of issues of safety Deoxycholic Acid Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings User Reviews Support Group Q & A Pronunciation (dee ox i KOE lik AS id) Index Terms ATX-101 Dosage Forms Excipient information presented when available (limited, particularly for generics); consult specific product labeling. Solution, Subcutaneous: Kybella: 20 mg/2 mL (2 mL) [contains benzyl alcohol] Slideshow Drug Treatments for Rheumatoid Arthritis - What Are Your Options? Brand Names: U.S. Kybella Pharmacologic Category Lipolytic Pharmacology Deoxycholic acid is a cytolytic drug that physically destroys the cell membrane causing lysis when injected into tissue. Absorption Rapid after subcutaneous injection Metabolism Not metabolized to any significant extent Excretion Feces (as intact drug) Time to Peak 18 minutes Duration of Action Post treatment deoxycholic plasma levels return to endogenous range within 24 hours Protein Binding 98% Use: Labeled Indications Submental convexity/fullness: Improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults. Limitations of use: The safe and effective use for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended. Contraindications Presence of infection at the injection sites Dosing: Adult Submental convexity/fullness: SubQ: Inject into submental subcutaneous fat tissue at an area-adjusted dose of 2 mg/cm 2 (maximum per treatment: 50 injections spaced 1 cm apart [0.2 mL each; total 10 mL]). Maximum number of treatments: 6 treatments spaced at 1-month intervals. Dosing: Renal Impairment There are no dosage adjustments provided in the manufacturer's labeling. Dosing: Hepatic Impairment There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); however, doses administered are ~3% of total body acid pool and are unlikely to be affected by hepatic impairment. Reconstitution Do not dilute. Administration Subcutaneous: Prior to each treatment, palpate the submental area to ensure sufficient submental fat in the target treatment area. Outline the planned treatment area with a surgical pen and apply a 1 cm injection grid to mark the injection sites; do not inject outside the defined parameters. Using a large bore needle, draw 1 mL into a sterile 1 mL syringe. Have the patient tense the platysma. Pinch the submental fat and, using a 30 gauge (or smaller) 0.5 inch needle, inject 0.2 mL into the preplatysmal fat next to each of the marked injection sites by advancing the needle perpendicular to the skin. Inject into fat tissue at the depth of approximately mid-way into the subcutaneous fat layer; avoid injection into the postplatysmal fat. Upon needle withdrawal, pressure may be applied to each injection site as necessary to minimize bleeding; an adhesive dressing may be applied. Ice/cold packs, topical and/or injectable local anesthesia (eg, lidocaine) may be used. Discard any remaining solution after use. Storage Store intact vials at 20 C to 25 C (68 F to 77 F); excursions are permitted between 15 C and 30 C (59 F and 86 F). Drug Interactions Agents with Antiplatelet Properties (e.g., P2Y12 inhibitors, NSAIDs, SSRIs, etc.): May enhance the adverse/toxic effect of Deoxycholic Acid. Specifically, the risk for bleeding or bruising in the treatment area may be increased. Monitor therapy Anticoagulants: May enhance the adverse/toxic effect of Deoxycholic Acid. Specifically, the risk for bleeding or bruising in the treatment area may be increased. Monitor therapy Adverse Reactions Frequency not always defined. Cardiovascular: Hypertension (3%), presyncope, syncope Central nervous system: Paresthesia (14%), headache (8%), neuropathy (4%, marginal mandibular) Dermatologic: Injection site pruritus (12%), skin tightness (5% injection site), skin discoloration at injection site, urticaria at injection site Gastrointestinal: Dysphagia (2%), nausea (2%) Hematologic & oncologic: Lymphadenopathy Local: Injection site reaction (96%), swelling at injection site (20% to 87%), bruising at injection site (72%), hematoma at injection site (72%), pain at injection site (16% to 70%), injection site numbness (42% to 66%), erythema at injection site (27%), induration at injection site (23%), injection site nodule (13%), warm sensation at injection site (4%), bleeding at injection site Neuromuscular & skeletal: Neck pain Respiratory: Oropharyngeal pain (3%) Warnings/Precautions Concerns related to adverse effects: Bruising/bleeding: Injection site hematoma or bruising has been reported. Dysphagia: Dysphagia has occurred in the setting of administration site reactions (eg, pain, swelling, and submental area induration). All occurrences resolved spontaneously (median 34 days; range 1 to 81 days). Nerve injury: Marginal mandibular nerve injury (eg, asymmetric smile or facial muscle paresis) has been reported. All injuries resolved spontaneously (median 44 days; range 1 to 298 days). Do not inject into or in close proximity to the marginal mandibular branch of the facial nerve. Disease-related concerns: Bleeding abnormalities: Use with caution in patients with bleeding abnormalities or who are currently taking antiplatelet or anticoagulant therapy. Excessive bleeding or bruising in treatment area may occur. Dysphagia: Avoid use in patients with current or prior history of dysphagia; condition may be exacerbated. Other warnings/precautions: Administration: For subcutaneous use only. Do not inject into or in close proximity (1 to 1.5 cm) of salivary glands, lymph nodes, or muscles. To avoid injury to the marginal mandibular nerve, do not inject above the inferior border of the mandible; do not inject within a region defined by a 1 to 1.5 cm line below the inferior border (from the angle of the mandible to the mentum); and only inject within the target submental fat treatment area. Appropriate use: Screen patients for other causes of submental convexity/fullness (eg, thyromegaly, cervical adenopathy). Use caution in patients with prior submental surgical or aesthetic treatments; changes in anatomy or landmarks, presence of scar tissue may impact safe administration or aesthetic result. Carefully consider use in patients with excessive skin laxity or prominent platysmal bands or other conditions for which reduction of submental fat may be aesthetically undesirable. Monitoring Parameters Monitor postinjection for submental area induration, pain or swelling or marginal mandibular nerve injury. Pregnancy Considerations Adverse events have been observed in some animal reproduction studies. Pregnant women and women of reproductive potential not using effective contraception were excluded from initial studies (McDiarmid, 2014; Rzany, 2014). Patient Education Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?) Patient may experience injection site bleeding, pain, or area that feels hard or numb, or headache. Have patient report immediately to prescriber facial weakness, uneven smile, severe injection site irritation, or difficulty swallowing (HCAHPS). Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients. Next Interactions Print this page Add to My Med List More about deoxycholic acid Side Effects During Pregnancy Dosage Information Drug Interactions Support Group En Español 3 Reviews Add your own review/rating Drug class: miscellaneous uncategorized agents Consumer resources Deoxycholic acid Deoxycholic acid Subcutaneous (Advanced Reading) Professional resources Deoxycholic Acid (AHFS Monograph) Other brands: Kybella Related treatment guides Submental Fullness} Drug Status Rx Availability Prescription only N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Deoxycholic acid Rating 3 User Reviews 6.3 /10 3 User Reviews 6.3 Rate it! Drug Class Miscellaneous uncategorized agents Related Drugs miscellaneous uncategorized agents Accutane , isotretinoin , anagrelide , Esbriet , Claravis Submental Fullness Kybella , More...} } motivated
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