"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"...
- Use of RADIESSE injectable implant in any person with active skin inflammation or infection in or near the treatment area should be deferred until the inflammatory or infectious process has been controlled.
- Injection procedure reactions have been observed consisting mainly of short-term (i.e., < 7 days) bruising, redness and swelling. Refer to adverse events sections for details.
- Special care should be taken to avoid injection into the blood vessels. An introduction into the vasculature may occlude the vessels and could cause infarction or embolism leading to ischemia, necrosis or scarring. This has been reported to occur in the lips, nose, glabellar or ocular area.
- Do not overcorrect (overfill) a contour deficiency because the depression should gradually improve within several weeks as the treatment effect of RADIESSE injectable implant occurs.
- The safety and effectiveness for use in the lips has not been established. There have been published reports of nodules associated with the use of RADIESSE injectable implant injected into the lips.
- The calcium hydroxylapatite (CaHA) particles of RADIESSE injectable implant are radiopaque and are clearly visible on CT Scans and may be visible in standard, plain radiography. Patients need to be informed of the radiopaque nature of RADIESSE injectable implant, so that they can inform their primary care health professionals as well as radiologists. In a radiographic study of 58 patients, there was no indication of RADIESSE injectable implant potentially masking abnormal tissues or being interpreted as tumors in CT Scans.
- Only health care providers with expertise in the correction of volume deficiencies in patients with human immunodeficiency virus should treat such patients with RADIESSE injectable implant after fully familiarizing themselves with the product, the product educational materials and the entire package insert.
- Packaged for single patient use. Do not resterilize. Do not use if package is opened or damaged. Do not use if the syringe end cap or syringe plunger is not in place.
- Safety of RADIESSE injectable implant beyond 3 years has not been investigated in clinical trials.
- The safety of RADIESSE injectable implant in patients with increased susceptibility to keloid formation and hypertrophic scarring has not been studied.
- As with all transcutaneous procedures, RADIESSE injectable implant injection carries a risk of infection. Standard precautions associated with injectable materials should be followed.
- Safety of RADIESSE injectable implant for use during pregnancy, in breastfeeding females or in patients under 18 years has not been established.
- Patients who are using medications that can prolong bleeding, such as aspirin or warfarin, may, as with any injection, experience increased bruising or bleeding at the injection site.
- Universal precautions must be observed when there is a potential for contact with patient body fluids. The injection session must be conducted with aseptic technique.
- 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.
- The patient should be informed that he or she should minimize exposure of the treated area to extensive sun or heat exposure for approximately 24 hours after treatment or until any initial swelling and redness has resolved.
- Safety and effectiveness in the periorbital area has not been established.
- No studies of interactions of RADIESSE injectable implant with drugs or other substances or implants have been conducted.
- The safety of RADIESSE injectable implant with concomitant dermal therapies such as epilation, UV irradiation, or laser, mechanical or chemical peeling procedures has not been evaluated in controlled clinical trials.
- If laser treatment, chemical peeling, or any other procedure based on active dermal response is considered after treatment with RADIESSE injectable implant, there is a possible risk of eliciting an inflammatory reaction at the implant site. This also applies if RADIESSE injectable implant is administered before the skin has healed completely after such a procedure.
- To help avoid needle breakage, do not attempt to straighten a bent needle. Discard it and complete the procedure with a replacement needle.
- Do not reshield used needles. Recapping by hand is a hazardous practice and should be avoided.
- Injection of RADIESSE injectable implant into patients with a history of previous herpetic eruption may be associated with reactivation of the herpes.
Patient Counseling Information
Refer to RADIESSE injectable implant PATIENT INFORMATION Guide.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 7/8/2013
Additional Radiesse Information
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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.
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