RESTYLANE® KYSSE with Lidocaine

Restylane® Kysse dermal fillers are supplied in individual treatment syringes with needles as indicated on the carton. The volume in each syringe is as stated on the syringe label and on the carton. The content of the syringe is sterile. Do not re-sterilize. Do not use the product if the package is open or damaged or if the expiry date or lot number is missing or illegible. Immediately return the damaged product to Galderma Laboratories, L.P.

• Restylane® Kysse is indicated for injection into the lips for lip augmentation and the correction of upper perioral rhytids in patients over the age of 21.

Restylane® Kysse is a sterile, biodegradable, viscoelastic, non-pyrogenic, clear, colorless, flexible, and homogeneous gel composed of hyaluronic acid of bacterial origin, with a moderate lifting capacity. Restylane® Kysse is crosslinked with BDDE (1,4-butanediol diglycidyl ether). The dermal fillers product has a sodium hyaluronate concentration of 20 mg/mL in phosphate-buffered saline at pH 7 and contains 3 mg/mL lidocaine hydrochloride.

Injection:

• Needle Selection: Use sterile needles with a size and length appropriate for lip injections (refer to product information). Common options include 30-gauge needles with lengths of 10mm to 13mm.
• Injection Technique: There are several techniques suitable for Restylane® Kysse, depending on the desired outcome:
  • Linear Retrograde Technique: Injections are made along the lip border in a backward direction for lip definition and shaping.
  • Papule Forming Technique: Small deposits of filler are placed strategically within the lips for volume enhancement.
  • Vermillion Border Technique: Injections are placed in specific points along the lip border for subtle lip augmentation. The practitioner will choose the most appropriate technique(s) based on the patient’s needs.
• Injection Depth: The product should be injected into the superficial to mid-dermis of the lips, avoiding deeper layers or blood vessels (refer to product instructions).
• Injection Volume: The amount of Restylane® Kysse dermal fillers used will vary depending on the patient’s lip size, desired outcome, and product characteristics. Start with a low volume and gradually increase if needed to achieve the optimal result.

Post-treatment:

• Cooling: Apply a cool compress to the lips for 10-15 minutes to minimize swelling and discomfort.
• Ice Massage (Optional): Gentle ice massage of the lips as instructed by the practitioner might help reduce swelling further.
• Results: Initial improvement in lip volume and definition might be noticeable immediately. However, optimal results with Restylane Kysse typically take 2 weeks to become fully visible as the product integrates into the tissue.

Additional Considerations:

• The number of treatment sessions and the interval between them can vary depending on the patient’s needs and desired outcome. Typically, one session is sufficient for initial lip enhancement. However, a follow-up session after a few weeks might be recommended for further refinement.
• Restylane® Kysse dermal fillers can be combined with other lip procedures like lip liner injections.
• Potential side effects like temporary redness, swelling, bruising, tenderness, and injection site irregularities can occur. Discuss potential risks and benefits with the patient before proceeding.
• Remember: It’s crucial for medical aesthetic practitioners to use their professional judgment and consider each patient’s individual needs and lip anatomy before administering Restylane® Kysse.

Contraindications

1. Restylane® Kysse is contraindicated for:
   • Patients with severe allergies such as manifested by a history of anaphylaxis or history or presence of multiple severe allergies.
   • Patients with a history of allergies to gram-positive bacterial proteins.
   • Patients with a history of allergies to lidocaine or other amide type anesthetics.

After-care

• A clean cloth dipped in cold water (cold compresses) wrung out and applied to the injected area may be used immediately after treatment to reduce swelling.
• Avoid touching the treated area within six hours following treatment to prevent accidental injury to the skin while the area is numb. After that, the area can be gently washed with soap and water.
• Avoid taking aspirin, NSAID, St. John’s Wort, blood thinners, and high doses of Vitamin E supplements for one week after treatment, as these agents may increase bruising and bleeding at the injection site.
• Minimize strenuous exercise and exposure to excessive heat, sun, or UV lamps for the first 24 hours after treatment, as exposure to any of these may cause temporary redness, swelling, and/or itching at the injection site. Until there is no redness or swelling, avoid exposure of the treated area to intense cold or heat such as sun lamps or sunbathing.