Mirabegron

Mirabegron is an FDA-registered drug product whose active ingredient is MIRABEGRON. It is labelled by REMEDYREPACK INC. taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 70518-4304, application ANDA209488, label effective 20260903. It is one of 4 FDA drug label records sharing the active ingredient MIRABEGRON. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing MIRABEGRON are most often described in connection with: mirabegron extended-release, overactive bladder, oab adult, symptoms urge, urinary incontinence, neurogenic detrusor, overactivity ndo, pediatric patients. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE Mirabegron extended-release tablets are a beta-3 adrenergic agonist indicated for the treatment of: Overactive bladder (OAB) in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency. ( 1.1 ) Neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older and weighing 35 kg or more. ( 1.2 ) 1.1 Adult Overactive Bladder (OAB) Mirabegron Monotherapy Mirabegron extended-release tablets are indicated for the treatment of OAB in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency. 1.2 Pediatric Neurogenic Detrusor Overactivity (NDO) Mirabegron extended-release tablets are indicated for the treatment of NDO in pediatric patients aged 3 years and older and weighing 35 kg or more.

2 DOSAGE AND ADMINISTRATION Mirabegron extended-release tablets and Mirabegron Granules are two different products and they are not substitutable on a milligram-per-milligram basis. Select the recommended product (Mirabegron extended-release tablets and Mirabegron Granules) based on the indication and patient's weight. OAB in Adults The recommended starting dose of mirabegron extended-release tablets is 25 mg orally once daily. ( 2.2 ) After 4 to 8 weeks, the mirabegron extended-release tablets dose may be increased to 50 mg orally once daily. ( 2.2 ) NDO in Pediatric Patients 3 Years and Older Pediatric Patients weighing 35 kg or more: Use mirabegron extended-release tablets: The recommended starting dosage of mirabegron extended-release tablets is 25 mg orally once daily. After 4 to 8 weeks, the mirabegron extended-release tablets dose may be increased to 50 mg orally once daily. ( 2.3 ) Adult or Pediatric Patients Patients with Renal or Hepatic Impairment : Refer to the full prescribing information for recommended dosage. ( 2.4 , 2.5 ) Administration Mirabegron extended-release tablets: Adult patients: Swallow mirabegron extended-release tablets whole with water. Do not chew, divide, or crush. Take with or without food. ( 2.7 ) Pediatric patients: Swallow mirabegron extended-release tablets whole with water. Do not chew, divide, or crush. Take with food. ( 2.7 ) 2.1 Important Dosage Information Mirabegron extended-release tablets and Mirabegron Granules are two different products and they are not substitutable on a milligram-per-milligram basis. Select the recommended product (Mirabegron extended-release tablets and Mirabegron Granules) based on the indication and patient's weight [see Indications and Usage ( 1 ) and Dosage and Administration ( 2.2 , 2.3 , 2.4 , 2.5 )]. 2.2 Recommended Dosage for Adult Patients with OAB Mirabegron Monotherapy The recommended starting dosage of mirabegron extended-release tablets is 25 mg orally once daily. If needed, increase to the maximum dosage of mirabegron extended-release tablets 50 mg orally once daily after 4 to 8 weeks. For administration instructions, see Dosage and Administration ( 2.7 ). 2.3 Recommended Dosage for Pediatric Patients Aged 3 Years and Older with NDO For pediatric patients 3 years of age and older, select the appropriate product (Mirabegron extended-release tablets and Mirabegron Granules) based on the patient's weight. Pediatric Patients weighing 35 kg or more: Use mirabegron extended-release tablets The recommended starting dosage of mirabegron extended-release tablets is 25 mg orally once daily. If needed, increase to a maximum dosage of mirabegron extended-release tablets 50 mg orally once daily after 4 to 8 weeks. For administration instructions, see Dosage and Administration (2.7) . 