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Myrbetriq mirabegron 8 mg/mL Granule, For Suspension, Extended Release — NDC 00469-5020-99 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Myrbetriq mirabegron 8 mg/mL Granule, For Suspension, Extended Release — NDC 0469-5020-99 (Billing 00469-5020-99)

by Astellas Pharma US, Inc. · 1 BOTTLE in 1 CARTON / 100 mL in 1 BOTTLE

This is a package of Myrbetriq mirabegron 8 mg/mL Granule, For Suspension, Extended Release from Astellas Pharma US, Inc., marketed since Mar 2021 and currently FDA-listed; retail pharmacies pay about $2.21 per mL (NADAC). It is this product's only package size.

NDC 00469-5020-99
🏷️ FDA NDC (as labeled) 0469-5020-99 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Mirabegron (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 5, 2026 — CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity. (Zydus Pharmaceuticals (USA) Inc) · FDA recall D-0745-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0469-5020-99
Product NDC 0469-5020
11-digit billing NDC 00469502099
NCPDP billing unit ML — per mL (volume)
RxCUI 1300791, 1300797, 1300801, 1300803, 2541233, 2541237
UNII MVR3JL3B2V
Application # NDA213801
SPL Set ID ba9e9e15-e666-4c56-9271-2e24739cfa2d
Established class (EPC) beta3-Adrenergic Agonist
Mechanism of action Adrenergic beta3-Agonists; Cytochrome P450 2D6 Inhibitors; Cytochrome P450 3A Inhibitors; P-Glycoprotein Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-03-25
Route ORAL
Dosage form GRANULE, FOR SUSPENSION, EXTENDED RELEASE
Substance MIRABEGRON
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 5420005000G220
GPI class Myrbetriq
GCN Seq No 082137
GCN 49454
HICL code 039357
Ingredient (HICL) Mirabegron
HIC1 code R
Therapeutic class — broad (HIC1) Kidney/Urinary Tract
HIC2 code R1
Therapeutic class — intermediate (HIC2) Affect Primarily Kidneys/Urinary Tract
HIC3 code R1V
Therapeutic class — specific (HIC3) Overactive Bladder Agents, Beta-3 Adrenergic Recep
AHFS code 86:12.08.12
AHFS class Selective Beta-3-Adrenergic Agonists
FDB label name MYRBETRIQ ER 8 MG/ML SUSP
FDB brand name Myrbetriq
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 082137
  • GCN: 49454
  • GPI-14 (Medi-Span): 5420005000G220
  • HICL (First Databank): 039357
  • AHFS class code: 86:12.08.12
  • RxCUI (RxNorm): 1300791
Why two NDCs? The FDA registers this code as 0469-5020-99 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00469-5020-99. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the beta3-Adrenergic Agonist class.

Pharmacologic class beta3-Adrenergic Agonist
Drug family (ATC) Drugs for urinary frequency and incontinence
How it works Cytochrome P450 2D6 Inhibitors, Adrenergic beta3-Agonists, P-Glycoprotein Inhibitors, Cytochrome P450 3A Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name MYRBETRIQ ER 8 MG/ML SUSP Ingredient Mirabegron
📖 What it is MedlinePlus · NLM

Mirabegron is used alone or in combination with solifenacin (Vesicare) to treat overactive bladder (a condition in which the bladder muscles contract uncontrollably and cause frequent urination, urgent need to urinate, and inability to control urination) in adults. It is also used to treat neurogenic detrusor overactivity (a bladder control condition caused by brain, spinal cord or nerve problem) in children 3 years of age and older. Mirabegron is in a class of medications called beta-3 adrenergic agonists. It works by relaxing the bladder muscles to prevent urgent, frequent, or uncontrolled u...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Mirabegron helps your bladder muscle relax so it can hold more urine before you feel a sudden urge to go. If you're dealing with overactive bladder — the urgency, the leaks, the co...
  • What is mirabegron actually supposed to do for me?
  • For adults taking the tablet, it doesn't matter — you can take it with or without food. But if a child is taking either the tablet or the oral suspension (granules), it should alwa...
  • Does it matter if I take it with food or on an empty stomach?
📖 Read our full Mirabegron guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $2.207 $220.70 / 100 ml
Medicaid paysCMS SDUD · 12 mo $2.24 $223.72 / 100 ml
Medicare drug plans payPart D · Q2 2026 $2.27 $227.31 / 100 ml
NADAC price history (per mL) — tap or hover for the price & month
Jul 2023 Feb 2026 May 2026 Sep 2026 $2.217 $2.207
Flat over the last 11 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00469-5020-99 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 100 mL in 1 BOTTLE 2021-03-25 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Myrbetriq 8 mg/mLthis 00469-5020-99 Astellas 1 bottle $2.207 AB Availability likely —
Mirabegron 8 mg/mL 67877-0890-88 Ascend 1 pouch — AB FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2021
First FDA approval
Mar 2021
📍
2026
Currently FDA-listed
5 years listed
🛡️
2036
Latest patent/protection listed
not a guaranteed launch date
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Sep 2036. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Mar 25, 2021 AB TE-rated RLD RS ⏳ ~10 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 10058536 — method of use (U-3108)
US 10058536*PED — drug product
2021 2023 2025 2027 2029 2031 2033 2035
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (2)
PatentTypeUse codeExpires
US 10058536 ↗ Method of use U-3108 Mar 31, 2036
US 10058536*PED ↗ Drug product — Sep 30, 2036
Common questions
Is there a generic version of MYRBETRIQ ER 8 MG/ML SUSP?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for MYRBETRIQ ER 8 MG/ML SUSP. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color Brown / Yellow
ShapeOval
ImprintAstellas;logo;355
Size12 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 23OV73Q5G9
    Acesulfame potassium is an artificial sweetener that tastes about 200 times sweeter than sugar. It's added to medicines to improve taste without adding calories or affecting blood sugar.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII 14255EXE39
    Ethylparaben is a preservative, a chemical that stops bacteria and mold from growing in the medicine. It keeps the product safe and effective throughout its shelf life.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 1699G8679Z
    A synthetic polymer that acts as a binder and helps hold tablet or capsule ingredients together. It may also be used to improve how the medicine dissolves or is absorbed in the digestive system.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

11 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerAstellas Pharma US, Inc.
Application holderASTELLAS PHARMA GLOBAL DEVELOPMENT INC
FDA applicationNDA213801 (NDA)
Labeler code00469
First marketedMar 2021
Product typeHuman Prescription Drug
Portfolio35 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 205 words ▾

1 INDICATIONS AND USAGE MYRBETRIQ is 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, either alone or in combination with the muscarinic antagonist solifenacin succinate. ( 1.1 ) • Neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older and weighing 35 kg or more. ( 1.2 ) MYRBETRIQ Granules is a beta-3 adrenergic agonist indicated for the treatment of NDO in pediatric patients aged 3 years and older.

( 1.2 )

1.1Adult Overactive Bladder (OAB) MYRBETRIQ Monotherapy MYRBETRIQ ® is indicated for the treatment of OAB in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency. MYRBETRIQ Combination Therapy with Solifenacin Succinate MYRBETRIQ, in combination with the muscarinic antagonist solifenacin succinate, is indicated for the treatment of OAB in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency.

1.2Pediatric Neurogenic Detrusor Overactivity (NDO) MYRBETRIQ Granules MYRBETRIQ ® Granules is indicated for the treatment of NDO in pediatric patients aged 3 years and older. MYRBETRIQ MYRBETRIQ is indicated for the treatment of NDO in pediatric patients aged 3 years and older and weighing 35 kg or more.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND A DM INISTRATION • MYRBETRIQ and MYRBETRIQ Granules are two different products and they are not substitutable on a milligram-per-milligram basis. Select the recommended product (MYRBETRIQ or MYRBETRIQ Granules) based on the indication and patient’s weight. Do not combine MYRBETRIQ and MYRBETRIQ Granules to achieve the total dose.

