Myrbetriq PI Flashcards
Indication Monotherapy
Myrbetriq is a beta 3 adrenergic agonist indicates for the treatment of OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Indication combo
Myrbetriq in combo with muscarinic solifenacin succinate antagonist of OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Dosing information- mono therapy
The recommended starting dose of Myrbetriq is 25mg once daily with or without food. Myrbetriq 25mg is effective within 8 weeks. Based on individual patient efficacy and tolerability the does maybe increased to 50mg once daily.
Myrbetriq should be taken with water, swallowed while and should not be chewed, divided, or crushed.
Dosing -combo
The recommended starting doses for the combination treatment are Myrbetriq 25mg once daily and solifenacin succinate 5mg once daily. Based on individual patient efficacy and tolerability, the Myrbetriq dose may be increased to 50mg the once daily after 4-8 weeks.
M & SS can be taken together with it without food.
Does adjustments in specific populations.
The daily dose of Myrbetriq should not exceed 25mg once daily in the following patients:
Patients with severe renal impairment & patients with moderate hepatic impairment.
Myrbetriq is not recommended for use in patients with end stage renal disease, or in patients with severe hepatic impairment.
Contraindications
Do not use Myrbetriq in patients who have known hypersensitivity reactions to mirebegron or any component of the tablet.
Warnings and Precautions
- Increases in Blood pressure
- Urinary retention in patients with bladder outlet obstruction and in patients taking muscarinic antagonist medications for OAB
- Angioadema
- Patients taking drugs metabolized by CYP2D6
Warning and precautions-
Increases in blood pressure
Myrbetriq can increase bp. Periodic bp determinations are recommended, especially in hypertensive patients. Myrbetriq is not recommended for use in patients with severe uncontrolled hypertension (180/110).
In 2 healthy volunteers studies, Myrbetriq was associated with dose related increases in supine bp. At the max dose of 50mg, the mean max increase in systolic/diastolic bp was approx. 3.5/1.5 mm Hg greater than placebo.
In contrast, in OAB patients in clinical trials, Myrbetriq taken as mono therapy or in combo with ss 5 mg, the mean increases was .5-1 mm Hg greater than placebo. Worsening of pre-existing hypertension was reported infrequently with Myrbetriq.
Warnings and Precautions :
Urinary 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 OAB. A controlled clinical safety study in patients with BOO did. It demonstrate an increases in urinary retention with Myrbetriq; however, Myrbetriq should still be administered with caution to patients with clinically significant BOO. Monitor these patients for signs and symptoms of urinary retention. Myrbetriq should be administered with caution to patients taking muscarinic antagonist medications for the treatment of OAB including ss
Warnings and precautions:
Angioadema
Angioadema of the face, lips, tongue, & or larynx has been reported with Myrbetriq. In some cases, angioadema occurred after the first dose. Cases of angioadema have been reported to occur hours after the first dose or multiple doses. Any, associated with upper airway swelling maybe life threatening. If involvement of the tongue, hypo pharynx or larynx occurs, promptly discontinue and Uniate appropriate measures to ensure patent airways
Warnings and precautions :
Patients taking drugs metabolized by the CYP2D6
Since mirabegron is a moderate CYP2D6 inhibitor, the systemic exposure to CYP2D6 substrates such as metoprolol and desipramine is increased with coadministered with Myrbetriq. Therefore, appropriate monitoring and dose adjustment may be necessary, especially with narrow therapeutic index drugs metabolized by CYP2D6, such as thioridazine, flecainide, and propafenone.
Adverse reactions
Hypertension/ urinary retention/ angioadema
Clinical trial experience- Monotherapy
3- 12 week, double blind, placebo controlled, safety and efficacy studies in patients with OAB ( studies 1,2,3) Myrbetriq was evaluated for safety in 2736 patients.
Myrbetriq was also evaluated for safety in 1633 patients who received Myrbetriq 50mg or 100mg in a 1-year, randomized, fixed-dose, double blind, active-controlled, safety study in patients with OAB.
Clinical trials (1,2,3) adverse events
The most frequent AE (.2%) leading to discontinuation for the 25mg and 50mg were nausea, headache, hypertension, diarrhea, constipation, dizziness, & tachycardia.
Afib (.2%) and prostate cancer (.1%) were reported as serious AES by more than 1 patient and at a rate greater than placebo.
The most commonly reported AES (>2%) were hypertension, nasopharngitis, urinary tract infection and headache.
The most commonly reported AES (>3%) were hypertension, UTI, headache and nasopharyngitis.
Study 4 AEs
50mg once daily - AE leading to discontinuation reported by more than 2 patients and a rate higher than active placebo: constipation (.9%), headache (.6%), dizziness (.5%), hypertension (.5%), dry eye (.4%), and UTI (.4%).
Serous AES- cerebrovascular accident (.4%), and osteoarthritis (.2%).
Neoplasms reported by 2 patients treated with Myrbetriq 100mg included breast cancer, lung. Malignant and prostate cancer.
