The Science Behind KYBELLA®

The Science Behind KYBELLA®: How Deoxycholic Acid Works to Reduce Submental Fullness

May 21, 2024

Submental fullness, also known as a “double chin,” is characterized by moderate to severe fat deposition beneath the chin. It can drastically impact an individual’s look and profile, resulting in dissatisfaction and a desire for cosmetic improvement. Submental fullness is a unique problem in the domain of aesthetic treatments because of its location. It is also difficult to lose fat in this area by diet and exercise alone.

KYBELLA® stands out as a unique and effective injectable treatment for submental fullness. KYBELLA® is a prescription drug used in adults to enhance the appearance and profile of moderate to severe fat beneath the chin, offering a safe and effective non-surgical option.

The key to KYBELLA®’s success is deoxycholic acid, a naturally occurring chemical in the body that aids in the digestion and absorption of dietary fat. When injected into the submental area, deoxycholic acid targets and destroys fat cells, significantly reducing submental fat. This innovative approach has made KYBELLA® the preferred choice for healthcare practitioners.

In this article, we will go deeper into the science behind KYBELLA®, looking at how deoxycholic acid works, how KYBELLA® injections are administered, and the clinical trials that have confirmed the product’s effectiveness and safety.

What is KYBELLA®?

KYBELLA® is an FDA-approved injectable treatment developed specifically to address double chin. It is a prescription medication for adults that improves the appearance and profile of moderate to severe fat under the chin. The active ingredient in KYBELLA® is deoxycholic acid, a naturally occurring molecule that aids in the digestion and absorption of dietary fat.

KYBELLA® works by specifically targeting fat cells in the submental region. When injected, deoxycholic acid kills fat cells, stopping them from storing or gaining fat. This reduces submental bulk and creates a more defined jawline and chin profile.

KYBELLA® was approved by regulatory organizations, including the United States Food and Drug Administration (FDA) after rigorous clinical trials confirmed its safety and effectiveness

These trials included over 1,600 participants and provided robust evidence supporting KYBELLA® as an effective treatment for submental fullness. The results showed significant improvements in the appearance and profile of moderate to severe submental fat, making KYBELLA® a trusted choice for healthcare professionals.

KYBELLA® offers a non-surgical option that delivers long-lasting results. As a prescription medicine, it should only be administered by trained healthcare professionals to ensure the correct injection technique and minimize potential side effects.

Understanding Deoxycholic Acid

Deoxycholic acid is a naturally occurring molecule in the body that plays a crucial role in the breakdown and absorption of dietary fat. It is a bile acid, which means it helps to emulsify fats and make them easier to digest and absorb. This unique property makes deoxycholic acid an ideal candidate for targeting and reducing fat cells in specific body areas, such as the submental area.

How Deoxycholic Acid Works on a Biological Level

On a biological level, deoxycholic acid works by disrupting the cell membrane of fat cells. When deoxycholic acid is injected into the treatment area, it causes the fat cells to rupture and release their contents. The body then metabolizes these contents, leading to the gradual reduction of fat in the targeted area. This process is highly specific to fat cells, minimizing damage to surrounding tissues and ensuring a focused treatment.

The Process of How Deoxycholic Acid is Used in KYBELLA® Injections

In the context of KYBELLA injections, deoxycholic acid is formulated as a clear, colorless injectable treatment that is administered directly into the submental fat. The treatment area is carefully marked by a healthcare professional to ensure accurate delivery of the injection. The number of injections and the amount of deoxycholic acid used will depend on the severity of the submental fullness and the desired outcome.

Once injected, deoxycholic acid begins to target the fat cells in the injection site. Patients may experience common side effects such as swelling, bruising, and numbness around the injection site. These side effects are typically temporary and resolve on their own. More serious adverse effects, such as necrosis or damage to an artery or vein, are rare but possible. It is important for healthcare professionals to follow the full prescribing information to minimize these risks and ensure safe and effective treatment.