2.4 Recommended Dosage in Adult Patients with Renal or Hepatic Impairment Dosage in Adults with Renal Impairment The recommended dosage of mirabegron extended-release tablets (administered orally once daily) in adult patients with renal impairment is described in Table 1 [see Use in Specific Populations ( 8.6 )]. For administration instructions, see Dosage and Administration ( 2.7 ). Table 1: Mirabegron Extended-Release Tablets Recommended Dosage in Adult Patients with Renal Impairment (Administered Orally Once Daily) Estimated GFR 1 Starting Dose Maximum Dose eGFR 30 to 89 mL/min/1.73 m 2 25 mg 50 mg eGFR 15 to 29 mL/min/1.73 m 2 25 mg 25 mg eGFR < 15 mL/min/1.73 m 2 or requiring dialysis Not Recommended 1. Estimated GFR using the modification of diet in renal disease (MDRD) formula Dosage in Adults with Hepatic Impairment The recommended dosage of mirabegron extended-release tablets (administered orally once daily) in adult patients with hepatic impairment is described in Table 2 [see Use in Specific Populations ( 8.7 )]. For administration instructions, see Dosage and Administration ( 2.7 ). Table 2: Mirabegron Recommended Dosage in Adult Patients with Hepatic Impairment (Administered Orally Once Daily) Hepatic Impairment Classification Starting Dose Maximum Dose Child-Pugh Class A ( Mild hepatic impairment 25 mg 50 mg Child-Pugh Class B ( Moderate hepatic impairment 25 mg 25 mg Child-Pugh Class C ( Severe hepatic impairment Not Recommended 2.5 Recommended Dosage in Pediatric Patients with Renal or Hepatic Impairment For pediatric patients 3 years of age and older, select the appropriate product (Mirabegron extended-release tablets and Mirabegron Granules) based on the patient's weight. Pediatric Patients weighing 35 kg or more with renal or hepatic impairment: Use Mirabegron Extended-Release Tablets Dosage in Pediatric Patients with Renal Impairment The recommended dosage of mirabegron extended-release tablets in pediatric patients with renal impairment weighing 35 kg or more (administered orally once daily) is described in Table 1 (above). Note that the dosage is the same as for adult patients with renal impairment [see Dosage and Administration (2.4) and Use in Specific Populations (8.6) ] . For administration instructions, see Dosage and Administration (2.7) . Dosage in Pediatric Patients with Hepatic Impairment The recommended dosage of mirabegron extended-release tablets in pediatric patients with hepatic impairment weighing 35 kg or more (administered orally once daily) is described in Table 2 (above). Note that the dosage is the same as for adult patients with hepatic impairment [see Dosage and Administration (2.4) and Use in Specific Populations (8.6) ] . For administration instructions, see Dosage and Administration (2.7) . 2.7 Administration Instructions Mirabegron extended-release tablets Adult patients: Swallow mirabegron extended-release tablets whole with water. Do not chew, divide, or crush. Take with or without food. Pediatric patients: Swallow mirabegron extended-release tablets whole with water. Do not chew, divide, or crush. Take with food [see Use in Specific Populations (8.4) ] . 2.8 Missed Dose Instruct patients to take any missed doses as soon as they remember, unless more than 12 hours have passed since the missed dose. If more than 12 hours have passed, the missed dose can be skipped, and the next dose should be taken at the usual time.

4 CONTRAINDICATIONS Mirabegron extended-release tablets are contraindicated in patients with known hypersensitivity reactions to mirabegron or any inactive ingredients of the tablet [see Adverse Reactions ( 6.1 , 6.2 )]. Hypersensitivity to mirabegron or any inactive ingredients. ( 4 )

6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling. Hypertension [see Warnings and Precautions ( 5.1 )] Urinary Retention [see Warnings and Precautions ( 5.2 )] Angioedema [see Warnings and Precautions ( 5.3 )] Most commonly reported adverse reactions with mirabegron monotherapy in adult patients with OAB (> 2% and > placebo) were hypertension, nasopharyngitis, urinary tract infection, and headache. ( 6.1 ) Most commonly reported adverse reactions with mirabegron in pediatric patients with NDO (≥ 3%) were UTI, nasopharyngitis, constipation, and headache. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Mirabegron Monotherapy for Adult OAB In three, 12-week, double-blind, placebo-controlled, safety and efficacy studies in patients with OAB (Studies 1, 2, and 3), mirabegron was evaluated for safety in 2,736 patients [see Clinical Studies ( 14.1 )]. Study 1 also included an active control. For the combined Studies 1, 2, and 3,432 patients received mirabegron 25 mg, 1,375 received mirabegron 50 mg, and 929 received mirabegron 100 mg once daily. In these studies, the majority of the patients were Caucasian (94%), and female (72%) with a mean age of 59 years (range 18 to 95 years). Mirabegron was also evaluated for safety in 1,632 patients who received mirabegron 50 mg once daily (n=812 patients) or