Kybella is a manmade form of a substance your body makes that helps to absorb fats. Deoxycholic acid works by destroying fat cells where it is injected into the body.

Kybella injection is used to help decrease the appearance of fat that hangs below the chin, sometimes called a double-chin.

Kybella has not been tested for safe use on other areas of the body.

Follow all directions on the Kybella label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Kybella is injected under the skin directly into the area beneath your chin. A healthcare provider will give you this injection.

You may be treated with a topical numbing medicine or an ice pack to ease pain and make you comfortable during the injections.

Kybella injection must be given in a series of up to 6 treatment sessions in order to be effective. You may receive up to 50 injections at each session.

Each treatment session should be spaced at least 1 month apart. Many people have had visible results after 2 to 4 sessions.

Your doctor will determine the right number of injections and how many sessions you need, depending on the results you want.

Usual Adult Dose for Submental Fat Reduction:

Area-adjusted dose of 2 mg/cm2 injected subcutaneously into fat tissue in the submental area.

Comments:
-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.
-The number of injections and the number of treatments should be tailored to the individual patient's submental fat distribution and treatment goals.

Use: Improvement in the appearance of moderate to severe convexity or fullness associated with submental fat.

You should not be treated with Kybella if you are allergic to deoxycholic acid, or if you have:

• an infection in or around the area to be treated.

Tell your doctor if you have ever had:

• surgery or other cosmetic treatments on your neck, chin, or face (or if you plan to have surgery on any of these areas);

• trouble swallowing;

• a thyroid disorder;

• swollen lymph glands in your neck; or

• a bleeding or blood clotting disorder such as hemophilia.

It is not known whether Kybella will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Kybella is not approved for use by anyone younger than 18 years old.

Call your doctor for instructions if you miss an appointment for your Kybella injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to Kybella: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• trouble swallowing;

• weak muscles in your face;

• a crooked smile;

• open skin sores or drainage around treated areas; or

• pain, burning, irritation, or skin changes where the injection was given.

Common Kybella side effects may include:

• numbness or hardening of treated areas;

• hair loss around treated areas; or

• pain, swelling, redness, or bruising, of treated areas.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• a blood thinner - warfarin, Coumadin, Jantoven; or

• any other medicines to prevent blood clots.

This list is not complete. Other drugs may interact with deoxycholic acid, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.