Trade Names:Radiesse- Implant, subcutaneous 0.25 mg
Calcium hydroxyapatite stimulates the body to produce new collagen, correcting facial wrinkles.
Subdermal implant for the correction of moderate to severe facial wrinkles and folds (eg, nasolabial folds); restoration and/or correction of signs of facial fat loss in patients with HIV.
Known susceptibility to keloid formation or hypertrophic scarring; severe allergies manifested by a history of anaphylaxis or history of multiple severe allergies; hypersensitivity to any component of the product.
Subdermal Individualize dosage depending on the site and extent of the restoration or augmentation desired. Based on clinical data, the minimum dose was 0.3 mL, and the max dose was 2.7 mL (mean, 1.2 mL). Patients received up to 3 injections during the initial treatment phase (weeks 0, 2, and 4). Two wk after each treatment, the level of correction was assessed and if correction was less than optimal, patients were re-treated using the same treatment materials as in the initial treatment.HIV-associated facial lipoatrophyAdults
Subdermal Individualize dosage depending on the site and extent of the restoration or augmentation desired. Based on clinical data, the mean initial treatment volumes were 4.8 mL for the initial treatment and 1.8 mL at 1 mo if necessary. At 6 mo, the mean touch-up volume was 2.4 mL. During the study, no patient received more than 3 treatments.
Store at 59° to 90°F.
Risk of bruising or bleeding at the injection site may be increased.
None well documented.
Erythema (67%); pruritus (47%).
Edema (69%); pain (55%).
Safety and efficacy not established.
Because the particles of the product are radiopaque, they are clearly visible in standard, plain radiography and CT scans.
Defer treatment in patients with skin inflammation or infection until process has been controlled.
Avoid injection into blood vessels, which may occlude the vessel and cause infarction or embolism.
Safety and efficacy for use in the lips or periorbital areas have not been established. Nodules have been reported.
A contour deficiency should not be overcorrected/overfilled because the depression should gradually improve over several weeks.
Safety and efficacy of use beyond 1 year has not been established.
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