By using deoxycholic acid in this targeted manner, KYBELLA® provides a non-surgical option for patients looking to improve the appearance and profile of moderate to severe submental fullness. The effectiveness of this treatment has been demonstrated in multiple clinical trials, which have shown significant and lasting reductions in submental fat. This makes KYBELLA a valuable tool for healthcare providers aiming to offer patients a reliable and minimally invasive solution for submental fullness.

The Mechanism of KYBELLA® Injections

Step-by-Step Process of How KYBELLA® Injections are Administered

1. Consultation and Assessment:

The healthcare professional begins with a thorough consultation to assess patients’ submental fullness and discuss their aesthetic goals. The patient’s medical history is reviewed, including any medications (such as antiplatelet or anticoagulant therapies) or herbal supplements.

2. Marking the Treatment Area:

The submental area is carefully marked to identify the precise locations for the injections. This ensures even distribution of the deoxycholic acid and optimal results.

3. Preparation:

The treatment area is cleaned and sterilized to minimize the risk of infection. A topical or local anesthetic may be applied to reduce discomfort during the procedure.

4. Injection Procedure:

KYBELLA® is administered via multiple small injections into the submental fat. The number of injections varies based on the extent of the fullness and the treatment plan. The healthcare provider follows a grid pattern to ensure uniform coverage of the submental area.

5. Post-Injection Care:

Patients may experience common side effects such as swelling, bruising, redness, and numbness around the injection site. These are typically mild to moderate and resolve within a few days. Patients are advised to avoid strenuous activities and direct sun exposure to the treated area immediately following the procedure.

How Deoxycholic Acid Targets and Destroys Fat Cells in the Submental Area

Deoxycholic acid, the active ingredient in KYBELLA®, breaks down the cell membrane of fat cells in the submental area. When injected into the submental fat, deoxycholic acid causes the fat cells to rupture. This process, known as adipocytolysis, leads to the destruction of the fat cells, rendering them unable to store or accumulate fat in the future.

The Body’s Natural Process of Eliminating the Destroyed Fat Cells

Once the fat cells in the submental area are destroyed by deoxycholic acid, the body’s natural processes take over to eliminate the cellular debris. The remnants of the ruptured fat cells are metabolized and cleared away by the body’s lymphatic system. This process involves:

  • Inflammatory Response:

The body initiates an inflammatory response to begin the breakdown and removal of the destroyed fat cells. This phase may be associated with temporary swelling and redness around the injection site.

  • Phagocytosis:

Macrophages and other immune cells engulf and digest the cellular debris through a process known as phagocytosis. This helps clear the treated area of the destroyed fat cells.

  • Metabolism and Excretion:

The liver processes the byproducts of the digested fat cells and excretes them from the body through the lymphatic and circulatory systems. This gradual elimination results in a noticeable reduction in submental fullness over time.

By leveraging the targeted action of deoxycholic acid, KYBELLA® provides a safe and effective injectable treatment for reducing moderate to severe submental fat, ultimately improving the appearance and profile of the chin and jawline. This mechanism ensures long-lasting results, as the destroyed fat cells do not regenerate.

Common and Possible Side Effects

KYBELLA® injections, like any medical treatment, can cause side effects. Understanding these effects is crucial for healthcare professionals to ensure patient safety and satisfaction.

Common Side Effects

The most common side effects reported in clinical trials and real-world applications include:

  • Swelling: Temporary swelling at the injection site is the most frequently reported side effect.
  • Bruising: Patients may experience bruising around the treatment area.
  • Numbness: Numbness or a loss of sensation in the treated area can occur.
  • Redness: Redness around the injection site is common but typically subsides within a few days.
  • Pain: Mild to moderate pain at the injection site is often reported by patients.
  • Hardness: Some patients might notice firmness or small areas of hardness in the treatment area.

