hyaluronic acid, non-animal stabilized (Rx)

Brand and Other Names:Restylane, Restylane-L, more...Juvederm Ultra, Juvederm Ultra Plus XC, Juvederm Ultra XC, Juvederm Voluma XC, Belotero Balance, Restylane Lyft, Restylane Silk, Restylane Refyne, Restylane Defyne, Juvederm Vollure XC, Juvederm Volbella XC
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

gel implantation (hyaluronic acid)

  • 20mg/mL (Restylane)

gel implantation (hyaluronic acid/lidocaine)

  • (15mg/mL)/0.3% (Juvederm Volbella XC)
  • (17.5mg/mL)/0.3% (Juvederm Vollure XC)
  • (20mg/mL)/0.3% (Restylane Contour, Restylane L, Restylane Lyft, Restylane Defyne, Restylane Refyne, Restylane Silk, Juvederm Voluma XC)
  • (22.5 mg/mL)/0.3% (Belotero Balance, Belotero Balance Plus)
  • (24mg/mL)0.3% (Juvederm Ultra XC, Juvederm Ultra Plus XC)

Note: Hyaluronic acid derived from bacterial source; some products may contain lidocaine

Facial Wrinkles and Folds

Indicated for mid-to-deep dermal implantation for the correction of moderate-to-severe facial wrinkles and folds (eg, nasolabial folds)

Belotero Balance, Belotero Balance Plus: Not to exceed 1.5 mL per treatment; not to exceed 6 mL/year

Restylane, Restylane-L: Not to exceed 6 mL per treatment; median dose is 3 mL

Restylane Lyft: Inject as required into deep dermis/superficial subcutis for cosmetic result; not to exceed 6 mL per treatment

Restylane Refyne: 1.5 mL/treatment site; for repeat treatment 1 mL/treatment site; not to exceed 6 mL

Restylane Defyne: 1.4 mL/treatment site; for repeat treatment 0.7 mL/treatment site; not to exceed 2 mL

Juvederm Ultra XC or Ultra Plus XC: 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

Juvederm Vollure XC: 1.7 mL/treatment site; for repeat treatment 1/3 of the volume per treatment site; not to exceed 20 mL/60 kg body mass per year

Correct to 100% of desired volume effect; do not overcorrect

Lip Augmentation

Indicated for lip augmentation and for correction of perioral rhytids

Restylane, Restylane-L, Restylane Silk

  • 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)

Restylane Kysse

  • Not to exceed 1.5 mL per lip (upper or lower) per treatment session
  • Optional treatment of perioral rhytids and philtral column may be performed; correct to 100% of desired volume effect (do not overcorrect)
  • Not to exceed 6 mL per treatment session (3 mL for lips, 3 mL for perioral area)

Juvederm

  • Vollabella XC: Usual dose: 2.6 mL/treatment site; for repeat treatment 1.6 mL/treatment normally used; not to exceed 20 mL/60 kg body mass per year
  • Ultra XC: 2.2 mL/treatment site; for repeat treatment 1.5 mL/treatment normally used; not to exceed 20 mL/60 kg body mass per year
  • Correct to 100% of desired volume effect; do not overcorrect

Cheek Augmentation

Indicated for cheek augmentation to correct age-related volume deficit in mid-face

Juvederm Voluma XC: Inject small boluses of 0.1-0.2 mL over a large area to reduce the risk of persistent lumping; an additional treatment may be needed to achieve the desired level of correction; not to exceed 20 mL/60 kg/year

Restylane Lyft: Inject up to 6 mL per treatment

Restylane Contour: Not to exceed 6 mL/treatment session or injected volume per subject and treatment (touch-up volume included) is 12 mL

Correct to 100% of desired volume effect; do not overcorrect

Administration: Deep (dermal/subcutaneous and/or submuscular/supraperiosteal)

Chin Augmentation

Indicated for augmentation of chin region to improve chin profile

Juvederm Voluma XC: Inject small boluses of 0.1-0.2 mL over a large area to reduce the risk of persistent lumping; an additional treatment may be needed to achieve the desired level of correction; not to exceed 20 mL/60 kg/year

Restylane Defyne: 2.6 mL/treatment site; for touch-up treatment 1.4 mL/treatment site; usual retreatment volume is 2.1 mL

Correct to 100% of desired volume effect; do not overcorrect

Administration: Deep (dermal/subcutaneous and/or submuscular/supraperiosteal)

Back of Hands Volume Loss

Indicated for injection into the subcutaneous plane in the dorsal hand to correct volume deficit in patients aged >21 yr

Restylane Lyft: Inject up to 3 mL per hand

If >3 mL per treatment session is needed to achieve optimal correction, a follow-up session is recommended

Using supplied needles, inject in small bolus or use the linear retrograde injection technique to deposit small volumes; avoid rapid flow or rapid injection

Infraorbital Hollowing

Juvederm Vollabella XC

Indicated for improvement of infraorbital hollowing

Usual dose: 1 mL/treatment site; for repeat treatment 0.4 mL/treatment normally used; not to exceed 20 mL/60 kg body mass per year

Injection >2.2 mL per infraorbital hollow has not been studied

Correct to 100% of desired volume effect; do not overcorrect

Degree and duration of correction depend on character of defect treated, tissue stress at the implant site, depth of implant in the tissue, and injection technique

Markedly indurated defects may be difficult to correct

Dosing Considerations

Before treatment

  • Obtain patient’s medical history
  • Educate patient on indications, contraindications, warnings, precautions, treatment responses, adverse reactions, and method of administration
  • Inform patients that supplemental touch-up treatments may be required to achieve and maintain maximum correction
  • Before and after treatment, conduct vision assessments (eg, visual acuity, extraocular motility, and visual field testing)

