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Mirvaso brimonidine tartrate 5 mg/g Gel — NDC 00299-5980-00 package photo

Mirvaso brimonidine tartrate 5 mg/g Gel

by Galderma Laboratories, L.P. · 1 TUBE in 1 BLISTER PACK (0299-5980-00) / 2 g in 1 TUBE
NDC 00299-5980-00
🏷️ FDA NDC (as labeled) 0299-5980-00 billing pads the labeler segment with a zero
This package
Contains2 g in 1 tube Pack sizes5 compare ↓
Also comes in: 30 g 00299-5980-35 2 g 00299-5980-02 30 g 00299-5980-30 45 g 00299-5980-45
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 0299-5980-00
Product NDC 0299-5980
11-digit billing NDC 00299598000
RxCUI 1437707, 1437709
UNII 4S9CL2DY2H
Application # NDA204708
SPL Set ID f6a4353f-ae69-4214-901f-e5d42a6fbde7
Established class (EPC) alpha-Adrenergic Agonist
Mechanism of action Adrenergic alpha-Agonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-08-23
Route TOPICAL
Dosage form GEL
Substance BRIMONIDINE TARTRATE
GPI-14 90060020104020
GPI class Mirvaso
GCN Seq No 076045
GCN 41249
HICL code 011786
Ingredient (HICL) Brimonidine Tartrate
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L5
Therapeutic class — intermediate (HIC2) Keratolytics/Keratoplastics
HIC3 code L5G
Therapeutic class — specific (HIC3) Rosacea Agents, Topical
AHFS code 52:40.04.00
AHFS class Alpha-Adrenergic Agonists (52:40)
FDB label name MIRVASO 0.33% GEL PUMP
FDB brand name Mirvaso
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 0299-5980-00 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00299-5980-00. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the alpha-Adrenergic Agonist class.

Pharmacologic class alpha-Adrenergic Agonist
Drug family (ATC) Other dermatologicals, Sympathomimetics in glaucoma therapy, Sympathomimetics used as decongestants
How it works Adrenergic alpha-Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerGalderma Laboratories, L.P.
Application holderGALDERMA LABORATORIES LP
FDA applicationNDA204708 (NDA)
Labeler code00299
First marketedAug 2013
Product typeHuman Prescription Drug
Portfolio50 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name MIRVASO 0.33% GEL PUMP Ingredient Brimonidine Tartrate
📗 Our plain-language guide HelloPharmacist
  • They contain the same active ingredient — brimonidine — but they're very different products. The eye drops are specifically formulated for use in the eye to lower pressure, while t...
  • I have both glaucoma drops and the rosacea gel — are they basically the same thing?
  • It can happen, and it's worth knowing about. Some people experience flushing or a temporary increase in redness a few hours after applying the gel — the redness-reducing effect can...
  • My facial redness seems worse some days after I use the gel — is that normal?
📖 Read our full Brimonidine guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Brimonidine Tartrate — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Brimonidine Tartrate (3 interactions) — ranked by severity →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII HHT01ZNK31
    Carbomer Homopolymer Type B is a synthetic polymer made from acrylic acid. It absorbs water and forms a gel, so it's used in medicines as a thickener, suspending agent, and to help create a smooth texture in creams, gels, and lotions.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

8 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 30 g 2 g 30 g 45 g
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Brimonidine 5 mg/g 45802-0078-30 Padagis 1 bottle $13.840 AB Availability likely —
Mirvaso 5 mg/gthis 00299-5980-00 Galderma 1 tube — AB FDA listed —
Brimonidine 5 mg/g 63629-9616-01 Bryant 1 bottle — AB FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2013
First FDA approval
Aug 2013
📍
2026
Currently FDA-listed
13 years listed
🛡️
2031
Latest patent/protection listed
not a guaranteed launch date
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jun 2031. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Aug 23, 2013 AB TE-rated RLD RS ⏳ ~4.7 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 8053427 — method of use (U-1428)
US 8513247 — method of use (U-1428)
US 8513249 — method of use (U-1428)
US 9861631 — method of use (U-1428)
US 9861632 — method of use (U-1428)
US 8163725 — drug product
US 10201517 — drug product
2013 2015 2017 2019 2021 2023 2025 2027 2029 2031
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (7)
PatentTypeUse codeExpires
US 8053427 ↗ Method of use U-1428 Jun 13, 2031
US 8513247 ↗ Method of use U-1428 Mar 25, 2031
US 8513249 ↗ Method of use U-1428 Mar 25, 2031
US 9861631 ↗ Method of use U-1428 Mar 25, 2031
US 9861632 ↗ Method of use U-1428 Mar 25, 2031
US 8163725 ↗ Drug product — Jun 13, 2031
US 10201517 ↗ Drug product — Jun 13, 2031
Common questions
Is there a generic version of MIRVASO 0.33% GEL PUMP?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for MIRVASO 0.33% GEL PUMP. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Mirvaso — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Mirvaso. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$53.7K
Claims incl. refills
73
Beneficiaries
49
Spend / beneficiary
$1,096.21
Spend / claim
$735.81
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Mirvaso (this brand).

