Kybella

Dosage Forms & Strengths

solution for injection

• 10mg/mL (supplied in 2mL vials)

Submental Fat Reduction

Indicated for improvement in the appearance of moderate-to-severe convexity or fullness associated with submental fat (ie, double chin) in adults

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

Up to 6 single treatments may be administered at intervals no less than 1 month apart

Dosing Considerations

Safe and effective use for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended

<18 years: Safety and efficacy not established

Not intended for use in children or adolescents

There are no adequate and well-controlled studies in pregnant women to inform the drug-associated risk

Animal data: Embryofetal development studies performed in rats and rabbits using SC doses administered during the period of organogenesis; for the basis of comparing animal to human doses, the maximum recommended human dose (MRHD) is 1.7 mg/kg (100 mg/60 kg); no evidence of fetal harm was observed in rats at up to the highest dose tested (50 mg/kg), which is 5-fold higher than the MRHD of deoxycholic acid based on a mg/m² comparison

Lactation: Unknown if distributed in human breast milk

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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.

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.

Serious side effects have been reported with Kybella. See the “Kybella Precautions” section.

Common side effects of Kybella include the following in the treatment area:

• swelling
• bruising
• pain
• numbness
• redness
• areas of hardness

This is not a complete list of Kybella side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

It is not known if Kybella crosses into human milk.  Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Kybella.

General

Deoxycholic acid is available in the following dosage form(s) and strength(s):

• Injection: 10 mg/mL sterile solution, supplied in 2 mL vials. Each vial is for single patient use.1

Dosage

It is essential that the manufacturer’s labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Deoxycholic acid is injected into subcutaneous fat tissue in the submental area using an area-adjusted dose of 2 mg/cm2:1

• 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.1

• Up to 6 single treatments may be administered at intervals no less than 1 month apart.1

Administration Instructions

• Dilution or admixture with other compounds is not recommended.1

• Consult manufacturer's labeling for additional information on administration of deoxycholic acid, including injection technique, before injection.1

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.

A nurse or other trained health professional will give you this medicine. This medicine 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.

• If you have an allergy to Kybella (deoxycholic acid) or any part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have an infection where the shot will be given.
• If you have ever had trouble swallowing.

This is not a list of all drugs or health problems that interact with Kybella.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Kybella, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Kybella. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Kybella.

Review Date: October 4, 2017

Fullness Associated with Submental Fat

Kybella™ (deoxycholic acid) injection is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults.

Limitation of use

The safe and effective use of Kybella for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended.

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 (deoxycholic acid) 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.

Kybella (deoxycholic acid) injection, 10 mg/mL is a clear, colorless, sterile solution supplied in 2 mL, single patient use vials in the following dispensing pack:

4 vials, NDC 61168-101-04

Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

Kybella has a unique hologram on the vial label. If you do not see a hologram, do not use the product and call 1-844-KYTHERA (1-844-598-4372).

Each vial is for a single patient use. Do not dilute. Discard unused portion.

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Advise patients to inform their healthcare professional if they develop signs of marginal mandibular nerve paresis (e.g., asymmetric smile, facial muscle weakness), difficulty swallowing, or if any existing symptom worsens.

Manufactured for Kythera Biopharmaceuticals, Inc., Westlake Village, CA 91362

© 2015 Kythera Biopharmaceuticals, Inc.

Trademarks owned by Kythera Biopharmaceuticals, Inc.

U.S. Patents 8,298,556; 7,622,130; 7,754,230; 8,242,294; 8,101,593; 8,367,649; 8,653,058, 8,461,140; 8,846,066; other patents pending

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

Call your doctor at once if you have:

• trouble swallowing;

• weak muscles in your face; or

• a crooked smile.

Common Kybella side effects may include:

• pain, swelling, bruising, or redness of treated skin areas; or

• numbness or hardening 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 FDA at 1-800-FDA-1088.