Deoxycholic Acid

FDA Drug Information • Also known as: Kybella

Brand Names: Kybella
Dosage Form: POWDER
Product Type: BULK INGREDIENT

Description

11 DESCRIPTION KYBELLA (deoxycholic acid) injection, 10 mg/mL is a clear colorless, sterile solution for subcutaneous use. It contains a cytolytic agent, deoxycholic acid, as the active ingredient. The chemical name of deoxycholic acid is 3α,12α-dihydroxy-5β-cholan-24-oic acid, and its molecular formula is C 24 H 40 O 4 , and its molecular weight is 392.57 g/mol. The chemical structure of deoxycholic acid is: Each 2 mL vial of KYBELLA injection contains 20 mg synthetic deoxycholic acid as the active ingredient and the following inactive ingredients: benzyl alcohol (18 mg), dibasic sodium phosphate (2.84 mg), sodium chloride (8.76 mg), sodium hydroxide (2.86 mg) in water for injection, USP. Hydrochloric acid and additional sodium hydroxide are added as necessary to adjust the formulation to pH 8.3. Each vial is for single patient use. The chemical structure of deoxycholic acid.

What Is Deoxycholic Acid Used For?

1 INDICATIONS AND USAGE KYBELLA ® (deoxycholic acid) injection is indicated for 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 of KYBELLA for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended. KYBELLA is a cytolytic drug indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults. ( 1 ) Limit ation s of use The safe and effective use of KYBELLA for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended. ( 1 )

Dosage and Administration

2 DOSAGE AND ADMINISTRATION 0.2 mL injections spaced 1 cm apart until all sites in the planned treatment area have been injected. ( 2.1 ) Up to 50 injections or 10 mL may be injected in a single treatment. ( 2.1 ) Up to 6 single treatments may be administered at intervals no less than 1-month apart. ( 2.1 ) See General Considerations for Administration and Injection Technique before injection. ( 2.2 , 2.3 ) Figure 1. Avoid the Marginal Mandibular Nerve Area Figure 2. Sagittal View of Platysma Area Figure 3. Injection Pattern 2.1 Dos age KYBELLA injection is injected into subcutaneous fat tissue in the submental area using an area-adjusted dose of 2 mg/cm 2 . A single treatment consists of up to a maximum of 50 injections, 0.2 mL each (up to a total of 10 mL), spaced 1 cm apart. Up to 6 single treatments may be administered at intervals no less than 1 month apart. See General Considerations for Administration ( 2.2 ) and Injection Technique ( 2.3 ) before injection. 2.2 General Considerations for Administration KYBELLA should be administered by a healthcare professional. Screen patients for other potential causes of submental convexity/fullness (e.g., thyromegaly and cervical lymphadenopathy). Give careful consideration to the use of KYBELLA in patients with excessive skin laxity, prominent platysmal bands or other conditions for which reduction of submental fat may result in an aesthetically undesirable outcome. Use caution in patients who have had prior surgical or aesthetic treatment of the submental area. Changes in anatomy/landmarks or the presence of scar tissue may impact the ability to safely administer KYBELLA or to obtain the desired aesthetic result. KYBELLA is clear, colorless and free of particulate matter. Visually inspect KYBELLA vials for particulate matter and/or discoloration, and discard the vial if the solution is discolored and/or contains particulate matter. After use, discard any remaining solution in the vial. 2. 3 Injection Technique The safe and effective use of KYBELLA depends on the use of the correct number and locations for injections, proper needle placement, and administration techniques. Healthcare professionals administering KYBELLA must understand the relevant submental anatomy and associated neuromuscular structures in the area involved and any alterations to the anatomy due to prior surgical or aesthetic procedures [ see W a r n in g s a n d Preca u ti o ns ( 5 ) ]. Avoid injections near the area of the marginal mandibular nerve Needle placement with respect to the mandible is very important as it reduces the potential for injury to the marginal mandibular nerve, a motor branch of the facial nerve. Injury to the nerve presents as an asymmetrical smile due to paresis of lip depressor muscles [ see Warnings and Precautions ( 5.1 ) ] . 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 1-1.5 cm line below the...

