Deoxycholic acid

What is Deoxycholic acid?[edit | edit source]

Deoxycholic acid (KYBELLA) is a cytolytic drug used to treat adults with moderate-to-severe fat below the chin, known as submental fat.

This medicine is used in adults to improve the appearance and profile of moderate to severe fat below the chin (submental fat), also called “double chin.”

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

This medicine cannot be used in patients with:

Recommended Dosage:

KYBELLA injection is injected into subcutaneous fat tissue in the submental area using an area-adjusted dose of 2 mg/cm2.
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.

Administration

KYBELLA is injected into the fat under your chin (up to 50 injections under your skin) by your healthcare provider.
KYBELLA injections may be given at least 1 month apart. You and your healthcare provider will decide how many treatments you need.
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.

This medicine is available in fallowing doasage form:

This medicine is available in fallowing brand namesː

The most common side effects of this medicine include:

KYBELLA can cause serious side effects, including:

Nerve injury in the jaw that can cause an uneven smile or facial muscle weakness
Trouble swallowing

Injection site problems including:

Cases of marginal mandibular nerve injury, manifested as an asymmetric smile or facial muscle weakness (paresis), were reported during clinical trials. Follow injection technique to avoid this injury.
Dysphagia may occur with KYBELLA use. Use in patients with pre-existing dysphagia may exacerbate the condition.
Submental hematoma/bruising occurs frequently after KYBELLA administration. Use with caution in patients who are being treated with antiplatelet or anticoagulant therapy or have coagulation abnormalities.
Avoid injecting in proximity to vulnerable anatomic structures due to the increased risk of tissue damage and vascular injury.
Cases of injection site alopecia have been reported with the administration of KYBELLA. Withhold subsequent treatments until resolution.
Cases of injection site ulceration and necrosis have been reported with the administration of KYBELLA. Do not administer KYBELLA into the affected area until complete resolution of the adverse reaction.

In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

Overdose related information is also available online at poisonhelp.org/help.
In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

There are no adequate and well-controlled studies of KYBELLA injection in pregnant women to inform the drug-associated risk.

Safety and effectiveness in patients below the age of 18 years have not been established and KYBELLA is not intended for use in children or adolescents.

Active ingredient: deoxycholic acid
Inactive ingredients: benzyl alcohol, dibasic sodium phosphate, hydrochloric acid, sodium chloride, sodium hydroxide and water for injection, USP.

KYBELLA® and its design are registered trademarks of Allergan Sales, LLC.

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) .
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.

Deoxycholic acid Resources
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