Possible Side Effects of KYBELLA® Injections

While common side effects are generally mild and resolve on their own, there are potential adverse effects that healthcare providers should monitor:

  • Necrosis: There is a rare risk of necrosis or tissue cell death if the injection inadvertently affects a blood vessel.
  • Facial Muscle Weakness: Patients may sometimes experience temporary facial muscle weakness, including difficulty smiling or uneven smile.
  • Trouble Swallowing: Difficulty swallowing, also known as dysphagia, can occur but is usually temporary.
  • Open Sores: Rarely, patients may develop open sores around the injection site.
  • Damage to an Artery or Vein: Inadvertent injection into an artery or vein can cause serious side effects, including damage and tissue death.

Patients should be informed about these possible side effects and advised to report any severe or unusual symptoms to their healthcare provider immediately.

Explanation of How Adverse Effects Are Managed and Mitigated

To manage and mitigate adverse effects, healthcare professionals should adhere to best practices and guidelines:

1. Proper Injection Technique:

Ensuring correct injection technique and precise placement is crucial to avoid complications like necrosis or damage to arteries or veins.

2. Patient Assessment and Preparation:

Conduct thorough assessments to identify any underlying conditions or medications (such as antiplatelet or anticoagulant therapies) that might increase the risk of adverse effects. Advise patients to avoid certain medications and supplements that could prolong bleeding or bruising.

3. Post-Injection Care:

Educate patients on what to expect post-treatment and how to care for the injection site. We recommend avoiding strenuous activities and exposing the treated area to direct sunlight.

4. Monitoring and Follow-Up:

Schedule follow-up appointments to monitor the treatment area and address any concerns promptly. Provide patients with clear instructions on when to seek medical advice if they experience severe or unusual symptoms.

By following these protocols and providing patients with comprehensive information on the common and possible side effects of KYBELLA®, healthcare professionals can effectively manage and mitigate adverse effects, ensuring a safe and positive treatment experience.

Adverse Effects and Safety Profile

Healthcare professionals can employ several strategies to minimize and manage the adverse effects of KYBELLA®:

1. Patient Selection and Screening:

Thoroughly screen patients to identify any contraindications, such as underlying medical conditions or current use of medications like antiplatelet or anticoagulant therapies.

Assess the patient’s overall health and suitability for KYBELLA® treatment.

2. Accurate Injection Technique:

Ensure precise injection technique to avoid complications like necrosis or damage to arteries or veins. Use a grid pattern to evenly distribute the injections and target the submental fat effectively.

3. Pre-Treatment Counseling:

Inform patients about the potential side effects and what to expect during and after the procedure. Advise patients on pre-treatment care, such as avoiding certain medications and supplements that could increase the risk of bruising or bleeding.

4. Post-Treatment Care and Monitoring:

Provide clear post-treatment instructions to help patients manage common side effects like swelling, bruising, and numbness. Schedule follow-up appointments to monitor the patient’s progress and address any concerns promptly.

Safety Measures and Protocols to Ensure Patient Well-Being During and After Treatment

To ensure patient well-being during and after KYBELLA® treatment, practitioners should adhere to the following safety measures and protocols:

1. Detailed Prescribing Information:

Follow the full prescribing information for KYBELLA®, including dosage, administration, and contraindications. Review the prescribing information with the patient to ensure they understand the treatment and its potential risks.

2. Sterile Technique:

Maintain a sterile environment during the procedure to minimize the risk of infection. Use sterile equipment and follow proper sanitation protocols.

3. Emergency Preparedness:

Be prepared to manage any adverse reactions that may occur during the procedure. Have emergency medical equipment and medications on hand to address severe reactions, such as anaphylaxis or significant bleeding.

4. Patient Education:

Educate patients on recognizing the signs of serious side effects, such as difficulty swallowing, facial muscle weakness, or open sores. Instruct patients to call their healthcare provider immediately if they experience any severe or unusual symptoms.

