Version May 2024
Facial wrinkles: Subdermal: Inject as required for cosmetic result (treatment volume varies based on indication/location); repeat treatment may be administered. Use a 1:1 correction factor. Do not overcorrect (overfill) a contour deficiency.
Hand augmentation: Subdermal: Inject in small boluses (0.2 to 0.5 mL per bolus [maximum: 0.5 mL per bolus]) as required for cosmetic result (number of injection points varies); maximum volume per hand: 3 mL. Repeat treatment may be administered (retreatment with volumes >1.6 mL/hand per treatment session may result in increased adverse events). Use a 1:1 correction factor. Do not overcorrect (overfill) a contour deficiency.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Incidences based on patient's diaries on days 1 to 3 postinjection of calcium hydroxylapatite.
>10%:
Cardiovascular: Edema (29%; maximal edema may occur on days 4 to 7 and may persist for up to 4 weeks)
Central nervous system: Pain (19%; may persist for up to 4 weeks)
Dermatologic: Erythema (33%; may persist up to 4 weeks), ecchymoses (14%; maximal ecchymosis may occur on days 4 to 7), pruritus (13%)
Infection: Infection (1% to >5%)
Local: Injection site reaction (13%; includes muscle tenderness, numbness, contour irregularity, and skin irritation; may persist for up to 4 weeks)
<1%, postmarketing, and/or case reports (includes long-term effects up to 3 years after treatment): Abscess, alopecia, application site reaction (exposed material, over injection, under injection, superficial injection, product displacement), bleeding at injection site, blepharoptosis, bullous pemphigoid, cold intolerance, dark circles, dizziness, double vision, eczema, facial wrinkling, flu-like symptoms, granuloma, hematoma, herpes simplex infection (including reactivation), hordeolum, hyperpigmentation (upper lip), hypersensitivity reaction, hyperventilation, inflammation, ischemia, localized blanching, nausea, nodule, pallor, paralysis, residual mass at injection site, scarring, skin blister, skin cyanosis, skin discoloration, skin necrosis, skin texture changes, tachyphylaxis, thrombosis, tingling sensation, urinary tract infection, venous obstruction
Hypersensitivity to calcium hydroxylapatite or any component of the formulation; severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies; bleeding disorders.
Radiesse Plus: Additional contraindication: Known hypersensitivity to lidocaine or anesthetics of the amide type.
Concerns related to adverse effects:
• Injection-site reactions: Transient injection-site reactions lasting <7 days, including bruising, redness, and swelling, have been observed. Coadministration of medications that may prolong bleeding (eg, aspirin, warfarin) may cause increased bruising or bleeding; use with caution.
• Vascular occlusion: Vascular occlusion may occur following intravascular injection, resulting in infarction or embolism and subsequent ischemia, necrosis, or scarring. Intravascular injection in the face has produced rare serious adverse events, including temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage (leading to stroke), skin necrosis, and damage to underlying facial structures. Do not use in vascular rich areas (eg, glabella, nose). Vascular occlusion of the lips, nose, or glabellar or ocular region has been reported. Discontinue use immediately if changes in vision, signs of stroke, blanching of skin, or unusual pain during or shortly after the procedure occur.
Disease-related concerns:
• Disorders of the hand: Use with caution in patients with autoimmune disease affecting the hand, hand implants, Dupuytren contracture, history of hand tumor, vascular malformations, Raynaud disease, and risk for tendon rupture; has not been studied.
• Fitzpatrick skin types IV-VI: Use with caution in patients with Fitzpatrick skin types IV-VI; may have increased risk in difficulty performing tasks following injection into the dorsum of the hand.
• Herpes: Treatment may result in herpes reactivation in patients with a history of herpetic eruption.
• HIV: Patients with HIV should only be treated by health care providers with expertise in the correction of volume deficiencies in these patients.
• Skin infection/inflammation: Patients with an active skin infection or inflammation in or near the treatment area should not undergo treatment until the inflammatory or infectious process has been controlled. Treatment carries a risk of infection; utilize standard aseptic precautions during treatment.
Dosage form specific issues:
• Radiesse Plus: Assess the risk versus benefit in patients with congenital methemoglobinemia, patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency, and patients receiving concomitant treatment with a methemoglobin-inducing agent.
