Cytolytic AgentPrescription OnlyPregnancy Cat. Not classifiedFDA Yes
Kybella
DEOXYCHOLIC ACID
1 INDICATIONS AND USAGE KYBELLA ® (deoxycholic acid) injection is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults. Limitations 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 is a cytolytic drug indicated for improvement in the appearance of moderate to severe convexity or fullness associated with ...
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Brand names:KYBELLA
Quick Reference
Medicine ClassCytolytic Agent
FDA ApprovedYes
PregnancyCategory Not classified
Quick Facts
- Active ingredient
- DEOXYCHOLIC ACID
- Medicine class
- Cytolytic Agent
- Brand names
- KYBELLA
- Availability
- Prescription only (Rx)
- Pregnancy category
- Not classified
- FDA approved
- Yes
What Is Kybella?
1 INDICATIONS AND USAGE KYBELLA ® (deoxycholic acid) injection is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults. Limitations 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 is a cytolytic drug indicated for improvement in the appearance of moderate to severe convexity or fullness associated with ...
Kybella (DEOXYCHOLIC ACID) belongs to the Cytolytic Agent class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.
Key Safety Information
- •Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
- •Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
- •Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
- •Avoid or limit alcohol while taking Kybella. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
- •Take Kybella with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
- •Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.
This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.
Uses & Indications
Kybella is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.
1 INDICATIONS AND USAGE KYBELLA ® (deoxycholic acid) injection is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults.
Limitations 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 is a cytolytic drug indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults.
( 1 ) Limit ation s 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.
Dosage Guide
The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.
AD
Adult Dosage
2 DOSAGE AND ADMINISTRATION 0.2 mL injections spaced 1 cm apart until all sites in the planned treatment area have been injected. ( 2.1 ) Up to 50 injections or 10 mL may be injected in a single treatment. ( 2.1 ) Up to 6 single treatments may be administered at intervals no less than 1-month apart. ( 2.1 ) See General Considerations for Administration and Injection Technique before injection. ( 2.2 , 2.3 ) Figure 1. Avoid the Marginal Mandibular Nerve Area Figure 2. Sagittal View of Platysma Area Figure 3. Injection Pattern 2.1 Dos age KYBELLA injection is injected into subcutaneous fat tissue in the submental area using an area-adjusted dose of 2 mg/cm 2 . 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. See General Considerations for Administration ( 2.2 ) and Injection Technique ( 2.3 ) before injection. 2.2 General Consider
Available Forms
Available Strengths
Side Effects
Common
- 6 ADVERSE REACTIONS The most common adverse reactions (>20% of subjects) include injection site edema/swelling, hematoma, pain, numbness, erythema and induration.
- ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
- 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
- In two double-blind, placebo-controlled clinical trials 513 subjects were treated with KYBELLA injection and 506 subjects were treated with placebo.
- The population was 19-65 years old, 85% were women, 87% Caucasian, 8% African American.
- At baseline the population had a mean BMI of 29 kg/m 2 , moderate to severe submental convexity (graded as 2 or 3 on a 0 to 4 scale) and without excessive skin laxity.
- Subjects received up to 6 treatments at least 1 month apart and were followed for up to 6 months after the last received treatment.
Serious
- 5 WARNINGS AND PR E CAUTIONS Marginal mandibular nerve (MMN) injury: Follow injection technique to avoid this injury.
- ( 2.3 , 5.1 ) Dysphagia may occur with KYBELLA use.
- Use in patients with pre-existing dysphagia may exacerbate the condition.
- ( 5.2 ) Submental hematoma/bruising occurs frequently after KYBELLA administration.
- Use with caution in patients who are being treated with antiplatelet or anticoagulant therapy or have coagulation abnormalities.
Rare
Medicine Interactions
Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.
MajorModerateMinor
Warnings & Contraindications
5 WARNINGS AND PR E CAUTIONS Marginal mandibular nerve (MMN) injury: Follow injection technique to avoid this injury. ( 2.3 , 5.1 ) Dysphagia may occur with KYBELLA use. Use in patients with pre-existing dysphagia may exacerbate the condition. ( 5.2 ) Submental hematoma/bruising occurs frequently after KYBELLA administration. Use with caution in patients who are being treated with antiplatelet or
How Kybella Works
12.1 Mechanism of Action KYBELLA injection is a cytolytic drug, which when injected into tissue physically destroys the cell membrane causing lysis.
Pharmacokinetics
Absorption
Absorption and Distribution Deoxycholic acid from KYBELLA is rapidly absorbed following subcutaneous injection
Metabolism
Metabolism and Excretion Endogenous deoxycholic acid is a product of cholesterol metabolism and is excreted intact in feces
Excretion
Excretion Endogenous deoxycholic acid is a product of cholesterol metabolism and is excreted intact in feces
Pregnancy & Breastfeeding Safety
Not classified
Breastfeeding
Many medications pass into breast milk in varying amounts. Before using Kybellawhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.
Storage & Handling
Store at room temperature. Keep away from moisture and heat. Keep out of reach of children.
Frequently Asked Questions
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Adult, pediatric, renal, and hepatic dosing for Kybella
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Kybella side effects
Complete adverse effect profile including common, serious, and rare reactions
Sources & References
- • FDA Prescribing Information — Official labeling and package insert for Kybella
- • U.S. National Library of Medicine — MedlinePlus drug information
- • American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
- • PubMed / MEDLINE — View clinical studies
Last reviewed by MedCentralHub Medical Review Board · MedCentralHub Editorial Policy
Medical Disclaimer
The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.