Version May 2024
Facial fat loss (lipoatrophy): Intradermal: Treatment should be individualized; total number of injections and total volume injected varies based on surface area to be corrected, not on depth or severity of deficiency to be corrected. Maximum volume should be limited to 0.1 to 0.2 mL per individual injection; typically requires ~1 vial per entire cheek area per treatment session. Typical course involves 3 to 6 treatment sessions. Separate treatment sessions by 4 weeks. Supplemental treatment sessions may be needed. Do not overfill contour deficiency.
Facial wrinkles: Intradermal: 0.1 to 0.2 mL per individual injection to a maximum of 2.5 mL (with 5 mL reconstitution method) or 4.5 mL (with 8 mL reconstitution method with addition of 1 mL lidocaine 2%) per nasolabial fold or 9 mL (with 8 mL reconstitution method with optional addition of 1 mL lidocaine 2%) per cheek as a single treatment. Minimum interval between treatment sessions: ≥3 to 4 weeks for correction of nasolabial fold contour deficiencies; 3 weeks for correction of other facial wrinkles; or 4 weeks for correction of fine lines and wrinkles in the cheek region. Up to 4 treatment sessions may be needed to achieve desired results.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Cardiovascular: Hypertension (3% to 14%)
Gastrointestinal: Diarrhea (10% to 18%), gastrointestinal reflux disease (3% to 13%)
Genitourinary: Urinary tract infection (2% to 17%)
Infection: Herpes simplex infection (≤12%)
Local: Bleeding at injection site (1% to 29%), bruising at injection site (1% to 44%), discomfort at injection site (10% to 19%), erythema at injection site (3% to 78%), hematoma at injection site (28%), injection site nodule (7% to 19%; with or without inflammation or discoloration), injection site pruritus (≤20%), injection site reaction (including burning sensation at injection site, papule of skin: 9% to 52% [with or without inflammation or discoloration, may be device-related]), pain at injection site (10% to 71%), swelling at injection site (≤81%), tenderness at injection site (81%)
Nervous system: Depression (≤20%), headache (4% to 12%), insomnia (7% to 17%)
Respiratory: Bronchitis (≤13%), sinusitis (≤21%), upper respiratory tract infection (≤17%)
1% to 10%:
Cardiovascular: Syncope (2%)
Dermatologic: Acne vulgaris (≤3%)
Infection: Streptococcal infection (2%)
Local: Injection site infection (<5%), induration at injection site (<5%), inflammation at injection site (10%), injection site lesion (<5%), rash at injection site (≤3%, including dermatitis)
Nervous system: Anxiety (≤10%), fatigue (4% to 9%), pain (3%)
Neuromuscular & skeletal: Arthralgia (3% to 9%), back pain (3% to 9%)
Respiratory: Cough (2%), nasopharyngitis (6%), pneumonia (7% to 10%)
Miscellaneous: Fever (<5%)
<1%:
Dermatologic: Bruise, burning sensation of skin, eczema, exfoliation of skin, local desquamation (injection site), pruritus, spider telangiectasia, xeroderma
Gastrointestinal: Colitis, gastritis, gastroenteritis, oral mucosal ulcer (mouth sores), toothache
Hematologic & oncologic: Skin neoplasm (acrochordon)
Hypersensitivity: Hypersensitivity reaction
Infection: Influenza
Nervous system: Migraine
Neuromuscular & skeletal: Muscle injury, muscle twitching, myalgia
Respiratory: Lower respiratory tract infection, paranasal congestion (pressure)
Miscellaneous: Cyst
Postmarketing:
Dermatologic: Alopecia, cellulitis, erythema of skin, folliculitis, hyperpigmentation, localized vesiculation, pustules, skin blister, skin discoloration (including localized blanching), skin photosensitivity, skin rash, skin tightness, urticaria, urticaria at injection site, wrinkling of skin
Gastrointestinal: Nausea
Hematologic & oncologic: Granuloma (including ectropion)
Hypersensitivity: Angioedema
Infection: Abscess, staphylococcal skin infection (at injection site: including methicillin-resistant)
Local: Application site discharge, atrophy at injection site, hypertrophy at injection site, injection site ischemia, injection site scarring (including hypertrophic scars), irritation at injection site, localized edema, residual mass at injection site, tissue necrosis at injection site, warm sensation at injection site
Nervous system: Dizziness, facial nerve paralysis (including deformity and facial asymmetry), hypoesthesia, malaise, myasthenia, paresthesia
Neuromuscular & skeletal: Keloids
Ophthalmic: Blepharoptosis, blindness, blurred vision, decreased visual acuity, dry eye syndrome, increased lacrimation
Respiratory: Dyspnea
Miscellaneous: Foreign body reaction
Hypersensitivity to poly-L-lactic acid or any component of the formulation; in patients with severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies; history or susceptibility to hypertrophic scarring or keloid formation.
