(KAL see um hi DROKS el AP a tite)
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.
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.
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.
Refer to adult dosing.
There are no dosage adjustments provided in the manufacturer 's labeling.
There are no dosage adjustments provided in the manufacturer 's labeling.
Open the foil pouch by tearing at the notches (marked 1 and 2), and remove the syringe from the foil pouch. There is a small amount of moisture normally present inside the foil pouch for sterilization purposes; this is not an indication of a defective product. A new injection needle may be used for each syringe, or the same injection needle may be connected to each new syringe.
The needle must be tightened securely to the syringe and primed with calcium hydroxylapatite injectable implant. Slowly push the syringe plunger until calcium hydroxylapatite injectable implant extrudes from the end of the needle. If leakage is noted at the Luer fitting, it may be necessary to tighten the needle, or to remove the needle and clean the surfaces of the Luer fitting, or, in extreme cases, replace both the syringe and the needle. Refer to manufacturer 's labeling for detailed instructions.
Radiesse: Lidocaine 2% may be mixed in the syringe; add 0.11 mL or 0.26 mL of lidocaine 2% to the 0.8 mL or 1.5 mL calcium hydroxylapatite syringe, respectively. Refer to manufacturer 's labeling for detailed instructions.
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.
Store between15 ‚ °C and 32 ‚ °C (59 ‚ °F and 90 ‚ °F). Do not use if the expiration date has been exceeded. Do not use the calcium hydroxylapatite injectable implant and lidocaine 2% mixture later than 2 hours after mixing.
Syringes are packaged for single patient use. Do not resterilize. Do not use if the package is opened or damaged or if the syringe end cap or plunger is not in place.
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%]
There are no known significant interactions.
Radiography: Calcium hydroxylapatite particles are radiopaque and are visible on CT scans and may be visible on standard radiography.
Incidences based on patients 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% (Limited to important or life-threatening; includes long-term effects up to 3 years after treatment): Abscess, alopecia, blepharoptosis, bullous pemphigoid, dizziness, double vision, eczema, facial wrinkling, flu-like symptoms, granuloma, hematoma, hordeolum, hyperpigmentation (upper lip), hypersensitivity reaction, inflammation, ischemia, localized blanching, nodule, pallor, paralysis, residual mass at injection site, scarring, skin blister, skin cyanosis, skin discoloration, skin necrosis, skin texture changes, tachyphylaxis, thrombosis, urinary tract infection, venous obstruction
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 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.
Reproduction studies have not been conducted. Pregnant women and women of reproductive potential who were not using effective contraception were excluded from clinical trials.
Subdermal injection may decrease the depth of facial wrinkles or correct volume loss in dorsum of hands.
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience injection site pain, redness, or edema. Have patient report immediately to prescriber signs of severe cerebrovascular disease (change in strength on one side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight), severe injection site irritation, numbness or tingling, or pale skin (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.