Restylane® Defyne

• Helps smooth out deep laugh lines (nasolabial folds and marionette lines).
• Helps restore a more youthful, natural-looking appearance, while helping you maintain your natural expressions.

What is Restylane Defyne for?

As you age, your facial skin begins to lose its elasticity and volume. As a result, your “laugh lines”, the creases that run from the sides of your nose toward the corners of your mouth, become more pronounced. Restylane Defyne injectable gel is designed to temporarily help counter this by smoothing out these wrinkles and folds and restoring a natural, soft look to your face. Restylane Defyne has been shown to maintain this effect for up to 12 months.

Note: Facial features can differ. Speak to your doctor about the lines on your face that are appropriate for treatment with Restylane Defyne

Are there any reasons why I should not receive Restylane Defyne??

Before using Restylane Defyne, your doctor will talk to you about your medical history, to determine if you are an appropriate candidate for treatment. You will be asked questions about possible allergies to ensure that Restylane Defyne can be safely administered. Tell your doctor about all of your medical conditions, including if you:

• Have severe allergies with a history of severe reactions (anaphylaxis). Use of Restylane Defyne may result in an allergic reaction.
• Are allergic to the anesthetic lidocaine or to any of the proteins used to make the hyaluronic acid in Restylane Defyne (bacterial proteins). Use may result in an allergic reaction

If you are not sure about your medical history concerning these allergies, please discuss further with your doctor

How was Restylane Defyne Studied?

Restylane Defyne was tested to ensure that it worked properly (effective) and was safe to use, in 162 patients before it was approved for use in all patients. These patients included 156 women, 6 men, and were from various ethnic groups with multiple skin tones (pale to dark skin). Each of these patients expressed desire to improve the appearance of their facial wrinkles and folds (laugh lines).

The study was created to compare two different dermal filler gel products. It was conducted by 11 different doctors in 11 different locations across the United States.

Patients who participated in the study received an initial treatment with Restylane Defyne on one side of their face and another, similar dermal filler gel, without anesthetic, on the other side of their face. Touch-up injections were given as needed, and each patient was monitored for 12 months following the procedure to measure the effects of the treatments. For each patient, the amount of product used was based on their individual needs.

In order to objectively measure improvements in appearance over 12 months, each patient was evaluated by a doctor other than one who had performed the treatment. Patients also evaluated themselves. To measure side effects following the procedure, each patient kept a diary for 21 days to record side effects. These were then shared with the doctors.

What will Restylane Defyne do for me?

Restylane Defyne temporarily reduces signs of aging on your face by smoothing the wrinkles and folds that form around your nose and extend down to the corners of your mouth (laugh lines). This natural, smooth look should last for up to 12 months.

What side effects were seen in the clinical study?

In the study of Restylane Defyne, most patients reported the following side effects at the site where they received the injection:

• Swelling
• Lumps/Bump Formation
• Redness
• Pain/Tenderness
• Bruising
• Itching

Most patients said their side effects were mild, short-lived and did not require them to call their doctor. These patients said that their side effects disappeared within 1-2 weeks.

Patients also reported that the anesthetic lidocaine, which is part of the Restylane Defyne injection and used to numb the injection site, significantly reduced pain during and after their procedure.