A recommended dosage for MYRBETRIQ Granules for adults has not been determined. ( 2.1 ) OAB in Adults • The recommended starting dose of MYRBETRIQ is 25 mg orally once daily, either alone or in combination with solifenacin succinate 5 mg orally once daily. ( 2.2 ) • After 4 to 8 weeks, the MYRBETRIQ dose may be increased to 50 mg orally once daily.

( 2.2 ) NDO in Pediatric Patients 3 Years and Older • Pediatric Patients weighing less than 35 kg: Use MYRBETRIQ Granules: The recommended starting dose of MYRBETRIQ Granules is weight-based and administered as an extended-release oral suspension once daily. After 4 to 8 weeks, increase to the lowest effective dose without exceeding the maximum recommended dose. ( 2.3 ) • Pediatric Patients weighing 35 kg or more: Use MYRBETRIQ or MYRBETRIQ Granules: o The recommended starting dosage of MYRBETRIQ is 25 mg orally once daily.

After 4 to 8 weeks, the MYRBETRIQ dose may be increased to 50 mg orally once daily. ( 2.3 ) o The recommended starting dosage of MYRBETRIQ Granules, administered as an extended-release oral suspension, is 6 mL (48 mg) orally once daily. After 4 to 8 weeks, increase to a maximum dosage of MYRBETRIQ Granules 10 mL (80 mg) orally once daily ( 2.3 ) Adult or Pediatric Patients with Renal or Hepatic Impairment : Refer to the full prescribing information for recommended dosage.

( 2.4 , 2.5 ) Preparation for MYRBETRIQ Granules : Refer to the full prescribing information. ( 2.6 ) Administration • MYRBETRIQ: o Adult patients: Swallow MYRBETRIQ whole with water. Do not chew, divide, or crush.

Take with or without food. ( 2.7 ) o Pediatric patients: Swallow MYRBETRIQ whole with water. Do not chew, divide, or crush.

Take with food. ( 2.7 ) • MYRBETRIQ Granules: o Pediatric patients: Take MYRBETRIQ Granules prepared as an extended-release oral suspension. Take with food.

( 2.7 )

2.1Important Dosage Information MYRBETRIQ and MYRBETRIQ Granules are two different products and they are not substitutable on a milligram-per-milligram basis: • Select the recommended product (MYRBETRIQ or MYRBETRIQ 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 )]. • Do not combine MYRBETRIQ and MYRBETRIQ Granules to achieve the total dose. • A recommended dosage for MYRBETRIQ Granules for adults has not been determined.

2.2Recommended Dosage for Adult Patients with OAB MYRBETRIQ Monotherapy The recommended starting dosage of MYRBETRIQ is 25 mg orally once daily. If needed, increase to the maximum dosage of MYRBETRIQ 50 mg orally once daily after 4 to 8 weeks. For administration instructions, see Dosage and Administration ( 2.7 ) .

MYRBETRIQ Combination Therapy with Solifenacin Succinate The recommended starting dosage for combination treatment is MYRBETRIQ 25 mg orally once daily and solifenacin succinate 5 mg orally once daily. If needed, increase to the maximum dosage of MYRBETRIQ 50 mg orally once daily after 4 to 8 weeks. Refer to the Prescribing Information for solifenacin succinate for additional information.

For administration instructions, see Dosage and Administration ( 2.7 ) .

2.3Recommended Dosage for Pediatric Patients Aged 3 Years and Older with NDO For pediatric patients 3 years of age and older, select the appropriate product (MYRBETRIQ or MYRBETRIQ Granules) based on the patient’s weight. Pediat ric Patients weighing less than 35 kg: Use MYRBETRIQ Granules The recommended starting and maximum doses of MYRBETRIQ Granules, administered as extended-release oral suspension once daily [see Dosage and Administration ( 2.6 )] , are shown in Table 1 . The r… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 120 words ▾

3 DOSAGE FORMS AND STRENGTHS MYRBETRIQ (mirabegron extended-release tablets) are supplied in two different strengths as described below: • 25 mg oval, brown, film-coated tablet, debossed with the (Astellas logo) and “325” • 50 mg oval, yellow, film-coated tablet, debossed with the (Astellas logo) and “355” MYRBETRIQ Granules (mirabegron for extended-release oral suspension): Each bottle is filled with approximately 8.3 g of yellowish white granules, which contain 830 mg of mirabegron. After reconstitution with 100 mL water, the oral suspension is pale brownish yellow to yellow with 8 mg/mL of mirabegron. • Extended-release tablets: 25 mg and 50 mg ( 3 ) • For extended-release oral suspension: 8 mg/mL of mirabegron after reconstitution ( 3 ) Astellas logo Astellas logo

⛔ Contraindications 43 words ▾

4 CONTRAINDICATIONS MYRBETRIQ/MYRBETRIQ Granules is contraindicated in patients with known hypersensitivity reactions to mirabegron or any inactive ingredients of the tablet or oral suspension [see Adverse Reactions ( 6.1 , 6.2 )] . Hypersensitivity to mirabegron or any inactive ingredients. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Increases in Blood Pressure : Can increase blood pressure in adult or pediatric patients. Periodically monitor blood pressure, especially in hypertensive patients. MYRBETRIQ/MYRBETRIQ Granules are not recommended in patients with severe uncontrolled hypertension.

( 5.1 ) • Urinary Retention in Patients With Bladder Outlet Obstruction and in Patients Taking Muscarinic Antagonist Drugs for Overactive Bladder : Administer with caution in these patients because of risk of urinary retention. ( 5.2 ) • Angioedema : Angioedema of the face, lips, tongue, and/or larynx has been reported with mirabegron. ( 5.3 , 6.2 )

5.1Increases in Blood Pressure Increases in Blood Pressure in Adults MYRBETRIQ/MYRBETRIQ Granules can increase blood pressure. Periodic blood pressure determinations are recommended, especially in hypertensive patients. MYRBETRIQ/MYRBETRIQ Granules is not recommended for use in patients with severe uncontrolled hypertension (defined as systolic blood pressure greater than or equal to 180 mm Hg and/or diastolic blood pressure greater than or equal to 110 mm Hg) [see Clinical Pharmacology ( 12.2 )] .

In two, randomized, placebo-controlled, healthy adult volunteer studies, MYRBETRIQ was associated with dose-related increases in supine blood pressure. In these studies, at the maximum recommended dose of 50 mg, the mean maximum increase in systolic/diastolic blood pressure was approximately 3.5/1.5 mm Hg greater than placebo. In contrast, in adult OAB patients in clinical trials, MYRBETRIQ, taken as monotherapy or in combination with solifenacin succinate 5 mg, the mean increase in systolic and diastolic blood pressure at the maximum recommended mirabegron dose of 50 mg was approximately 0.5 to 1 mm Hg greater than placebo.

Worsening of pre-existing hypertension was reported infrequently in patients taking MYRBETRIQ. Increases in Blood Pressure in Pediatric Patients 3 Years and Older MYRBETRIQ/MYRBETRIQ Granules can increase blood pressure in pediatric patients. Blood pressure increases may be larger in children (3 to less than 12 years of age) than in adolescents (12 to less than 18 years of age).

Periodic blood pressure determinations are recommended. MYRBETRIQ/MYRBETRIQ Granules is not recommended for use in pediatric patients with severe uncontrolled hypertension, defined as a systolic and/or diastolic blood pressure above the 99 th percentile plus 5 mm Hg for age, sex, and stature using appropriate reference values [see Adverse Reactions ( 6.1 )] .

5.2Urinary Retention in Patients with Bladder Outlet Obstruction and in Patients Taking Muscarinic Antagonist Medications for OAB In patients taking MYRBETRIQ, urinary retention has been reported to occur in patients with bladder outlet obstruction (BOO) and in patients taking muscarinic antagonist medications for the treatment of OAB. A controlled clinical safety study in patients with BOO did not demonstrate increased urinary retention in patients treated with mirabegron; however, MYRBETRIQ should still be administered with caution to patients with clinically significant BOO.

