Label Changes for:
Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- MIRVASO topical gel is contraindicated in patients who have experienced a hypersensitivity reaction to any component. Reactions have included angioedema, urticarial, and contact dermatitis.
WARNINGS AND PRECAUTIONS
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.
Local Vasomotor Adverse Reactions
- 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.
- 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.
- 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.
- 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
- 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
- Before using MIRVASO topical gel, tell your doctor about all of your medical conditions including if you:
- plan to have any laser procedures
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
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.