Generic Name and Formulations:
Deoxycholic acid 10mg/mL; soln for SC inj; contains benzyl alcohol.
Indications for KYBELLA:
To improve the appearance of moderate-to-severe convexity or fullness associated with submental fat.
Limitations Of use:
Not recommended for treating outside of the submental region.
See full labeling. Should be administered by a healthcare professional. Give by SC inj into SC fat tissue in the submental area using an area-adjusted 2mg/cm2 dose. ≥18yrs: 0.2mL inj spaced 1cm apart. Max 50 injections (up to 10mL total) per single treatment; up to 6 single treatments given at least 1 month apart.
<18yrs: not established.
Infection at inj sites.
Screen for thyromegaly and cervical lymphadenopathy. Excessive skin laxity, prominent platysmal bands, or other conditions. Prior surgical or aesthetic treatment to submental area. Avoid injection into or near marginal mandibular branch of facial nerve, platysma, salivary glands, lymph nodes, muscles. Dysphagia or history of; avoid. Bleeding abnormalities. Inj site alopecia, ulceration, and necrosis; withhold until resolved. Pregnancy. Nursing mothers.
Excessive bleeding or bruising may occur with concomitant antiplatelets or anticoagulants; caution.
Inj site reactions (eg, edema/swelling, hematoma, pain, numbness, erythema, induration, paresthesia, nodule), headache, oropharyngeal pain, hypertension, nausea, dysphagia; paresis.
Single-patient use vials (2mL)—4
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