KYBELLA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for KYBELLA (KYBELLA).
Kybe lla (deoxycholic acid) is a cytolytic drug that disrupts cell membranes of adipocytes, causing lysis and subsequent removal of fat cells. It acts as a detergent that solubilizes the cell membrane of adipose tissue, leading to inflammation and eventual elimination of the fat cells via macrophages.
| Metabolism | Deoxycholic acid is a bile acid that is not extensively metabolized; it is primarily excreted unchanged in feces. Some conjugation with taurine or glycine may occur in the liver. |
| Excretion | Renal (excreted as unchanged deoxycholic acid and metabolites); <5% fecal |
| Half-life | Terminal half-life of deoxycholic acid is approximately 24 hours; clinically, multiple treatments may be needed for cumulative effect |
| Protein binding | 99% bound primarily to albumin and beta-2-glycoprotein I |
| Volume of Distribution | Deoxycholic acid Vd approximately 0.08 L/kg (indicating limited extravascular distribution) |
| Bioavailability | Injection into subcutaneous fat yields 100% bioavailability (local administration) |
| Onset of Action | Visible reduction in submental fat typically observed after 2–4 treatment sessions (each session spaced 1 month apart); individual results may vary |
| Duration of Action | Results are durable; fat cells destroyed do not regenerate; further fat gain in treated area is prevented; repeat treatments may be needed for optimal results |
KybeLla (deoxycholic acid) is administered as subcutaneous injections into submental fat. The recommended dose per treatment session is 0.2 mL per injection site, with up to 10 injection sites per session (total 2 mL). Sessions are spaced at least 1 month apart, for up to 6 treatments.
| Dosage form | SOLUTION |
| Renal impairment | No specific renal dose adjustment guidelines are provided by manufacturer. Use caution in severe renal impairment. |
| Liver impairment | No specific hepatic dose adjustment guidelines are provided. KybeLla has not been studied in patients with hepatic impairment. |
| Pediatric use | Safety and efficacy in pediatric patients (<18 years) have not been established; use is not recommended. |
| Geriatric use | Clinical studies did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently. No specific geriatric dose adjustment is recommended. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for KYBELLA (KYBELLA).
| Breastfeeding | Deoxycholic acid is endogenously present in breast milk. Subcutaneous administration results in minimal systemic absorption, so no exogenous contribution is expected. M/P ratio not applicable. |
| Teratogenic Risk | KYBELLA (deoxycholic acid) is not absorbed systemically after subcutaneous injection; therefore, fetal exposure is negligible. No teratogenic effects are expected in any trimester. |
| Fetal Monitoring |
■ FDA Black Box Warning
No boxed warning.
| Serious Effects |
["Presence of infection in the treatment area","Known hypersensitivity to deoxycholic acid or any of the excipients"]
| Precautions | ["Risk of necrosis or ulceration at injection site","Marginal mandibular nerve injury (temporal weakness/paresis of the lower lip)","Dysphagia or difficulty swallowing (rare)","Injection site reactions (pain, swelling, bruising, induration)","Risk of injection site alopecia"] |
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| No specific maternal or fetal monitoring is required due to negligible systemic absorption. |
| Fertility Effects | No effects on fertility are anticipated due to minimal systemic absorption. |