Restylane Refyne Generic Name & Formulations
Legal Class
PP
General Description
Hyaluronic acid 20mg/mL, lidocaine 3mg/mL; injectable gel implant.
Pharmacological Class
Hyaluronan.
How Supplied
Single-use syringe—1 (w. needles)
Manufacturer
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