BETMIGA

What it is

BETMIGA contains mirabegron 25 mg or 50 mg as the active ingredient. BETMIGA is available as prolonged-release film-coated tablets for oral administration. Mirabegron is an agonist of the human beta 3-adrenoceptor.

Approved indications

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

Dosing overview

The recommended starting dose of BETMIGA is 25 mg once daily. Based on individual patient efficacy and tolerability the dose may be increased to 50 mg once daily. BETMIGA can be taken with or without food. The tablet should be taken with liquids, swallowed whole and is not to be chewed, divided, or crushed. No dose adjustment is necessary in patients with mild or moderate renal impairment. In patients with severe renal impairment, the recommended dose is 25 mg once daily. No dose adjustment is necessary in patients with mild hepatic impairment. In patients with moderate hepatic impairment the recommended dose is 25 mg once daily.

Key safety warnings

BETMIGA can increase blood pressure and heart rate. Blood pressure should be measured at baseline and monitored periodically during BETMIGA treatment, especially in hypertensive patients. There is limited data in patients with moderate (grade 2) hypertension and thus, caution is advised. Angioedema of the face, lips, tongue, and/or larynx has been reported with BETMIGA. In some cases angioedema occurred after the first dose. Cases of angioedema have been reported to occur hours after the first dose or after multiple doses. Angioedema associated with upper airway swelling may be life threatening. If involvement of the tongue, hypopharynx, or larynx occurs, promptly discontinue BETMIGA and initiate appropriate therapy and/or measures necessary to ensure a patent airway. Urinary retention in patients with bladder outlet obstruction and in patients taking antimuscarinic medications for OAB has been reported in postmarketing experience. BETMIGA should be administered with caution to patients with bladder outlet obstruction and with caution in patients taking antimuscarinic agents. Mirabegron is a moderate CYP2D6 inhibitor and systemic exposure to CYP2D6 substrates such as metoprolol and desipramine is increased when co-administered with mirabegron. Appropriate monitoring and dose adjustment may be necessary, especially with narrow therapeutic index drugs metabolised by CYP2D6 such as thioridazine, flecainide and propafenone.

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Patients with severe uncontrolled hypertension (systolic ≥180 mmHg and/or diastolic ≥110 mmHg).

Regulatory history

The TGA approved BETMIGA on 26 September 2013, with initial ARTG registration on 17 October 2013. BETMIGA mirabegron 25 mg and 50 mg film-coated prolonged-release tablets are registered on the Australian Register of Therapeutic Goods (ARTG 199664 and ARTG 199668).