For example, monitor these patients for signs and symptoms of urinary retention. MYRBETRIQ should also be administered with caution to patients taking muscarinic antagonist medications for the treatment of OAB, including solifenacin succinate [see Clinical Pharmacology ( 12.2 )] .

5.3Angioedema Angioedema of the face, lips, tongue, and/or larynx has been reported with MYRBETRIQ/MYRBETRIQ Granules. In some cases, angioedema occurred after the first dose, however, cases 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 MYRBETRIQ/MYRBETRIQ Granules and provide appropriate therapy and/or measures necessary to ensure a patent airway [see Adverse Reactions ( 6.2 )] .

5.4Patients Taking Drugs Me… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

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 MYRBETRIQ 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 MYRBETRIQ, in combination with solifenacin succinate in adult patients with OAB (> 2% and > placebo and > comparator), were dry mouth, urinary tract infection, constipation, and tachycardia.

( 6.1 ) • Most commonly reported adverse reactions with MYRBETRIQ/MYRBETRIQ Granules in pediatric patients with NDO (≥ 3%) were UTI, nasopharyngitis, constipation, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Astellas Pharma US, Inc. at 1-800-727-7003 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical 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. MYRBETRIQ 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), MYRBETRIQ was evaluated for safety in 2736 patients [see Clinical Studies ( 14.1 )] .

Study 1 also included an active control. For the combined Studies 1, 2, and 3, 432 patients received MYRBETRIQ 25 mg, 1375 received MYRBETRIQ 50 mg, and 929 received MYRBETRIQ 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).

MYRBETRIQ was also evaluated for safety in 1632 patients who received MYRBETRIQ 50 mg once daily (n=812 patients) or MYRBETRIQ 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 MYRBETRIQ in a previous 12-week study. In Study 4, 1385 patients received MYRBETRIQ continuously for at least 6 months, 1311 patients received MYRBETRIQ for at least 9 months, and 564 patients received MYRBETRIQ 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 8 lists the 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 MYRBETRIQ 25 mg or 50 mg once daily for up to 12 weeks.

The most commonly reported adverse reactions (greater than 2% of MYRBETRIQ patients and greater than placebo) were hypertension, nasopharyngitis, urinary tract infection, and headache. Table 8: Percentages of Patients with Adverse Reactions, Derived from All Adverse Events, Exceeding Placebo Rate and Reported in ≥ 1% of OAB Patients Treated with MYRBETRIQ 25 mg or 50 mg Once Daily in Studies 1, 2, and 3 Adverse Reaction Placebo (%) MYRBETRIQ 25 mg (%) MYRBETRIQ 50 mg (%) Number of Patients 1380 432 1375 Hypertension Includes reports of blood pressure above the normal range, and BP increased from baseline, occurring predominantly in subjects with baseline hypertension.

7.611.3

7.5Nasopharyngitis 2.5 3.5

3.9Urinary Tract Infection 1.8 4.2

2.9Headache 3.0 2.1

3.2Constipation 1.4 1.6

1.6Upper Respiratory Tract Infection 1.7 2.1

1.5Arthralgia 1.1 1.6

1.3Diarrhea 1.3 1.2

1.5Tachycardia 0.6 1.6

1.2Abdominal Pain 0.… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Drug interaction studies were conducted in adult patients to investigate the effect of coadministered drugs on the pharmacokinetics of mirabegron and the effect of mirabegron on the pharmacokinetics of coadministered drugs (e.g., ketoconazole, rifampin, solifenacin succinate, tamsulosin, and oral contraceptives) [see Clinical Pharmacology ( 12.3 )] . No dose adjustment is recommended when these drugs are coadministered with mirabegron. The following are drug interactions for which monitoring is recommended: • Drugs Metabolized by CYP2D6 : Mirabegron is a CYP2D6 inhibitor and, when used concomitantly with drugs metabolized by CYP2D6, especially narrow therapeutic index drugs, appropriate monitoring and possible dose adjustment of those drugs may be necessary.

( 5.4 , 7.1 , 12.3 ) • Digoxin : When initiating a combination of mirabegron and digoxin with or without solifenacin succinate, use the lowest dose of digoxin; monitor serum digoxin concentrations to titrate digoxin dose to desired clinical effect. ( 7.2 , 12.3 )

7.1Drugs Metabolized by CYP2D6 Since mirabegron is a moderate CYP2D6 inhibitor, the systemic exposure of drugs metabolized by CYP2D6 enzyme is increased when coadministered with mirabegron. Therefore, appropriate monitoring and dose adjustment may be necessary when MYRBETRIQ/MYRBETRIQ Granules is coadministered with these drugs, especially with narrow therapeutic index CYP2D6 substrates [see Warnings and Precautions ( 5.4 ) and Clinical Pharmacology ( 12.3 )] .

7.2Digoxin When given in combination, 100 mg mirabegron increased mean digoxin C max from 1.01 to 1.3 ng/mL (29%) and AUC from 16.7 to 19.3 ng.h/mL (27%). Concomitant administration of 0.25 mg digoxin with a combination of 5 mg solifenacin and 50 mg mirabegron increased digoxin AUC tau and C max by approximately 10% and 14%, respectively. For patients who are initiating a combination of mirabegron and digoxin, the lowest dose for digoxin should initially be considered.

Serum digoxin concentrations should be monitored and used for titration of the digoxin dose to obtain the desired clinical effect [see Clinical Pharmacology ( 12.3 )] .

7.3Warfarin The mean C max of S - and R -warfarin was increased by approximately 4% and AUC by approximately 9% when administered as a single dose of 25 mg after multiple doses of 100 mg mirabegron. Following a single dose administration of 25 mg warfarin, mirabegron had no effect on the warfarin pharmacodynamic endpoints such as International Normalized Ratio (INR) and prothrombin time. However, the effect of mirabegron on multiple doses of warfarin and on warfarin pharmacodynamic end points such as INR and prothrombin time has not been fully investigated [see Clinical Pharmacology ( 12.3 )] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no studies with the use of MYRBETRIQ/MYRBETRIQ Granules in pregnant women or adolescents to inform a drug-associated risk of major birth defects, miscarriages, or adverse maternal or fetal outcomes. Mirabegron administration to pregnant animals during organogenesis resulted in reversible skeletal variations (in rats) at 22-fold (via AUC) the maximum recommended human dose (MRHD) of 50 mg/day and decreased fetal body weights (in rabbits) at 14-fold the MRHD. At maternally-toxic exposures in rats (96-fold), decreased fetal weight and increased fetal mortality were observed and, in rabbits (36-fold), cardiac findings (fetal cardiomegaly and fetal dilated aortae) were observed [see Data ] .

The estimated background risks of major birth defects and miscarriage for the indicated populations are unknown. In the U.S. general population, the estimated background risk of major birth defects or miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively. Data Animal Data No embryo-fetal lethality or morphological fetal developmental abnormalities were produced in pregnant rats following daily oral administration of mirabegron during the period of organogenesis (Days 7 to 17 of gestation) at 0, 10, 30, 100, or 300 mg/kg, doses which were associated with systemic exposures (AUC) 0, 1, 6, 22, and 96-fold the MRHD.

Skeletal variations (wavy ribs, delayed ossification) were observed in fetuses at doses 22-fold the systemic exposure at the MRHD and were reversible during development. Exposures 96-fold the MRHD were maternally-toxic (mortality, decreased body weight gain) and associated with fetal growth reduction. Pregnant rabbits were treated with daily oral doses of mirabegron at 0, 3, 10, or 30 mg/kg/day during the period of organogenesis (Days 6 to 20 of gestation), which resulted in plasma exposures that were 0, 1, 14, or 36-fold the MRHD based on AUC.

