Approved Uses For Evolysse

Evolysse™ Smooth and Evolysse™ Form are injected into the skin to smooth wrinkles that form in dynamic areas of the face, especially between the nose and corners of the mouth (NLFs), in adults 22 and older.

IMPORTANT SAFETY INFORMATION

Are there any reasons why I should not receive treatment with EVOLYSSE injectable hyaluronic acid products?

Do not use EVOLYSSE products if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), or if you are allergic to lidocaine or Gram-positive bacterial proteins.

What precautions should my doctor advise me about?

• Minimize exposure to extreme heat or cold as doing so may cause temporary redness, swelling, and/or itching at the injection site.
• Tell your doctor if you are using medication that can prolong bleeding, such as aspirin, ibuprofen, or other blood thinners, as this may increase bruising or bleeding at the injection site.
• Tell your doctor if you are planning laser treatment, chemical peel, or any other procedure after treatment as there is a possible risk of an inflammatory reaction at the treatment site.
• EVOLYSSE products are intended for dynamic wrinkles and folds such as NLFs. The safety and effectiveness for other treatment areas have not been established.
• Tell your doctor if you are on therapy used to decrease your immune response, which can increase risk of infection with treatment.
• Tell your doctor if you are pregnant or breastfeeding. The safety for use during pregnancy or in women who are breastfeeding has not been studied.
• Tell your doctor if you have a history of excessive scarring (thick, hard scars) or pigmentation disorders, as use of these products may result in additional scars or changes in pigmentation.
• Tell your doctor if you have a history of cold sores. Any injections, including EVOLYSSE products, around the mouth may trigger a recurrence of your cold sores.
• The use of EVOLYSSE products where skin sores, pimples, rashes, hives, cysts, or infections are present should be postponed until healing is complete. Use of EVOLYSSE products where these are present could delay healing or make your skin problems worse.

What are the possible side effects of treatment?

The most commonly reported side effects with EVOLYSSE products were tenderness, swelling, bruising, redness, lumps, pain, discoloration, itching, and headache.  Most side effects were mild and went away on their own within 1 week.

What are other possible adverse events?

As with all skin injection procedures, there is a risk of infection.
One of the risks with using these products is unintentional injection into a blood vessel. Although the chances of this happening are very small, complications can be serious and may be permanent, and include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin. If you have changes in your vision, signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms, or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion), white appearance of the skin, or unusual pain during or shortly after treatment, you should call your doctor immediately.

To report a side effect with any EVOLYSSE product, please call the Evolus Customer Experience at 1-877-386-5871.

EVOLYSSE products are available only by a licensed physician or properly licensed practitioner.

For complete patient label information, please visit EvolusRx.com