DEOXYCHOLIC ACID
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DEOXYCHOLIC ACID (DEOXYCHOLIC ACID).
Deoxycholic acid is a cytolytic agent that disrupts cell membranes of adipocytes when injected subcutaneously, causing adipocyte lysis and subsequent tissue necrosis. The detergent action solubilizes triglycerides and induces an inflammatory response, leading to removal of fat cells.
| Metabolism | Metabolized via hepatic conjugation with glycine and taurine, followed by enterohepatic recirculation. Primarily eliminated in feces via bile; minor urinary excretion. |
| Excretion | Primarily fecal (biliary) as metabolites; less than 5% renal excretion of unchanged drug. |
| Half-life | Terminal elimination half-life is approximately 11 hours; indicates systemic clearance within 2-3 days. |
| Protein binding | >99% bound to albumin and other plasma proteins. |
| Volume of Distribution | Approximately 3.7 L/kg, indicating extensive tissue distribution beyond plasma volume. |
| Bioavailability | Subcutaneous administration: 100% (as it is the only route); no oral bioavailability as the drug is degraded in GI tract. |
| Onset of Action | Subcutaneous injection: Clinical effect (reduction of submental fat) observed within 1-2 hours as local tissue reaction; visible fat reduction after multiple treatments. |
| Duration of Action | Therapeutic effect lasts for several months; repeated treatments may be required every 1-2 months for optimal results. |
Subcutaneous injection: 1 mg/cm² per treatment session, divided into 0.1 mL aliquots spaced 1 cm apart, up to a maximum of 50 mg per session. Sessions repeated every 1-2 months for up to 6 sessions.
| Dosage form | SOLUTION |
| Renal impairment | No specific dose adjustment recommended; use with caution in severe renal impairment (eGFR <30 mL/min/1.73 m²) due to lack of data. |
| Liver impairment | No specific dose adjustment recommended; use with caution in moderate to severe hepatic impairment (Child-Pugh class B or C) due to potential increased exposure. |
| Pediatric use | Not approved for use in pediatric patients (<18 years); safety and efficacy not established. |
| Geriatric use | No specific dose adjustment; limited data in patients ≥65 years, but no significant age-related differences observed in pharmacokinetics. Use standard dosing with monitoring for adverse effects. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DEOXYCHOLIC ACID (DEOXYCHOLIC ACID).
| Breastfeeding | It is not known whether deoxycholic acid is excreted in human milk. No M/P ratio is available. Because many drugs are excreted in human milk, caution should be exercised when deoxycholic acid is administered to a nursing woman. Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for the drug and any potential adverse effects on the breastfed child. |
| Teratogenic Risk | Deoxycholic acid is a bile acid. There are no adequate and well-controlled studies in pregnant women. Animal studies have not been conducted. It is not known whether deoxycholic acid can cause fetal harm when administered to a pregnant woman. Therefore, it should be used during pregnancy only if clearly needed. No trimester-specific fetal risks have been identified due to lack of data. |
■ FDA Black Box Warning
Risk of serious injection site reactions including skin necrosis, ulceration, and vascular injury. Must be administered by a trained healthcare professional, and only into submental fat. Avoid injection into or near other fatty areas or anatomical structures.
| Serious Effects |
Absolute: Known hypersensitivity to deoxycholic acid or any component of the formulation; presence of infection at the injection site; current treatment with anticoagulants or antiplatelet therapy (unless specifically managed). Relative: History of significant bleeding disorder; history of facial nerve palsy; poor skin laxity; severe ptosis; pregnancy or breastfeeding.
| Precautions | Injection site reactions (e.g., hematoma, edema, pain, numbness); risk of marginal mandibular nerve injury (temporary or permanent facial asymmetry); skin ulceration/necrosis; dysphagia; injection into anatomical structures other than submental fat; patient selection (exclude those with redundant skin, platysmal bands, or other causes of submental fullness). |
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| Fetal Monitoring | No specific monitoring requirements are established for deoxycholic acid during pregnancy or lactation. Routine prenatal and postnatal care is recommended. Observe for any adverse effects related to the injection site or systemic reactions. |
| Fertility Effects | There are no data on the effects of deoxycholic acid on fertility in humans. Animal studies have not been performed to evaluate the impact on fertility. No known effects on reproductive function have been reported. |