direct) glucuronidation, amide hydrolysis, and minimal oxidative metabolism in vivo by CYP2D6 and CYP3A4

            Possible involvement of butylcholinesterase, uridine diphospho-glucuronosyltransferases (UGT) and alcohol dehydrogenase

            Moderate CYP2D6 inhibitor

            Elimination

            Half-Life: 50 hr

            Total body clearance: 57 L/hr (following IV administration)

            Excretion: Urine 55%; feces 34%

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            Administration

            Instructions

            May take with or without food

            Swallow whole with water, do not chew, divide, or crush tablet

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            Images

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

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            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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