Safety not established

  • Use during pregnancy, in breastfeeding females, patients <22 years (Juvederm, Restylane Lyft), or patients <18 years (Restylane)
  • Patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders
  • Juvederm Vollabella XC: Safety and effectiveness for anatomic regions other than lips, perioral area, and infraorbital hollows have not been established

Not established

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Adverse Effects

>10%

Juvederm (all formulations)

  • Firmness (33.3-89%)
  • Swelling (41.7-83%)
  • Tenderness to touch (47.7-81%)
  • Redness (34.8-81%)
  • Bruising (40.2-78%)
  • Lumps/ bumps (38.6-75%)
  • Discoloration (18.9-78%)
  • Pain after injection (33.3-47%)
  • Itching (11.4-33%)

Restylane (all formulations)

  • Swelling (89.4%)
  • Tenderness (86.6%)
  • Redness (80.3%)
  • Bruising (78.2%)
  • Pain (8-76.1%)
  • Itching (47.2%)
  • Contusion (44%)
  • Lip swelling (43%)

Belotero Balance (all formulations)

  • Swelling (68.7%)
  • Bruising (54.5%)
  • Erythema (51.7%)
  • Induration (50.7%)
  • Pain (48.8%)
  • Nodule (43.6%)
  • Discoloration (28.9%)
  • Pruritus (21.8%)

1-10%

Restylane (all formulations)

  • Lip pain (10%)
  • Lip disorder (5%)
  • Headache (5%)
  • Other (2.1%)

Postmarketing events

Restylane (all formulations)

  • Mass formation/induration
  • Pain/tenderness
  • Papules/nodules
  • Erythema
  • Inflammation
  • Short duration of effect
  • Presumptive bacterial infections and abscess formation
  • Bruising/hematoma
  • Ischemia and necrosis including pallor, due to unintentional intravascular injection or embolization
  • Injection site reactions including warmth, burning sensation and exfoliation
  • Hypersensitivity/angioedema
  • Neurological symptoms including hypoaesthesia and paraesthesia
  • Granuloma/foreign body reaction
  • Device dislocation
  • Deformity/asymmetry
  • Discoloration
  • Eye disorders including eye pain and eyelid oedema
  • Symptoms of reactivation of herpes infection
  • Pruritus
  • Blisters/vesicles
  • Rash
  • Atrophy/scarring
  • Acne
  • Dermatitis
  • Encapsulation
  • Extrusion of device
  • Urticaria
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Warnings

Contraindications

Severe allergies manifested by history of anaphylaxis or history or presence of multiple severe allergies

Hypersensitivity to gram-positive bacteria proteins or lidocaine

Bleeding disorders

Restylane, Restylane-L, Restylane Defyne, Restylane Refyne: Implantation in anatomical spaces other than dermis or submucosal implantation for lip augmentation

Cautions

Defer use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present until underlying process has been controlled

Injection-site reactions consist mainly of short-term inflammatory symptoms starting early after treatment and lasting ≤ 30 days

Use with caution in patients on immunosuppressive therapy

Risk of embolization

  • Introduction injectable gel into vasculature may lead to embolization, occlusion of vessels, ischemia, or infarction
  • Rare, but serious, adverse events associated with intravascular injection of soft-tissue fillers in face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia, or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures
  • Immediately stop injection if symptoms (eg, vision changes, signs of a stroke, blanching of skin, unusual pain during or shortly after the procedure) occur
  • Promptly evaluate and treat appropriately

Belotero Balance only

  • Patients with a history of previous herpetic eruption may be associated with reactivation of the herpes
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Pregnancy & Lactation

Pregnancy

Safety and efficacy not established

Lactation

Safety and efficacy not established

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.

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Pharmacology

Mechanism of Action

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

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Administration

Implantation Administration

Single-patient use only; do not resterilize; discard if package is open or damaged

Refer to prescribing information for specific administration instructions

Use supplementary anesthesia for additional pain management during and after injection.

After ensuring that treatment area was thoroughly washed with soap and water, swab area with alcohol or other antiseptic; before injecting, depress plunger rod until product flows out of the needle

After insertion of the needle, and just before injection, retract plunger rod to slightly aspirate and verify needle is not intravascular

After first small amount of material has been injected into patient, wait a full 3 seconds to allow lidocaine to take effect before proceeding with rest of injection

Injection technique may vary with regard to angle and orientation of the needle bevel, injection depth, and quantity administered; injecting too superficially may result in visible lumps and/or discoloration

Inject by applying slow and even pressure on the plunger rod; stop injection before needle is pulled out of skin to prevent material from leaking out or being placed too superficially in the skin

If needle is blocked, do not increase the pressure on the plunger; stop injection and replace needle

Advise patients within the first 24 hours to avoid strenuous exercise, extensive sun or heat exposure, and alcoholic beverages

If treated area is swollen, apply an ice pack to site for a short period

To report an adverse reaction, phone the Allergan product support department at 1-877-345-5372

Storage

Restylane or Juvederm (All formulations)

  • Store at room temperature (up to 25ºC [77ºF]); use prior to expiration date printed on label
  • Do NOT freeze; protect from light

Belotero Balance

  • Store at room temperature (up to 30ºC [86ºF]); use prior to expiration date printed on label
  • Do NOT freeze; protect from light
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Images

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Patient Handout

A Patient Handout is not currently available for this monograph.
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Formulary

FormularyPatient Discounts

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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.

Tier Description
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.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.