Deoxycholic acid

Deoxycholic acid is a synthetic version of a substance that your body naturally produces to help absorb fats. Deoxycholic acid works by breaking down fat cells in the area where it is injected.

Deoxycholic acid is used to reduce the appearance of fat under the chin, which is often referred to as a double-chin.

Deoxycholic acid has not been tested for safe use on other parts of the body.

Deoxycholic acid may also be used for reasons not mentioned in this medication guide.

Deoxycholic acid 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 help reduce pain and make you comfortable during the injections.

Deoxycholic acid must be given in a series of up to 6 treatment sessions 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 seen visible results after 2 to 4 sessions.

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

Follow all instructions on your medicine label and package. Inform each of your healthcare providers about all your medical conditions, allergies, and all medicines you are taking.

You should not be treated with deoxycholic acid if you are allergic to it, 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 deoxycholic acid 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.

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

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

Deoxycholic acid may cause serious side effects. Call your doctor immediately 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 side effects of deoxycholic acid 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 the FDA at 1-800-FDA-1088.

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.

Call your doctor for instructions if you miss an appointment for your deoxycholic acid 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, drinks, or activities.

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 affect deoxycholic acid, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.