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Juvéderm Voluma XC

Last reviewed on RxList: 2/20/2019
Juvéderm Voluma XC Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 2/20/2019

Juvéderm Voluma XC (hyaluronic acid) Injectable Gel is a dermal filler that contains a small quantity of local anesthetic (lidocaine) indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face in adults over the age of 21. Common side effects of Juvéderm Voluma XC include injection site reactions such as:

  • tenderness,
  • swelling,
  • firmness,
  • lumps/bumps,
  • bruising, pain,
  • redness,
  • discoloration, and
  • itching

The amount of Juvéderm Voluma XC injectable gel used to achieve optimal outcomes ranges from 1.2 mL to 13.9 mL, with a median volume of 6.6 mL. Juvéderm Voluma XC may interact with immunosuppressive therapy or substances that can prolong bleeding, such as aspirin, ibuprofen, or other blood thinners. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Juvéderm Voluma XC; it is unknown how it would affect a fetus. Consult your doctor before breastfeeding.

Our Juvéderm Voluma XC (hyaluronic acid) Injectable Gel Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Juvéderm Voluma XC Professional Information

SIDE EFFECTS

Adverse Events

Clinical Evaluation Of JUVEDERM VOLUMA™ XC

In the randomized, controlled clinical trial to evaluate the safety and effectiveness of JUVEDERM VOLUMA™ XC, there were 238 subjects treated with JUVEDERM VOLUMA™ XC in the mid-face (zygomaticomalar region, anteromedial cheek, and/or submalar region, see Figure 1) during the primary phase of the study. Touch-up treatments occurred approximately 30 days after initial injection. After the 6-month blinded “no treatment” control period, control subjects were allowed to receive treatment; 32 control subjects were treated in the study. Preprinted diary forms were used by subjects after treatment to record specific signs and symptoms experienced during each of the first 30 days after initial, touch-up, and repeat treatments in each region of the mid-face. Of the 270 subjects who underwent treatment (from both the treatment and control groups), 265 completed the diary forms. A subset of subjects has also undergone repeat treatment following completion of the extended follow-up phase of the study, with 120 subjects completing diary forms after repeat treatment. Subjects were instructed to rate each treatment site response listed on the diary as “Mild (barely noticeable),” “Moderate (uncomfortable),” “Severe (severe discomfort),” or “None.”

After initial treatment with JUVEDERM VOLUMA™ XC, 98% of subjects reported experiencing a local treatment site response. Subjects rated treatment site responses as predominantly mild (21.5%) or moderate (59.2%) in severity with a duration of 2 to 4 weeks. For those treatment site responses evaluated as moderate or severe, the median duration as moderate or severe was 2 days, and the median time to complete resolution was 6 days. Based on available data from 120 subjects, the severity of CTRs following repeat treatment is similar, with a reduced incidence and duration compared to initial treatment.

Treatment site responses reported by > 5% of subjects after initial treatments are summarized by severity in Table 1 and by duration in Table 2.

Table 1: Treatment Site Responses by Maximum Severity Occurring in > 5% of Subjects After Initial Treatment (N = 265)

Treatment Site Response Total % (n/Nb) Severitya
Mild % (n/N) Moderate % (n/N) Severe % (n/N)
Any Treatment Site Response 98.1% (260/265) 21.5% (56/260) 59.2% (154/260) 19.2% (50/260)
Tenderness 92.1% (244/265) 46.3% (113/244) 50.0% (122/244) 3.7% (9/244)
Swelling 85.7% (227/265) 46.7% (106/227) 43.6% (99/227) 9.7% (22/227)
Firmness 82.3% (218/265) 37.6% (82/218) 54.6% (119/218) 7.8% (17/218)
Lumps/Bumps 81.1% (215/265) 41.4% (89/215) 48.8% (105/215) 9.8% (21/215)
Bruising 77.7% (206/265) 37.4% (77/206) 51.5% (106/206) 11.2% (23/206)
Pain 66.4% (176/265) 59.1% (104/176) 38.6% (68/176) 2.3% (4/176)
Redness 66.0% (175/265) 60.0% (105/175) 36.0% (63/175) 4.0% (7/175)
Discoloration 41.1% (109/265) 62.4% (68/109) 27.5% (30/109) 10.1% (11/109)
Itching 38.5% (102/265) 70.6% (72/102) 18.6% (19/102) 10.8% (11/102)
a Maximum severity reported in the diary. The denominator for percentages by severity is the number of subjects with the corresponding treatment site response.
b N denotes number of subjects who recorded responses in the diaries after the initial treatment.

Treatment site responses reported by ≤ 5% of subjects included ache, acne, bulge, bumps, cheek larger upon waking up, dry patch, fine wrinkles, injection/needle marks, numbness, pigmentation from treatment, puffiness, rash, scratch near injection point, soreness, tightness, and yellowness.