At 10 mg/kg/day (14-fold the MRHD) and higher, fetal body weights were reduced. At 30 mg/kg/day, maternal toxicity (increased heart rate, mortality, reduced body weight gain, reduced food consumption) occurred, and fetal deaths, fetal cardiomegaly and fetal dilated aortae were observed at systemic exposure levels (AUC) 36-fold the MRHD. In a pre- and postnatal developmental study, rats were treated with daily oral doses of mirabegron at 0, 10, 30, or 100 mg/kg/day (0, 1, 6, or 22-fold the MRHD) from day 7 of gestation until day 20 after birth.

Decreased maternal body weight was observed along with decreased pup survival in the first few days after birth (92.7% survival) compared to the control group (98.8% survival), at 100 mg/kg/day (22-fold the MRHD). Pup body weight gain was reduced until postnatal day 7 but not further affected throughout the remainder of the lactation period. In utero and lactational exposure did not affect developmental milestones, behavior, or fertility of offspring.

No effects were observed at 30 mg/kg/day.

8.2Lactation Risk Summary There are no data on the presence of mirabegron in human milk, the effects on the breastfed child, or the effects on milk production. Mirabegron-related material was present in rat milk and in the stomach of nursing pups following administrations of a single 10 mg/kg oral dose of 14 C-labeled mirabegron to lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for MYRBETRIQ/MYRBETRIQ Granules and any potential adverse effects on the breastfed child from mirabegron or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness have been established only for the following pediatric indications: • MYRBETRIQ: Treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 3 years of age and older and weighing 35 kg or more. • MYRBETRIQ Granules: T… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary There are no studies with the use of MYRBETRIQ/MYRBETRIQ Granules in pregnant women or adolescents to inform a drug-associated risk of major birth defects, miscarriages, or adverse maternal or fetal outcomes. Mirabegron administration to pregnant animals during organogenesis resulted in reversible skeletal variations (in rats) at 22-fold (via AUC) the maximum recommended human dose (MRHD) of 50 mg/day and decreased fetal body weights (in rabbits) at 14-fold the MRHD. At maternally-toxic exposures in rats (96-fold), decreased fetal weight and increased fetal mortality were observed and, in rabbits (36-fold), cardiac findings (fetal cardiomegaly and fetal dilated aortae) were observed [see Data ] .

The estimated background risks of major birth defects and miscarriage for the indicated populations are unknown. In the U.S. general population, the estimated background risk of major birth defects or miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively. Data Animal Data No embryo-fetal lethality or morphological fetal developmental abnormalities were produced in pregnant rats following daily oral administration of mirabegron during the period of organogenesis (Days 7 to 17 of gestation) at 0, 10, 30, 100, or 300 mg/kg, doses which were associated with systemic exposures (AUC) 0, 1, 6, 22, and 96-fold the MRHD.

Skeletal variations (wavy ribs, delayed ossification) were observed in fetuses at doses 22-fold the systemic exposure at the MRHD and were reversible during development. Exposures 96-fold the MRHD were maternally-toxic (mortality, decreased body weight gain) and associated with fetal growth reduction. Pregnant rabbits were treated with daily oral doses of mirabegron at 0, 3, 10, or 30 mg/kg/day during the period of organogenesis (Days 6 to 20 of gestation), which resulted in plasma exposures that were 0, 1, 14, or 36-fold the MRHD based on AUC.

At 10 mg/kg/day (14-fold the MRHD) and higher, fetal body weights were reduced. At 30 mg/kg/day, maternal toxicity (increased heart rate, mortality, reduced body weight gain, reduced food consumption) occurred, and fetal deaths, fetal cardiomegaly and fetal dilated aortae were observed at systemic exposure levels (AUC) 36-fold the MRHD. In a pre- and postnatal developmental study, rats were treated with daily oral doses of mirabegron at 0, 10, 30, or 100 mg/kg/day (0, 1, 6, or 22-fold the MRHD) from day 7 of gestation until day 20 after birth.

Decreased maternal body weight was observed along with decreased pup survival in the first few days after birth (92.7% survival) compared to the control group (98.8% survival), at 100 mg/kg/day (22-fold the MRHD). Pup body weight gain was reduced until postnatal day 7 but not further affected throughout the remainder of the lactation period. In utero and lactational exposure did not affect developmental milestones, behavior, or fertility of offspring.

No effects were observed at 30 mg/kg/day.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The safety and effectiveness have been established only for the following pediatric indications: • MYRBETRIQ: Treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 3 years of age and older and weighing 35 kg or more. • MYRBETRIQ Granules: Treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 3 years of age and older. The safety and effectiveness of MYRBETRIQ/MYRBETRIQ Granules in pediatric patients aged 3 years and older have been established for the treatment of neurogenic detrusor overactivity (NDO) and the information on this use is discussed throughout the labeling.

Use of MYRBETRIQ/MYRBETRIQ Granules for this indication is supported by evidence from a 52-week, open-label, baseline-controlled, multicenter, dose titration trial in pediatric patients 3 years of age and older with NDO (Study 9) [see Adverse Reactions ( 6.1 ), Clinical Studies ( 14.3 )] . Results showed an improvement from baseline in maximum cystometric (bladder) capacity (MCC) with MYRBETRIQ/MYRBETRIQ Granules use [see Clinical Studies ( 14.3 )] . The most commonly reported adverse reactions in Study 9 (≥ 3%) were UTI, nasopharyngitis, constipation, and headache.

Increased mean systolic and diastolic blood pressures with use of MYRBETRIQ/MYRBETRIQ Granules occurred in patients less than 12 years of age with larger increases in patients younger than 8 years of age [see Adverse Reactions ( 6.1 )] . Take MYRBETRIQ/MYRBETRIQ Granules with food to reduce potential exposure-related risks, such as increased heart rate, as predicted by modeling of vital signs data in Study 9 [see Clinical Pharmacology ( 12.3 )] .

🧓 Geriatric Use 66 words ▾

8.5Geriatric Use Of 5648 patients who received MYRBETRIQ monotherapy in the phase 2 and 3 studies for OAB, 2029 (35.9%) were 65 years of age or older, and 557 (9.9%) were 75 years of age or older. No overall differences in safety or effectiveness were observed between patients younger than 65 years of age and those 65 years of age or older in these studies.

🆘 Overdosage 90 words ▾

10 OVERDOSAGE Mirabegron has been administered to healthy volunteers at single doses up to 400 mg. At this dose, adverse events reported included palpitations (1 of 6 subjects) and increased pulse rate exceeding 100 beats per minute (bpm) (3 of 6 subjects). Multiple doses of mirabegron up to 300 mg daily for 10 days showed increases in pulse rate and systolic blood pressure when administered to healthy volunteers.

Treatment for overdosage should be symptomatic and supportive. In the event of overdosage, pulse rate, blood pressure and ECG monitoring is recommended.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Mirabegron is an agonist of the human beta-3 adrenergic receptor (AR) as demonstrated by in vitro laboratory experiments using the cloned human beta-3 AR. Mirabegron relaxes the detrusor smooth muscle during the storage phase of the urinary bladder fill-void cycle by activation of beta-3 AR which increases bladder capacity. Although mirabegron showed very low intrinsic activity for cloned human beta-1 AR and beta-2 AR, results in humans indicate that beta-1 AR stimulation occurred at a mirabegron dose of 200 mg.

12.2Pharmacodynamics Urodynamics The effects of mirabegron on maximum urinary flow rate and detrusor pressure at maximum flow rate were assessed in a urodynamic study consisting of 200 male patients with lower urinary tract symptoms (LUTS) and BOO. Administration of mirabegron once daily for 12 weeks did not adversely affect the mean maximum flow rate or mean detrusor pressure at maximum flow rate in this study. Nonetheless, mirabegron should be administered with caution to patients with clinically significant BOO [see Warnings and Precautions ( 5.2 )] .

Cardiac Electrophysiology The effect of multiple doses of mirabegron 50 mg, 100 mg, and 200 mg (four times the maximum recommended dose) once daily on QTc interval was evaluated in a randomized, placebo- and active-controlled (moxifloxacin 400 mg), four-treatment arm, parallel crossover study in 352 healthy subjects. In a study with demonstrated ability to detect small effects, the upper bound of the one-sided 95% confidence interval for the largest placebo-adjusted, baseline-corrected QTc based on individual correction method (QTcI) was below 10 msec.

