deoxycholic acid (Rx)

Brand and Other Names:Kybella
  • Print

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

solution for injection

  • 10mg/mL (supplied in 2mL vials)

Submental Fat Reduction

Indicated for improvement in the appearance of moderate-to-severe convexity or fullness associated with submental fat (ie, double chin) in adults

Injected into subcutaneous fat tissue in the submental area using an area-adjusted dose of 2 mg/cm²

A single treatment consists of up to a maximum of 50 injections, 0.2 mL each (up to a total of 10 mL), spaced 1 cm apart

Up to 6 single treatments may be administered at intervals no less than 1 month apart

Dosing Considerations

Safe and effective use for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended

<18 years: Safety and efficacy not established

Not intended for use in children or adolescents

Next:

Adverse Effects

>10%

Edema/swelling at injection sites (87%)

Hematoma/bruising (72%)

Pain (70%)

Numbness (66%)

Erythema (27%)

Induration (23%)

Paresthesia (14%)

Nodule (13%)

Pruritus (12%)

1-10%

Headache (8%)

Skin tightness (5%)

Site warmth (4%)

Nerve injury (4%)

Oropharyngeal pain (3%)

Hypertension (3%)

Nausea (2%)

Dysphagia (2%)

Postmarketing Reports

Ulceration, necrosis, and alopecia at injection site

Previous
Next:

Warnings

Contraindications

Presence of infection at the injection sites

Cautions

Marginal mandibular nerve injury, manifested as an asymmetric smile or facial muscle weakness (paresis), were reported during clinical trials; do not inject into or in close proximity to the marginal mandibular branch of the facial nerve

Difficulty swallowing (dysphagia) occurred in clinical trials in the setting of administration site reactions (eg, pain, swelling, and induration of the submental area); current or prior history of dysphagia may exacerbate the condition; avoid use in these patients

Injection site hematoma/bruising reported in 72% of patients treated; caution in patients with bleeding abnormalities or who are currently being treated with antiplatelet or anticoagulant therapy as excessive bleeding or bruising in the treatment area may occur

Risk of injecting in proximity to vulnerable anatomic structures; to avoid potential tissue damage, should not be injected into or in close proximity (1-1.5 cm) to salivary glands, lymph nodes, and muscles

Injection site alopecia have been reported; consider withhold subsequent treatment until resolution

Injections that are too superficial (into the dermic) may result in skin ulceration and necrosis; do not administer into affected area until complete resolution

Previous
Next:

Pregnancy & Lactation

Pregnancy

There are no adequate and well-controlled studies in pregnant women to inform the drug-associated risk

Animal data: Embryofetal development studies performed in rats and rabbits using SC doses administered during the period of organogenesis; for the basis of comparing animal to human doses, the maximum recommended human dose (MRHD) is 1.7 mg/kg (100 mg/60 kg); no evidence of fetal harm was observed in rats at up to the highest dose tested (50 mg/kg), which is 5-fold higher than the MRHD of deoxycholic acid based on a mg/m² comparison

Lactation

Unknown if distributed in human breast milk

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Previous
Next:

Pharmacology

Mechanism of Action

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

Absorption

Rapidly absorbed following SC injection

Peak plasma time: 18 minutes

Peak plasma concentration (100 mg dose): 1024 ng/mL; 3.2-fold higher than average Cmax observed during 24-hr baseline endogenous period in absence of an administered dose

AUC: 7896 ng•hr/mL (1.6-fold higher over equivalent endogenous period)

Post-treatment deoxycholic acid plasma levels returned to the endogenous range within 24 hr

Distribution

Protein bound: 98%

Metabolism

Endogenous deoxycholic acid is a product of cholesterol metabolism and is excreted intact in feces

Deoxycholic acid is not metabolized to any significant extent under normal conditions

Elimination

Deoxycholic acid from Kybella joins the endogenous bile acid pool in the enterohepatic circulation and is excreted along with the endogenous deoxycholic acid in the feces

Previous
Next:

Administration

General Instructions

Should be administered by a healthcare professional

Screen patients for other potential causes of submental convexity/fullness (eg, thyromegaly, cervical lymphadenopathy)

Give careful consideration to the use in patients with excessive skin laxity, prominent platysmal bands, or other conditions for which reduction of submental fat may result in an aesthetically undesirable outcome

Caution in patients who have had prior surgical or aesthetic treatment of the submental area

Changes in anatomy/landmarks or the presence of scar tissue may impact the ability to safely administer or to obtain the desired aesthetic result

Deoxycholic acid solution is clear, colorless, and free of particulate matter; visually inspect vials for particulate matter and/or discoloration, and discard the vial if the solution is discolored and/or contains particulate matter

Each vial is for single use; discard any remaining solution in the vial

Injection Technique

Safe and effective use depends on the use of the correct number and locations for injections, proper needle placement, and administration techniques

Healthcare professionals administering deoxycholic acid must understand the relevant submental anatomy and associated neuromuscular structures in the area involved and any alterations to the anatomy due to prior surgical or aesthetic procedures

Avoid injections near the area of the marginal mandibular nerve

  • Needle placement with respect to the mandible is very important as it reduces the potential for injury to the marginal mandibular nerve, a motor branch of the facial nerve; injury to the nerve presents as an asymmetrical smile due to paresis of lip depressor 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)
    • Inject only within the target submental fat treatment area
    • See diagram in Prescribing Information

Avoid injection into the platysma

  • Prior to each treatment session, palpate the submental area to ensure sufficient submental fat and to identify subcutaneous fat between the dermis and platysma (preplatysmal fat) within the target treatment area (see diagram in Prescribing Information)
  • The number of injections and the number of treatments should be tailored to the individual patient’s submental fat distribution and treatment goals

Injecting into the treatment area

  • Use of ice/cold packs, topical and/or injectable local anesthesia (eg, lidocaine) may enhance patient comfort
  • 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 of the defined parameters

  • See diagram in prescribing information
  • Using a large-bore needle, draw 1-mL of deoxycholic acid solution into a sterile 1 mL syringe and expel any air bubbles in the syringe barrel
  • 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 of deoxycholic acid solution into the preplatysmal fat next to each of the marked injection sites by advancing the needle perpendicular to the skin
  • Injections that are too superficial (into the dermis) may result in skin ulceration; do not withdraw the needle from the subcutaneous fat during injection as this could increase the risk of intradermal exposure and potential skin ulceration
  • Avoid injecting into the postplatysmal fat by injecting deoxycholic acid into fat tissue at the depth of approximately mid-way into the subcutaneous fat layer
  • If at any time resistance is met as the needle is inserted, indicating the possibility of contact with fascial or nonfat tissue, the needle must be withdrawn to an appropriate depth before the injection is administered
  • Avoid injecting into other tissues (eg, muscle, salivary glands, lymph nodes)
  • Upon needle withdrawal, pressure may be applied to each injection site as necessary to minimize bleeding; an adhesive dressing may be applied
Previous
Next:

Images

Previous
Next:

Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
Additional Offers
Email to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Email Forms to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Previous
Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.