Belkyra (Deoxycholic Acid)

What Is Belkyra and What Is It Used For?

Belkyra (deoxycholic acid) is an injectable prescription medicine used in adults to reduce moderate to severe submental fat — the unwanted fat beneath the chin commonly known as a “double chin” — when this condition has a significant psychological impact on the patient.

Submental fullness, colloquially referred to as a “double chin,” is a common aesthetic concern that affects both men and women of all ages and body types. While often associated with weight gain, submental fat can also be influenced by genetic predisposition, aging, and changes in skin elasticity. For many individuals, submental fullness persists despite diet and exercise, leading to self-consciousness and reduced confidence in social and professional settings.

The active substance in Belkyra is deoxycholic acid, a bile acid that occurs naturally in the human body. In its physiological role, deoxycholic acid is produced in the liver and aids in the emulsification and absorption of dietary fat in the intestines. The deoxycholic acid used in Belkyra is a synthetic, non-human and non-animal-derived form that is chemically identical to the naturally occurring molecule. This means the body can metabolize and process it through the same pathways.

When Belkyra is injected in small quantities directly beneath the skin of the submental area, the deoxycholic acid disrupts the cell membranes of adipocytes (fat cells), causing them to break open and release their lipid contents. This process, known as adipocytolysis, triggers the body’s natural inflammatory response, which gradually clears the destroyed cellular debris. Over the weeks following treatment, the body reabsorbs the released fat through its normal metabolic pathways, resulting in a measurable reduction in submental fullness.

A critical feature of Belkyra treatment is that the fat reduction is permanent. Once fat cells in the submental area are destroyed, they do not regenerate. This distinguishes Belkyra from temporary cosmetic treatments such as injectable dermal fillers or skin-tightening procedures. However, significant weight gain after treatment could cause any remaining fat cells in the area to enlarge, which could partially diminish the cosmetic result.

Regulatory Approval and International Use

Belkyra received marketing authorization from the European Medicines Agency (EMA) in 2017 and is approved in numerous countries including the EU member states, Canada, and Australia. In the United States, the same formulation is marketed under the brand name Kybella and was approved by the FDA in 2015. The clinical evidence supporting both products is identical, as they are manufactured by AbbVie (formerly Allergan Aesthetics) using the same formulation and production process.

The approval of Belkyra was based on two pivotal phase III clinical trials (REFINE-1 and REFINE-2) involving over 1,000 patients. These randomized, double-blind, placebo-controlled studies demonstrated that patients treated with Belkyra experienced statistically significant and clinically meaningful reductions in submental fat compared to placebo, as measured by both clinician-assessed and patient-reported outcomes. Satisfaction rates were high, with the majority of treated patients reporting improved self-perception of their chin profile.

What Should You Know Before Taking Belkyra?

Before receiving Belkyra, your doctor will examine the area under your chin and discuss your medical history. You must not receive Belkyra if you are allergic to deoxycholic acid, if you have an infection at the injection site, or if you are pregnant. Special caution is needed if you have had previous surgery or scarring in the chin or neck area.

Patient selection is an essential component of safe and effective Belkyra treatment. Your healthcare provider will conduct a thorough assessment of your submental area before each treatment session. This includes evaluating the amount and distribution of submental fat, the quality and elasticity of the overlying skin, the presence of prominent platysma bands (neck muscles), and any anatomical factors that could affect treatment outcomes or increase the risk of complications.

Contraindications

You must not receive Belkyra if:

• You are allergic (hypersensitive) to deoxycholic acid or any of the other ingredients in the formulation (sodium chloride, sodium hydroxide, hydrochloric acid, disodium phosphate anhydrous, water for injections)
• You have an active infection in the chin or neck area where the product would be injected

If you have had a previous allergic reaction to any injectable treatment, discuss this with your doctor before proceeding with Belkyra.

Warnings and Precautions

Talk to your doctor, pharmacist, or nurse before receiving Belkyra if any of the following apply to you:

• Previous surgery in the chin or neck area: Including liposuction, facelift, neck lift, or other procedures that may have altered the anatomy or created scarring
• Difficulty swallowing (dysphagia): Pre-existing swallowing problems should be disclosed as Belkyra may temporarily worsen this condition
• Enlarged thyroid or lymph nodes: These conditions require careful evaluation before treatment
• Bleeding disorders: Or if you are taking anticoagulant or antiplatelet medications that increase bleeding risk
• Scarring or keloid formation tendency: Tissue damage from the treatment could potentially lead to scar formation

Who Should Not Use Belkyra

Belkyra is not suitable for everyone with submental fullness. Your doctor should carefully consider whether the treatment is appropriate if:

