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new drug

Saadqa Sumbal

on 20 October 2012

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Transcript of Myrbetriq

Mirabegron (Myrbetriq®) Overactive Bladder Drug Profile Extended release tablet for oral use. FDA approved for OAB. Depression
Lack of self-control, independence, self-esteem and curtailment of normal activities.
Medical complications
Perineal dermatitis
Worsening of pressure ulcers
Reduced QOL
Fewer social and personal interactions
Increase psychological stress
Overall decreased QOL Complications Safety Profile Unique mechanism of action, so may be an option for patients who initially didn't respond to antimuscarinics.
Because it has different adverse effect profile so it may be a choice for patients who do not tolerate antimuscarinics side effects Claims New class of medications.
Other FDA approved OAB medications are antimuscarinics, which include following: darifenacin, fesoterodine, oxybutynin, solifenacin, tolterodine, trospium etc. New intervention/
Me-too drug Clinical Trials Greater than 2% and greater than placebo
urinary tract infection
headach Common Adverse
Effects Blood Pressure:
Myrbetriq can increase blood pressure.
Periodic blood pressure determinations are recommended, especially in hypertensive patients.
Myrbetriq is not recommended for use in severe uncontrolled hypertensive patients.
Urinary Retention can occur in:
Patients with bladder outlet obstruction
Patients taking antimuscarinic drugs for overactive bladder Administer with caution in these patients because of risk of urinary retention Warning & Precautions Urethral sphincter
Maintains adequate pressure to stop urine flow
Proximal sphincter-involuntary control
Distal sphincter-voluntary and involuntary control
Accommodates increasing volume of urine without a significant increase of pressure
Smooth muscle (detrusor muscle) activity is suppressed during filling
Normal voiding
Occurs with a coordinated relaxation of the urethral sphincter and a voluntary contraction of the bladder
Ideally the bladder is completely emptied
Both voluntary and involuntary muscle contraction caused by activation of muscarinic receptors
M2-bladder smooth muscle
M3-mediates the emptying contractions and the involuntary bladder contractions Pathophysiology Epidemiology Types of UI
Urethral underactivity (Stress Urinary Incontinence (SUI))
Bladder overactivity (Urge urinary incontinence (UUI))
Urethral overactivity and/or bladder underactivity (Overflow incontinence)
Mixed incontinence (MUI) and other types Etiology & Mechanisms Behavioral interventions
1st line for SUI, UUI, MUI
Lifestyle modifications
Scheduling regimens
Pelvic floor muscle rehabilitation
Patient must be active participant
Regular follow up is needed
Provide support/encouragement
Monitor progress Standard Treatment Drugs Metabolized by CYP2D6 (e.g. Metoprolol and Desipramine):
Mirabegron is moderate CYP2D6 inhibitor
When used concomitantly with drugs metabolized by CYP2D6, especially narrow therapeutic index drugs (e.g. Warfarine), appropriate monitoring and possible dose adjustment of those drugs may be necessary.
in a combination of Myrbetriq and digoxin,the lowest dose of digoxin is recommended.
appropriate monitoring and titration of digoxin dose to desired clinical effect is recommeded. Drug Interactions Dosage and Administration Available in the two strengths 25mg and 50mg
Recommended starting dose is 25 mg once daily, with or without food
May increase dose to 50 mg once daily based on individual's efficacy and tolerability
Swallow the whole tablet with water, do not chew, divide or crush Guidelines for Use:
This drug may be covered for patients when there is documentation that the following criteria are met.
Treatment failure or intolerance to at least two generic formulary preferred urinary antispasmodics
Treatment failure or intolerance to at least two generic formulary preferred OAB therapies.
No hypertension, or controlled via treatment, based on 3 most recent BP readings, which must be provided
Quanity Limit:
one tablet per day BCN Guidelines Conclusion References Because Myrbetriq is a new class due to its unique mechanism of action, it may be a good option for patients who do not respond to antimuscarinics.
Myrbetriq has a different adverse effect profile and therefore may be a good option for patients who do not tolerate antimuscarinics, such as geriatric patients who are more sensitive to constipation and other adverse effects. Safety/ Efficacy Cardiovascular Safety Recommendations:
reduce the dose to 25 mg once daily in patients with moderate hepatic impairment.
However, mirabegron is not recommended in patients with severe hepatic disease. Hepatic Impairment Renal Impairment