By implementing these strategies and adhering to safety protocols, healthcare professionals can minimize the risk of adverse effects and ensure a safe and effective treatment experience for patients undergoing KYBELLA® injections. This comprehensive approach helps to maintain high standards of care and patient satisfaction.

Comparing KYBELLA® with Other Treatments

KYBELLA® and liposuction are two prominent treatments for reducing submental fullness, each with distinct approaches and outcomes.

Feature KYBELLA Liposuction
Method Injectable treatment using deoxycholic acid to destroy fat cells. Surgical procedure that physically removes fat through suction.
Procedure Non-surgical, involving multiple small injections directly into the submental fat. Invasive surgery requiring anesthesia and small incisions
Recovery Time Minimal downtime, with common side effects such as swelling, bruising, and numbness. Longer downtime, typically involving significant bruising, swelling, and a recovery period of several weeks.
Results A gradual reduction in submental fat, with visible improvements after a few weeks to months. Immediate reduction in fat with noticeable contouring of the submental area.

 

Pros and Cons of KYBELLA® versus Alternative Methods

KYBELLA®:

Pros Cons
Non-surgical with minimal invasiveness. Multiple treatment sessions may be required to achieve desired results.
No need for anesthesia or incisions. Common side effects include swelling, bruising, and numbness.
Gradual and natural-looking results. Potential for adverse effects such as necrosis or facial muscle weakness.
Can be performed in a clinical setting with minimal downtime.

Liposuction:

Pros Cons
Non-surgical with minimal invasiveness. Multiple treatment sessions may be required to achieve desired results.
No need for anesthesia or incisions. Common side effects include swelling, bruising, and numbness.
Gradual and natural-looking results. Potential for adverse effects such as necrosis or facial muscle weakness.
Immediate and significant reduction in submental fat. Invasive surgery with associated risks of infection, scarring, and complications from anesthesia.
One-time procedure with predictable results. Longer recovery period with more noticeable post-operative swelling and bruising.
Ability to remove larger volumes of fat in a single session. Potential for uneven results or contour irregularities.

 

Patient Suitability and Considerations for Choosing KYBELLA®

Ideal Candidates:

  1. Adults with moderate to severe submental fullness who prefer a non-surgical treatment.
  2. Patients with realistic expectations about gradual improvements.
  3. Individuals seeking a procedure with minimal downtime and disruption to their daily activities.

Considerations:

  1. KYBELLA® is not suitable for patients with loose or sagging skin in the submental area, as it specifically targets fat cells.
  2. Patients with medical conditions affecting the neck or chin area or those taking certain medications (e.g., antiplatelet or anticoagulant therapies) may need to be evaluated carefully.
  3. Not recommended for children under 18 years of age or individuals with a history of severe allergies to the components of KYBELLA®.

Assessment:

A thorough consultation with a healthcare professional is essential to assess the patient’s suitability for KYBELLA®. Discussing the patient’s medical history, current medications, and treatment goals will help determine the best approach.

Expectations:

Patients should be informed about the potential side effects, including common side effects such as swelling, bruising, and numbness, as well as more serious adverse effects. Understanding the gradual nature of the results and the need for multiple sessions can help set realistic expectations.

Pipeline Medical: Competitive Pricing for KYBELLA®

Pipeline Medical is a premier single-source medical supply provider dedicated to serving non-acute customers with unmatched efficiency and cost savings. Acting as a Group Purchasing Organization (GPO), Distributor, and Material Manager, Pipeline Medical offers a comprehensive solution that significantly reduces healthcare practices’ time and financial expenditures.

One of Pipeline Medical’s most compelling offerings is its exclusive Allergan program, which allows practices to purchase KYBELLA® at highly competitive prices. This program allows practices to access the same pricing as a $500,000 practice, buying directly from Allergan. This elite pricing structure enables healthcare providers to offer KYBELLA® treatments at a cost-effective rate, enhancing their ability to attract and retain patients seeking non-surgical solutions for submental fullness.