Table 2: Duration of Treatment Site Responses After Initial Treatment (N = 265)

Treatment Site Response Total% (n/Nb) Durationa
1-3 Days % (n/N) 4-7 Days % (n/N) 8-14 Days % (n/N) 15-30 Days % (n/N) >30 Days % (n/N)
Any Treatment Site Response 98.1% (260/265) 8.1% (21/260) 22.7% (59/260) 24.6% (64/260) 24.6% (64/260) 20.0% (52/260)
Tenderness 92.1% (244/265) 29.9% (73/244) 30.7% (75/244) 27.9% (68/244) 8.6% (21/244) 2.9% (7/244)
Swelling 85.7% (227/265) 41.0% (93/227) 33.0% (75/227) 17.6% (40/227) 5.3% (12/227) 3.1% (7/227)
Firmness 82.3% (218/265) 26.6% (58/218) 29.8% (65/218) 20.2% (44/218) 11.0% (24/218) 12.4% (27/218)
Lumps/Bumps 81.1% (215/265) 21.4% (46/215) 22.3% (48/215) 22.3% (48/215) 18.1% (39/215) 15.8% (34/215)
Bruising 77.7% (206/265) 24.8% (51/206) 30.6% (63/206) 29.6% (61/206) 14.6% (30/206) 0.5% (1/206)
Pain 66.4% (176/265) 56.3% (99/176) 31.3% (55/176) 9.7% (17/176) 2.8% (5/176) 0% (0/176)
Redness 66.0% (175/265) 59.4% (104/175) 28.0% (49/175) 8.6% (15/175) 2.3% (4/175) 1.7% (3/175)
Discoloration 41.1% (109/265) 64.2% (70/109) 19.3% (21/109) 6.4% (7/109) 5.5% (6/109) 4.6% (5/109)
Itching 38.5% (102/265) 81.4% (83/102) 16.7% (17/102) 2.0% (2/102) 0% (0/102) 0% (0/102)
a Maximum duration reported in the diary. The denominator for percentages by duration is the number of subjects with the corresponding treatment site response.
b N denotes number of subjects who recorded responses in the diaries after the initial treatment.

Treatment site responses reported in subject diaries that lasted longer than 30 days were considered adverse events (AEs). AEs were also reported by the Treating Investigator at all follow-up visits where applicable. Table 3 summarizes device- and injection-related AEs that occurred with a frequency of > 1%. These adverse events were seen more frequently in subjects that received injection volumes greater than 9 mL, and in older subjects (> 60 years). Rarely, adverse events occurred weeks to months after the injection procedure.

Among the 270 treated subjects, 32.6% (88/270) experienced device- and injection-related AEs following initial and touch-up treatment, 99% (624/627) of which were reported at a treatment site. The treatment site AEs were evenly divided across the 3 mid-facial regions. Information on AEs following repeat treatment is being collected as part of the post-approval study.

Table 3: Device- and Injection-Related Adverse Events Reported by Treating Investigator and Subjects Occurring in > 1% of Treated Subjects (N = 270)

Adverse Event Treated Subjects % (n/N)
Treatment site mass 18.9% (51/270)
Treatment site induration 14.1% (38/270)
Treatment site swelling 7.0% (19/270)
Treatment site pain 5.9% (16/270)
Treatment site hematoma 3.7% (10/270)
Treatment site discoloration 2.2% (6/270)
Treatment site erythema 1.9% (5/270)
Treatment site reaction 1.5% (4/270)

Device- and injection related adverse events occurring in ≤ 1% of subjects included injection site hypertrophy (0.7%), nodule (0.7%), inflammation (0.4%), injection site anesthesia (0.4%), injection site dryness (0.4%), injection site erosion (0.4%), mass (0.4%), contusion (0.4%) and syncope (0.4%).

Two subjects (0.7%; 2/270) reported 3 serious adverse events (SAEs) that were considered to be related to the device. Approximately 6 months after treatment, after being scratched near the treated area by a tree branch, one subject experienced inflammation under the left eye. The subject also experienced nodularity in the right cheek approximately 7 months after treatment. The second subject experienced lumps in the cheeks approximately 7 months after treatment. A couple of days before the onset, the subject experienced myofascial pain and body aches. Treatment of the SAEs included topical steroids, oral antibiotics, intralesional steroids, anti-inflammatory medication, and hyaluronidase. All events resolved.

Other Safety Data

Post-Market Surveillance

JUVEDERM VOLUMA™ without lidocaine has been marketed outside the US since 2005, and JUVEDERM VOLUMA™ with lidocaine has been marketed outside the US since 2009.

As of December 31, 2012, the following AEs were received from post-market surveillance for JUVEDERM VOLUMA™ with and without lidocaine with a frequency ≥ 5 and were not observed in the clinical study; this includes reports received globally from all sources including scientific journals and voluntary reports. All AEs obtained through post-market surveillance are listed in order of number of reports received: inflammatory reaction, lack of correction, infection, migration, granuloma, allergic reaction, abscess, necrosis, numbness, and vision abnormalities.

Reported treatments include: antibiotics, steroids, hyaluronidase, anti-inflammatories, antihistamines, aspiration, radio frequency therapy, laser treatment, ice, massage, warm compress, analgesics, anti-viral, ultrasound, excision, drainage, and surgery.

Vision abnormalities have been reported following injection of JUVEDERM VOLUMA™, with and without lidocaine, into the nose, glabella, periorbital area, and/or cheek, with a time to onset ranging from immediate to 1 week following injection. Reported treatments include anticoagulant, steroid treatment and surgery. Outcomes ranged from resolved to ongoing at the time of last contact. Events requiring medical intervention, and events where resolution information is not available, were reported after injection of JUVEDERM VOLUMA™ with and without lidocaine in the highly vascularized areas of the glabella, nose, and periorbital area, which are outside the device indications for use (see WARNINGS section).

Read the entire FDA prescribing information for Juvéderm Voluma XC (Hyaluronic Acid Injectable Gel Dermal Filler)

Related Resources for Juvéderm Voluma XC

© Juvéderm Voluma XC Patient Information is supplied by Cerner Multum, Inc. and Juvéderm Voluma XC Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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