Hylaform

WARNINGS

  • Use of Hylaform gel at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present, should be deferred until the underlying process has been controlled.
  • The safety and efficacy of Hylaform gel for use in lip augmentation has not been established.
  • Injection procedure reaction to Hylaform gel has been observed as consisting mainly of short-term inflammatory symptoms starting early after treatment and with less than 7 days duration. Refer to the Clinical Studies section for details.

PRECAUTIONS

  • Hylaform gel is packaged for single patient use ready for use. Do not resterilize. Do not use if package is opened or damaged.
  • Based on preclinical studies, patients should be limited to 20 mL of Hylaform gel per 60 kg (130 lbs) body mass per year. The safety of injecting greater amounts has not been established.
  • The safety or effectiveness of Hylaform gel for the treatment of anatomic regions other than nasolabial folds has not been established in controlled clinical studies.
  • Long-term safety and effectiveness of Hylaform gel beyond one year have not been investigated in clinical trials.
  • As with all transcutaneous procedures, Hylaform gel implantation carries a risk of infection. Standard precautions associated with injectable materials should be followed.
  • The safety of Hylaform gel for use during pregnancy, in breastfeeding females or in patients under 18 years has not been established.
  • The safety of Hylaform gel in patients with increased susceptibility to keloid formation, hypertrophic scarring and pigmentation disorders has not been studied. Hylaform gel should not be used in patients with known susceptibility to keloid formation, hypertrophic scarring or pigmentation disorders. Genzyme is conducting a post approval study to determine the likelihood of keloid formation and pigmentation disorders in patients with Fitzpatrick Scale Skin types (V - VI receiving Hylaform injections
  • Hylaform gel should be used with caution in patients on immunosuppressive therapy.
  • Patients who are using substances that can prolong bleeding, such as aspirin, non-steroidal anti-inflammatory drugs and warfarin may, as with any injection, experience increased bruising or bleeding at injection sites.
  • After use, treatment syringes and needles may be potential biohazards. Handle accordingly and dispose of in accordance with accepted medical practice and applicable local, state and federal requirements.
  • Hylaform gel 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 INAMED Corporation at (800) 624-4261.
  • The patient should be informed that he or she should minimize exposure of the treated area to excessive sun and UV lamp exposure and extreme cold weather 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 Hylaform gel there is a possible risk of eliciting an inflammatory reaction at the implant site. This also applies if Hylaform gel is administered before the skin has healed completely after such a procedure.

Last reviewed on RxList: 7/11/2013
This monograph has been modified to include the generic and brand name in many instances.

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.