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Kybella Generic Name & Formulations
Legal Class
Rx
General Description
Deoxycholic acid 10mg/mL; soln for SC inj; contains benzyl alcohol.
Pharmacological Class
Cytolytic.
How Supplied
Single-patient use vials (2mL)—4
Manufacturer
Generic Availability
NO
Kybella Indications
Indications
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.
Kybella Dosage and Administration
Adult
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.
Children
<18yrs: not established.
Kybella Contraindications
Contraindications
Infection at inj sites.
Kybella Boxed Warnings
Not Applicable
Kybella Warnings/Precautions
Warnings/Precautions
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. Possible vascular injury due to inadvertent intravascular inj. Dysphagia or history of; avoid. Bleeding abnormalities. Inj site alopecia, ulceration, necrosis, and infection; withhold until resolved. Pregnancy. Nursing mothers.
Kybella Pharmacokinetics
Elimination
Fecal.
Kybella Interactions
Interactions
Excessive bleeding or bruising may occur with concomitant antiplatelets or anticoagulants; caution.
Kybella Adverse Reactions
Adverse Reactions
Inj site reactions (eg, edema/swelling, hematoma, pain, numbness, erythema, induration, paresthesia, nodule), headache, oropharyngeal pain, hypertension, nausea, dysphagia; paresis.
Kybella Clinical Trials
See Literature
Kybella Note
Not Applicable
Kybella Patient Counseling
See Literature
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