deoxycholic acid (Rx)

>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, infection, and alopecia at injection site

Immune system disorders: Hypersensitivity reactions including rash, urticaria, and itching

Nervous system disorders: Oral hypoaesthesia and oral paraesthesia

Administration site conditions: Scarring

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, necrosis, and infection; some cases of injection site infection have included cellulitis and abscess requiring intravenous antibiotic treatment and incision and drainage; do not administer into affected area until complete resolution

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.

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

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

Storage

Store at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)