Calcium Hydroxylapatite

(KAL see um hi DROKS el AP a tite)

Subdermal injection may decrease the depth of facial wrinkles or correct volume loss in dorsum of 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.

Refer to adult dosing.

There are no dosage adjustments provided in the manufacturer’s labeling.

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.

There are no known significant interactions.

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.