Aesthetic medicine:

Indications for RESTYLANE KYSSE:

Lip augmentation. Correction of upper perioral rhytids.

Adult Dosage:

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 Dosage:

Not established.

RESTYLANE KYSSE Contraindications:

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

RESTYLANE KYSSE 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 Classification:

Hyaluronan.

RESTYLANE KYSSE 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).

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]).

Generic Drug Availability:

NO

How Supplied:

Single-use syringe—1 (w. needles)