Calcium Hydroxylapatite

Pronunciation: KAL-see-um hye-DROX-ee-la-pa-tite
Class: Physical adjunct

Trade Names

Radiesse
- Implant, subcutaneous 0.25 mg

Pharmacology

Calcium hydroxyapatite stimulates the body to produce new collagen, correcting facial wrinkles.

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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.

Contraindications

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 Administration

Nasolabial fold
Adults

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
Adults

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.

General Advice

  • 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  • Apply slow continuous even pressure to the syringe plunger to inject the implant as the needle is withdrawn.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.

Storage/Stability

Store at 59° to 90°F.

Drug Interactions

Medications that prolong bleeding (eg, aspirin, warfarin)

Risk of bruising or bleeding at the injection site may be increased.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Dermatologic

Erythema (67%); pruritus (47%).

Hematologic-Lymphatic

Ecchymosis (63%).

Miscellaneous

Edema (69%); pain (55%).

Precautions

Pregnancy

Undetermined.

Lactation

Undetermined.

Children

Safety and efficacy not established.

CT scans

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.

Injection

Avoid injection into blood vessels, which may occlude the vessel and cause infarction or embolism.

Injection site

Safety and efficacy for use in the lips or periorbital areas have not been established. Nodules have been reported.

Overcorrection

A contour deficiency should not be overcorrected/overfilled because the depression should gradually improve over several weeks.

Treatment duration

Safety and efficacy of use beyond 1 year has not been established.

Patient Information

  • 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.

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