Juvederm Voluma Xc

— THERAPEUTIC CATEGORIES —
  • Aesthetic medicine

Juvederm Voluma Xc Generic Name & Formulations

General Description

Hyaluronic acid 20mg/mL, 0.3% w/w lidocaine; injectable gel implant.

Pharmacological Class

Dermal filler.

How Supplied

Single-use syringe—1 (w. needles)

Manufacturer

Generic Availability

NO

Juvederm Voluma Xc Indications

Indications

Cheek augmentation to correct age-related mid-face volume deficit. Chin augmentation to improve the chin profile. Augmentation of the temple region to improve moderate to severe temple hollowing.

Juvederm Voluma Xc Dosage and Administration

Adult

See full labeling. Inject slowly with least amount of pressure necessary. Wait 3 secs after injecting first small amount before proceeding with rest of the inj. May use supplementary anesthesia during and post-inj. >21yrs: Individualize. Cheek or chin augmentation: give as small boluses (0.1–0.2mL) by deep inj (subcutaneous and/or supraperiosteal). Temple  region augmentation: give as boluses (up to max 3 per side during a single visit) by supraperiosteal inj. All max limit: 20mL/60kg per year. May require touch-up treatments to achieve desired effect.

Children

Not established.

Juvederm Voluma Xc Contraindications

Contraindications

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

Juvederm Voluma Xc Boxed Warnings

Not Applicable

Juvederm Voluma Xc 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 occur. Risk of infection. Defer if active inflammatory process or infection is present at specific sites. Use in non-mid-face areas: not established. Skin injury near treatment site. Known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders: not studied. Advise patients to avoid strenuous exercise, extensive sun or heat exposure within first 24hrs. Pregnancy, nursing mothers, patients with very thin skin in the mid-face region, cannula inj for cheek augmentation (in those with Fitzpatrick Skin Types V and VI), cannula inj to improve temple hollowing: not established. 

Juvederm Voluma Xc Pharmacokinetics

See Literature

Juvederm Voluma Xc Interactions

Interactions

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

Juvederm Voluma Xc Adverse Reactions

Adverse Reactions

Inj site reactions (eg, tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, itching); rare: vision impairment, blindness, cerebral ischemia/hemorrhage, stroke, skin necrosis, facial structure damage, late-onset nodules.

Juvederm Voluma Xc Clinical Trials

See Literature

Juvederm Voluma Xc Note

Not Applicable

Juvederm Voluma Xc Patient Counseling

See Literature