Version May 2024
Submental convexity/fullness: SUBQ: Inject into submental subcutaneous fat tissue at an area-adjusted dose of 2 mg/cm2 (maximum per treatment: 50 injections spaced 1 cm apart [0.2 mL each; total 10 mL]). Maximum number of treatments: 6 treatments spaced at ≥1-month intervals.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); however, doses administered are ~3% of total body acid pool and are unlikely to be affected by hepatic impairment.
Refer to adult dosing. Use with caution; initiate therapy at lowest recommended dose.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%:
Local: Injection-site reaction (96%; including bleeding at injection site, bruising at injection site [≤72%], erythema at injection site [27%], hematoma at injection site [≤72%], induration at injection site [13% to 23%], injection-site nodule [13%], injection-site numbness [42% to 66%], injection-site pruritus [12%], pain at injection site [16% to 70%], paresthesia [14%], skin discoloration at injection site, skin tightness [5%], swelling at injection site [20% to 87%], urticaria at injection site, warm sensation at injection site [4%])
1% to 10%:
Cardiovascular: Hypertension (3%)
Gastrointestinal: Dysphagia (2%), nausea (2%)
Nervous system: Headache (8%), nerve injury (4%; marginal mandibular paresis)
Respiratory: Oropharyngeal pain (3%)
Frequency not defined:
Cardiovascular: Presyncope, syncope
Hematologic & oncologic: Lymphadenopathy
Neuromuscular & skeletal: Neck pain
Postmarketing:
Dermatologic: Alopecia (injection site), cicatrix of skin (injection site)
Gastrointestinal: Oral hypoesthesia, oral paresthesia
Hypersensitivity: Hypersensitivity reaction
Local: Injection-site infection (including abscess at injection site and cellulitis at injection site), skin ulceration at injection site, tissue necrosis at injection site
Presence of infection at the injection sites
Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to deoxycholic acid or any component of the formulation
Concerns related to adverse effects:
• Alopecia: Injection site alopecia has been reported. Onset and duration may vary and persist; consider withholding additional treatments until alopecia resolves.
• Bruising/bleeding: Injection site hematoma or bruising has been reported.
• Dysphagia: Dysphagia has occurred in the setting of administration site reactions (eg, pain, swelling, and submental area induration). All occurrences resolved spontaneously (median 34 days; range 1 to 81 days).
• Dysphagia: Dysphagia has occurred in the setting of administration site reactions (eg, pain, swelling, and submental area induration). All occurrences resolved spontaneously (median 34 days; range 1 to 81 days).
• Injection-site reactions: Injection site ulceration, necrosis, and infection have been reported with superficial (into the dermis) administration. Cases of infection may include abscess and cellulitis and require IV antibiotics and/or incision and drainage to treat. Avoid subsequent administration into affected area until ulceration/necrosis/infection has resolved.
• Nerve injury: Marginal mandibular nerve injury (eg, asymmetric smile or facial muscle paresis) has been reported. All injuries resolved spontaneously (median 44 days; range 1 to 298 days). Do not inject into or in close proximity to the marginal mandibular branch of the facial nerve.
Disease-related concerns:
• Bleeding abnormalities: Use with caution in patients with bleeding abnormalities or who are currently taking antiplatelet or anticoagulant therapy. Excessive bleeding or bruising in treatment area may occur.
• Dysphagia: Avoid use in patients with current or prior history of dysphagia; condition may be exacerbated.
Other warnings/precautions:
• Administration: For subcutaneous use only; do not inadvertently inject into an artery or vein (vascular injury may occur). Do not inject into or in close proximity (1 to 1.5 cm) of salivary glands, lymph nodes, or muscles. To avoid injury to the marginal mandibular nerve, do not inject above the inferior border of the mandible; do not inject within a region defined by a 1 to 1.5 cm line below the inferior border (from the angle of the mandible to the mentum); and only inject within the target submental fat treatment area.
• Appropriate use: Screen patients for other causes of submental convexity/fullness (eg, thyromegaly, cervical adenopathy). Use caution in patients with prior submental surgical or aesthetic treatments; changes in anatomy or landmarks, presence of scar tissue may impact safe administration or aesthetic result. Carefully consider use in patients with excessive skin laxity or prominent platysmal bands or other conditions for which reduction of submental fat may be aesthetically undesirable.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Subcutaneous:
Kybella: 20 mg/2 mL (2 mL) [contains benzyl alcohol]
No
Solution (Kybella Subcutaneous)
20 mg/2 mL (per mL): $0.00
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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Subcutaneous:
Belkyra: 20 mg/2 mL (2 mL) [contains benzyl alcohol]
SUBQ: For subcutaneous administration only; do not inadvertently inject into an artery or vein. Prior to each treatment, palpate the submental area to ensure sufficient submental fat in the target treatment area. Outline the planned treatment area with a surgical pen and apply a 1 cm injection grid to mark the injection sites; do not inject outside the defined parameters. Using a large bore needle, draw 1 mL into a sterile 1 mL syringe. Have the patient tense the platysma. Pinch the submental fat and, using a 30 gauge (or smaller) 0.5 inch needle, inject 0.2 mL into the preplatysmal fat next to each of the marked injection sites by advancing the needle perpendicular to the skin. Inject into fat tissue at the depth of approximately mid-way into the subcutaneous fat layer; avoid injection into the postplatysmal fat. Upon needle withdrawal, pressure may be applied to each injection site as necessary to minimize bleeding; an adhesive dressing may be applied. Ice/cold packs, topical and/or injectable local anesthesia (eg, lidocaine) may be used. Discard any remaining solution after use.
Submental convexity/fullness: Improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults.
Limitations of use: The safe and effective use for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended.
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.
Agents with Antiplatelet Properties (e.g., P2Y12 inhibitors, NSAIDs, SSRIs, etc.): May enhance the adverse/toxic effect of Deoxycholic Acid. Specifically, the risk for bleeding or bruising in the treatment area may be increased. Risk C: Monitor therapy
Anticoagulants: May enhance the adverse/toxic effect of Deoxycholic Acid. Specifically, the risk for bleeding or bruising in the treatment area may be increased. Risk C: Monitor therapy
Women of reproductive potential not using effective contraception were excluded from initial studies (McDiarmid 2014; Rzany 2014).
Adverse events have been observed in some animal reproduction studies. Pregnant women were excluded from initial studies (McDiarmid 2014; Rzany 2014).
It is not known if deoxycholic acid from this preparation is excreted in breast milk. According to the manufacturer, the decision to breast-feed during therapy should consider the benefits of breast-feeding, the risk of exposure to the infant, and the benefits of treatment to the mother. Breast-feeding women were excluded from initial studies (McDiarmid 2014; Rzany 2014).
Monitor postinjection for submental area induration, pain or swelling or marginal mandibular nerve injury.
Deoxycholic acid is a cytolytic drug that physically destroys the cell membrane causing lysis when injected into tissue.
Duration: Post treatment deoxycholic plasma levels return to endogenous range within 24 hours
Absorption: Rapid after subcutaneous injection
Protein binding: 98%
Metabolism: Not metabolized to any significant extent
Time to peak: 18 minutes
Excretion: Feces (as intact drug)
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