Restylane – Refyne

AGING IS NATURAL

Your unique facial expressions show the world what you think and how you feel—you smirk, frown, pucker up, and smile from ear to ear.

But over time, your skin loses volume and the lines around that adorable pout or quirky grin don’t go away. That’s when it may be time for Restylane® Refyne and Restylane® Defyne.2-4

Indication:

Restylane® Refyne is for mid-to-deep injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds,in patients over the age of 21.

“It was a really pleasant surprise. The lines are softened, the effect is totally natural.”

—Kristen

Actual patient, 2 weeks after treatment. 1.0 mL Restylane Defyne to nasolabial folds, 1.0 mL Restylane Defyne to marionette lines. Patient was compensated for her time.

LOOK YOUR NATURALLY EXPRESSIVE BEST

Two new fillers designed to give your laugh lines a pick-me-up.

Restylane Refyne and Restylane Defyne are formulated to act like your body’s own naturally occurring hyaluronic acid (HA), restoring volume to your skin. 2,3,5 Using unique XpresHAn™ technology,each product is designed to give you just the right amount of lift, along with the flexibility to show a range of facial expressions without looking unnatural.1                   

Did you know? Restylane Refyne and Restylane Defyne are the only facial fillers that have been shown in clinical studies to help maintain natural movement and expressions. 1-3*

*In the Natural Expression Study, the naturalness of facial expressions and motion was measured in 63 subjects for 1 month after their treatment.1

Indication:

Restylane® Defyne is for mid-to-deep injection into the facial tissue for the correction of moderate to severe deep facial wrinkles and folds, such as nasolabial folds,in patients over the age of 21.

Please see Important Safety Information on pages 10 and 11 for the Restylane family of products.

REFYNE YOUR LAUGH LINES

ElFIE

*Actual patient, 2 weeks after treatment. Results unretouched. Individual results may vary.
*1.5 mL Restylane Refyne to nasolabial folds, 1.0 mL Restylane Refyne to marionette lines.

Real-life results that help maintain natural movement when you’re smiling, frowning, and even puckering up 1,2

Are your laugh lines starting to make you frown? Restylane Refyne provides flexibility and subtle support for laugh lines. Your natural-looking results can last up to 12 months.1,2*

“I feel better about my appearance overall.”—Elfie

Patient was compensated for her time.

*In a Phase III comparator trial, 59% of 170 Restylane Refyne subjects and 65% of 170 Juvéderm® Ultra subjects maintained their results after 12 months.1

30 days after treatment1†

of those treated with Restylane Refyne said they looked natural when smiling and relaxed.

of those treated with Restylane Refyne said they felt attractive and looked younger than their actual age.

†In the Patient Experience Study, 20 subjects reported their treatment satisfaction, as well as how long it took them to feel comfortable returning to their normal activities.1

Important Safety Information

The use of these products on gel-injection sites with skin sores, pimples, rashes, hives, cysts, or infections should be postponed until healing is complete.

Please see additional Important Safety Information on pages 10 and 11 for the Restylane family of products.

DEFYNE YOUR EXPRESSION

KRISTEN

*Actual patient, 2 weeks after treatment. Results unretouched. Individual results may vary.
*1.0 mL Restylane Defyne to nasolabial folds, 1.0 mL Restylane Defyne to marionette lines.

Real-life results that help maintain natural expression when you’re smiling, frowning, and even puckering up1,3

Have deeper laugh lines? Restylane Defyne provides flexibility and more support for deeper laugh lines. Your natural-looking results can last up to 12 months.1,3*

*In a Phase III comparator trial, 64% of 162 Restylane Defyne subjects and 67% of 162 Juvéderm® Ultra Plus subjects maintained their results after 12 months.1

Important Safety Information

The most commonly observed side effects are swelling, redness, pain, bruising, headache, tenderness, lump formation, and itching at the injection site.

Please see additional Important Safety Information on pages 10 and 11 for the Restylane family of products.

30 days after treatment1†

of Restylane Defyne subjects felt they looked natural when smiling and relaxed.

†In the Patient Experience Study, 20 subjects reported their treatment satisfaction, as well as how long it took them to feel comfortable returning to their normal activities.1

“I’m really happy that I made the decision to get Restylane Defyne. It made a big improvement in how I feel about my looks.”

—Kristen

Patient was compensated for her time.

WHAT TO EXPECT WITH TREATMENT

Customized fillers for just the right look

Whether your laugh lines are subtle or deep, Restylane Refyne and Restylane Defyne provide just the right amount of support and flexibility that’s right for you.1-3

Little downtime

Most people experience minimal downtime after treatment with Restylane Refyne and Restylane Defyne.1*

2 hours was all it took for some subjects treated with Restylane Refyne or Restylane Defyne to feel comfortable returning to social engagement.1*

Renew, refresh, repeat

Once treated, your new look should last up to 12 months. Then, simply repeat your treatment.1-3†

“I was able to return to work almost right away.” 

—Marguerite

Actual patient, 2 weeks after treatment. 1.0 mL Restylane Refyne to marionette lines, 2.5 mL of Restylane® Lyft to cheeks. Patient was compensated for her time.

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                                           of people sharing their treatment experiences.