mirabegron 100 mg (n=820 patients) in a 1-year, randomized, fixed- dose, double-blind, active-controlled, safety study in patients with OAB (Study 4). Of these patients, 731 received mirabegron in a previous 12-week study. In Study 4, 1385 patients received mirabegron continuously for at least 6 months, 1,311 patients received mirabegron for at least 9 months, and 564 patients received mirabegron for at least 1 year. The most frequent adverse events (0.2%) leading to discontinuation in Studies 1, 2 and 3 for the 25 mg or 50 mg dose were nausea, headache, hypertension, diarrhea, constipation, dizziness, and tachycardia. Atrial fibrillation (0.2%) and prostate cancer (0.1%) were reported as serious adverse events by more than 1 patient and at a rate greater than placebo. Table 3 the lists adverse reactions, derived from all adverse events that were reported in Studies 1, 2 and 3 at an incidence greater than placebo and in 1% or more of patients treated with mirabegron 25 mg or 50 mg once daily for up to 12 weeks. The most commonly reported adverse reactions (greater than 2% of mirabegron patients and greater than placebo) were hypertension, nasopharyngitis, urinary tract infection, and headache. Table 3: Percentages of Patients with Adverse Reactions, Derived from All Adverse Events, Exceeding Placebo Rate and Reported in ≥ 1% of OAB Patients Treated with mirabegron 25 mg or 50 mg Once Daily in Studies 1, 2, and 3 Adverse Reaction Placebo (%) Mirabegron 25 mg (%) Mirabegron 50 mg (%) Number of Patients 1380 432 1375 Hypertension * 7.6 11.3 7.5 Nasopharyngitis 2.5 3.5 3.9 Urinary Tract Infection 1.8 4.2 2.9 Headache 3.0 2.1 3.2 Constipation 1.4 1.6 1.6 Upper Respiratory Tract Infection 1.7 2.1 1.5 Arthralgia 1.1 1.6 1.3 Diarrhea 1.3 1.2 1.5 Tachycardia 0.6 1.6 1.2 Abdominal Pain 0.7 1.4 0.6 Fatigue 1.0 1.4 1.2 * Includes reports of blood pressure above the normal range, and BP increased from baseline, occurring predominantly in subjects with baseline hypertension. Other adverse reactions reported by less than 1% of patients treated with mirabegron in Studies 1, 2, or 3 included: Cardiac disorders: palpitations, blood pressure increased [see Clinical Pharmacology ( 12.2 )] Eye disorders: glaucoma [see Clinical Pharmacology ( 12.2 )] Gastrointestinal disorders: dyspepsia, gastritis, abdominal distension Infections and Infestations: sinusitis, rhinitis Investigations: GGT increased, AST increased, ALT increased, LDH increased Renal and urinary disorders: nephrolithiasis, bladder pain Reproductive system and breast disorders: vulvovaginal pruritus, vaginal infection Skin and subcutaneous tissue disorders: urticaria, leukocytoclastic vasculitis, rash, pruritus, purpura, lip edema Table 4 lists the rates of the most commonly reported adverse reactions, derived from all adverse events in patients treated with mirabegron 50 mg for up to 52 weeks in Study 4. The most commonly reported adverse reactions (>3% of mirabegron patients) were hypertension, urinary tract infection, headache, and nasopharyngitis. Table 4: Percentages of Patients with Adverse Reactions, Derived from All Adverse Events, Reported in >2% of OAB Patients Treated with mirabegron 50 mg Once Daily in Study 4 Adverse Reaction Mirabegron 50 mg (%) Active Control (%) Number of Patients 812 812 Hypertension 9.2 9.6 Urinary Tract Infection 5.9 6.4 Headache 4.1 2.5 Nasopharyngitis 3.9 3.1 Back Pain 2.8 1.6 Constipation 2.8 2.7 Dry Mouth 2.8 8.6 Dizziness 2.7 2.6 Sinusitis 2.7 1.5 Influenza 2.6 3.4 Arthralgia 2.1 2.0 Cystitis 2.1 2.3 In Study 4, in patients treated with mirabegron 50 mg once daily, adverse reactions leading to discontinuation reported by more than 2 patients and at a rate greater than active control included: constipation (0.9%), headache (0.6%), dizziness (0.5%), hypertension (0.5%), dry eyes (0.4%), nausea (0.4%), vision blurred (0.4%), and urinary tract infection (0.4%). Serious adverse events reported by at least 2 patients and exceeding active control included cerebrovascular accident (0.4%) and osteoarthritis (0.2%). Serum ALT/AST increased from baseline by greater than 10-fold in 2 patients (0.3%) taking mirabegron 50 mg; and these markers subsequently returned to baseline while both patients continued mirabegron. In Study 4, serious adverse events of neoplasm were reported by 0.1%, 1.3%, and 0.5% of patients treated with mirabegron 50 mg, mirabegron 100 mg and active control once daily, respectively. Neoplasms reported by 2 patients treated with mirabegron 100 mg included breast cancer, lung neoplasm malignant and prostate cancer. A