Deoxycholic acid

>10%

Edema/swelling at injection sites (87%)

Hematoma/bruising (72%)

Pain (70%)

Numbness (66%)

Erythema (27%)

Induration (23%)

Paresthesia (14%)

Nodule (13%)

Pruritus (12%)

1-10%

Headache (8%)

Skin tightness (5%)

Site warmth (4%)

Nerve injury (4%)

Oropharyngeal pain (3%)

Hypertension (3%)

Nausea (2%)

Dysphagia (2%)

You should not use deoxycholic acid if you are allergic to it, or if you have:

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

To make sure deoxycholic acid is safe for you, tell your doctor if you have:

• a history of 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 this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether deoxycholic acid passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

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

Tell your doctor about all your current medicines and any you start or stop using, especially:

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

• any 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 interactions are listed in this medication guide.

Specific Drugs

It is essential that the manufacturer’s labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Please see product labeling for drug interaction information.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Face muscle weakness or uneven smile.
• Very bad irritation where the shot was given.
• Trouble swallowing.

• Kybella

Presence of infection at the injection sites

Do not dilute.

Agents with Antiplatelet Properties (e.g., P2Y12 inhibitors, NSAIDs, SSRIs, etc.): May enhance the adverse/toxic effect of Deoxycholic Acid. Specifically, the risk for bleeding or bruising in the treatment area may be increased. Monitor therapy

Anticoagulants: May enhance the adverse/toxic effect of Deoxycholic Acid. Specifically, the risk for bleeding or bruising in the treatment area may be increased. Monitor therapy

Concerns related to adverse effects:

• Bruising/bleeding: Injection site hematoma or bruising has been reported.

• Dysphagia: Dysphagia has occurred in the setting of administration site reactions (eg, pain, swelling, and submental area induration). All occurrences resolved spontaneously (median 34 days; range 1 to 81 days).

• Nerve injury: Marginal mandibular nerve injury (eg, asymmetric smile or facial muscle paresis) has been reported. All injuries resolved spontaneously (median 44 days; range 1 to 298 days). Do not inject into or in close proximity to the marginal mandibular branch of the facial nerve.

Disease-related concerns:

• Bleeding abnormalities: Use with caution in patients with bleeding abnormalities or who are currently taking antiplatelet or anticoagulant therapy. Excessive bleeding or bruising in treatment area may occur.

• Dysphagia: Avoid use in patients with current or prior history of dysphagia; condition may be exacerbated.

Other warnings/precautions:

• Administration: For subcutaneous use only. Do not inject into or in close proximity (1 to 1.5 cm) of salivary glands, lymph nodes, or muscles. To avoid injury to the marginal mandibular nerve, do not inject above the inferior border of the mandible; do not inject within a region defined by a 1 to 1.5 cm line below the inferior border (from the angle of the mandible to the mentum); and only inject within the target submental fat treatment area.

• Appropriate use: Screen patients for other causes of submental convexity/fullness (eg, thyromegaly, cervical adenopathy). Use caution in patients with prior submental surgical or aesthetic treatments; changes in anatomy or landmarks, presence of scar tissue may impact safe administration or aesthetic result. Carefully consider use in patients with excessive skin laxity or prominent platysmal bands or other conditions for which reduction of submental fat may be aesthetically undesirable.

Adverse events have been observed in some animal reproduction studies. Pregnant women and women of reproductive potential not using effective contraception were excluded from initial studies (McDiarmid, 2014; Rzany, 2014).

Applies to deoxycholic acid: subcutaneous solution

Along with its needed effects, deoxycholic acid may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking deoxycholic acid:

• Headache
• muscle weakness in the face
• pain in the mouth or throat
• pounding in the ears
• slow or fast heartbeat
• trouble swallowing
• uneven smile

• Fainting
• neck pain
• swollen, painful, or tender lymph glands in the neck

Some side effects of deoxycholic acid may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Bleeding, blistering, bruising, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tightness of the skin, tingling, ulceration, or warmth at the injection site

• Nausea

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.

Data not available