Increase in SBP with Mirabegron increases the potential for CVD risk compared to Placebo

Based on the SBP increase seen in the TQT study, the potential for CVD risk is magnified with Mirabegron 50 mg QD compared to Placebo This drug and its metabolites are primarily eliminated by the kidneys, the exposure in renal impairment and in particular in severe condition would be expected to be higher than healthy subjects with normal renal function. Based on this, the sponsor proposed to reduce the dose to 25 mg in patients with severe renal impairment. Mirabegron is not recommended in patients with
End Stage Renal Disease (ESRD).
1. FDA approves new overactive bladder drug. WebMD. 28 June 2012. [Web]. < http://www.webmd.com/urinary-incontinence-oab/news/20120628/fda-approves-new-overactive-bladder-drug>. Accessed 30 AUG 2012.
2. FDA Monogram. Drugs@fda.June 2012. [Web]. <http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202611s000lbl.pdf>. Accessed 25 AUG 2012.
3. Myrbetriq® [package insert]. Northbrook, IL: Astellas Pharma US, Inc; June 2012.
4. Micromedex® Healthcare Series. [Internet database]. Greenwood Village, CO: Thomson Reuters (Healthcare) Inc. Updated periodically. Accessed 5 SEP 2012.
5. FDA approves Myrbetriq for overactive bladder. FDA. 28 June 2012. [Web]. <http://www.fda.gov.authenticate.library.duq.edu/NewsEvents/Newsroom/PressAnnouncements/ucm310096.htm>. Accessed 12 SEP 2012.
6. A study to evaluate the efficacy, safety and tolerability of mirabegron and solifenacin alone and in combination for the treatment of overactive bladder. Clinical Trials. Updated 2012 April 9. [Web]. <http://www.clinicaltrials.gov/ct2/show/NCT01340027?term=mirabegron&rank=10>. Accessed 10 SEP 2012.
7. Myrbetriq NDA approval letter. Dept of Health and Human Services. FDA. [Web]. <http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202611Orig1s000ltr.pdf>. Accessed 25 AUG 2012.
8. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline. American Urological Association (AUA). May 2012.
9. Reproductive and Urological Drugs Advisory Committee Presentation. FDA. 5 APR 2012. [Web]. <http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/UCM300110.pdf>. Accessed 17 SEP 2012.
10. A Cross-Sectional, Population-Based, Multinational Study
of the Prevalence of Overactive Bladder and Lower Urinary
Tract Symptoms: Results from the EPIC.European Association of Urology. 2007 Study<http://www.europeanurology.com/article/S1569-9056(06)00327-7/pdf>. Accessed 18 SEP 2012. Pivotal Phase 3 Studies Criteria for Entry
OAB for at least 3 months
On average 8 micturitions per 24 hours
At least 3 episodes of urgency with or without incontinence in 3-day diary period
Treatment naïve or prior antimuscarinic therapy
Study 178-CL-046 & Study 178-CL-047 (12 weeks)
Mirabegron 50 mg daily
Mirabegron 100 mg daily
Tolterodine ER 4 mg daily (exception in study 178-CL-046)
Study 178-CL-074 (12 weeks)
Mirabegron 25 mg daily
Mirabegron 50 mg daily
The co-primary efficacy endpoints in all 3 trials were:
Change, from baseline to end of treatment (Week 12), in mean number of incontinence episodes per 24 hours
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. Agonist of the human beta-3 adrenergic receptor(AR).
It also has some beta-1 AR activity
Increases the bladder capacity during storage phase by relaxing the detrusor smooth muscle.
Extensively metabolized to 10 metabolites by multiple pathways such as dealkylation, oxidation, glucuronidation and hydrolysis.
Primary isoenzyme is CYP3A4
Moderate inhibitor of CYP2D6
Mainly excreted by urine and feces Mechanism of Action Presented by Saadqa Sumbal
LECOM School of Pharmacy
Erie, PA
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