causal relationship between mirabegron and these reported neoplasms has not been established. In a separate clinical study in Japan, a single case was reported as Stevens-Johnson syndrome with increased serum ALT, AST, and bilirubin in a patient taking mirabegron 100 mg as well as an herbal medication (Kyufu Gold). Mirabegron for Pediatric Neurogenic Detrusor Overactivity (NDO) The safety of mirabegron was evaluated in a 52-week, open-label, baseline-controlled, multicenter, dose titration study (Study 9) [see Clinical Studies (14.3)] . The study included 86 pediatric patients 3 to 17 years of age with neurogenic detrusor overactivity (NDO); 55% were female, 72% were White. Treatment was initiated at the weight-based starting recommended dose and was increased to a dose equivalent of mirabegron 50 mg daily dose in adults by Week 8. Subsequent to the dose titration period, patients continued their optimized dose for the duration of the 52-week study (mean exposure duration 303 days, range 1 to 390 days). The most commonly reported adverse reactions were UTI, nasopharyngitis, constipation, and headache. Table 5 lists the adverse reactions that were reported in 2% or more of patients treated with mirabegron in Study 9. Table 5: Percentages of Patients with Adverse Reactions Reported in ≥ 2% of Patients 3 to 17 Years of Age with Neurogenic Detrusor Overactivity (NDO) Treated with Mirabegron in Study 9 Adverse Reaction Percentage (%) of Patients Reporting Adverse Reactions N=86 N umber of Patients 51 (59.3) Urinary Tract Infection 1 24.4 Nasopharyngitis 5.8 Constipation 4.7 Headache 3.5 Nausea 2.3 Gastroenteritis 2.3 Rhinitis 2.3 Cough 2.3 1. Includes any recorded UTI while patient was on treatment with mirabegron. Increased Blood Pressure in Pediatric Patients with NDO Treated with mirabegron: Mean systolic and diastolic blood pressures increased in Study 9 by 4.3 mm Hg and 1.7 mm Hg, respectively, in patients less than 12 years of age on mirabegron at a dose equivalent of mirabegron 50 mg daily dose in adults. The blood pressure increases were larger in patients less than 8 years of age with mean systolic and diastolic blood pressure increases of 5.9 mm Hg and 2.3 mm Hg, respectively. Ten (24%) patients less than 12 years of age who were normotensive at baseline had at least one blood pressure measured at or above the 95 th percentile for age, sex, and stature during Study 9. Stage 1 hypertension, defined as repeated blood pressure measurements at or above the 95 th percentile for age, sex, and stature, was sustained in six of these 10 patients (60%) at the end of the study. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of mirabegron. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following events have been reported in association with mirabegron use in worldwide postmarketing experience: Cardiac disorders: atrial fibrillation Gastrointestinal disorders: nausea, constipation, diarrhea Nervous system disorders: dizziness, headache There have been postmarketing reports of confusion, hallucinations, insomnia and anxiety in patients taking mirabegron. The majority of these patients had pre-existing medical conditions or concomitant medications that may cause confusion, hallucinations, insomnia and anxiety. A causal relationship between mirabegron and these disorders has not been established. Skin and subcutaneous tissue disorders: angioedema of the face, lips, tongue, and larynx, with or without respiratory symptoms [see Warnings and Precautions ( 5.3 )] ; pruritus Renal and urinary disorders: urinary retention [see Warnings and Precautions ( 5.2 )]

FDA lists 4 drug label records with MIRABEGRON as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Mirabegron used for?
1 INDICATIONS AND USAGE Mirabegron extended-release tablets are a beta-3 adrenergic agonist indicated for the treatment of: Overactive bladder (OAB) in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency. ( 1.1 ) Neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older and weighing 35 kg or more. ( 1.2 ) 1.1 Adult Overactive …

Who makes Mirabegron?
REMEDYREPACK INC. is the labeler of record for Mirabegron. 4 FDA label records share the active ingredient MIRABEGRON, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Mirabegron come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Mirabegron prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing MIRABEGRON?
Yes. 4 FDA drug label records list MIRABEGRON as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Mirabegron been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.