Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

MYRBETRIQ (NDA-202611)

(MIRABEGRON)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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03/25/2021 (SUPPL-17)

Approved Drug Label (PDF)

Other

(Extensive changes throughout label related to the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 3 years and older and weighing 35 kg or more; please refer to label)

04/27/2018 (SUPPL-11)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Increases in Blood Pressure

(Additions and/or revisions are underlined)

In contrast, in 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 MYRBETRIQ dose of 50 mg was approximately 0.5 to 1 mm Hg greater than placebo. Worsening of pre-existing hypertension was reported infrequently in MYRBETRIQ patients.

5.2 Urinary Retention in Patients with Bladder Outlet Obstruction and in Patients Taking Muscarinic Antagonist Medications for OAB

(Additions and/or revisions are underlined)

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 MYRBETRIQ patients; 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.

6 Adverse Reactions

(Additions and/or revisions are underlined)

The following adverse reactions are discussed in more detail in other sections of the labeling.

Hypertension
Urinary retention
Angioedema

6.1 Clinical Trials Experience

(Extensive revisions; please refer to labeling)

6.2 Postmarketing Experience

(Additions and/or revisions are underlined)

The following adverse reactions have been identified during post-approval use of mirabegron. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following events have been reported in association with mirabegron use in worldwide postmarketing experience:

Cardiovascular disorders: atrial fibrillation

7 Drug Interactions

7.2 Digoxin

(Additions and/or revisions are underlined)

When given in combination, 100 mg mirabegron increased mean digoxin Cmax 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 AUCtau and Cmax by approximately 10% and 14%, respectively.

8 Use in Specific Populations

8.1 Pregnancy

(Pregnancy and Lactation Labeling Rule (PLLR) Conversion; Extensive Additions and/or revisions please refer to labeling)

8.2 Lactation

(Pregnancy and Lactation Labeling Rule (PLLR) Conversion; Additions and/or revisions are underlined)

Risk Summary

There is no information 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 14C-labeled mirabegron to lactating rats.

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

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions are underlined)

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Inform patients that MYRBETRIQ has also been associated with infrequent urinary tract infections, rapid heartbeat, rash, and pruritus.

Inform patients that urinary retention has been reported when taking MYRBETRIQ in combination with muscarinic antagonist drugs used in the treatment of overactive bladder.

Inform patients that MYRBETRIQ, when taken in combination with solifenacin succinate, has been associated with dry mouth, urinary tract infection, constipation, and tachycardia.

Patient Information MYRBETRIQ® (meer-BEH-trick) (mirabegron) extended-release tablets for oral use

(Additions and/or revisions are underlined)

The most common side effects of MYRBETRIQ include:

joint pain
dry mouth
flu symptoms
sinus (sinus irritation)
back pain
inflammation of the bladder (cystitis)

07/28/2017 (SUPPL-12)

Approved Drug Label (PDF)

6 Adverse Reactions

6.2 Postmarketing Experience

(additions underlined)

Because these spontaneously reported events are from the worldwide postmarketing experience, from a population of uncertain size, the frequency of events and the role of mirabegron in their causation cannot be reliably determined.

The following events have been reported in association with mirabegron use in worldwide postmarketing experience:

Gastrointestinal disorders: nausea, constipation, diarrhea

Nervous system disorders: dizziness, headache

There have been postmarketing reports of confusion, hallucinations, insomnia and anxiety in patients taking mirabegron. The majority of these patients had pre-existing medical conditions or concomitant medications that may cause confusion, hallucinations, insomnia and anxiety. A causal relationship between mirabegron and these disorders has not been established.

Skin and subcutaneous tissue: angioedema of the face, lips, tongue, and larynx, with or without respiratory symptoms; pruritus

Urologic: urinary retention

08/16/2016 (SUPPL-7)

Approved Drug Label (PDF)

6 Adverse Reactions

Postmarketing Experience

Additions are bolded:

Gastrointestinal disorders: constipation, diarrhea

Nervous system disorders: dizziness, headache

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PI - What are the possible side effects of MYRBETRIQ®?

The most common side effects of MYRBETRIQ® include: (addition of the following):

constipation
diarrhea
dizziness