July 23, 2016
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"The US Food and Drug Administration (FDA) has approved Juvederm Ultra XC (Allergan) for injection into the lips and perioral area for lip augmentation in adults older than 21 years, the company announced today. It is a new indication for t"...





  • Defer use of Restylane at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present until the process has been controlled.
  • Injection site reactions (e.g., swelling, redness, tenderness, or pain) to Restylane have been observed as consisting mainly of short-term minor or moderate inflammatory symptoms starting early after treatment and with less than 7 days duration in the nasolabial folds and less than 14 days duration in the lips. Rare post-market reports of immediate post-injection reactions included extreme swelling of lips, the whole face and symptoms of hypersensitivity such as anaphylactic shock.
  • Restylane must not be implanted into blood vessels. Localized superficial necrosis and scarring may occur after injection in or near vessels, such as in the lips, nose, or glabellar area. It is thought to result from the injury, obstruction, or compromise of blood vessels.
  • Delayed onset inflammatory papules have been reported following the use of dermal fillers. Inflammatory papules that may occur rarely should be considered and treated as a soft tissue infection.
  • Injections of greater than 1.5 mL per lip (upper or lower) per treatment session significantly increases the occurrence of the total of moderate and severe injection site reactions. If a volume of more than 3 mL is needed to achieve optimal correction, a follow-up treatment session is recommended.
  • In a meta-analysis of all Restylane Premarket Approval Studies (that included 42 patients under the age of 36 and 820 patients over the age of 35), the incidence of swelling was higher in younger patients (28%) compared to older patients (18%) and incidence of contusion was higher in older patients (28%) compared to younger patients (14%). The majority of these events were mild in severity.


  • Restylane is packaged for single patient use. Do not resterilize. Do not use if package is opened or damaged.
  • Based on U.S. clinical studies, patients should be limited to 6.0 mL per patient per treatment in wrinkles and folds such as the nasolabial folds and to 1.5 mL per lip per treatment. The safety of injecting greater amounts has not been established.
  • The safety or effectiveness of Restylane for the treatment of anatomic regions other than nasolabial folds or lips has not been established in controlled clinical studies.
  • The safety and efficacy of Restylane for lip augmentation has not been established in patients under the age of 21 years.
  • As with all transcutaneous procedures, Restylane implantation carries a risk of infection. Standard precautions associated with injectable materials should be followed.
  • The safety of Restylane for use during pregnancy, in breastfeeding females or in patients under 18 years has not been established.
  • Formation of keloids may occur after dermal filler injections including Restylane. Keloid formation was not observed in studies involving 430 patients (including 151 African-Americans and 37 other patients of Fitzpatrick Skin Types IV, V and VI). For additional information please refer to Studies MA-1400-02, MA-1400-01, and 31GE0003 in the Clinical Trials Section.
  • Restylane injection may cause hyperpigmentation at the injection site. In a clinical study of 150 subjects with pigmented skin (of African- American heritage and Fitzpatrick Skin Types IV, V, and VI), the incidence of post-inflammatory hyperpigmentation was 9% (14/150). 50% of these events lasted up to six weeks after initial implantation.
  • The safety profile for Restylane lip augmentation in persons of color is based upon information from 38 and 3 subjects with Fitzpatrick Skin Types IV and V, respectively. Within this population, the incidence of adverse events was similar to the overall study population, with the exception that swelling occurred more frequently in persons of color.
  • Restylane should be used with caution in patients on immunosuppressive therapy.
  • Bruising or bleeding may occur at Restylane injection sites. Restylane should be used with caution in patients who have undergone therapy with thrombolytics, anticoagulants, or inhibitors of platelet aggregation in the preceding 3 weeks.
  • After use, syringes and needles should be handled as potential biohazards. Disposal should be in accordance with accepted medical practice and applicable local, state and federal requirements.
  • The safety of Restylane with concomitant dermal therapies such as epilation, UV irradiation, or laser, mechanical or chemical peeling procedures has not been evaluated in controlled clinical trials.
  • Patients should minimize exposure of the treated area to excessive sun, UV lamp exposure and extreme cold weather at least until any initial swelling and redness has resolved.
  • If laser treatment, chemical peeling or any other procedure based on active dermal response is considered after treatment with Restylane, there is a possible risk of eliciting an inflammatory reaction at the implant site. This also applies if Restylane is administered before the skin has healed completely after such a procedure.
  • Injection of Restylane into patients with a history of previous herpetic eruption may be associated with reactivation of the herpes.
  • Restylane is a clear, colorless gel without particulates. In the event that the content of a syringe shows signs of separation and/or appears cloudy, do not use the syringe and notify Galderma Laboratories, L.P. at 1-855-425-8722. Glass is subject to breakage under a variety of unavoidable conditions. Care should be taken with the handling of the glass syringe and with disposing of broken glass to avoid laceration or other injury.
  • Restylane should not be mixed with other products before implantation of the device.
This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 3/28/2016


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