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  • Betmiga
    / Astellas


    Active Ingredient
    Mirabegron 25 mg, 50 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Prolonged-Release Tablets

    30 X 25 mg

    not in the basket chart 85010 2584

    Prolonged-Release Tablets

    30 X 50 mg

    not in the basket chart 85013 2585

    Dosage

    Adults (including elderly patients): The recommended dose is 50 mg once daily with or without food.
    Renal and hepatic impairment: The drug has not been studied in patients with end stage renal disease (GFR < 15 mL/min/1.73m² or patients requiring haemodialysis) or severe hepatic impairment (Child-Pugh Class C) and it is therefore not recommended for use in these patient populations.
    For daily dosing recommendations for subjects with renal or hepatic impairment in the absence and presence of strong CYP3A inhibitors: Please refer to the  prescribing information.
    Gender: No dose adjustment is necessary according to gender.
    Paediatric population: The safety and efficacy of mirabegron in children below 18 years of age have not yet been established. No data are available.
    Method of administration: The tablet is to be taken, with liquids, swallowed whole and is not to be chewed, divided, or crushed. It may be taken with or without food.
    See prescribing information for full details.


    Indications

    Symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients.
    Severe uncontrolled hypertension defined as systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg.


    Special Precautions

    Renal impairment: Betmiga has not been studied in patients with end stage renal disease (GFR < 15 mL/min/1.73 m² or patients requiring haemodialysis) and, therefore, it is not recommended for use in this patient population. Data are limited in patients with severe renal impairment (GFR 15 to 29 mL/min/1.73 m² ); based on a pharmacokinetic study a dose reduction to 25 mg is recommended in this population. This medicinal product is not recommended for use in patients with severe renal impairment (GFR 15 to 29 mL/min/1.73 m²) concomitantly receiving strong CYP3A inhibitors.
    Hepatic impairment: Betmiga has not been studied in patients with severe hepatic impairment (Child-Pugh Class C) and, therefore, it is not recommended for use in this patient population. This medicinal product is not recommended for use in patients with moderate hepatic impairment (Child-Pugh B) concomitantly receiving strong CYP3A inhibitors.
    Hypertension: Mirabegron can increase blood pressure. Blood pressure should be measured at baseline and periodically during treatment with mirabegron, especially in hypertensive patients.
    Data are limited in patients with stage 2 hypertension (systolic blood pressure ≥ 160 mm Hg or diastolic blood pressure ≥ 100 mm Hg).
    Patients with congenital or acquired QT prolongation: Betmiga, at therapeutic doses, has not demonstrated clinically relevant QT prolongation in clinical studies. However, since patients with a known history of QT prolongation or patients who are taking medicinal products known to prolong the QT interval were not included in these studies, the effects of mirabegron in these patients is unknown. Caution should be exercised when administering mirabegron in these patients.
    Patients with bladder outlet obstruction and patients taking antimuscarinics medicinal products for OAB: Urinary retention in patients with bladder outlet obstruction (BOO) and in patients taking antimuscarinic
    medicinal products for the treatment of OAB has been reported in ostmarketing experience in patients taking mirabegron. A controlled clinical safety study in patients with BOO did not demonstrate increased urinary retention in patients treated with Betmiga; however, Betmiga should be administered with caution to
    patients with clinically significant BOO. Betmiga should also be administered with caution to patients taking antimuscarinic medicinal products for the treatment of OAB.


    Side Effects

    Common: Urinary tract infection, Headache, Dizziness, Tachycardia, Nausea, Constipation, Diarrhoea.
    See prescribing information for full details.  


    Drug interactions

    Clinically relevant drug interactions between mirabegron and medicinal products that inhibit induce or are a substrate for one of the CYP isozymes or transporters are not expected except for the inhibitory effect of mirabegron on the metabolism of CYP2D6 substrates.
    Caution is advised if mirabegron is co-administered with medicinal products with a narrow therapeutic index and significantly metabolised by CYP2D6, such as thioridazine, Type 1C antiarrhythmics (e.g., flecainide, propafenone) and tricyclic antidepressants (e.g., imipramine, desipramine). Caution is also advised if mirabegron is co-administered with CYP2D6 substrates that are individually dose titrated. Increases in mirabegron exposure due to drug-drug interactions may be associated with increases in pulse rate.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: There are limited amount of data from the use of this drug in pregnant women. Studies in animals have shown reproductive toxicity. This medicinal product is not recommended during pregnancy.
    Lactation: Mirabegron is excreted in the milk of rodents and therefore is predicted to be present in human milk. No studies have been conducted to assess the impact of mirabegron on milk production in humans, its presence in human breast milk, or its effects on the breast-fed child. Betmiga should not be administered during breast-feeding.


    Overdose

    Mirabegron has been administered to healthy volunteers at single doses up to 400 mg. At this dose, adverse events reported included palpitations (1 of 6 subjects) and increased pulse rate exceeding 100 beats per minute (bpm) (3 of 6 subjects). Multiple doses of mirabegron up to 300 mg daily for 10 days showed increases in pulse rate and systolic blood pressure when administered to healthy volunteers.
    Treatment for overdose should be symptomatic and supportive. In the event of overdose, pulse rate, blood pressure, and ECG monitoring is recommended.


    Manufacturer
    Astellas Pharma Europe BV, The Netherlands
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