By partnering with Pipeline Medical, practices can instantly transform their access to premium KYBELLA® pricing, ensuring they remain competitive in the ever-evolving aesthetic market. This strategic advantage not only improves the practice’s financial health but also elevates the level of care and satisfaction provided to patients. Embrace the benefits of Pipeline Medical’s exclusive Allergan program today and take your practice to new heights with KYBELLA®.

Connect with Pipeline Medical today to learn more about their exclusive Allergan program and how it can transform your access to KYBELLA® and other premium products.

Conclusion

KYBELLA® is a groundbreaking treatment for moderate to severe submental fullness. This injectable procedure uses the power of deoxycholic acid to effectively target and kill fat cells, resulting in a more contoured and aesthetically attractive chin profile. Understanding the science underlying KYBELLA® and its mode of action is critical for healthcare providers seeking to improve patient outcomes and assure safe, effective therapy.

For practitioners, KYBELLA® provides a non-surgical solution that can be seamlessly integrated into aesthetic treatments. It offers people a minimally intrusive treatment for submental fullness. KYBELLA®, with its proven efficacy and safety profile, should be regarded a beneficial addition to the range of treatments available from aesthetic professionals.

FAQs About KYBELLA®

What is KYBELLA®?

KYBELLA® is the first and only FDA-approved injectable treatment to reduce fat under the chin, also known as submental fullness or a “double chin.” It contains synthetic deoxycholic acid, which targets and destroys fat cells.

How does KYBELLA® work?

KYBELLA® works by using synthetic deoxycholic acid to break down and absorb dietary fat. When injected into the submental area, it destroys fat cells, leading to a noticeable reduction in submental fullness.

Is KYBELLA® safe and effective?

Yes, KYBELLA® is a safe and effective FDA-approved injectable treatment. Clinical trials in the setting of submental fullness have demonstrated its efficacy in reducing fat under the chin and improving the chin profile.

What are the possible side effects of KYBELLA®?

Common side effects include swelling, bruising, pain, numbness, and redness at the injection site. There have been cases of injection site infection, which have included symptoms like open sores and severe swelling. Patients should be aware of the potential for adverse effects and discuss them with their healthcare provider.

How many injections of KYBELLA® will I need?

The number of injections varies depending on the individual’s needs and the amount of submental fat. A healthcare provider will create a customized treatment plan, which may involve multiple sessions spaced a month apart.

Who should avoid KYBELLA®?

Patients with medical conditions in or near the neck area, including bleeding problems, or those who have had surgery on their face, should exercise caution. It is not known if KYBELLA® is safe for people with certain health conditions or if it passes into breast milk. Always consult your healthcare provider before starting treatment.

What should I tell my healthcare provider before getting KYBELLA®?

Inform your provider about all the medicines you take, any cosmetic treatments on your face, and any medical conditions, especially in or near the neck area. Discuss any bleeding problems, allergies, or previous surgeries on your face.

Can KYBELLA® be used with other cosmetic treatments?

KYBELLA® can be part of a comprehensive aesthetic treatment plan, but it’s essential to inform your provider about any other cosmetic treatments on your face to avoid adverse interactions and ensure safe and effective results.

What is the role of Allergan Aesthetics in KYBELLA®?

KYBELLA® is a product of Allergan Aesthetics, a leader in the aesthetic industry. Their rigorous clinical trials and commitment to safety have established KYBELLA® as a trusted treatment for submental fullness.

How can I minimize the risk of adverse effects?

To minimize the risk of adverse effects, ensure that KYBELLA® is administered by a qualified healthcare professional who follows the full prescribing information. Report any unusual symptoms, such as injection site problems or signs of infection, to your provider immediately.

Picture of by Kinza Khan
by Kinza Khan

May 21, 2024