Concerns related to adverse effects:
• Injection-site reactions: Injection-site reactions including, bleeding, bruising, edema, erythema, and inflammation, have occurred within days to months after injection.
• Photosensitivity: Patients should be instructed to limit exposure to excessive sunlight or UV lamps until any swelling or redness is resolved.
Disease related concerns:
• Bleeding disorders: Use with caution in patients with bleeding disorders and patients on anticoagulant therapy; may have increased risk of hematoma, bleeding, or bruising at injection site.
• Skin infection/inflammation: Patients with an active skin infection or inflammation skin eruptions (such as cysts, pimples, rashes, or hives) 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.
Other warnings/precautions:
• Appropriate administration: Dermal fillers, including poly-L-lactic acid, 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 2021).
• Appropriate use: Avoid IM or intravascular administration; may lead to embolization, occlusion of the vessels, ischemia, or infarction. Inject product slowly and apply the least amount of pressure necessary. Rare but serious adverse events associated with intravascular injection of soft tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if patient exhibits symptoms, such as, change in vision, signs of a stroke, blanching of the skin, or unusual pain during or shortly after the procedure. Avoid use with implants. Avoid overcorrection of contour deficit; improvement occurs over weeks of treatment. Safety and efficacy have not been established for use in larger amounts, at different frequencies, at anatomic sites different than specified for intended use, or at sites with previous dermal fillers. Concomitant use with laser, chemical peeling procedures, or other procedure may increase risk of inflammation at the implant site, especially prior to complete healing of the skin. Has not been evaluated in immunocompromised patients. Also refer to manufacturer's labeling for detailed product-specific warnings and precautions.
• Experienced provider: Should be administered by an experienced health care provider who has appropriate training, experience, and knowledge of anatomy at injection site, and knowledge of aseptic technique.
• Radiopaque: Patients should inform health care providers that they are receiving poly-L-lactic acid; microparticles of poly-L-lactic acid may be visible on CT scans, MRIs, ultrasound, or X-rays.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, powder for suspension:
Sculptra: Poly-L-lactic acid USP
No
Suspension (reconstituted) (Sculptra Injection)
367.5 mg (per each): $594.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
For injection into deep dermis or subdermal regions (ie, SUBQ or supraperiosteally) using an indication-specific appropriate injection technique. Avoid IM or IV injection. Space injections 0.5 to 1 cm apart. Administer using 26-gauge needle (with 5 mL reconstitution method) or 25-gauge needle (with 8 mL reconstitution method); do not bend needle. Occasionally agitate syringe during session to maintain a uniform suspension. Eliminate air prior to initial injection. Stretch skin prior to inserting needle. Massage treatment area in a circular motion after every 3 to 4 injections and for ≥2 minutes at the end of the treatment session to evenly distribute. Do not fully correct or overcorrect. Local or topical anesthetic may be used prior to injecting. See prescribing information for detailed administration technique instructions.
Facial fat loss (lipoatrophy): Restoration and/or correction of the signs of facial fat loss (lipoatrophy) in patients with human immunodeficiency virus (HIV).
Facial wrinkles: Correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles, including fine lines and wrinkles in the cheek region, in immunocompetent patients.
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
Reproduction studies have not been conducted. Safety for use in pregnant women has not been established.
It is not known if poly-L-lactic acid is excreted in breast milk. Safety for use in nursing women has not been established. HIV-infected mothers are discouraged from breast-feeding to decrease potential transmission of HIV.
Vision assessments (before and after treatment).
Poly-L-lactic acid is an immunologically inert synthetic polymer. It increases dermal thickness by causing a local reaction leading to an increase in collagen deposits. It is eventually degraded and undergoes resorption.
Onset of action: Weeks to months for full effect of treatment
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