hyaluronic acid, non-animal stabilized (Restylane, Restylane-L, Juvederm Ultra, Juvederm Ultra Plus XC, Juvederm Ultra XC, Juvederm Voluma XC, Perlane, Belotero Balance, Restylane Lyft, Restylane Silk)

Dosing and uses of Restylane, Restylane-L (hyaluronic acid, non-animal stabilized)

• Adult
• Pediatric

 

Adult dosage forms and strengths

gel dermal injection

• 20mg/mL
• 24mg/mL

 

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

Product selection

• 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)

 

Pediatric dosage forms and strengths

Not established

 

Restylane, Restylane-L (hyaluronic acid, non-animal stabilized) adverse (side) effects

>10%

Swelling (81-90%)

Redness (81-90%)

Tenderness (61-92%)

Firmness (86-89%)

Bruising (52-87%)

Lumps/bumps (56-83%)

Skin discoloration (33-78%)

Pruritus (25-36%)

Pain (51-60%)

Itching (31-40%)

 

1-10%

Fatigue (1%)

Nausea (<2%)

 

<1%

Allergic reaction

Angioedema

Vasovagal reaction

Peripheral edema

Herpetic eruptions

Rash

Effusion

 

Warnings

Contraindications

Hypersensitivity

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

 

Cautions

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

Embolization

• 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 and lactation

Pregnancy category: NA

Lactation: not known whether excreted in human milk/ not recommended

 

Pregnancy categories

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.

 

Pharmacology of Restylane, Restylane-L (hyaluronic acid, non-animal stabilized)

Mechanism of action

Gel of hyaluronic acid (biological polysaccharide) generated by Streptococcus spp