Restylane Refyne

— THERAPEUTIC CATEGORIES —
  • Aesthetic medicine

Restylane Refyne 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 Refyne Indications

Indications

Correction of moderate to severe facial wrinkles and folds (eg, nasolabial folds).

Restylane Refyne Dosage and Administration

Adult

See full labeling. Inject slowly into the mid to deep dermis with least amount of pressure necessary. May use supplementary anesthesia during and post-inj. >21yrs: Individualize. Initial treatment: usually 1.5mL per site; repeat treatment: usually 1mL per site. May require touch-up treatments to achieve desired effects.

Children

Not established.

Restylane Refyne Contraindications

Contraindications

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

Restylane Refyne Boxed Warnings

Not Applicable

Restylane Refyne Warnings/Precautions

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 with permanent implant. Risk of infection. Defer if active inflammatory process, infection or tumor 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 Refyne or if product is given before skin has healed completely after such a procedure. Bleeding disorders. Risk of herpes reactivation in patients with a history of herpetic eruption. Advise patients to avoid strenuous exercise and extensive sun or heat exposure within first 24hrs. Patients (<22yrs), pregnancy, nursing mothers: not established.

Restylane Refyne Pharmacokinetics

See Literature

Restylane Refyne Interactions

Interactions

Caution with concomitant immunosuppressants. Increased bruising or bleeding at inj sites with concomitant aspirin, NSAIDs, warfarin.

Restylane Refyne Adverse Reactions

Adverse Reactions

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

Restylane Refyne Clinical Trials

See Literature

Restylane Refyne Note

Not Applicable

Restylane Refyne Patient Counseling

See Literature