Top reported reactions

Erythema573
Flushing279
Condition Aggravated275
Eye Pain250
Headache186
Eye Irritation185
Fatigue185

Age at onset

Infant2
Child1
Adolescent3
Adult201
Elderly453

Reporter sex

4,127 reports
Male · 39%
Female · 61%
Unknown · 0%

Serious outcomes

Hospitalization748
Death187
Disabling91
Life-threatening52
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 301 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
00299-5980-00 You're viewing this 1 TUBE in 1 BLISTER PACK (0299-5980-00) / 2 g in 1 TUBE — — 2013-08-23 Active
00299-5980-02 2 g in 1 TUBE (0299-5980-02) — — 2013-08-23 Active
00299-5980-30 30 g in 1 TUBE (0299-5980-30) — — 2013-08-23 Active
00299-5980-35 1 BOTTLE, PUMP in 1 CARTON (0299-5980-35) / 30 g in 1 BOTTLE, PUMP $21.47 / g $643.98 2013-08-23 Active
00299-5980-45 45 g in 1 TUBE (0299-5980-45) — — 2013-08-23 Active

Pack size FAQ

What quantity is in NDC 00299-5980-00?
NDC 00299-5980-00 is listed by the FDA — 1 tube in 1 blister pack / 2 g in 1 tube.
What NDC number is used to bill for this package of Mirvaso brimonidine tartrate 5 mg/g Gel?
Bill NDC 00299-5980-00 — the 11-digit billing format is 00299598000. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 0299-5980-00, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00299-5980-00, written without dashes as 00299598000. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00299-5980-00, the first segment (00299) is the labeler code FDA assigned to Galderma Laboratories, L.P.; the middle segment (5980) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Galderma Laboratories, L.P.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 4 other package presentations of this same product, including 1 bottle (00299-5980-35), 2 g (00299-5980-02), 30 g (00299-5980-30). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Galderma Laboratories, L.P. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Patient Medication Information
🎯 Indications and Usage 65 words ▾

1 INDICATIONS AND USAGE MIRVASO (brimonidine) topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) erythema of rosacea in adults 18 years of age or older. MIRVASO (brimonidine) topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) facial erythema of rosacea in adults 18 years of age or older.( 1 )

⏱️ Dosage and Administration 128 words ▾

2 DOSAGE AND ADMINISTRATION 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 )

💊 Dosage Forms and Strengths 60 words ▾

3 DOSAGE FORMS AND STRENGTHS MIRVASO (brimonidine) topical gel, 0.33% is a white to light yellow opaque aqueous gel. Each gram of gel contains 5 mg of brimonidine tartrate, equivalent to 3.3 mg of brimonidine free base. Gel, 0.33%; Each gram of gel contains 5 mg of brimonidine tartrate, equivalent to 3.3 mg of brimonidine free base. ( 3 )

⛔ Contraindications 52 words ▾

4 CONTRAINDICATIONS 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 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS 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 )

5.1Potentiation 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.

5.2Severe 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.

5.3Serious 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.

5.4Systemic 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.

5.5Local 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.

5.6Hypersensitivity 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.

🤒 Adverse Reactions ~2 min read ▾

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 [ 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 .

6.1Clinical 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 for vehicle are presented in Table 1. Table 1 - Adverse Reactions Reported in Clinical Trials by at Least 1% of Subjects Treated for 29 Days Preferred Term MIRVASO Topical Gel (N=330) n (%) Vehicle Gel (N=331) n (%) Subjects with at least one adverse reaction, Number (%) of Subjects 109 (33) 91 (28) Erythema 12 (4%) 3 (1%) Flushing 9 (3%) 0 Skin burning sensation 5 (2%) 2 (1%) Dermatitis contact 3 (1%) 1 (<1%) Dermatitis 3 (1%) 1 (<1%) Skin warm 3 (1%) 0 Paraesthesia 2 (1%) 1 (<1%) Acne 2 (1%) 1 (<1%) Pain of skin 2 (1%) 0 Vision blurred 2 (1%) 0 Nasal congestion 2 (1%) 0 Open-label, Long-term Study An open-label study of MIRVASO topical gel when applied once daily for up to one year was conducted in subjects with persistent (nontransient) facial erythema of rosacea.

