Mirabegron interactions

Food & lifestyle

• high-fat foods

  Minor

  Absorption

  Food reduces the oral absorption and bioavailability of mirabegron. According to the product labeling, administration of a 50 mg tablet with a high-fat meal decreased mirabegron peak plasma concentration (Cmax) and systemic exposure (AUC) by 45% and 17%, respectively, whereas administration with a low-fat meal decreased mirabegron Cmax and AUC by 75% and 51%, respectively.

  What to do: In phase 3 clinical studies demonstrating both safety and efficacy, mirabegron was administered without regards to food content and intake. Therefore, mirabegron can be taken with or without food at the recommended dosage.

  1 source

  1. "Product Information. Myrbetriq (mirabegron)." Astellas Pharma US, Inc (2012):

Conditions

Conditions in which Mirabegron needs care, as documented in this source.

• Hypertension

  Moderate

  Mirabegron can increase blood pressure. In clinical studies, the use of mirabegron was associated with dose-related increases in supine blood pressure. At the maximum recommended dose of 50 mg, the mean maximum increase in systolic/diastolic blood pressure was approximately 3.5/1.5 mmHg greater than placebo in healthy volunteers and approximately 0.5 to 1 mmHg greater than placebo in patients with overactive bladder. Worsening of preexisting hypertension was reported infrequently in patients receiving mirabegron. Therapy with mirabegron should be administered cautiously in patients with hypertension. Periodic blood pressure determinations are recommended. Mirabegron is not recommended for use in patients with severe, uncontrolled hypertension, defined as systolic blood pressure >=180 mm Hg and/or diastolic blood pressure >=110 mm Hg.

  1 source

  1. "Product Information. Myrbetriq (mirabegron)." Astellas Pharma US, Inc (2012):

• Kidney Diseases

  Moderate

  Mirebegron is partially eliminated by the kidney through active tubular secretion and glomerular filtration, with renal clearance accounting for approximately 25% of the total clearance. Following administration of a single 100 mg dose, mean mirabegron peak plasma concentration (Cmax) and systemic exposure (AUC) increased by 6% and 31%, respectively, in volunteers with mild renal impairment (estimated GFR 60 to 89 mL/min/1.73 m2), 23% and 66%, respectively, in volunteers with moderate renal impairment (estimated GFR 30 to 59 mL/min/1.73 m2), and 92% and 118%, respectively, in patients with severe renal impairment (estimated GFR 15 to 29 mL/min/1.73 m2) compared to volunteers with normal renal function. No dosage adjustment is necessary in patients with mild or moderate renal impairment. In patients with severe renal impairment, the daily dosage of mirabegron should not exceed 25 mg. Mirabegron has not been studied in patients with end stage renal disease (CrCl <15 mL/min or estimated GFR <15 mL/min/1.73 m2 or requirement for hemodialysis). Mirabegron is not recommended for use in these patients.

  1 source

  1. "Product Information. Myrbetriq (mirabegron)." Astellas Pharma US, Inc (2012):

• Liver Diseases

  Moderate

  Mirebegron is partially metabolized by the liver through multiple pathways. Following administration of a single 100 mg dose, mean mirabegron peak plasma concentration (Cmax) and systemic exposure (AUC) increased by 9% and 19%, respectively, in volunteers with mild hepatic impairment (Child-Pugh Class A) and 175% and 65%, respectively, in volunteers with moderate hepatic impairment (Child-Pugh Class B) compared to volunteers with normal hepatic function. No dosage adjustment is necessary in patients with mild hepatic impairment. In patients with moderate hepatic impairment, the daily dosage of mirabegron should not exceed 25 mg. Mirabegron has not been studied in patients with severe hepatic impairment (Child-Pugh Class C). Mirabegron is not recommended for use in these patients.

  1 source

  1. "Product Information. Myrbetriq (mirabegron)." Astellas Pharma US, Inc (2012):

• Urinary Retention

  Moderate

  Although an increased risk of urinary retention was not observed in a controlled clinical safety study in patients with bladder outlet obstruction, urinary retention has been reported in this population during postmarketing use. Therapy with mirabegron should be administered cautiously in patients with clinically significant bladder outlet obstruction and conditions predisposing to urinary retention.

  1 source

  1. "Product Information. Myrbetriq (mirabegron)." Astellas Pharma US, Inc (2012):