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THE RESTYLANE LINE OF PRODUCTS

Restylane Refyne and Restylane Defyne are the latest additions to the Restylane portfolio and have been used over 600,000 times worldwide. 1 With over 30 million treatments worldwide and counting, the full Restylane line of products has a rich history of delivering natural-looking and long-lasting results.1-3

For information on the entire Restylane line, talk to your doctor or visit RestylaneUSA.com

*In the Patient Experience Study, 73% (8 out of 11) of the Restylane Refyne subjects and 22% (2 out of 9) of the Restylane Defyne subjects felt comfortable returning to their normal activities within 2 hours.1

†In 2 Phase III comparator trials, 59% of 170 Restylane Refyne subjects and 64% of 162 Restylane Defyne subjects maintained their results after 12 months.1

References: 1. Data on file, Galderma Laboratories, L.P.; 2016. 2. Restylane Refyne. Instructions for Use. Fort Worth, TX: Galderma Laboratories, L.P.; 2016. 3. Restylane Defyne. Instructions for Use. Fort Worth, TX: Galderma Laboratories, L.P.; 2016. 4. Vleggaar D, Fitzgerald R. J Drugs Dermatol. 2008;7(3):209-220. 5. Papakonstantinou E, Roth M, Karakiulakis G. Dermatoendocrinol. 2012;4(3):253–258.

Please see additional Important Safety Information on pages 10 and 11 for the Restylane family of products.

Important Safety Information

The Restylane family of products includes Restylane®, Restylane-L®, Restylane® Lyft with Lidocaine, Restylane® Silk, Restylane® Refyne, and Restylane® Defyne.

APPROVED USES

Restylane® and Restylane-L® are for mid-to-deep injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. Restylane® and Restylane-L® are also indicated for injection into the lips in patients over the age of 21.

Restylane® Lyft with Lidocaine is for deep implantation into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and for cheek augmentation and for the correction of age-related midface contour deficiencies in patients over the age of 21.

Restylane® Silk is for lip augmentation and for correction of perioral wrinkles in patients over the age of 21.

Restylane® Refyne is for mid-to-deep injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, in patients over the age of 21.

Restylane® Defyne is for mid-to-deep injection into the facial tissue for the correction of moderate to severe deep facial wrinkles and folds, such as nasolabial folds, in patients over the age of 21.

Are there any reasons why I should not use products within the Restylane® family? (Contraindications)

To ensure a safe procedure, your doctor will talk to you about your medical history to determine if you are an appropriate candidate for treatment. You should not use products within the Restylane family if:

  • ‍You have severe allergies with a history of severe reactions (anaphylaxis)
  • You are allergic to lidocaine or to any of the gram-positive bacterial proteins used to make hyaluronic acid
  • ‍You are prone to bleeding or have been diagnosed with a bleeding disorder

Are there other precautions that I should discuss with my doctor?

  • ‍Tell your doctor if you are breastfeeding, pregnant, or trying to become pregnant. The safety of these products for use during pregnancy, or in women who are breastfeeding, has not been studied
  • Restylane, Restylane-L, Restylane® Lyft with Lidocaine, Restylane Refyne and Restylane Defyne are intended to treat facial wrinkles and folds, such as nasolabial folds. Restylane and Restylane-L are also intended for lip enhancement. Treatments in other areas of the face have not been evaluated in clinical studies
  • ‍The safety and effectiveness of Restylane® Silk for areas other than the lips and perioral area have not been evaluated in clinical studies
  • ‍Tell your doctor if you have any history of scarring, particularly thick and stiff scars, or any pigmentation (skin color) disorders. These side effects can occur with hyaluronic acid fillers in general
  • ‍Tell your doctor if you are planning other laser treatments or a chemical peel, as there is a possible risk of inflammation at the treatment site if these procedures are performed after treatment
  • ‍Patients who experience skin injury near the site of injection with these products may be at a higher risk for side effects
  • ‍Tell your doctor if you are on any medications to decrease your body’s immune response (immunosuppressive therapy). Using these medications may increase your risk of bruising or bleeding at the gel injection site
  • ‍Tell your doctor if you are using any “blood thinners” such as aspirin, warfarin, or any other medications that affect bleeding. Using these medications may increase your risk of bruising or bleeding at the gel injection site
  • ‍The use of these products on gel injection sites with skin sores, pimples, rashes, hives, cysts, or infections should be postponed until healing is complete. Use of product in these areas could delay healing or make your skin problems worse

What are the possible side effects?

The most commonly observed side effects are swelling, redness, pain, bruising, headache, tenderness, lump formation, and itching at the injection site. These are typically mild in severity and typically resolve in less than 7 days in nasolabial folds and less than 14 days in lips. Serious but rare side effects include delayed onset infections, recurrence of herpetic eruptions, and superficial necrosis at the injection site.

One of the risks with using this product is unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, the complications can be serious, and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin.

As with all skin injection procedures, there is a risk of infection.

To report a side effect with any of the Restylane products, please call Galderma Laboratories, L.P. at 1-855-425-8722.

The Restylane family of products is available only through a licensed practitioner. Complete Instructions for Use are available at www.RestylaneUSA.com.

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