Pronunciation: KAL-see-um hye-DROX-ee-la-pa-tite
Class: Physical adjunct
- Implant, subcutaneous 0.25 mg
Calcium hydroxyapatite stimulates the body to produce new collagen, correcting facial wrinkles.
Indications and Usage
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.
Dosage and AdministrationNasolabial fold
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 lipoatrophy
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.
- Administer with a 25- to 27-gauge needle with Luer lock fittings.
- Twist the calcium hydroxylapatite syringe onto the Luer lock fitting of the needle and prime the needle with the product.
- Avoid passing the injection needle through scar tissue and cartilage.
- Apply slow continuous even pressure to the syringe plunger to inject the implant as the needle is withdrawn.
- Product is for single patient use. Do not resterilize.
Store at 59° to 90°F.
Drug InteractionsMedications that prolong bleeding (eg, aspirin, warfarin)
Risk of bruising or bleeding at the injection site may be increased.
Laboratory Test Interactions
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.
Inflammation or infection
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.
- Inform patient to minimize exposure of the treatment area to extensive sun or heat exposure for approximately 24 h after treatment or until any swelling and redness have resolved.
Copyright © 2009 Wolters Kluwer Health.