Restylane Kysse

— THERAPEUTIC CATEGORIES —
  • Aesthetic medicine

Restylane Kysse Generic Name & Formulations

General Description

Hyaluronic acid 20mg/mL, lidocaine 3mg/mL; injectable gel implant.

Pharmacological Class

Hyaluronan.

How Supplied

Single-use syringe—1 (w. needles)

Generic Availability

NO

Restylane Kysse Indications

Indications

Lip augmentation. Correction of upper perioral rhytids.

Restylane Kysse Dosage and Administration

Adult

See full labeling. Inject slowly with least amount of pressure necessary. Individualize. >21yrs (Lips): inject into submucosal layer (avoid IM inj), max 1.5mL/upper lip and 1.5mL/lower lip per treatment; (Rhytids): inject into the mid-dermis to the subcutaneous layer. Total max 6mL per treatment. Both: may require touch-up to achieve desired effects.

Children

Not established.

Restylane Kysse Contraindications

Contraindications

History of anaphylaxis or presence of multiple severe allergies. Allergies to Gram (+) bacterial proteins.

Restylane Kysse Boxed Warnings

Not Applicable

Restylane Kysse Warnings/Precautions

Warnings/Precautions

Should only be used by trained and experienced healthcare practitioners. Monitor patients for at least 1 hour after procedure. Avoid intravascular inj; discontinue immediately if changes in vision, signs of stroke, blanching of skin or unusual pain during or shortly after procedure occurs. Avoid implantation in or near blood vessels or vascular rich areas. Undergone prior surgical procedure in the planned treatment area. Risk of infection. Defer if active inflammatory process or infection is present at specific sites. Avoid sites with permanent implants. Risk of herpes reactivation in patients with a history of herpetic eruption. Concomitant epilation, UV irradiation, or laser, mechanical or chemical peeling procedures: not evaluated. Possible risk of an inflammatory reaction at implant site if laser treatment, chemical peeling, or any other procedure based on active dermal response is considered after Restylane Kysse or if product is given before skin has healed completely after such a procedure. Bleeding disorders. Epilepsy. Impaired cardiac conduction. Avoid excessive sun, UV lamp exposure, or extreme cold weather. Severe hepatic or renal impairment. Patients (<22yrs), pregnancy, nursing mothers: not established.

Restylane Kysse Pharmacokinetics

See Literature

Restylane Kysse Interactions

Interactions

Caution with concomitant immunosuppressants. Increased bruising or bleeding at inj sites with concomitant aspirin, NSAIDs, warfarin. Caution with concomitant agents structurally related to amide-type anesthetics (eg, certain antiarrhythmics).

Restylane Kysse Adverse Reactions

Adverse Reactions

Inj site reactions (eg, swelling, tenderness, bruising, lumps/bumps, redness, pain, skin discoloration, itching); delayed inflammatory papules, pigmentation changes (esp. in patients with dark skin [Fitzpatrick Type IV-VI]).

Restylane Kysse Clinical Trials

See Literature

Restylane Kysse Note

Not Applicable

Restylane Kysse Patient Counseling

See Literature