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Deoxycholic Acid


General


Pronunciation

(dee ox i KOE lik AS id)


Brand Names: U.S.

  • Kybella

Indications


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


Dosing 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.


Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturers labeling.


Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturers labeling (has not been studied); however, doses administered are ~3% of total body acid pool and are unlikely to be affected by hepatic impairment.


Reconstitution

Do not dilute.


Administration

Subcutaneous: 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).


Dosage Forms/Strengths


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]


Compatibility

Admixture with other drugs or solutions is not recommended.


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


Monitoring Parameters

Monitor postinjection for submental area induration, pain or swelling or marginal mandibular nerve injury.


Adverse Reactions


Frequency not always defined.

Cardiovascular: Hypertension (3%), presyncope, syncope

Central nervous system: Paresthesia (14%), headache (8%), nerve damage (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:

- 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.

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.


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).


Actions


Pharmacology

Deoxycholic acid is a cytolytic drug that physically destroys the cell membrane causing lysis when injected into tissue.


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%


Patient and Family Education


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, pain, or area that feels hard or numb, or headache. Have patient report immediately to prescriber facial weakness, uneven smile, severe injection site irritation, or trouble 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.

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