Mirvaso

Brimonidine works by narrowing blood vessels.

Brimonidine topical (for the skin) is used to treat facial rosacea (enlarged facial blood vessels) in adults.

Brimonidine topical may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not use this medicine if you are allergic to brimonidine.

To make sure brimonidine topical is safe for you, tell your doctor if you have:

• coronary artery disease or circulation problems;
• heart disease or a blood vessel disorder;
• Raynaud's syndrome (numbness or cold feeling in your hands or feet);
• depression;
• low blood pressure;
• an autoimmune disorder called Sjogren's syndrome;
• a build-up of scar tissue on your skin (scleroderma); or
• if you take a heart or blood pressure medication.

FDA pregnancy category B. Brimonidine topical is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether brimonidine topical passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Mirvaso is a prescription medication used to treat persistent redness on the face of adults with rosacea. This medication should only be used topically on the face. Mirvaso is not a cure for rosacea. Other forms of this medication are available for different indications and these forms should not be interchanged.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Mirvaso. See the “Mirvaso Precautions” section.

Common side effects of Mirvaso include the following:

• redness on the skin
• flushing
• skin burning sensation
• contact dermatitis
• feeling of skin warmth
• tingling sensation
• acne
• pain at the application site
• blurred vision
• nasal congestion

This is not a complete list of Mirvaso side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Mirvaso falls into category B. There are no well-done studies that have been done in humans with Mirvaso. In animal studies, pregnant animals were given this medication, and the babies had a few medical issues related to this medication. This medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Brimonidine works by narrowing blood vessels.

Brimonidine topical (for the skin) is used to treat facial rosacea (enlarged facial blood vessels) in adults.

Brimonidine topical may also be used for purposes not listed in this medication guide.

It is important that your doctor check your progress at regular visits for any unwanted effects that may be caused by this medicine.

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

If you (especially your child) get this medicine into the mouth or swallow it accidentally, check with your doctor right away if you have the following symptoms: lack of energy, trouble breathing or stops breathing, a slow heartbeat, confusion, sweating, restlessness, muscle spasms, or twitching.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Dizziness or passing out.
• Slow heartbeat.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

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.

Usual Adult Dose for Acne Rosacea:

Maintenance dose: Apply a pea-size amount of gel once daily to: central forehead, chin, nose, each cheek.

Use: Topical treatment of persistent (nontransient) facial erythema of rosacea in adults 18 years of age or older. This medicine is not for oral, ophthalmic, or intravaginal use.

An overdose of Mirvaso is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Applies to brimonidine topical: topical gel

General

The most commonly reported adverse reactions are headache, erythema, pruritus, flushing and skin burning sensation.[Ref]

Dermatologic

Common (1% to 10%): Acne, allergic contact dermatitis, contact dermatitis, dermatitis, erythema, pruritus, rosacea, skin burning sensation, skin irritation, skin pain, warm skin
Uncommon (0.1% to 1%): Dry skin, skin discomfort, papular rash
Postmarketing reports: Aggravated erythema, face swelling, pallor, urticaria[Ref]

Respiratory

Common (1% to 10%): Nasal congestion, nasopharyngitis, upper respiratory track infection
Postmarketing reports: Throat tightness[Ref]

Ocular

Common (1% to 10%): Blurred vision, increased intraocular pressure
Uncommon (0.1% to 1%): Eyelid edema[Ref]

Nervous system

Common (1% to 10%): Headache, paresthesia
Postmarketing reports: Dizziness[Ref]

Cardiovascular

Common (1% to 10%): Flushing
Postmarketing reports: Bradycardia, hypotension, orthostatic hypotension[Ref]

Other

Uncommon (0.1% to 1%): Feeling hot, peripheral coldness[Ref]

Gastrointestinal

Uncommon (0.1% to 1%): Dry mouth
Postmarketing reports: Lip swelling, tongue swelling[Ref]

Hypersensitivity

Postmarketing reports: Angioedema, hypersensitivity[Ref]

Local

Postmarketing reports: Excessive whitening at application site[Ref]

Some side effects of Mirvaso may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.