Subjects were allowed to use other rosacea therapies. A total of 276 subjects applied MIRVASO topical gel for at least one year. The most common adverse events ( > 4% of subjects) for the entire study were flushing (10%), erythema (8%), rosacea (5%), nasopharyngitis (5%), skin burning sensation (4%), increased intraocular pressure (4%), and headache (4%).

Allergic contact dermatitis Allergic contact dermatitis to MIRVASO topical gel was reported in approximately 1% of subjects across the clinical development program. Two subjects underwent patch testing with individual product ingredients. One subject was found to be sensitive to brimonidine tartrate, and one subject was sensitive to phenoxyethanol (a preservative).

6.2Postmarketing 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 systemic disorders: dizziness Skin and subcutaneous disorders: pallor

🔄 Drug Interactions 109 words ▾

7 DRUG INTERACTIONS

7.1Anti-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.

7.2CNS 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.

7.3Monoamine 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.

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Category B. There are no adequate and well-controlled studies of MIRVASO topical gel in pregnant women. In animal studies, brimonidine crossed the placenta and entered into the fetal circulation to a limited extent.

MIRVASO topical gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Brimonidine tartrate was not teratogenic when given at oral doses up to 2.5 mg/kg/day in pregnant rats during gestation days 6 through 15 and 5 mg/kg/day in pregnant rabbits during gestation days 6 through 18.

8.3Nursing Mothers It is not known whether brimonidine tartrate is excreted in human milk, although in animal studies, brimonidine tartrate has been shown to be excreted in breast milk. Because of the potential for serious adverse reactions from MIRVASO topical gel in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

8.4Pediatric Use Keep MIRVASO topical gel out of reach of children. Serious adverse reactions were experienced by two children of a subject in a clinical trial who accidentally ingested MIRVASO topical gel [ See Warnings and Precautions ( 5.3 ) ] . Safety and effectiveness in pediatric patients have not been established.

8.5Geriatric Use One hundred and five subjects aged 65 and older were included in clinical trials with MIRVASO topical gel. No overall differences in safety or effectiveness were observed between subjects > 65 years of age and younger adult subjects. Clinical studies of MIRVASO topical gel did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

🤰 Pregnancy 91 words ▾

8.1Pregnancy Pregnancy Category B. There are no adequate and well-controlled studies of MIRVASO topical gel in pregnant women. In animal studies, brimonidine crossed the placenta and entered into the fetal circulation to a limited extent.

MIRVASO topical gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Brimonidine tartrate was not teratogenic when given at oral doses up to 2.5 mg/kg/day in pregnant rats during gestation days 6 through 15 and 5 mg/kg/day in pregnant rabbits during gestation days 6 through 18.

🧒 Pediatric Use 53 words ▾

8.4Pediatric Use Keep MIRVASO topical gel out of reach of children. Serious adverse reactions were experienced by two children of a subject in a clinical trial who accidentally ingested MIRVASO topical gel [ See Warnings and Precautions ( 5.3 ) ] . Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 67 words ▾

8.5Geriatric Use One hundred and five subjects aged 65 and older were included in clinical trials with MIRVASO topical gel. No overall differences in safety or effectiveness were observed between subjects > 65 years of age and younger adult subjects. Clinical studies of MIRVASO topical gel did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

🆘 Overdosage 60 words ▾

10 OVERDOSAGE 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.

🧬 Clinical Pharmacology 164 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Brimonidine is a relatively selective alpha-2 adrenergic agonist. Topical application of MIRVASO topical gel may reduce erythema through direct vasoconstriction.

12.3Pharmacokinetics Absorption The absorption of brimonidine from MIRVASO topical gel was evaluated in a clinical trial in 24 adult subjects with facial erythema associated with rosacea. All enrolled subjects received once daily topical application of MIRVASO topical gel 1 gram to the entire face for 29 days. Pharmacokinetic assessments were performed on Day 1, Day 15, and Day 29.

The mean plasma maximum concentration (C max ) and area under the concentration-time curve (AUC) were highest on Day 15, with C max and AUC values (± standard deviation) of 46 ± 62 pg/mL and 417 ± 264 pg.hr/mL, respectively. The systemic drug exposure was slightly lower on Day 29 indicating no further drug accumulation. Metabolism Brimonidine is extensively metabolized by the liver.