• You are generally overweight — Belkyra is not a weight-loss treatment and is not intended for patients whose submental fullness is primarily caused by overall excess body weight
• You have body dysmorphic disorder — a condition where a person has a distorted perception of their appearance. Belkyra treatment is unlikely to resolve the underlying psychological distress in these cases
• You have very loose or sagging skin under the chin without significant fat deposits — reducing fat in this scenario may worsen the appearance of loose skin
• You have prominent platysma bands — visible neck muscle bands that may become more apparent after fat reduction

Pregnancy and Breastfeeding

The effects of Belkyra on pregnant or breastfeeding women have not been studied. As a precautionary measure, use of Belkyra is not recommended during pregnancy. If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or nurse before receiving this treatment.

Driving and Operating Machinery

Belkyra is not expected to directly affect your ability to drive or operate machinery. However, you are personally responsible for assessing whether you are in a suitable condition to perform these activities after treatment. Swelling, pain, and numbness at the injection site are very common side effects that may cause temporary discomfort. Consider these factors and consult your healthcare provider if you are unsure.

Children and Adolescents

Belkyra is not intended for use in children and adolescents under 18 years of age. The safety and efficacy of this treatment have not been established in the pediatric population.

How Does Belkyra Interact with Other Drugs?

No formal drug interaction studies have been conducted with Belkyra. However, medications that affect blood clotting — such as anticoagulants and antiplatelet agents — may increase the risk of bruising and bleeding at the injection site. Always inform your doctor about all medications you are currently taking.

Because Belkyra is administered locally as a subcutaneous injection rather than taken systemically, the potential for systemic drug interactions is relatively low. The deoxycholic acid in Belkyra acts directly on fat cells at the injection site and is subsequently metabolized through the body’s normal bile acid pathways. Nevertheless, certain medications and supplements can affect the treatment experience and recovery.

Medications That May Affect Treatment

Local Anaesthetics

To improve comfort during Belkyra treatment, your healthcare provider may use oral analgesics, NSAIDs, topical anaesthetic cream, injectable local anaesthetic (such as lidocaine), or ice packs applied to the treatment area. These are considered standard practice and are not known to interact negatively with deoxycholic acid. Your healthcare provider will determine the most appropriate pain management strategy based on your individual needs and preferences.

It is important to inform your doctor about all medicines you are currently taking, have recently taken, or plan to take — including over-the-counter medicines, vitamins, and herbal supplements. While the risk of systemic interactions with Belkyra is low, this information helps your healthcare provider plan the treatment safely and manage any potential complications.

What Is the Correct Dosage of Belkyra?

Belkyra is injected by a healthcare professional in small amounts (0.2 mL per injection point) spaced 1 cm apart beneath the chin. The maximum dose per session is 10 mL (100 mg, equivalent to 50 injections). Most patients require 2 to 4 treatment sessions, with a maximum of 6 sessions spaced at least 4 weeks apart.

Belkyra is administered exclusively by a qualified healthcare professional — typically a dermatologist, plastic surgeon, or other physician with expertise in aesthetic procedures and detailed knowledge of the submental anatomy. The treatment is never self-administered and always takes place in a clinical setting. The dosage is individualized based on the patient’s specific distribution of submental fat and their treatment goals.

Treatment Protocol

What Happens During a Treatment Session

A typical Belkyra treatment session follows a structured process designed to maximize both safety and efficacy:

1. Assessment: Your doctor examines and palpates the submental area to confirm that sufficient subcutaneous fat is present and to identify the appropriate treatment zone
2. Marking: The treatment area is outlined with a surgical pen and a grid pattern of 1 cm intervals is applied to ensure even distribution of injections
3. Pain management: Topical anaesthetic cream, injectable local anaesthetic (e.g., lidocaine), oral analgesics, or cooling ice packs may be applied as your healthcare provider deems appropriate
4. Injection: Using a fine-gauge needle (30G or smaller), the healthcare provider delivers 0.2 mL of Belkyra at each marked injection point, with the needle perpendicular to the skin surface into the subcutaneous fat
5. Post-treatment care: Ice may be applied to reduce swelling. You will be observed briefly and given aftercare instructions

The total number of injection points varies depending on the size of the treatment area and the distribution of submental fat, but must not exceed 50 injections (10 mL) per session. The entire procedure typically takes 15 to 20 minutes once the area has been prepared.

Overdose

If you receive more Belkyra than the recommended dose, you may experience an increase in side effects at the injection site, particularly increased swelling, pain, and tissue reactions. If this occurs, inform your healthcare provider. Because Belkyra is always administered by a healthcare professional in a controlled clinical setting, the risk of accidental overdose is very low.

