Pronunciation:

des-ox-i-KOE-lik AS-id

Brand Names:

• Kybella

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Dermatological Agent

Uses of This Medicine:

Deoxycholic acid is used to help improve the appearance of moderate to severe fat below the chin (submental fat), also called double chin.

This medicine is to be given only by or under the immediate supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Deoxycholic acid is not indicated for use in children. Safety and efficacy have not been established.

Older adults—

Although appropriate studies on the relationship of age to the effects of deoxycholic acid have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving deoxycholic acid.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems or
• Trouble swallowing, or history of—Use with caution. May make these conditions worse.

• Infection at the injection site—Should not be used in patients with this condition.

• Medical conditions in or near the neck area (eg, thyroid problems, lymph node problems) or
• Surgery or cosmetic treatment on the face, neck, or chin—Use with caution. May increase risk for more serious side effects.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. It is injected into the fat under the skin of your chin.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Precautions While Using This Medicine:

Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

This medicine may cause nerve injury in the jaw. Check with your doctor right away if you have an uneven smile or muscle weakness in the face.

Tell your doctor if you are using an antiplatelet medicine (eg, aspirin) or a blood thinner (eg, warfarin). These medicines may increase the risk of bleeding or bruising in the treatment area.

This medicine may cause injection site reactions (eg, ulcers, necrosis, and infection). Check with your doctor right away if you have pain, redness, swelling, or open sores at the injection site.

Side Effects of This Medicine:

Along with its needed effects, a medicine 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:

Less common

Headache

muscle weakness in the face

pain in the mouth or throat

pounding in the ears

slow or fast heartbeat

trouble swallowing

uneven smile

Incidence not known

Blue-green to black skin discoloration

cracking of the skin

fainting

neck pain

pain, redness, or sloughing of the skin at the injection site

swollen, painful, or tender lymph glands in the neck

Some side effects 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:

More common

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

Less common

Nausea

Incidence not known

Hair loss at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.