Excretion Urinary excretion is the major route of elimination of brimonidine and its metabolites.

🧬 Mechanism of Action 24 words ▾

12.1Mechanism of Action Brimonidine is a relatively selective alpha-2 adrenergic agonist. Topical application of MIRVASO topical gel may reduce erythema through direct vasoconstriction.

📦 How Supplied / Storage and Handling 71 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING MIRVASO (brimonidine) topical gel, 0.33% is a white to light yellow opaque gel, supplied in a laminated tube or pump with a child resistant cap in the following sizes: 30 gram tube NDC 0299-5980-30 30 gram pump NDC 0299-5980-35 45 gram tube NDC 0299-5980-45 Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature].

📋 Description 119 words ▾

11 DESCRIPTION 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

💬 Information for Patients 126 words ▾

17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information and Instructions for Use) Patients using MIRVASO topical gel should receive the following information and instructions: This medication is to be used as directed by the physician. It is for external use only. MIRVASO topical gel should not be applied to irritated skin or open wounds.

Avoid contact with the eyes and lips. Patients should wash their hands immediately after applying the medication. Some patients using MIRVASO topical gel may experience erythema, flushing or excessive whitening.

Patients should report any adverse reactions to their physician. Keep out of reach of children. Marketed by: GALDERMA LABORATORIES, L.P., Fort Worth, Texas 76177 USA Made in Canada.

All trademarks are the property of their respective owners. P52849-2 or P51217-3

💬 Patient Medication Information ~3 min read ▾

PATIENT INFORMATION MIRVASO (Mer-VAY-soe) (brimonidine) topical gel Important information: MIRVASO ® topical gel is for use on the face only. Do not use MIRVASO topical gel in your eyes, mouth, or vagina. Keep MIRVASO topical gel out of the reach of children.

If anyone, especially a child, accidentally swallows MIRVASO topical gel, they may have serious side effects and need to be treated in a hospital. Get medical help right away if you, a child, or anyone else swallows MIRVASO topical gel and has any of these symptoms: • lack of energy, trouble breathing or stops breathing, a slow heart beat, confusion, sweating, restlessness, muscle spasms, or twitching. What is MIRVASO topical gel?

MIRVASO topical gel is a prescription medicine that is used on your skin (topical) to treat facial redness due to rosacea that does not go away (persistent) in adults who are 18 years of age or older. It is not known if MIRVASO topical gel is safe and effective in children. Who should not use MIRVASO topical gel?

Do not use MIRVASO topical gel if you have had a serious allergic reaction to any of the ingredients in MIRVASO topical gel. See the end of this Patient Information leaflet for a list of ingredients in MIRVASO topical gel. See “What are the possible side effects of MIRVASO topical gel?” What should I tell my doctor before using MIRVASO topical gel?

Before using MIRVASO topical gel, tell your doctor about all of your medical conditions including if you: • have depression • have heart or blood vessel problems • have dizziness or blood pressure problems • have problems with blood circulation or have had a stroke • have dry mouth or Sjögren’s Syndrome • have skin tightening or scleroderma • have Raynaud’s phenomenon • have irritated skin or open sores • plan to have any laser procedures • are pregnant or plan to become pregnant. It is not known if MIRVASO topical gel will harm your unborn baby. • are breastfeeding.

It is not known if MIRVASO topical gel passes into your breast milk. You and your doctor should decide if you will use MIRVASO topical gel or breastfeed. You should not do both.

Tell your doctor about all the medicines you take , including prescription and over-the-counter medicines, skin products, vitamins, and herbal supplements. Using MIRVASO topical gel with certain other medicines may affect each other and can cause serious side effects. How should I use MIRVASO topical gel?

See the detailed Instructions for Use that comes with your MIRVASO topical gel tube or pump for information about how to apply MIRVASO topical gel correctly. • Use MIRVASO topical gel exactly as your doctor tells you. Do not use more MIRVASO topical gel than prescribed. Call your doctor if you are not sure. • You should not apply MIRVASO topical gel to irritated skin or open wounds. • MIRVASO topical gel is for use on your skin only.

Do not use MIRVASO topical gel in your eyes, mouth, or vagina. Avoid contact with your lips and eyes. 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: o swelling of your face, lips, tongue, or throat o hives o trouble breathing The most common side effects of MIRVASO topical gel include: • redness • flushing • burning sensation of the skin • skin reactions (contact dermatitis).

Skin re…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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