What Are the Side Effects of Belkyra?

The most common side effects of Belkyra are injection site reactions including pain, swelling, bruising, numbness, and hardness of the tissue. These are experienced by the majority of patients and typically resolve within 2 to 4 weeks. More serious but less common side effects include nerve injury causing an uneven smile, difficulty swallowing, and tissue necrosis.

Like all medicines, Belkyra can cause side effects, although not everyone experiences them. Because Belkyra works by physically destroying fat cells, some degree of inflammation and tissue reaction at the injection site is expected and is part of the normal treatment response. Most side effects are localized to the treated area and resolve within the interval between treatment sessions (4 weeks).

The side effect profile of Belkyra has been well characterized through extensive clinical trial programs involving thousands of patients. The REFINE-1 and REFINE-2 pivotal trials, along with their open-label extension studies, provided robust data on the frequency and nature of adverse events. Post-marketing surveillance has further contributed to our understanding of the safety profile.

When to Seek Immediate Medical Attention

Contact your doctor or healthcare provider immediately if you experience any of the following after Belkyra treatment:

• An uneven smile or difficulty moving your lower lip — this may indicate nerve injury
• Open sores, blistering, or darkening of the skin at the injection site — potential signs of tissue necrosis
• Increasing redness, warmth, swelling, or pain that worsens rather than improves over time — possible signs of infection
• Difficulty swallowing that persists or is severe
• Signs of allergic reaction such as widespread rash, itching, swelling of the face or throat, or difficulty breathing

Most injection site reactions observed in clinical trials improved during the 4-week period between treatments. However, some reactions — particularly numbness or altered sensation — may persist for a longer period in some patients. If tissue necrosis or significant scarring occurs, you should never receive Belkyra treatment again.

How Should You Store Belkyra?

Belkyra does not require any special storage conditions. It should be kept out of the sight and reach of children and should not be used after the expiry date. Once a vial is opened, the solution should be used immediately. Only clear, colourless solutions without visible particles should be used.

Belkyra is supplied as a ready-to-use solution in single-use glass vials. Under normal circumstances, patients do not need to store or handle Belkyra themselves, as the product is managed entirely by the healthcare professional or clinic providing the treatment. However, understanding the storage requirements can help ensure you are receiving a product that has been properly maintained.

The product should be stored at room temperature with no special temperature requirements. Each vial contains 2 mL of solution. Once the aluminium flip-off cap has been removed and the rubber stopper has been punctured, the remaining solution should be used promptly. Each vial is intended for single-patient use only — any unused solution must be discarded and should never be saved for later use or shared between patients.

Before administration, the healthcare professional will visually inspect the solution. Only clear, colourless, and sterile solutions free of visible particles may be used. If the vial, seal, or cap appears damaged, the product should not be used. The vial should be gently inverted several times before drawing up the solution for injection. The product must not be diluted.

What Does Belkyra Contain?

Each millilitre of Belkyra contains 10 mg of the active substance deoxycholic acid. The inactive ingredients include sodium chloride, sodium hydroxide, hydrochloric acid, disodium phosphate anhydrous, and water for injections. Each vial holds 2 mL (20 mg deoxycholic acid).

Active Ingredient

The active substance is deoxycholic acid, a secondary bile acid that is naturally produced in the human body by bacterial metabolism of primary bile acids in the intestine. The deoxycholic acid in Belkyra is synthetically manufactured and is chemically identical to the endogenous form. It acts locally at the injection site by disrupting the cell membranes of fat cells (adipocytes), leading to their permanent destruction.

Inactive Ingredients (Excipients)

• Water for injections — the primary solvent used to create the injectable solution
• Sodium chloride — provides isotonicity to make the solution compatible with body tissues
• Sodium hydroxide — used for dissolution of the active substance and pH adjustment
• Hydrochloric acid — used for pH adjustment to ensure physiological compatibility
• Disodium phosphate anhydrous — acts as a buffering agent to maintain stable pH

Appearance and Packaging

Belkyra is a clear, colourless, sterile solution for injection. It is supplied in Type I glass vials with chlorobutyl rubber stoppers, aluminium flanged caps, and polypropylene snap-off closures. Each carton contains 4 vials, and each vial holds 2 mL of solution. The product is intended for single-patient use only.

The marketing authorization holder is AbbVie. Manufacturing is performed by Almac Pharma Services Ltd. (Portadown, United Kingdom) and Allergan Pharmaceuticals International Ltd. (Dublin, Ireland).

Frequently Asked Questions