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.

MIRVASO (NDA-204708)

(BRIMONIDINE TARTRATE)

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

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07/27/2016 (SUPPL-5)

Approved Drug Label (PDF)

4 Contraindications

MIRVASO topical gel is contraindicated in patients who have experienced a hypersensitivity reaction to any component. Reactions have included angioedema, urticarial, and contact dermatitis.

5 Warnings and Precautions

Local Vasomotor Adverse Reactions

Erythema

Some subjects in the clinical trials discontinued use of MIRVASO topical gel because of erythema. Some subjects in the clinical trials reported a rebound phenomenon, where erythema was reported to return worse compared to the severity at baseline. Erythema appeared to resolve after discontinuation of MIRVASO topical gel.
The treatment effect of MIRVASO topical gel may begin to diminish hours after application.
From postmarketing reports, some patients have experienced erythema involving areas of the face that were previously not affected by erythema and in areas (e.g., neck and chest) outside of the treatment sites.

Flushing

Some subjects in the clinical trials discontinued use of MIRVASO topical gel because of flushing.
Intermittent flushing occurred in some subjects treated with MIRVASO topical gel in the clinical trials. The onset of flushing relative to application of MIRVASO topical gel varied, ranging from approximately 30 minutes to several hours. Flushing appeared to resolve after discontinuation of MIRVASO topical gel.
From postmarketing reports, some patients have experienced increased frequency of flushing and/or increased depth of erythema with the flushing. Additionally, some patients reported new onset of flushing.

Pallor and Excessive Whitening

From postmarketing reports, some patients have experienced pallor or excessive whitening at or outside the application site following treatment with MIRVASO topical gel.

Hypersensitivity

Allergic contact dermatitis was reported in the clinical trials for MIRVASO topical gel.
Events reported post marketing with the use of MIRVASO topical gel include angioedema, throat tightening, tongueswelling, and urticarial [see Adverse Reactions (6.2)]. Institute appropriate therapy and discontinue MIRVASO topical gel, if clinically significant hypersensitivity reaction occurs.

Systemic Adverse Reactions of Alpha 2-adrenergic agonists

Postmarketing cases of bradycardia, hypotension (including orthostatic hypotension) and dizziness have been reported. Some cases required hospitalization. Some cases involved application of MIRVASO topical gel in unapproved dosing regimens and for unapproved indications, including the application of MIRVASO topical gel following laser procedures.
Avoid applying MIRVASO topical gel to irritated skin or open wounds.

6 Adverse Reactions

The following adverse drug reactions are discussed in greater detail in other sections of the label:

Systemic Adverse Reactions of Alpha-2 Adrenergic Agonists
Local Vasomotor Adverse Reactions
Hypersensitivity

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of MIRVASO topical gel. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure.

Cardiovascular disorders: bradycardia, hypotension (including orthostatic hypotension)
Immune system disorders: angioedema, hypersensitivity, lip swelling, swollen tongue, throat tightness, urticaria
Nervous system disorders: dizziness
Skin and subcutaneous disorders: pallor

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

Before using MIRVASO topical gel, tell your doctor about all of your medical conditions including if you:

plan to have any laser procedures

MG - The most common side effects of MIRVASO

Skin redness is common after applying MIRVASO topical gel, and may be worse than before you applied it. You may also develop redness on areas of your face that were not affected by rosacea, as well as on your neck and chest.
Skin flushing is common and may happen off and on after applying MIRVASO topical gel. In some cases, the flushing may be new, may happen more often, or you may have increased redness with flushing.
Pale colored skin or very white skin (excessive whitening) can happen at or outside the treated area.
Tell your doctor if you get skin redness, flushing, and pale colored skin that is uncomfortable for you.

MG - What are the possible side effects of MIRVASO topical gel?

MIRVASO topical gel may cause serious side effects, including:

See “Important information” at the beginning of this Patient Information leaflet.
Problems with blood circulation. People who use MIRVASO topical gel can have problems with blood circulation, including a slow heart rate, low blood pressure, and dizziness. These problems may sometimes be serious and lead to hospitalization. See “What should I tell my doctor before using MIRVASO topical gel?”
Serious allergic (hypersensitivity) reactions have happened in people who use MIRVASO topical gel. Stop using MIRVASO topical gel and go to the nearest hospital emergency room right away if you have any of the following signs and symptoms of a serious allergic reaction including:
- swelling of your face, lips, tongue, or throat
- trouble breathing
- hives