For the 50 mg mirabegron dose group (the maximum approved dosage), the mean difference from placebo on QTcI interval at 4 to 5 hours post-dose was 3.7 msec (upper bound of the 95% CI 5.1 msec). For the mirabegron 100 mg and 200 mg dose groups (dosages greater than the maximum approved dose and resulting in substantial multiples of the anticipated maximum blood levels at 50 mg), the mean differences from placebo in QTcI interval at 4 to 5 hours post dose were 6.1 msec (upper bound of the 95% CI 7.6 msec) and 8.1 msec (upper bound of the 95% CI 9.8 msec), respectively.

At the mirabegron 200 mg dose, in females, the mean effect was 10.4 msec (upper bound of the 95% CI 13.4 msec). In this thorough QT study, mirabegron increased heart rate on ECG in a dose-dependent manner. Maximum mean increases from baseline in heart rate for the 50 mg, 100 mg, and 200 mg dose groups compared to placebo were 6.7 bpm, 11 bpm, and 17 bpm, respectively.

In the clinical efficacy and safety studies, the change from baseline in mean pulse rate for mirabegron 50 mg was approximately 1 bpm. In this thorough QT study, mirabegron also increased blood pressure in a dose-dependent manner (see Effects on Blood Pressure) . Effects on Blood Pressure In a study of 352 healthy subjects assessing the effect of multiple daily doses of 50 mg, 100 mg, and 200 mg (four times the maximum recommended dose) of mirabegron for 10 days on the QTc interval, the maximum mean increase in supine systolic blood pressure (SBP)/diastolic blood pressure (DBP) at the maximum recommended dose of 50 mg was approximately 4.0/1.6 mm Hg greater than placebo [see Warnings and Precautions ( 5.1 )] .

The 24-hour average increases in SBP compared to placebo were 3.0, 5.5, and 9.7 mm Hg at mirabegron doses of 50 mg, 100 mg, and 200 mg, respectively. Increases in DBP were also dose-dependent, but were smaller than SBP. In another study in 96 healthy subjects to assess the impact of age on pharmacokinetics of multiple daily doses of 50 mg, 100 mg, 200 mg, and 300 mg (six times the maximum recommended dose) of mirabegron for 10 days, SBP also increased in a dose-dependent manner.

The mean maximum increases in SBP were approximately 2.5, 4.5, 5.5, and 6.5 mm Hg for mirabegron exposures associated with doses of 50 mg, 100 mg, 200 mg, and 300… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 84 words ▾

12.1Mechanism of Action Mirabegron is an agonist of the human beta-3 adrenergic receptor (AR) as demonstrated by in vitro laboratory experiments using the cloned human beta-3 AR. Mirabegron relaxes the detrusor smooth muscle during the storage phase of the urinary bladder fill-void cycle by activation of beta-3 AR which increases bladder capacity. Although mirabegron showed very low intrinsic activity for cloned human beta-1 AR and beta-2 AR, results in humans indicate that beta-1 AR stimulation occurred at a mirabegron dose of 200 mg.

📦 How Supplied / Storage and Handling 208 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1MYRBETRIQ (mirabegron extended-release tablets) MYRBETRIQ is supplied as oval, film-coated, extended-release tablets, available in bottles as follows: Strength 25 mg 50 mg Shape/Color Oval/Brown Oval/Yellow Branding on Tablet logo, 325 logo, 355 Bottles of 30 NDC 0469-2601-30 NDC 0469-2602-30 Bottles of 90 NDC 0469-2601-90 NDC 0469-2602-90 Store and Dispense Store at 20°C to 25°C (68°F to 77°F) with excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. logo.jpg logo.jpg

16.2MYRBETRIQ Granules (mirabegron for extended-release oral suspension) MYRBETRIQ Granules (mirabegron for extended-release oral suspension) is supplied as granules in bottles with a child-resistant cap packaged in an aluminum pouch with desiccant. Each bottle is filled with approximately 8.3 g of yellowish white granules, which contain 830 mg of mirabegron. After reconstitution with 100 mL water, the oral suspension is pale brownish yellow to yellow with 8 mg/mL of mirabegron.

1 Carton Containing 1 Bottle NDC 0469-5020-99 Store and Dispense Store MYRBETRIQ Granules at 20°C to 25°C (68°F to 77°F) with excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store the reconstituted suspension at 20°C to 25°C (68°F to 77°F) for up to 28 days. Discard the unused portion after 28 days.

📋 Description 182 words ▾

11 DESCRIPTION MYRBETRIQ (mirabegron extended-release tablets) for oral use and MYRBETRIQ Granules (mirabegron for extended-release oral suspension) are beta-3 adrenergic agonists. The chemical name of mirabegron is 2-(2-aminothiazol-4-yl)-N-[4-(2-{[(2R)-2-hydroxy-2-phenylethyl]amino}ethyl)phenyl]acetamide having an empirical formula of C 21 H 24 N 4 O 2 S and a molecular weight of 396.51. The structural formula of mirabegron is: Mirabegron is a white powder.

It is practically insoluble in water (0.082 mg/mL). It is soluble in methanol and dimethyl sulfoxide. Each MYRBETRIQ (mirabegron extended-release tablets) for oral use contains either 25 mg or 50 mg of mirabegron and the following inactive ingredients: butylated hydroxytoluene, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, polyethylene oxide, red ferric oxide (25 mg tablet only), and yellow ferric oxide.

Each bottle of MYRBETRIQ Granules (mirabegron for extended-release oral suspension) contains approximately 8.3 g of granules, which contain 830 mg of mirabegron, and the following inactive ingredients: acesulfame potassium, diluted hydrochloric acid, ethylparaben, hypromellose, magnesium stearate, mannitol, methylparaben, silicon dioxide, simethicone, sodium polystyrene sulfonate, and xanthan gum. After reconstituted with 100 mL water, the suspension contains 8 mg/mL of mirabegron. Mirabegron structural formula

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient and/or caregiver to read the FDA-approved patient labeling (Patient Information). Increases in Blood Pressure Inform patients and/or their caregivers that MYRBETRIQ/MYRBETRIQ Granules may increase blood pressure. Advise patients, especially patients with hypertension, to periodically monitor their blood pressure and report increased measurement to their health care provider [see Warnings and Precautions ( 5.1 )] .

Urinary Retention Inform patients and/or their caregivers that MYRBETRIQ may cause urinary retention in adult patients with bladder outlet obstruction and in patients taking muscarinic antagonist medications for the treatment of OAB. Advise patients to contact their physician if they experience these effects while taking MYRBETRIQ [see Warnings and Precautions ( 5.2 )] . Angioedema Inform patients and/or their caregivers that MYRBETRIQ/MYRBETRIQ Granules may cause angioedema.

Advise patients and/or their caregivers to promptly discontinue MYRBETRIQ/MYRBETRIQ Granules and seek medical attention if angioedema associated with the upper airway swelling occurs as this may be life-threatening [see Warnings and Precautions ( 5.3 )] . Drug Interactions Advise patients to report their use of any other prescription or nonprescription medications or dietary supplements because co-administration with MYRBETRIQ/MYRBETRIQ Granules may require a dose adjustment and/or increased monitoring of these drugs [see Drug Interactions ( 7 )].

Administration Instructions MYRBETRIQ Advise adult patients to swallow MYRBETRIQ whole with water and not to chew, divide, or crush. Advise adult patients to take MYRBETRIQ with or without food. Advise pediatric patients and/or their caregivers to swallow MYRBETRIQ whole with water and not to chew, divide, or crush.

Advise pediatric patients to take MYRBETRIQ with food. MYRBETRIQ Granules Advise pediatric patients and/or their caregivers to use an appropriate measuring device and instructions for measuring the correct dose of MYRBETRIQ Granules for extended-release oral suspension. Instruct patients or their caregivers that patients should take MYRBETRIQ Granules for extended-release oral suspension orally within 1 hour after preparation with food once daily and not save the dose for later.

