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Deoxycholic Acid

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Overview

What is KYBELLA?

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 CHO, and its molecular weight is 392.57 g/mol. The chemical structure of deoxycholic acid is:

Each 2 mL vial of KYBELLA (deoxycholic acid) 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. 



What does KYBELLA look like?



What are the available doses of KYBELLA?

Injection: 10 mg/mL. KYBELLA (deoxycholic acid) injection is a clear, colorless, sterile solution supplied in 2 mL vials intended for single patient use.  Each milliliter of the solution contains 10 mg of deoxycholic acid.

What should I talk to my health care provider before I take KYBELLA?

How should I use KYBELLA?

KYBELLA (deoxycholic acid) injection is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults.

0.2 mL injections spaced 1 cm apart until all sites in the planned treatment area have been injected. ()

Up to 50 injections or 10 mL may be injected in a single treatment. ()

Up to 6 single treatments may be administered at intervals no less than 1-month apart. ()

See General Considerations for Administration and Injection Technique before injection. (, )


What interacts with KYBELLA?

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What are the warnings of KYBELLA?

Sorry No Records found


What are the precautions of KYBELLA?

Sorry No Records found


What are the side effects of KYBELLA?

Sorry No records found


What should I look out for while using KYBELLA?

KYBELLA (deoxycholic acid) injection is contraindicated in the presence of infection at the injection sites.


What might happen if I take too much KYBELLA?

Injection of excessive doses/volumes of KYBELLA (deoxycholic acid) injection may increase the risk of adverse reactions. 


How should I store and handle KYBELLA?

Storage and HandlingStore at 20ºC-25ºC (68ºF-77ºF); excursions permitted to 15ºC- 30ºC (59ºF -86ºF) [See USP Controlled Room Temperature].Storage and HandlingStore at 20ºC-25ºC (68ºF-77ºF); excursions permitted to 15ºC- 30ºC (59ºF -86ºF) [See USP Controlled Room Temperature].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 61168-101-04Store 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.  Discard unused portion.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 61168-101-04Store 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.  Discard unused portion.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 61168-101-04Store 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.  Discard unused portion.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 61168-101-04Store 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.  Discard unused portion.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 61168-101-04Store 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.  Discard unused portion.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

KYBELLA (deoxycholic acid) injection is a cytolytic drug, which when injected into tissue physically destroys the cell membrane causing lysis.

Non-Clinical Toxicology
KYBELLA (deoxycholic acid) injection is contraindicated in the presence of infection at the injection sites.

Cases of marginal mandibular nerve injury, manifested as an asymmetric smile or facial muscle weakness (paresis), were reported during clinical trials.  To avoid the potential for nerve injury, KYBELLA (deoxycholic acid) injection should not be injected into or in close proximity to the marginal mandibular branch of the facial nerve.  All marginal mandibular nerve injuries reported from the trials resolved spontaneously (range 1-298 days, median 44 days).

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Interactions

Interactions

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