Dosing & Uses
Dosage Forms & Strengths
gel dermal injection
Facial Wrinkles & Folds
Indicated for mid-to-deep dermal implantation for the correction of moderate-to-severe facial wrinkles and folds (eg, nasolabial folds)
Restylane: Not to exceed 6 mL per treatment; median dose is 3 mL
Juvederm Ultra Plus: 1.6 mL/treatment site; for repeat treatment 0.7 mL/treatment normally used; not to exceed 20 mL/60 kg body mass per year
- Restylane contains larger particles and is used for deeper wrinkles
- Juvederm Ultra Plus products are less viscous and indicated for finer lines
- For specific injection technique, see specific brand package insert
Lip Augmentation (Restylane Silk)
Indicated for submucosal implantation for lip augmentation
Restylane: Do not exceed 1.5 mL per lip (upper or lower) per treatment session
If >3 mL per treatment session is needed to achieve optimal correction, a follow-up session is recommended
Touch up retreatment: Mean volume is 0.7 mL (upper and lower lips combined)
Retreatment at 6 months: Mean volume is 1.5 mL (upper and lower lips combined)
Mid-Facial Volume Loss
Gel filler indicated to correct age-related volume loss in the midface (zygomaticomalar region, anteromedial cheek, and/or submalar region); results last up to 2 yr
Juvederm Voluma XC: Inject up to 12 mL between 2 sessions 1 month apart (ie, initial and touchup sessions)
Restylane Lyft: Inject up to 6 mL per treatment
Products also contains 0.3% lidocaine
Administration: Deep (dermal/subcutaneous and/or submuscular/supraperiosteal)
Skin discoloration (33-78%)
Intradermal formulation: History of anaphylaxis, or multiple severe allergies (Juvederm); bleeding disorders (Perlane, Restylane); history of hypersensitivity to gram-positive bacterial proteins (Juvederm), Perlane, Restylane) or lidocaine (Juvederm, UltraXC, Juvederm Ultra Plus XC)
Use in breast augmentation, and implantation into bone, tendon, ligament or muscle
Implantation into blood vessels due to risk of vascular occlusion, infarction or embolism
Defer use at sites with active inflammatory process or infection until inflammation is controlled
Hypersensitivity with swelling redness, tenderness, induration and rare acneform papules at injection site has been documented
Short term inflammatory symptoms beginning early, of less than 7 days duration at injection sites reported
Localized superficial necrosis may occur after injection in the glabellar area
Long-term safety and effectiveness beyond 1 year not evaluated
Safety during pregnancy, breast-feeding females or patients <18 years not established
Safety in patients at risk for keloid formation and hypertrophic scarring not studied
Use with caution in patients on immunosuppresive treatment
Remove synovial fluid or effusion if present prior to injection (intra-articular)
Do not use if syringe contents show signs of separation and/or appears cloudy (notify Medicis Aesthetics, Inc. at 1-866-222-1480)
Minimize exposure of treated skin to excessive sun/ UV lamp exposure, extreme cold weather, laser treatment, chemical peeling, etc. until initial swelling and redness resolved
- Rare, but serious, injuries may occur as a result of unintentional injection of a soft tissue filler into blood vessels in the face
- May result in restricted blood supply to tissues and lead to embolization, which could cause vision impairment, blindness, stroke, and damage and/or necrosis of the skin and underlying facial structures
Pregnancy & Lactation
Pregnancy Category: NA
Lactation: not known whether excreted in human milk/ not recommended
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Gel of hyaluronic acid (biological polysaccharide) generated by Streptococcus spp
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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.
|1||This drug is available at the lowest co-pay. Most commonly, these are generic drugs.|
|2||This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.|
|3||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.|
|NC||NOT COVERED – Drugs that are not covered by the plan.|
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