Deoxycholic Acid

Deoxycholic Acid is a prescription medication used for the reduction of submental fat.

• Deoxycholic Acid is available under various brand names: Kybella.

Common side effects of Deoxycholic Acid include:

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

Serious side effects of Deoxycholic Acid include:

• 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
• open sores (ulcers)
• damage and tissue cell-death (necrosis) around the injection site
• Begin to develop weakness in the muscles of your face, or your smile becomes uneven
• Difficulty swallowing, or worsening symptoms
• Develop open sores or drainage from the treatment area

Rare side effects of Deoxycholic Acid include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Solution for injection

• 10 mg/mL (supplied in 2 mL vials)

Submental Fat Reduction

Adult dosage

• 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

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Deoxycholic Acid has no noted severe interactions with any other drugs.
• Deoxycholic Acid has no noted serious interactions with any other drugs.
• Deoxycholic Acid has no noted  moderate interactions with any other drugs.
• Deoxycholic Acid has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Presence of infection at the injection sites

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Deoxycholic Acid?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Deoxycholic Acid?”

Cautions

• Marginal mandibular nerve injury, manifested as an asymmetric smile or facial muscle weakness (paresis), were reported during clinical trials; do not inject into or in close proximity to the marginal mandibular branch of the facial nerve
• Difficulty swallowing (dysphagia) occurred in clinical trials in the setting of administration site reactions (eg, pain, swelling, and induration of the submental area); current or prior history of dysphagia may exacerbate the condition; avoid use in these patients
• Injection site hematoma/bruising reported in 72% of patients treated; caution in patients with bleeding abnormalities or who are currently being treated with antiplatelet or anticoagulant therapy as excessive bleeding or bruising in the treatment area may occur
• Risk of injecting in proximity to vulnerable anatomic structures; to avoid potential tissue damage, should not be injected into or in close proximity (1-1.5 cm) to salivary glands, lymph nodes, and muscles
• Injection site alopecia have been reported; consider withhold subsequent treatment until resolution
• Injections that are too superficial (into the dermic) may result in skin ulceration and necrosis; do not administer into affected area until complete resolution

Pregnancy & Lactation

• There are no adequate and well-controlled studies in pregnant women to inform the drug-associated risk
• Lactation
  • Unknown if distributed in human breast milk