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Deoxycholic Acid

Medically reviewed by Drugs.com. Last updated on Jul 24, 2020.

Pronunciation

(dee ox i KOE lik AS id)

Index Terms

  • ATX-101

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]

Brand Names: U.S.

  • Kybella

Pharmacologic Category

  • Lipolytic

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%

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

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: 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.

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

>10%:

Dermatologic: Injection site pruritus (12%)

Local: 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 reaction (96%), pain at injection site (16% to 70%), swelling at injection site (20% to 87%)

Nervous system: Paresthesia (14%; injection site)

1% to 10%:

Cardiovascular: Hypertension (3%)

Dermatologic: Skin tightness (5%; injection site)

Gastrointestinal: Dysphagia (2%), nausea (2%)

Local: Warm sensation at injection site (4%)

Nervous system: Headache (8%), nerve injury (4%; marginal mandibular paresis)

Respiratory: Oropharyngeal pain (3%)

Frequency not defined:

Cardiovascular: Presyncope, syncope

Dermatologic: Skin discoloration at injection site, urticaria at injection site

Hematologic & oncologic: Lymphadenopathy

Local: Bleeding at injection site

Neuromuscular & skeletal: Neck pain

Postmarketing:

Dermatologic: Alopecia (injection site), cicatrix of skin (injection site), skin ulceration at injection site

Gastrointestinal: Oral hypoesthesia, oral paresthesia

Hypersensitivity: Hypersensitivity reaction

Local: Tissue necrosis at injection site

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 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.

Monitoring Parameters

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

Reproductive Considerations

Women of reproductive potential not using effective contraception were excluded from initial studies (McDiarmid 2014; Rzany 2014).

Pregnancy Considerations

Adverse events have been observed in some animal reproduction studies. Pregnant women were excluded from initial studies (McDiarmid 2014; Rzany 2014).

Patient Education

What is this drug used for?

• It is used to improve the look of fat below the chin (double chin).

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Injection site bleeding; area that feels hard or numb, bruising, redness, or swelling

• Headache

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Facial weakness

• Uneven smile

• Trouble swallowing

• Injection site skin sores, skin ulcers, drainage, pain, discoloration, or temperature change

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.