Other warnings/precautions:
• Appropriate administration: Dermal fillers, including calcium hydroxylapatite, should be administered using a syringe with a needle or cannula. Needle-free devices for injection of dermal fillers are not FDA-approved and may cause serious injuries or permanent harm to the skin, lips, or eyes. FDA-approved dermal fillers should not be transferred into needle-free injection devices (FDA Safety Communication 2021).
• Appropriate use: Safety and efficacy has not been established in patients with severe loss of fatty tissue with visible veins and tendons. Safety in patients with increased susceptibility to keloid formation and hypertrophic scarring has not been studied. Concomitant use with epilation, ultraviolet radiation, or laser, mechanical, or chemical peeling procedures has not been studied; there is a risk of inflammation at the implant site if these concomitant procedures are performed, especially prior to complete healing of the skin. Patients should minimize strenuous activity and exposure of the treatment area to extensive sun or heat for 24 hours or until any swelling and redness has resolved.
• Appropriate use: Hand augmentation: The effect on hand function is unknown. Avoid injection into veins or tendons; may weaken or cause tendons to rupture or cause embolization or thrombosis. Use in the dorsum of the hand may result in swelling; remove rings prior to treatment and until swelling has resolved. Adverse events may occur that last >14 days. Temporary difficulty performing activities may occur with injection into the dorsum of the hand; nodules, bumps, or lumps in the dorsum of the hand may last up to 1 year. Higher volume injections are associated with increased bruising; volumes >3 mL per hand in a treatment session have not been studied; retreatment with volumes greater than ~1.6 mL per hand in a treatment session may result in increased adverse events (eg, redness, pain, swelling, difficulty performing activities). Treatment for >1 year has not been studied.
• Appropriate use: Facial wrinkles: Contours should not be overfilled; facial wrinkles should gradually improve over several weeks following treatment. Safety and efficacy for use in the lips and periorbital area have not been established; nodules have been reported when injected into the lips. Treatment for >3 years has not been studied.
• Experienced physician: Should be administered by an experienced health care provider who has appropriate training, experience, knowledge of anatomy at injection site, and knowledge of aseptic technique.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Implant, Subdermal:
Radiesse: (0.8 mL, 1.5 mL)
Radiesse Plus: (0.8 mL, 1.5 mL) [contains lidocaine hydrochloride 0.3%]
Subdermal: Do not inject into blood vessels or veins or tendons in the hand. Local or topical anesthesia may be used at the injection site. Avoid passing through scar tissue and cartilage, if possible. Insert needle at approximately a 30-degree angle to the skin. Advance the needle into the subdermis; slowly inject the implant material in linear threads while withdrawing the needle. Continue placing additional lines of material until the desired level of correction is achieved; do not overcorrect. The implant material should be completely surrounded by soft tissue without leaving globular deposits. The injected area may be massaged as needed to achieve even distribution of the implant.
The needle should slide under the dermis; if significant resistance is encountered when pushing the plunger, move the needle slightly or change the injection needle. Needle jams are more common with needles smaller than 27 gauge. To help avoid needle breakage, do not attempt to straighten a bent needle; discard it and complete the procedure with a replacement needle.
Hand augmentation: Immediately after injection, cover injection site with sterile gauze and have patient sit on hand to warm implant while the contralateral hand is being treated. After contralateral hand is treated, cover with gauze and have patient sit on it. Remove gauze from initial hand, have patient make a fist and gently massage dorsum of hand to spread evenly; repeat with contralateral hand.
Facial wrinkles: Subdermal implantation for correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, and also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in patients with HIV.
Hand augmentation: Subdermal implantation to correct volume loss in the dorsum of the hands.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
COVID-19 Vaccine (mRNA): May enhance the adverse/toxic effect of Dermal Fillers. Specifically, the risk for swelling at or near the site of dermal filler injection (usually face or lips) may be increased. Risk C: Monitor therapy
Women of reproductive potential who were not using effective contraception were excluded from clinical trials.
Reproduction studies have not been conducted. Pregnant women were excluded from clinical trials.
It is not known if calcium hydroxylapatite is excreted in breast milk. Lactating women were excluded from clinical trials.
Subdermal injection may decrease the depth of facial wrinkles or correct volume loss in dorsum of hands.
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