Juvéderm Voluma XC Side Effects Center

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 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 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)

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)