mirvaso
Mirvaso (Brimonidine Tartrate) is an alpha-adrenergic agonist used to treat Open-Angle Glaucoma.
Brimonidine Tartrate · by Galderma Labs LP
Available as a generic: Brimonidine Tartrate
Key facts
- Active ingredient
- Brimonidine Tartrate
- Drug class
- Alpha-Adrenergic Agonist
- Form
- Topical
- Strength
- Brimonidine Tartrate EQ 0.33% Base
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- open-angle glaucoma
- Manufacturer
- Galderma Labs LP
- What the pharmacy pays
- ~$10.38 per ml — not your price
- FDA application
- NDA204708
What is Mirvaso?
From the FDA label:MIRVASO (brimonidine) topical gel, 0.33% contains brimonidine tartrate, an alpha adrenergic agonist. The molecular formula of brimonidine tartrate is C 11 H 10 BrN 5 • C 4 H 6 O 6 . It has the following structural formula: Chemically, brimonidine tartrate is 5-Bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate. Brimonidine tartrate has a molecular weight of 442.24 and appears as white to slightly yellowish powder. Each gram of MIRVASO (brimonidine) topical gel, 0.33% contains 5 mg of the active ingredient brimonidine tartrate (equivalent to 3.3 mg of brimonidine free base), in a white to light yellow opaque gel composed of the inactive ingredients carbomer homopolymer type B, glycerin, methylparaben, phenoxyethanol, propylene glycol, purified water, sodium hydroxide, and titanium dioxide. chem-structure
How to use
Apply a pea-sized amount once daily to each of the five areas of the face: central forehead, chin, nose, each cheek. MIRVASO topical gel should be applied smoothly and evenly as a thin layer across the entire face avoiding the eyes and lips. Wash hands after applying MIRVASO topical gel. MIRVASO topical gel is for topical use only and not for oral, ophthalmic, or intravaginal use. Apply a pea-sized amount once daily to each of the five areas of the face (forehead, chin, nose, each cheek) avoiding the eyes and lips. ( 2 ) Hands should be washed immediately after applying MIRVASO topical gel. ( 2 ) For topical use only ( 2 ) Not for oral, ophthalmic, or intravaginal use. ( 2 )
Side effects
The following adverse drug reactions are discussed in greater detail in other sections of the label: Systemic Adverse Reactions of Alpha-2 Adrenergic Agonists [ see Warnings and Precautions ( 5.4 ) ] Local Vasomotor Adverse Reactions [ see Warnings and Precautions ( 5.5 ) ] Hypersensitivity [ see Warnings and Precautions ( 5.6 ) ] In controlled clinical trials with MIRVASO topical gel the most common adverse reactions (incidence > 1%) included erythema, flushing, skin burning sensation, and contact dermatitis. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Galderma Laboratories, L.P. at 1-866-735-4137 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. During clinical trials, 1210 subjects were exposed to MIRVASO topical gel. A total of 833 subjects were treated for persistent (nontransient) erythema associated with rosacea, and 330 of those were treated once daily for 29 days in vehicle-controlled trials. Adverse reactions that occurred in at least 1% of subjects treated with MIRVASO topical gel once daily for 29 days and for which the rate for MIRVASO topical gel exceeded the rate…
Warnings
Important safety information
Potentiation of Vascular Insufficiency ( 5.1 ) Severe Cardiovascular Disease ( 5.2 ) Serious Adverse Reactions Following Ingestion of MIRVASO topical gel ( 5.3 ) Systemic Adverse Reactions of Alpha-2 Adrenergic Agonists ( 5.4 ) Local Vasomotor Adverse Reactions ( 5.5 ) Hypersensitivity ( 5.6 ) 5.1 Potentiation of Vascular Insufficiency MIRVASO topical gel should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud’s phenomenon, orthostatic hypotension, thrombangiitis obliterans, scleroderma, or Sjögren’s syndrome. 5.2 Severe Cardiovascular Disease Alpha-2 adrenergic agonists can lower blood pressure. MIRVASO topical gel should be used with caution in patients with severe or unstable or uncontrolled cardiovascular disease. 5.3 Serious Adverse Reactions Following Ingestion of MIRVASO topical gel Two young children of a subject in a clinical trial experienced serious adverse reactions following accidental ingestion of MIRVASO topical gel. Adverse reactions experienced by one or both children included lethargy, respiratory distress with apneic episodes (requiring intubation), sinus bradycardia, confusion, psychomotor hyperactivity, and diaphoresis. Both children were hospitalized overnight and discharged the following day without sequelae. Keep MIRVASO topical gel out of the reach of children. 5.4 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. 5.5 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 .[see Adverse Reactions ( 6.1 )]. 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 [ see Adverse Reactions ( 6.1 ) ]. 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. 5.6 Hypersensitivity Allergic contact dermatitis was reported in the clinical trials for MIRVASO topical gel [ see Adverse Reactions ( 6.1 ) ]. Events reported post marketing with the use of MIRVASO topical gel include angioedema, throat tightening, tongue swelling, and urticaria, [ see Adverse Reactions ( 6.2 ) ]. Institute appropriate therapy and discontinue MIRVASO topical gel, if clinically significant hypersensitivity reaction occurs.
