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calcium hydroxylapatite (Rx)Brand and Other Names:Radiesse

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

subdermal gel

  • 0.8mL
  • 1.5mL
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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

Safety and efficacy not established

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Adverse 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%)

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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
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Pregnancy & 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.

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Pharmacology

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

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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)

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Images

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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