The bottle should be shaken for 1 minute each day if the suspension will not be used for 2 or more days. When ready to use, shake the bottle vigorously for 1 minute then let it stand until the foam on top of the suspension is gone (approximately 1 to 2 minutes). Missed Dose Instruct patients and/or their caregivers 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. Marketed and Distributed by: Astellas Pharma US, Inc. Northbrook, IL 60062 MYRBETRIQ is a registered trademark of Astellas Pharma Inc.

All other trademarks are the property of their respective owners. © 2012 – 2021 Astellas Pharma US, Inc.

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Absorption MYRBETRIQ Monotherapy for Adult OAB After oral administration of mirabegron in healthy volunteers, mirabegron was absorbed to reach maximum plasma concentrations (C max ) at approximately 3.5 hours. The absolute bioavailability increased from 29% at a dose of 25 mg to 35% at a dose of 50 mg. Mean C max and AUC increased more than dose proportionally.

This relationship was more apparent at doses above 50 mg. In the overall population of males and females, a 2-fold increase in dose from 50 mg to 100 mg mirabegron increased C max and AUC tau by approximately 2.9- and 2.6-fold, respectively, whereas a 4-fold increase in dose from 50 to 200 mg mirabegron increased C max and AUC tau by approximately 8.4- and 6.5-fold. Steady-state concentrations were achieved within 7 days of once daily dosing with mirabegron.

After once daily administration, plasma exposure of mirabegron at steady-state was approximately double that seen after a single dose. MYRBETRIQ/MYRBETRIQ Granules for Pediatric Neurogenic Detrusor Overactivity (NDO) The median T max of mirabegron following oral administration of a single dose of MYRBETRIQ or mirabegron for extended-release oral suspension in pediatric patients under fed state was 4-5 hours. Population pharmacokinetic analysis predicted that the median T max of MYRBETRIQ or mirabegron for extended-release oral suspension at steady-state was 3-4 hours.

Effect of Food MYRBETRIQ Monotherapy for Adult OAB There were no clinically significant differences in mirabegron pharmacokinetics when administered with or without food in adult patients. MYRBETRIQ/MYRBETRIQ Granules for Pediatric Neurogenic Detrusor Overactivity (NDO) In the fasted state, steady-state mirabegron AUC increased by 120% relative to the fed state in pediatric patients receiving MYRBETRIQ. Fasted C max and AUC increased by 170% and 80%, respectively, compared to the fed state following administration of MYRBETRIQ Granules in healthy volunteers.

Distribution MYRBETRIQ Monotherapy for Adult OAB Mirabegron is extensively distributed in the body. The volume of distribution at steady-state (V ss ) is approximately 1670 L following intravenous administration. Mirabegron is bound (approximately 71%) to human plasma proteins, and shows moderate affinity for albumin and alpha-1 acid glycoprotein.

Mirabegron distributes to erythrocytes. Based on an in vitro study, erythrocyte concentrations of 14 C-mirabegron were about 2-fold higher than in plasma. MYRBETRIQ/MYRBETRIQ Granules for Pediatric Neurogenic Detrusor Overactivity (NDO) Mirabegron volume of distribution was relatively large in pediatric patients (the range of mean V z /F under fed state in pediatric patients across studies: 4895-13726 L) and increased with increasing body weight.

Elimination MYRBETRIQ Monotherapy for Adult OAB The terminal elimination half-life (t 1/2 ) of mirabegron is approximately 50 hours in patients. MYRBETRIQ/MYRBETRIQ Granules for Pediatric Neurogenic Detrusor Overactivity (NDO) The mean terminal elimination half-life (t 1/2 ) of mirabegron is approximately 26 to 31 hours in pediatric patients. Metabolism Mirabegron is metabolized via multiple pathways involving dealkylation, oxidation, (direct) glucuronidation, and amide hydrolysis.

Mirabegron is the major circulating component following a single dose of 14 C-mirabegron. Two major metabolites were observed in human plasma and are phase 2 glucuronides representing 16% and 11% of total exposure, respectively. These metabolites are not pharmacologically active toward beta-3 adrenergic receptor.

Although, in vitro studies suggest a role for CYP2D6 and CYP3A4 in the oxidative metabolism of mirabegron, in vivo results indicate that these isozymes play a limited role in the overall elimination. In healthy subjects who were genotypically poor metabolizers of CYP2D6, mean C max and AUC tau were approximately 16% and 17% higher than in extensive metabolizers of CYP2D6, respectively. In vitro and ex viv… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics ~3 min read ▾

12.2Pharmacodynamics Urodynamics The effects of mirabegron on maximum urinary flow rate and detrusor pressure at maximum flow rate were assessed in a urodynamic study consisting of 200 male patients with lower urinary tract symptoms (LUTS) and BOO. Administration of mirabegron once daily for 12 weeks did not adversely affect the mean maximum flow rate or mean detrusor pressure at maximum flow rate in this study. Nonetheless, mirabegron should be administered with caution to patients with clinically significant BOO [see Warnings and Precautions ( 5.2 )] .

Cardiac Electrophysiology The effect of multiple doses of mirabegron 50 mg, 100 mg, and 200 mg (four times the maximum recommended dose) once daily on QTc interval was evaluated in a randomized, placebo- and active-controlled (moxifloxacin 400 mg), four-treatment arm, parallel crossover study in 352 healthy subjects. In a study with demonstrated ability to detect small effects, the upper bound of the one-sided 95% confidence interval for the largest placebo-adjusted, baseline-corrected QTc based on individual correction method (QTcI) was below 10 msec.

For the 50 mg mirabegron dose group (the maximum approved dosage), the mean difference from placebo on QTcI interval at 4 to 5 hours post-dose was 3.7 msec (upper bound of the 95% CI 5.1 msec). For the mirabegron 100 mg and 200 mg dose groups (dosages greater than the maximum approved dose and resulting in substantial multiples of the anticipated maximum blood levels at 50 mg), the mean differences from placebo in QTcI interval at 4 to 5 hours post dose were 6.1 msec (upper bound of the 95% CI 7.6 msec) and 8.1 msec (upper bound of the 95% CI 9.8 msec), respectively.

At the mirabegron 200 mg dose, in females, the mean effect was 10.4 msec (upper bound of the 95% CI 13.4 msec). In this thorough QT study, mirabegron increased heart rate on ECG in a dose-dependent manner. Maximum mean increases from baseline in heart rate for the 50 mg, 100 mg, and 200 mg dose groups compared to placebo were 6.7 bpm, 11 bpm, and 17 bpm, respectively.

In the clinical efficacy and safety studies, the change from baseline in mean pulse rate for mirabegron 50 mg was approximately 1 bpm. In this thorough QT study, mirabegron also increased blood pressure in a dose-dependent manner (see Effects on Blood Pressure) . Effects on Blood Pressure In a study of 352 healthy subjects assessing the effect of multiple daily doses of 50 mg, 100 mg, and 200 mg (four times the maximum recommended dose) of mirabegron for 10 days on the QTc interval, the maximum mean increase in supine systolic blood pressure (SBP)/diastolic blood pressure (DBP) at the maximum recommended dose of 50 mg was approximately 4.0/1.6 mm Hg greater than placebo [see Warnings and Precautions ( 5.1 )] .

The 24-hour average increases in SBP compared to placebo were 3.0, 5.5, and 9.7 mm Hg at mirabegron doses of 50 mg, 100 mg, and 200 mg, respectively. Increases in DBP were also dose-dependent, but were smaller than SBP. In another study in 96 healthy subjects to assess the impact of age on pharmacokinetics of multiple daily doses of 50 mg, 100 mg, 200 mg, and 300 mg (six times the maximum recommended dose) of mirabegron for 10 days, SBP also increased in a dose-dependent manner.

