Betmiga

Betmiga can only be obtained with a prescription and is available as prolonged-release tablets and as prolonged-release granules that are used to make a suspension that is taken by mouth. ‘Prolonged‑release’ means that mirabegron is released slowly from the tablet or granules over a few hours.

Betmiga is taken once a day. In children, the dose and form taken depends on the patient’s body weight. In patients who have reduced kidney or liver function the doctor may need to prescribe a lower dose or avoid the use of Betmiga, especially in patients taking certain other medicines.

For more information about using Betmiga, see the package leaflet or contact your doctor or pharmacist.

The active substance in Betmiga, mirabegron, is a beta-3-adrenergic-receptor agonist. It works by attaching to and activating beta-3 receptors that are found in the muscle cells of the bladder. When activated, beta-3 receptors cause the bladder muscles to relax. This is thought to lead to an increase in the capacity of the bladder and changes in the way the bladder contracts, resulting in fewer bladder contractions and thus fewer unwanted urination episodes.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Betmiga have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Betmiga are continuously monitored. Side effects reported with Betmiga are carefully evaluated and any necessary action taken to protect patients.

Betmiga received a marketing authorisation valid throughout the EU on 20 December 2012.

Adults

Betmiga has been studied in three main studies involving 4,611 adults with overactive bladder syndrome. Patients received Betmiga or placebo (a dummy treatment) every day for 3 months. The main measure of effectiveness was the change in the number of urination episodes and incontinence episodes per day after 3 months of treatment.

Treatment with Betmiga was shown to be effective in reducing the number of urination and incontinence episodes. After 3 months of treatment, on average, Betmiga reduced the number of urination episodes by 1.8 per day compared with a reduction of 1.2 per day for placebo. Betmiga resulted in a reduction of 1.5 incontinence episodes per day compared with a reduction of 1.1 incontinence episodes per day for placebo.

Children

A study involving 86 children and adolescents aged from 3 to less than 18 years with NDO showed that after 24 weeks of treatment, on average patients had an increase in the maximum cystometric capacity (MCC) of around 87 millilitres (mL). MCC is a measure of the largest volume of urine that the bladder can store comfortably before there is a strong need to urinate. The study did not compare Betmiga with other medicines or placebo.

For the full list of side effects and restrictions with Betmiga, see the package leaflet.

The most common side effects with Betmiga in adults (which may affect up to 1 in 10 people) include tachycardia (rapid heartbeat) and urinary tract infection (infection of the structures that carry urine). Serious but uncommon side effects include atrial fibrillation (cardiac rhythm disorder).

Overall, the safety profile in children and adolescents is similar to that seen in adults. The most common side effects with Betmiga in children include urinary tract infection, constipation and nausea (feeling sick).

Betmiga must not be used in people who have hypertension (high blood pressure) that is severe and uncontrolled.

The European Medicines Agency considered that the beneficial effects seen with Betmiga in adults were modest but comparable to the benefits of other medicines authorised for the treatment of overactive bladder syndrome.

Betmiga was also shown to control bladder activity in children and adolescents aged from 3 to less than 18 years with NDO. Although there were some limitations in the main study in children, such as the small number of patients involved in the study, the lack of a comparator and limited data on the long-term effects in these patients, treatment with Betmiga was shown to improve the bladder’s ability to store urine. The treatment effect was in line with that reported in published studies with other medicines commonly used to treat NDO.

Regarding its safety, most side effects are comparable to those of other medicines used for treating overactive bladder syndrome. The potential risk of hypersensitivity (allergic reactions) and effects on the heart have been adequately addressed in the product information.

The European Medicines Agency therefore decided that Betmiga’s benefits are greater than its risks and it can be authorised for use in the EU.

The most common side effects with Betmiga are tachycardia (rapid heartbeat) seen in just over 1 person in 100, and urinary tract infection (infection of the structures that carry urine) seen in just under 3 people in 100. Serious but uncommon side effects include atrial fibrillation (cardiac rhythm disorder). For the full list of all side effects reported with Betmiga, see the package leaflet.

Betmiga must not be used in people who have hypertension (high blood pressure) that is severe and uncontrolled. For the full list of restrictions, see the package leaflet.

The CHMP noted that the beneficial effects seen with Betmiga were modest but comparable to the benefits of other medicines authorised for this condition. Regarding its safety, most side effects are comparable to those of other medicines used for treating overactive bladder syndrome. The potential risk of hypersensitivity (allergic reactions) and effects on the heart has been adequately addressed in the product information. The CHMP therefore decided that Betmiga’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Betmiga is a medicine containing the active substance mirabegron. It is available as prolonged-release tablets (25 mg, 50 mg). ‘Prolonged-release’ means that mirabegron is released slowly from the tablet over a few hours.

Betmiga is used in adults with overactive bladder syndrome. It is used to treat certain symptoms of the condition: urgency (sudden urge to urinate), increased urinary frequency (the need to urinate frequently) and urge incontinence (involuntary leakage of urine from the bladder when a sudden strong need to urinate is felt).

The medicine can only be obtained with a prescription.

Betmiga has been studied in three main studies involving 4,611 patients with overactive bladder syndrome. Patients received Betmiga (25 mg, 50 mg or 100 mg) or placebo (a dummy treatment) every day for 3 months. The main measure of effectiveness was the change in the number of urinations and incontinence episodes per day after 3 months of treatment.

Treatment with 50 mg a day of Betmiga was shown to be effective in reducing the number of urination and incontinence episodes. After 3 months of treatment, on average Betmiga 50 mg reduced the number of urinations by 1.8 per day compared with a reduction of 1.2 per day for placebo. Betmiga 50 mg resulted in a reduction of 1.5 incontinence episodes per day compared with a reduction of 1.1 incontinence episodes per day for placebo.