Betmiga

Betmiga Special Precautions

mirabegron

Manufacturer:

Astellas

Distributor:

Zuellig
Full Prescribing Info
Special Precautions
Renal impairment: Mirabegron (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 (see Pharmacodynamics: Pharmacokinetics under Action) a dose reduction to 25 mg is recommended in this population. Mirabegron (Betmiga) 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 (see Interactions).
Hepatic impairment: Mirabegron (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. Mirabegron (Betmiga) is not recommended for use in patients with moderate hepatic impairment (Child-Pugh B) concomitantly receiving strong CYP3A inhibitors (see Interactions).
Hypertension: Mirabegron (Betmiga) can increase blood pressure, Blood pressure should be measured at baseline and periodically during treatment with Mirabegron (Betmiga), 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: Mirabegron (Betmiga), at therapeutic doses, has not demonstrated clinically relevant QT prolongation in clinical studies (see Pharmacology: Pharmacodynamics). 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 (Betmiga) in these patients is unknown. Caution should be exercised when administering mirabegron in these patients.
Patients with bladder outlet obstruction and patients taking antimuscarinics medications for OAB: Urinary retention in patients with bladder outlet obstruction (BOO) and in patients taking antimuscarinic medications for the treatment of OAB has been reported in post marketing experience in patients taking mirabegron. A controlled clinical safety study in patients with BOO did not demonstrate increased urinary retention in patients treated with Mirabegron (Betmiga); however, Mirabegron (Betmiga) should be administered with caution to patients with clinically significant BOO. Mirabegron (Betmiga) should also be administered with caution to patients taking antimuscarinic medications for the treatment of OAB.
Effects on ability to drive and use machines: Mirabegron (Betmiga) has no or negligible influence on the ability to drive and use machines.
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