Aesthetic medicine:

Indications for RESTYLANE DEFYNE:

Correction of moderate to severe, deep facial wrinkles and folds (eg, nasolabial folds). Chin augmentation of mild to moderate chin retrusion.

Adult Dosage:

See full labeling. Inject slowly with least amount of pressure necessary. May use supplementary anesthesia during and post-inj. Individualize. >21yrs: Nasolabial folds (inject into mid to deep dermis): initial treatment usually 1.4mL per site; repeat treatment or touch up: usually 0.7mL per site. Max 2mL per site and treatment. Chin retrusion (inject into mid to deep dermis or in subcutaneous to supraperiosteal implantation): initial treatment usually 2.6mL depending on severity; repeat treatment: usually 2.1mL; touch-up: usually 1.4mL. Max 4mL for initial and re-treatments (eg, 2mL in chin and 2mL in area inferior to the lower lip). Max 2mL for touch-up.

Children Dosage:

Not established.

RESTYLANE DEFYNE Contraindications:

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

RESTYLANE DEFYNE Warnings/Precautions:

Should only be used by trained and experienced healthcare practitioners. Obtain patient's complete medical history prior to initiation. 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 sites in close proximity to a permanent implant. 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. Use in non-facial areas: not established. 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 Defyne or if product is given before skin has healed completely after such a procedure. Hypertrophic scars formation or any other healing disorders. Bleeding disorders. Epilepsy. Impaired cardiac conduction. Risk of herpes reactivation in those with a history of herpetic eruption. Avoid excessive sun, UV lamp exposure, or extreme temperatures. Severe hepatic or renal impairment. Patients (<22yrs), pregnancy, nursing mothers: not established.

RESTYLANE DEFYNE Classification:

Hyaluronan.

RESTYLANE DEFYNE Interactions:

Caution with concomitant immunosuppressants, other local anesthetics or agents related to amide-type. Increased bruising or bleeding at inj sites with concomitant aspirin, NSAIDs, warfarin.

Adverse Reactions:

Inj site reactions (eg, redness, swelling, bruising, lump/bump formation, pain/tenderness, 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)