The mean maximum increases in SBP were approximately 2.5, 4.5, 5.5, and 6.5 mm Hg for mirabegron exposures associated with doses of 50 mg, 100 mg, 200 mg, and 300 mg, respectively. In three, 12-week, double-blind, placebo-controlled, safety and efficacy studies (Studies 1, 2, and 3) in patients with OAB receiving mirabegron 25 mg, 50 mg, or 100 mg (two times the maximum recommended dose) once daily, mean increases in SBP/DBP compared to placebo of approximately 0.5 – 1 mm Hg were observed. Morning SBP increased by at least 15 mm Hg from baseline in 5.3%, 5.1%, and 6.7% of placebo, mirabegron 25 mg and mirabegron 50 mg patients, respectively.

Morning DBP increased by at least 10 mm Hg in 4.6%, 4.1%, and 6.6% of placebo, m… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1MYRBETRIQ Monotherapy for Adult OAB MYRBETRIQ was evaluated in three, 12-week, double-blind, randomized, placebo-controlled, parallel group, multicenter clinical trials in patients with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency (Studies 1, 2, and 3). Entry criteria required that patients had symptoms of overactive bladder for at least 3 months duration, at least 8 micturitions per day, and at least 3 episodes of urgency with or without incontinence over a 3-day period.

The majority of patients were Caucasian (94%) and female (72%) with a mean age of 59 years (range 18 – 95 years). The population included both naïve patients who had not received prior muscarinic antagonist pharmacotherapy for overactive bladder (48%) and those who had received prior muscarinic antagonist pharmacotherapy for OAB (52%). In Study 1 (NCT00689104), patients were randomized to placebo, MYRBETRIQ 50 mg, MYRBETRIQ 100 mg, or an active control once daily.

In Study 2 (NCT00662909), patients were randomized to placebo, MYRBETRIQ 50 mg or MYRBETRIQ 100 mg once daily. In Study 3 (NCT00912964), patients were randomized to placebo, MYRBETRIQ 25 mg or MYRBETRIQ 50 mg once daily. The co-primary efficacy endpoints in all 3 trials were (1) change from baseline to end of treatment (Week 12) in mean number of incontinence episodes per 24 hours and (2) change from baseline to end of treatment (Week 12) in mean number of micturitions per 24 hours, based on a 3-day micturition diary.

An important secondary endpoint was the change from baseline to end of treatment (Week 12) in mean volume voided per micturition. Results for the co-primary endpoints and mean volume voided per micturition from Studies 1, 2, and 3 are shown in Table 13 . Table 13: Mean Baseline and Change from Baseline at Week 12 Week 12 is the last observation on treatment. for Incontinence Episodes, Micturition Frequency, and Volume Voided per Micturition in Patients with Overactive Bladder in Studies 1, 2, and 3 Parameter Study 1 Study 2 Study 3 Placebo MYRBETRIQ 50 mg Placebo MYRBETRIQ 50 mg Placebo MYRBETRIQ 25 mg MYRBETRIQ 50 mg Number of Incontinence Episodes per 24 Hours For incontinence episodes per 24 hours, the analysis population is restricted to patients with at least 1 episode of incontinence at baseline. n 291 293 325 312 262 254 257 Baseline (mean) 2.67 2.83 3.03 2.77 2.43 2.65

2.51Change from baseline (adjusted mean Least squares mean adjusted for baseline, gender, and geographical region. ) -1.17 -1.57 -1.13 -1.47 -0.96 -1.36 -1.38 Difference from placebo (adjusted mean ) -- -0.41 -- -0.34 -- -0.40 -0.42 95% Confidence Interval -- (-0.72, -0.09) -- (-0.66, -0.03) -- (-0.74, -0.06) (-0.76, -0.08) p-value -- 0.003 Statistically significantly superior compared to placebo at the 0.05 level with multiplicity adjustment. -- 0.026 -- 0.005 0.001 Number of Micturitions per 24 Hours n 480 473 433 425 415 410 426 Baseline (mean) 11.71 11.65 11.51 11.80 11.48 11.68

11.66Change from baseline (adjusted mean ) -1.34 -1.93 -1.05 -1.66 -1.18 -1.65 -1.60 Difference from placebo (adjusted mean ) -- -0.60 -- -0.61 -- -0.47 -0.42 95% Confidence Interval -- (-0.90, -0.29) -- (-0.98, -0.24) -- (-0.82, -0.13) (-0.76, -0.08) p-value -- < 0.001 -- 0.001 -- 0.007 0.015 Volume Voided (mL) per Micturition n 480 472 433 424 415 410 426 Baseline (mean) 156.7 161.1 157.5 156.3 164.0 165.2 159.3 Change from baseline (adjusted mean ) 12.3 24.2 7.0 18.2 8.3 12.8

20.7Difference from placebo (adjusted mean ) -- 11.9 -- 11.1 -- 4.6 12.4 95% Confidence Interval -- (6.3, 17.4) -- (4.4, 17.9) -- (-1.6, 10.8) (6.3, 18.6) p-value -- < 0.001 -- 0.001 -- 0.15 < 0.001 MYRBETRIQ 25 mg was effective in treating the symptoms of OAB within 8 weeks and MYRBETRIQ 50 mg was effective in treating the symptoms of OAB within 4 weeks. Efficacy of both 25 mg and 50 mg doses of MYRBETRIQ was maintained through the 12-week treatment period. Figures 3 through 8 show t… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 179 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity Long-term carcinogenicity studies were conducted in rats and mice dosed orally with mirabegron for two years. Male rats were dosed at 0, 12.5, 25, or 50 mg/kg/day and female rats and both sexes of mice were dosed at 0, 25, 50, or 100 mg/kg/day. Mirabegron showed no carcinogenic potential at systemic exposures (AUC) 38 to 45-fold higher than the MRHD in rats and 21 to 38-fold higher than the MRHD in mice than the human systemic exposure at the 50 mg dose.

Mutagenesis Mirabegron was not mutagenic in the Ames bacterial reverse mutation assay, did not induce chromosomal aberrations in human peripheral blood lymphocytes at concentrations that were not cytotoxic, and was not clastogenic in the rat micronucleus assay. Impairment of Fertility Fertility studies in rats showed that mirabegron had no effect on either male or female fertility at non-lethal doses up to 100 mg/kg/day. Systemic exposures (AUC) at 100 mg/kg in female rats was estimated to be 22-fold the MRHD in women and 93-fold the MRHD in men.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 176 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity Long-term carcinogenicity studies were conducted in rats and mice dosed orally with mirabegron for two years. Male rats were dosed at 0, 12.5, 25, or 50 mg/kg/day and female rats and both sexes of mice were dosed at 0, 25, 50, or 100 mg/kg/day. Mirabegron showed no carcinogenic potential at systemic exposures (AUC) 38 to 45-fold higher than the MRHD in rats and 21 to 38-fold higher than the MRHD in mice than the human systemic exposure at the 50 mg dose.

Mutagenesis Mirabegron was not mutagenic in the Ames bacterial reverse mutation assay, did not induce chromosomal aberrations in human peripheral blood lymphocytes at concentrations that were not cytotoxic, and was not clastogenic in the rat micronucleus assay. Impairment of Fertility Fertility studies in rats showed that mirabegron had no effect on either male or female fertility at non-lethal doses up to 100 mg/kg/day. Systemic exposures (AUC) at 100 mg/kg in female rats was estimated to be 22-fold the MRHD in women and 93-fold the MRHD in men.

📄 Patient Package Insert ~3 min read ▾

Patient Information MYRBETRIQ ® (meer-BEH-trick) (mirabegron extended-release tablets) for oral use MYRBETRIQ ® (meer-BEH-trick) GRANULES (mirabegron for extended-release oral suspension) What are MYRBETRIQ tablets and MYRBETRIQ GRANULES? Adults • MYRBETRIQ tablets is a prescription medicine that can be used alone or with solifenacin succinate to treat adults with the following symptoms due to a condition called overactive bladder (OAB) : o Urge urinary incontinence: a strong need to urinate with leaking or wetting accidents o Urgency: a strong need to urinate right away o Frequency: urinating often Children • MYRBETRIQ tablets is a prescription medicine used to treat children 3 years of age and older weighing at least 77 pounds (35 kg) , with a condition called neurogenic detrusor overactivity (NDO) . • MYRBETRIQ GRANULES is a prescription medicine used to treat children 3 years of age and older with a condition called neurogenic detrusor overactivity (NDO) .