Side Effects (Adverse Reactions)

6 ADVERSE REACTIONS The most common adverse reactions (>20% of subjects) include injection site edema/swelling, hematoma, pain, numbness, erythema and induration. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6 . 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two double-blind, placebo-controlled clinical trials 513 subjects were treated with KYBELLA injection and 506 subjects were treated with placebo. The population was 19-65 years old, 85% were women, 87% Caucasian, 8% African American. At baseline the population had a mean BMI of 29 kg/m 2 , moderate to severe submental convexity (graded as 2 or 3 on a 0 to 4 scale) and without excessive skin laxity. Subjects received up to 6 treatments at least 1 month apart and were followed for up to 6 months after the last received treatment. The most commonly reported adverse reactions are listed below ( Table 1 ). Table 1. Adverse Reactions in the Pooled Trials 1 and 2 a Adverse reactions KYBELLA (N=513) n (%) Placebo (N=506) n (%) Injection site reactions 492 (96%) 411 (81%) edema/swelling 448 (87%) 218 (43%) hematoma/bruising 368 (72%) 353 (70%) pain 356 (70%) 160 (32%) numbness 341 (66%) 29 (6%) erythema 136 (27%) 91 (18%) induration 120 (23%) 13 (3%) paresthesia 70 (14%) 20 (4%) nodule 68 (13%) 14 (3%) pruritus 64 (12%) 30 (6%) skin tightness 24 (5%) 6 (1%) site warmth 22 (4%) 8 (2%) nerve injury b 20 (4 %) 1 (<1%) Headache 41 (8%) 20 (4%) Oropharyngeal pain 15 (3%) 7 (1%) Hypertension 13 (3%) 7 (1%) Nausea 12 (2%) 3 (1%) Dysphagia 10 (2%) 1 (<1%) a Adverse reactions that occurred in ≥ 2% KYBELLA treated subjects and at greater incidence than placebo b Marginal mandibular nerve paresis Other adverse reactions associated with the use of KYBELLA include: injection site hemorrhage, injection site discoloration, pre-syncope/syncope, lymphadenopathy, injection site urticaria, and neck pain. Adverse reactions that lasted more than 30 days and occurred in more than 10% of subjects were injection site numbness (42%), injection site edema/swelling (20%), injection site pain (16%), and injection site induration (13%). 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of KYBELLA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to KYBELLA exposure. Administration site conditions : injection site ulceration, necrosis, infection, alopecia, scarring, and mass. Immune System Disorders: Hypersensitivity reactions including rash, urticaria, and itching. Nervous System Disorders: Oral hypoaesthesia and oral paraesthesia. Procedural Complications: Vascular injury due to inadvertent intravascular injection.

Contraindications

4 CONTRAINDICATIONS KYBELLA injection is contraindicated in the presence of infection at the injection sites. KYBELLA is contraindicated: In the presence of infection at the injection sites . ( 4 )

Pregnancy and Breastfeeding

8 . 1 Preg n a n c y Risk Summary There are no adequate and well-controlled studies of KYBELLA injection in pregnant women to inform the drug-associated risk. In animal reproduction studies, no fetal harm was observed with the subcutaneous administration of deoxycholic acid to rats during organogenesis at doses up to 5 times the maximum recommended human dose (MRHD) of 100 mg [see Data] . The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk of major birth defects in the U.S. general population is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. Data Animal Data Embryofetal development studies have been performed in rats and rabbits using subcutaneous doses of deoxycholic acid administered during the period of organogenesis. For the basis of comparing animal to human doses, the MRHD is 1.7 mg/kg (100 mg/60 kg). No evidence of fetal harm was observed in rats at up to the highest dose tested (50 mg/kg) which is 5-fold higher than the MRHD of KYBELLA based on a mg/m 2 comparison. However, missing intermediate lung lobe was noted in rabbits at all dose levels tested including the lowest dose (10 mg/kg) which is 2-fold higher than the MRHD of KYBELLA based on a mg/m 2 comparison. These effects may be related to maternal toxicity, which was also seen at all dose levels tested.

How Supplied

1 6 HOW SUPPLIED/STORAGE AND HANDLING KYBELLA (deoxycholic acid) injection, 10 mg/mL is a clear, colorless, sterile solution supplied in 2 mL, single patient use vials in the following dispensing pack: 4 vials, NDC 61168-101-04 Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. KYBELLA has a unique hologram on the vial label. If you do not see a hologram, do not use the product and call 1-800-678-1605. Each vial is for a single patient use. Do not dilute or mix KYBELLA with other compounds. Discard unused portion.

About This Information

This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

What are side effects?

Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

What are drug interactions?

Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.