Dosing and uses of Radiesse (calcium hydroxylapatite)
Adult dosage forms and strengths
subdermal geL
- 0.8mL
- 1.5mL
Facial Wrinkles and Folds
Indicated for subdermal implantation for the correction of moderate-to-severe facial wrinkles and folds (eg, nasolabial folds)
Amount injected varies depending on the site and extent of restoration/augmentation desired
See Administration section; also see prescribing information for complete instructions and injection technique
Facial Fat Loss
Indicated for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with HIV
Amount injected varies depending on the site and extent of restoration/augmentation desired
See Administration section; also see prescribing information for complete instructions and injection technique
Hand Augmentation
Indicated for hand augmentation to correct volume loss in the dorsum of the hands
Inject using small boluses, 0.2-0.5 mL/bolus; not to exceed 0.5 mL/bolus
See Administration section; also see prescribing information for complete instructions and injection technique
Pediatric dosage forms and strengths
Safety and efficacy not established
Radiesse (calcium hydroxylapatite) adverse (side) effects
>10%
Edema (69.2%)
Erythema (66.7%)
Ecchymosis (63.2%)
Soreness, numbness, contour irregularity, tenderness, irritation (29.9%)
Pain (28.2%)
Pruritus (18%)
Hand augmentation
- Swelling (20.4%)
- Bruising (18.6%)
- Other (vagal response, dry skin, hypersensitivity, needle pricks) (11%)
1-10% (Hand Augmentation)
Redness (8%)
Pain (6.2%)
Nodule, bumps/lumps (6.2%)
Itching (3.5%)
Difficulty performing activities (1.8%)
<1%
Nodule (0.9%)
Warnings
Contraindications
Severe allergies manifested by history of anaphylaxis, or history or presence of multiple severe allergies
Known hyposensitivity to any of the components
Bleeding disorders
Cautions
Defer treatment with active skin inflammation or infection in or near treatment area
Injection reactions observed (eg, bruising, redness, swelling)
Avoid injection into blood vessels; may cause occlusion and lead to infarction or embolism
Do not overcorrect (overfill) a contour deficiency; the depression should gradually improve within several weeks
Safety and efficacy not established for use in the lips; reports of nodules associated when injected into the lips
Calcium hydroxylapatite particles are radiopaque and are clearly visible on CT Scans and may be visible in standard, plain radiography
Patients on anticoagulants or antiplatelets may experience increased bruising or bleeding at injection site
Instruct patient to minimize exposure of treated area to extensive sun or heat for ~24 hr after treatment or until any initial swelling and redness has resolved
Has not been studies for use in periorbital area, during pregnancy or breast feeding, in patients susceptible to keloid formation and hypertrophic scarring, or beyond 1 year of use
Embolization
- Rare, but serious, injuries may occur as a result of unintentional injection of a soft tissue filler into blood vessels in the face
- May result in restricted blood supply to tissues and lead to embolization, which could cause vision impairment, blindness, stroke, and damage and/or necrosis of the skin and underlying facial structures
Hand augmentation
- Special care should be taken to avoid injection into veins or tendons in the hand; injection into tendons may weaken tendons and cause tendon rupture, while injection into veins may cause embolization or thrombosis
- May cause nodules, bumps or lumps in the dorsum of the hand
- Injection into patients with very severe loss of fatty tissue with marked visibility of veins and tendons has not been studied
Pregnancy and lactation
Pregnancy category: C
Lactation: Unknown whether distributed in breast milk
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Radiesse (calcium hydroxylapatite)
Mechanism of action
Sterile, nonpyrogenic, semi-solid, cohesive implant, whose principle component is synthetic calcium hydroxylapatite suspended in a gel carrier of sterile water for injection, glycerin and sodium carboxymethylcellulose
CaHA particle size range of 25-45 microns
Administration
General Instructions
Inject subdermally with 25 ga outer diameter and 27 ga inner diameter needle (Luer lock fittings)
Use a 1:1 correction factor; do not overcorrect
Also see full prescribing information
Facial Injection
Insert needle with bevel down at ~30 degree angle to the skin and slide under dermis to the point you wish to begin the injection
Advance the needle into the subdermis to the starting location, carefully push the plunger of the syringe to start the injection and slowly inject material in linear threads while withdrawing the needle
Hand Injection
Advance the needle between the subcutaneous layer and superficial fascia with the syringe parallel to the dorsum of the hand
Carefully push the plunger of the syringe to start the injection and inject in small boluses, 0.2-0.5 mL/bolus
Not to exceed 0.5 mL/bolus
The number of boluses will vary depending on the extent of treatment desired
Volumes >3 mL/hand in a treatment session have not been studied
Increased bruising is associated with higher volume injection
Retreatment with volumes greater than ~1.6 mL/hand in a treatment session can result in increased adverse events (redness, pain, swelling, and difficulty performing activities)
