Dosage Forms
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]
Pharmacology
Mechanism of Action
Deoxycholic acid is a cytolytic drug that physically destroys the cell membrane causing lysis when injected into tissue.
Pharmacokinetics/Pharmacodynamics
Absorption
Rapid after subcutaneous injection
Metabolism
Not metabolized to any significant extent
Excretion
Feces (as intact drug)
Time to Peak
18 minutes
Duration of Action
Post treatment deoxycholic plasma levels return to endogenous range within 24 hours
Protein Binding
98%
Use: Labeled Indications
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.
Contraindications
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
Dosage and Administration
Dosing: Adult
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.
Reconstitution
Do not dilute.
Administration
SubQ: 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.
Storage
Store intact vials at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F).
Drug Interactions
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. 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. Monitor therapy
Adverse Reactions
Frequency not always defined.
Cardiovascular: Hypertension (3%), presyncope, syncope
Central nervous system: Paresthesia (14%), headache (8%), neuropathy (4%, marginal mandibular)
Dermatologic: Injection site pruritus (12%), skin tightness (5% injection site), skin discoloration at injection site, urticaria at injection site
Gastrointestinal: Dysphagia (2%), nausea (2%)
Hematologic & oncologic: Lymphadenopathy
Local: Injection site reaction (96%), swelling at injection site (20% to 87%), bruising at injection site (72%), hematoma at injection site (72%), pain at injection site (16% to 70%), injection site numbness (42% to 66%), erythema at injection site (27%), induration at injection site (23%), injection site nodule (13%), warm sensation at injection site (4%), bleeding at injection site
Neuromuscular & skeletal: Neck pain
Respiratory: Oropharyngeal pain (3%)
Warnings/Precautions
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).
- 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.
- Ulceration and necrosis: Injection site ulceration and necrosis have been reported with superficial (into the dermis) administration. Avoid subsequent administration into affected area until ulceration/necrosis has resolved.
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 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.
Monitoring Parameters
Monitor postinjection for submental area induration, pain or swelling or marginal mandibular nerve injury.
Pregnancy
Pregnancy Considerations
Adverse events have been observed in some animal reproduction studies. Pregnant women and women of reproductive potential not using effective contraception were excluded from initial studies (McDiarmid, 2014; Rzany, 2014).
Patient Education
- 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 bleeding or area that feels hard or numb or headache. Have patient report immediately to prescriber skin sores, skin ulcers, facial weakness, uneven smile, severe injection site pain or irritation, discoloration at injection site, or difficulty swallowing (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.
