Kybella

What is Kybella?

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

It is not known if Kybella is safe and effective in children under 18 years of age.

It is not known if Kybella is safe and effective for the treatment of fat outside of the submental area.

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 C24H40O4, 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.

Mechanism of Action

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

Who should not use Kybella?

Do not receive Kybella if:

• you have an infection in the treatment area

What should I tell my healthcare provider before using Kybella?

Before receiving Kybella, tell your healthcare provider about all of your medical conditions, including if you:

• have had or plan to have surgery on your face, neck, or chin
• have had cosmetic treatments on your face, neck, or chin
• have had or have medical conditions in or near the neck area
• have had or have trouble swallowing
• have bleeding problems
• are pregnant or plan to become pregnant. It is not known if Kybella will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Kybella passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you take a medicine that prevents the clotting of your blood (antiplatelet or anticoagulant medicine).

How should I take Kybella?

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

What are the possible side effects of Kybella?

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:
  • a collection of blood under the skin (hematoma) or bruising
  • damage to an artery or vein if Kybella is inadvertently injected into it
  • hair loss
  • nausea
  • open sores (ulcers)
  • damage and tissue cell-death (necrosis) around the injection site

Call your healthcare provider if you:

• begin to develop weakness in the muscles of your face, or your smile becomes uneven
• you have difficulty swallowing, or if any of the symptoms that you already have get worse
• develop open sores or drainage from the treatment area

The most common side effects of Kybella include:

• swelling
• redness
• pain
• areas of hardness in the treatment area
• numbness

These are not all of the possible side effects of Kybella. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Kybella.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for more information about Kybella that is written for health professionals.

What are the ingredients in Kybella?

Active ingredient: deoxycholic acid

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

Label

PRINCIPAL DISPLAY PANEL