Kybella (deoxycholic acid)

The manufacturer recommends an area-adjusted deoxycholic acid dose of 2 mg/cm2.

Up to 50 injections (0.2 mL each), or a total of 10 mL, of deoxycholic acid may be given in a single treatment session. Up to 6 single treatments may be administered at intervals of at least 1 month.

Deoxycholic acid injection should be inspected visually for particulate matter and discoloration prior to administration. Unopened vials of deoxycholic acid should be stored at 20-25degreesC, with excursions between 15 and 30degreesC permitted. Do not dilute or mix the drug with other compounds.

Prior to administration of the drug, the planned treatment area should be outlined with a surgical pen and a 1-cm injection grid should be applied to mark the injection sites.

Deoxycholic acid should be injected only within the target submental fat treatment area. To avoid injury to the marginal mandibular nerve, deoxycholic acid should not be injected above the inferior border of the mandible or within a region defined by a 1-1.5-cm line below the inferior border (from the angle of the mandible to the mentum). Injections into other tissues, such as muscle, salivary glands, and lymph nodes, should be avoided.

Using a large-bore needle, 1 mL of deoxycholic acid should be drawn into a sterile 1-mL syringe; any air bubbles in the syringe barrel should be expelled. Individuals receiving the drug should be instructed to tense the platysma. The submental fat should be pinched and, using a 30-gauge or smaller 0.5-inch needle, 0.2 mL of deoxycholic acid should be injected into the preplatysmal fat next to each of the marked injection sites (1 cm apart) by advancing the needle perpendicular to the skin. Upon withdrawal of the needle, pressure may be applied to each injection site if needed to minimize bleeding; an adhesive dressing also may be applied.

Injections that are too superficial (into the dermis) may result in skin ulceration and necrosis. The needle should not be withdrawn from the subcutaneous fat during injection as this may increase the risk of intradermal injection of the drug and potential skin ulceration.

Entry of deoxycholic acid into the postplatysmal fat should be avoided by injecting the drug at a depth approximately mid-way into the subcutaneous fat layer.

If at any time resistance is met during insertion of the needle, indicating the possibility of contact with fascial or nonfat tissue, the needle must be withdrawn to an appropriate depth before the drug is administered.

Vials of deoxycholic acid are for single use only; following administration of the intended dose, any remaining solution in the vial should be discarded.

No dosing information is available for this tab.

No dosing information is available for this tab.

In vitro studies have shown that at clinically relevant concentrations, deoxycholic acid does not inhibit or induce cytochrome P-450 (CYP) isoenzymes.

Deoxycholic acid does not inhibit P-glycoprotein (P-gp); breast cancer resistance protein (BCRP); multidrug resistance-associated protein (MRP) 4 or MRP2; organic anion transport protein (OATP) 1B1, 2B1, or 1B3; organic cation transporter (OCT) 1 or OCT2; organic anion transporter (OAT) 1 or OAT3; sodium taurocholate co-transporting polypeptide (NTCP); or apical sodium-dependent bile acid transporter (ASBT).

Deoxycholic acid should be used with caution in patients receiving anticoagulant or antiplatelet therapy; excessive bleeding or bruising in the treatment area may occur.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

Deoxycholic acid is contraindicated in the presence of infection at the injection sites.

There are no contraindication contraindications for this drug.

• Dysphagia

• Increased risk of bleeding

Adverse effects reported in 2% or more of individuals receiving deoxycholic acid and more frequently than with placebo in 2 clinical trials (pooled data) include injection-site reactions (edema/swelling, hematoma/bruising, pain, numbness, erythema, induration, paresthesia, nodule, pruritus, skin tightness, skin warmth, nerve injury), headache, oropharyngeal pain, hypertension, nausea, and dysphagia.

Injection-site edema/swelling, hematoma, pain, numbness, erythema, and induration were reported in more than 20% of individuals treated with deoxycholic acid in clinical trials.

Less Frequent

• Paresis from marginal mandibular branch of facial nerve

Rare or Very Rare

• Dermal necrosis
• Hemorrhage
• Injection site necrosis
• Lymphadenopathy
• Skin ulcer

More Frequent

• Bruising
• Hematoma
• Hypoesthesia
• Injection site sequelae
• Pain

Less Frequent

• Headache disorder
• Hypertension
• Nausea
• Neuralgia
• Paresthesia
• Sensation of warmth
• Skin nodules
• Sore throat

Rare or Very Rare

• Alopecia
• Dyschromia
• Dysphagia
• Edema
• Erythema
• Induration of skin
• Injection site infection
• Neck pain
• Oral hypoesthesia
• Oral paresthesia
• Pruritus of skin
• Scar of skin
• Skin hypopigmentation
• Skin rash
• Syncope
• Urticaria
• Voice change

No enhanced messaging available.

Safety and efficacy of deoxycholic acid have not been established in individuals younger than 18 years of age; the manufacturer states that the drug is not intended for use in children or adolescents.

There are no adequate and well-controlled studies of deoxycholic acid in pregnant women. Animal reproductive studies have not shown evidence of fetal harm with subcutaneous administration of deoxycholic acid during organogenesis at doses up to 5 times the maximum recommended dose (MRHD).

Data are lacking on the presence of synthetic deoxycholic acid in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for deoxycholic acid and any potential adverse effects on the breastfed child from deoxycholic acid or the underlying maternal condition.

Clinical trials of deoxycholic acid did not include sufficient numbers of adults 65 years of age or older to determine whether geriatric individuals respond differently than younger individuals. Other clinical experience has not revealed age-related differences in response. The greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy in geriatric individuals also should be considered.