It is not known if MYRBETRIQ tablets and MYRBETRIQ GRANULES to treat NDO, are safe and effective in children under 3 years of age. Who should not take MYRBETRIQ tablets or MYRBETRIQ GRANULES? Do not take MYRBETRIQ tablets or MYRBETRIQ GRANULES if you are allergic to mirabegron or any of the ingredients in MYRBETRIQ tablets or MYRBETRIQ GRANULES.

See the end of this Patient Information leaflet for a complete list of ingredients in MYRBETRIQ tablets and MYRBETRIQ GRANULES. Before you take MYRBETRIQ tablets or MYRBETRIQ GRANULES, tell your doctor about all of your medical conditions, including if you: • have liver problems. • have kidney problems. • have very high uncontrolled blood pressure. • have trouble emptying your bladder or you have a weak urine stream. • are pregnant or plan to become pregnant. It is not known if MYRBETRIQ tablets or MYRBETRIQ GRANULES will harm your unborn baby.

Talk to your doctor if you are pregnant or plan to become pregnant. • are breastfeeding or plan to breastfeed. It is not known if MYRBETRIQ tablets or MYRBETRIQ GRANULES passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take MYRBETRIQ tablets or MYRBETRIQ GRANULES.

Tell your doctor about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. MYRBETRIQ tablets and MYRBETRIQ GRANULES may affect the way other medicines work, and other medicines may affect how MYRBETRIQ tablets and MYRBETRIQ GRANULES work. Especially tell your doctor if you take: • thioridazine (Mellaril or Mellaril-S) • flecainide (Tambocor) • propafenone (Rythmol) • digoxin (Lanoxin) • solifenacin succinate (VESIcare) How should I take MYRBETRIQ tablets? • Take MYRBETRIQ tablets exactly as your doctor tells you to take it. • You should take 1 MYRBETRIQ tablet 1 time a day. • If your doctor prescribes MYRBETRIQ tablets and solifenacin succinate together, you should take 1 MYRBETRIQ tablet and 1 solifenacin succinate tablet at the same time, 1 time a day. • You should take MYRBETRIQ tablets with water and swallow the tablet whole. • Do not chew, break, or crush the tablet. • Adults can take MYRBETRIQ tablets with or without food. • Adults can take MYRBETRIQ tablets and solifenacin succinate together with or without food. • Children should take MYRBETRIQ tablets with food . • If you miss a dose of MYRBETRIQ tablets, take it as soon as possible.

If it has been more than 12 hours since taking the last dose of MYRBETRIQ tablets, skip that dose and take the next dose at the usual time. • If you take too much MYRBETRIQ tablets, call your doctor or go to the nearest hospital emergency room right away. How should I take MYRBETRIQ GRANULES? • You or your child should take MYRBETRIQ GRANULES exactly as the doctor tells you to take it. • You or your child should take MYRBETRIQ GRANULES by mouth 1 time a day. • You or your child should take MYRBETRIQ GRANULES with food . • You or your child should take MYRBETRIQ GRANULES immediately… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 25 words ▾

Indications and Usage ( 1.2 ) 3/2021 Dosage and Administration ( 2 ) 3/2021 Warnings and Precautions, Increase in Blood Pressure ( 5.1 ) 3/2021

📄 Package Label / Principal Display Panel 124 words ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 25 mg NDC 0469-2601-30 Myrbetriq ® (mirabegron extended-release tablets) 25 mg Once-Daily Swallow tablet whole. Do not cut, crush, or chew tablet. 30 tablets Rx Only 25mg Extended release tablet carton

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 50 mg NDC 0469-2602-30 Myrbetriq ® (mirabegron extended-release tablets) 50 mg Once-Daily Swallow tablet whole. Do not cut, crush, or chew tablet. 30 tablets Rx Only 50mg Extended release tablet carton

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 8 mg/mL NDC 0469-5020-99 Myrbetriq ® Granules ( mirabegron for extended-release oral suspension) 8 mg/ml PHARMACIST: Reconstitute product prior to dispensing and dispense with dosing device. Discard after ____/ ____/ ____ Shake vigorously for 1 minute before each use. Rx only 100 mL Myrbetriq Granules carton image

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
7K
Units reimbursed last 4 qtrs
880K
Gross reimbursed last 4 qtrs
$1.97M
Avg / prescription
$283.14
Avg / unit
$2.2372
Latest quarter Q1 2026
1.9KRx
Medicaid pays / mL
$2.2372
gross reimbursed
vs
NADAC / mL
$2.2070
acquisition cost
=
Spread
+$0.0302
+1% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
47% FFS 53% MCO
Fee-for-service · 3,254 Rx Managed care · 3,699 Rx
State Medicaid map
Alaska: no data reported AK Maine: 4,600 units · 330 per 100k residents ME Washington: 8,870 units · 114 per 100k residents WA Idaho: 31,300 units · 1,594 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 4,190 units · 73.0 per 100k residents MN Wisconsin: 25,100 units · 425 per 100k residents WI Michigan: 37,670 units · 375 per 100k residents MI New York: 65,680 units · 336 per 100k residents NY Vermont: no data reported VT New Hampshire: 1,600 units · 114 per 100k residents NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 1,400 units · 43.7 per 100k residents IA Illinois: 17,980 units · 143 per 100k residents IL Indiana: 47,460 units · 692 per 100k residents IN Ohio: 46,100 units · 391 per 100k residents OH Pennsylvania: 58,243 units · 449 per 100k residents PA New Jersey: 26,380 units · 284 per 100k residents NJ Massachusetts: 60,847 units · 869 per 100k residents MA California: 77,835 units · 200 per 100k residents CA Utah: 5,104 units · 149 per 100k residents UT Colorado: 4,800 units · 81.7 per 100k residents CO Nebraska: 15,200 units · 768 per 100k residents NE Missouri: 10,100 units · 163 per 100k residents MO Kentucky: 48,100 units · 1,063 per 100k residents KY West Virginia: no data reported WV Virginia: 18,680 units · 214 per 100k residents VA Maryland: 4,860 units · 78.6 per 100k residents MD Connecticut: 20,900 units · 578 per 100k residents CT Rhode Island: 12,060 units · 1,101 per 100k residents RI Arizona: 2,200 units · 29.6 per 100k residents AZ New Mexico: no data reported NM Kansas: 9,300 units · 316 per 100k residents KS Arkansas: no data reported AR Tennessee: 18,380 units · 258 per 100k residents TN North Carolina: 5,400 units · 49.8 per 100k residents NC South Carolina: 8,435 units · 157 per 100k residents SC Delaware: 8,900 units · 863 per 100k residents DE Oklahoma: no data reported OK Louisiana: 18,900 units · 413 per 100k residents LA Mississippi: 21,700 units · 738 per 100k residents MS Alabama: 3,800 units · 74.4 per 100k residents AL Georgia: 8,880 units · 80.5 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 101,040 units · 331 per 100k residents TX Florida: 17,960 units · 79.4 per 100k residents FL
Units reimbursed · per 100k residents
29.61,594
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Idaho 1,594 /100k
2 Rhode Island 1,101 /100k
3 Kentucky 1,063 /100k
4 Massachusetts 869 /100k
5 Delaware 863 /100k
6 Nebraska 768 /100k
7 Mississippi 738 /100k
8 Indiana 692 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Myrbetriq — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Myrbetriq. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$395.78M
Claims incl. refills
606.8K
Beneficiaries
351.6K
Spend / beneficiary
$1,125.55
Spend / claim
$652.25
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
← 00469-4425-30 · Astellas 00469-6501-89 · Astellas →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.