Mirabegron oral modified release
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations of mirabegron
Symptomatic treatment of urinary urgency, frequency or urge incontinence
50 mg once daily.
50 mg once daily.
Patients with Renal Impairment
GFR 30 to 89 ml/minute/1.73 metre squared: No reduction required. Reduce to 25 mg daily if taken with strong CYP3A inhibitors.
GFR 15 to 29 ml/minute/1.73 metre squared: Reduce to 25 mg daily. Not recommended with strong CYP3A inhibitors.
Patients with Hepatic Impairment
Mild hepatic impairment (Child-Pugh class A): No reduction required. Reduce to 25 mg daily if taken with strong CYP3A inhibitors.
Moderate hepatic impairment (Child-Pugh class B): Reduce to 25 mg daily. Not recommended with strong CYP3A inhibitors.
Children under 18 years
End stage renal disease
Severe hepatic impairment - Child-Pugh score greater than or equal to 10
Uncontrolled severe hypertension
Precautions and Warnings
Systolic blood pressure above 160mm Hg
Bladder outflow obstruction
Hepatic impairment - Child-Pugh score between 7 and 9
Renal impairment - glomerular filtration rate below 30ml/minute/1.73m sq
Reduce dose in patients with severe renal impairment
Monitor blood pressure pre-treatment and periodically thereafter
Reduce dose in hepatic impairment where Child Pugh greater than 7
Female: Ensure adequate contraception during treatment
Pregnancy and Lactation
Mirabegron is contraindicated in pregnancy.
There is limited data on the use of mirabegron in pregnant women. Studies in animals have shown reproductive toxicity.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Mirabegron is contraindicated in breastfeeding.
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 breastfed child.
Mirabegron is excreted in the milk of rodents and therefore is predicted to be present in human milk.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Bladder outflow obstruction
Gamma glutamyl transferase (GGT) increased
Increase in serum ALT/AST
Increased blood pressure
Oedema of the lips
Urinary tract infections
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: May 2016
Joint Formulary Committee. British National Formulary. 71st ed. London: BMJ Group and Pharmaceutical Press; 2016.
Summary of Product Characteristics: Betmiga 25 mg & 50 mg prolonged-release tablets. Astellas Pharma Ltd. Revised March 2016.
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