Mirvaso

Mirvaso is a prescription medication used to treat persistent redness on the face of adults with rosacea.

Mirvaso belongs to a group of drugs called alpha adrenergic agonists. These work by constricting blood vessels in the skin, which reduces the amount of blood flow to the facial area and decreases redness associated with rosacea.

This medication comes in topical gel form and is applied to the face once daily.

Common side effects of Mirvaso include redness, flushing, skin burning sensation, and contact dermatitis.

Mirvaso can also cause blurred vision. Do not drive or operate heavy machinery until you know how Mirvaso affects you.

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.

• Galderma Laboratories, L.P.

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 about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medicines to lower blood pressure, including clonidine (Catapres), metoprolol (Toprol XL, Lopressor), carvedilol (Coreg), bisoprolol (Zebeta), betaxolol (Kerlone), nebivolol (Bystolic), propranolol (Inderal), and digoxin (Lanoxin)
• barbiturates including phenobarbital, pentobarbital (Nembutal), and secobarbital (Seconal)
• opiates including fentanyl (Abstral, Fentora, Onsolis, Actiq)
• sedatives or tranquilizers including diazepam (Valium), lorazepam (Ativan), alprazolam (Xanax), zolpidem (Ambien), zaleplon (Sonata), and eszopiclone (Lunesta)
• monoamine oxidase inhibitors such as tranylcypromine (Parnate), phenelzine (Nardil), selegiline (Eldepryl, Zelapar), isocarboxazid (Marplan), and rasagiline (Azilect)
• antidepressants such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil)

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

Serious side effects have been reported with Mirvaso including the following:

• Worsening of vascular disease. Mirvaso 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.
• Hypotension. Mirvaso may can lower blood pressure. It should be used with caution in patients with severe or unstable or uncontrolled cardiovascular disease.

Mirvaso can cause blurred vision. Do not drive or operate heavy machinery until you know how Mirvaso affects you.

Do not take Mirvaso if you are allergic to Mirvaso or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Mirvaso, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Mirvaso, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Mirvaso or to any of its ingredients
• 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
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

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.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Mirvaso has been detected in breast milk in animal studies. It is not known if Mirvaso crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Mirvaso.

Use Mirvaso exactly as prescribed.

Mirvaso comes in topical gel form and is applied once daily. It is for external use only.

Mirvaso should not be applied to irritated skin or open wounds.

Avoid contact with the eyes and lips.

Wash your hands immediately after applying the medication.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take 2 doses of Mirvaso at the same time.

Use this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• how you respond to this medication

The recommended dose Mirvaso is a pea-sized amount of gel applied to each of the five areas of the face (forehead, chin, nose, and each cheek) once daily.

If you take too much Mirvaso, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Mirvaso is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Store Mirvaso at room temperature.

Keep this and all medicines out of the reach of children.