Who should not take Mirvaso
MIRVASO topical gel is contratindicated in patients who have experienced a hypersensitivity reaction to any component. Reactions have included angioedema, urticaria, and contact dermatitis [ see Warnings and Precautions (5.6) and Adverse Reactions (6.1 , 6.2 ) ]. Known hypersensitivity to any component of MIRVASO topical gel ( 4 )
Overdose — what happens if you take too much
No information is available on overdose in adults with MIRVASO topical gel. Oral overdoses of other alpha-2 adrenergic agonists have been reported to cause symptoms such as hypotension, asthenia, vomiting, lethargy, sedation, bradycardia, arrhythmias, miosis, apnoea, hypotonia, hypothermia, respiratory depression, and seizure. Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
7.1 Anti-hypertensives/Cardiac Glycosides Alpha-2 agonists, as a class, may reduce blood pressure. Caution in using drugs such as beta-blockers, anti-hypertensives and/or cardiac glycosides is advised. 7.2 CNS Depressants Although specific drug-drug interactions studies have not been conducted with MIRVASO topical gel, the possibility of an additive or potentiating effect with CNS depressants (alcohol, barbiturates, opiates, sedatives, or anaesthetics) should be considered. 7.3 Monoamine Oxidase Inhibitors Monoamine oxidase (MAO) inhibitors may theoretically interfere with the metabolism of brimonidine and potentially result in an increased systemic side-effect such as hypotension. Caution is advised in patients taking MAO inhibitors which can affect the metabolism and uptake of circulating amines.
Drug class
How this class works, per Alpha-1 Receptor Agonists - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Mirvaso ranks — best-rated alpha-adrenergic agonist for:
Dosage forms
Topical
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Mirvaso treat?
- Mirvaso (Brimonidine Tartrate) may be used to treat open-angle glaucoma, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Mirvaso work?
- Mirvaso is a alpha-adrenergic agonist. Alpha-adrenergic agonists switch on alpha receptors on blood-vessel walls, much like the body's own adrenaline. This tightens the smooth muscle around the vessels, narrowing them to raise blood pressure or reduce swelling and congestion.
- How much does Mirvaso cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $10.38 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Iopidine — about $9.81 on the same basis.
- Is there a coupon or discount for Mirvaso?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Mirvaso. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Mirvaso?
- Mirvaso is marketed by Galderma Labs LP. You can see Galderma Labs LP's full profile, rating, and other products on pharmaranks.
- Is Mirvaso a brand-name or generic drug?
- Mirvaso is a brand-name product with the active ingredient Brimonidine Tartrate. Lower-cost generic equivalents containing Brimonidine Tartrate are available — ask your pharmacist.
- Is Mirvaso available over the counter?
- No. Mirvaso is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Mirvaso come in?
- Mirvaso is currently marketed as topical, per the FDA's National Drug Code Directory.
- What class of drug is Mirvaso?
- Mirvaso is classified as alpha-adrenergic agonist, per the FDA's Established Pharmacologic Class.
- Is Mirvaso FDA-registered?
- Mirvaso is on record with the U.S. FDA under application number NDA204708. You can verify this on its official FDA label.
- Is Mirvaso safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Mirvaso. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Mirvaso?
- Mirvaso's side effects are taken directly from its FDA label. From the label: The following adverse drug reactions are discussed in greater detail in other sections of the label: Systemic Adverse Reactions of Alpha-2 Adrenergic Agonists [ see Warnings and Precautions ( 5.4 ) ] Local Vasomotor Adverse Reactions [ see Warnings and Precautions ( 5.5 ) ] Hypersensitivity [ see Wa… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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