Deoxycholic acid is a secondary bile acid, which means it is produced through the bacterial transformation of primary bile acids in the intestines. Bile acids are essential components of the digestive system and play a significant role in the digestion and absorption of dietary fats.

Deoxycholic acid is formed from cholic acid by the removal of a hydroxyl group. It is one of the many bile acids found in the human body and is involved in the emulsification and digestion of fats. Bile acids, including deoxycholic acid, help break down dietary fats into smaller molecules, making them more accessible for absorption in the small intestine. They also facilitate the transport of fat-soluble vitamins and other lipids through the digestive process.

Deoxycholic acid Injection (Kybella) is used for cosmetic purposes. It is used to reduce the submental convexity in adults to improve their appearance.

Deoxycholic acid Uses:

• Submental convexity/ submental fullness:
  • It is injected subQ into the submental fats to improve the appearance of moderate to severe submental convexity due to submental fats in adults.
• Limitations of use:
  • It has not been studied in individuals with fatty accumulation outside the submental area and is not recommended for administration elsewhere.

Deoxycholic acid Injection (Kybella) Dose in Adults

Deoxycholic acid Injection (Kybella) Dose for Submental convexity/ submental fullness:

For deoxycholic acid in the treatment of submental convexity or fullness:

• Location: Inject deoxycholic acid under the skin in the submental area (under the chin).
• Dose Adjustment: The dose should be adjusted based on the size of the area, with 2 mg of deoxycholic acid per square centimeter of the treatment area.
• Maximum Dose: The maximum amount of deoxycholic acid for a single treatment is 50 injections. These injections should be spaced 1 centimeter apart from each other, and each injection contains 0.2 mL of the solution. In total, this adds up to 10 mL of deoxycholic acid per treatment.
• Maximum Treatments: A maximum of 6 treatments can be done for the same area. Each treatment should be spaced at least 1 month apart from the previous one.

These guidelines are typically used in cosmetic procedures to reduce fat under the chin and improve the appearance of the jawline.

Use in Children:

Not indicated.   

Pregnancy Risk Category: N

• In some studies involving animals, there were negative effects observed during pregnancy.
• Pregnant women and women who could become pregnant (but were not using effective birth control) were not included in the initial research studies. This was done in studies conducted by McDiarmid in 2014 and Rzany in 2014.

Use during breastfeeding:

• It is uncertain whether deoxycholic acid from this preparation is passed into breast milk.
• The manufacturer recommends that the decision to breastfeed while undergoing this treatment should take into account the advantages of breastfeeding, the potential risk to the infant, and the benefits of the treatment for the mother.
• Breastfeeding women were not part of the initial studies conducted by McDiarmid in 2014 and Rzany in 2014. This means that there isn't enough data to determine the safety of this treatment for breastfeeding women and their infants.

Dose in Kidney Disease:

• The manufacturer's labeling does not contain specific dosage adjustments for individuals with kidney (renal) impairment.
• This means that the recommended dosage remains the same for individuals with or without kidney problems.

Dose in Liver disease:

• The manufacturer's labeling does not offer specific dosage adjustments, and the reason for this is that the doses administered are approximately 3% of the total body acid pool.
• This low percentage suggests that the treatment is unlikely to be influenced by liver (hepatic) impairment.
• In other words, hepatic impairment is unlikely to significantly impact the metabolism or effectiveness of the treatment due to the very small proportion of the total body acid pool that it represents.

Side effects of Deoxycholic acid Injection (Kybella):

• Cardiovascular:
  • Hypertension
  • Presyncope
  • Syncope
• Central nervous system:
  • Paresthesia
  • Headache
  • Neuropathy
• Dermatologic:
  • Injection site pruritus
  • Skin tightness
  • Skin discoloration at the injection site
  • Urticaria at the injection site
• Gastrointestinal:
  • Dysphagia
  • Nausea
• Hematologic & oncologic:
  • Lymphadenopathy
• Local:
  • Bruising at the injection area
  • Hematoma at injection area
  • Injection site reaction
  • Swelling at injection area
  • Erythema at the injection area
  • Induration at injection area
  • Warm sensation at injection area
  • Bleeding at injection area
  • Pain at injection area
  • Injection site numbness
  • Injection site nodule
• Neuromuscular & skeletal:
  • Neck pain
• Respiratory:
  • Oropharyngeal pain

Contraindications to Deoxycholic acid Injection (Kybella):

The presence of infection at the injection sites is considered a contraindication for the use of deoxycholic acid in both Canadian and US labeling. This means that the treatment should not be administered in areas where there is an active infection.

In Canadian labeling, there is an additional contraindication that is not present in the US labeling. It is stated that the treatment is contraindicated in individuals with hypersensitivity to deoxycholic acid or any component of the formulation. This means that if a person is known to be allergic or hypersensitive to deoxycholic acid or any ingredient in the formulation, they should not undergo this treatment in Canada. Allergies or hypersensitivity can lead to adverse reactions, so it's essential to avoid the treatment in such cases.

Warnings and precautions

Alopecia

• Alopecia refers to hair loss.
• Injection site alopecia means that hair loss has been reported at the areas where the injections were administered.
• The onset (when it starts) and duration (how long it lasts) of this hair loss can vary, and it may persist over time.
• The recommendation is to consider not administering additional treatments until the hair loss (alopecia) at the injection sites has resolved.
• In other words, it's advised to wait until the hair has regrown before continuing with further treatments to avoid exacerbating the issue.

Bruising/bleeding:

• Sometimes, after getting injections, there can be bruising or bleeding at the injection site, which is also called a hematoma.
• This means that there might be some skin discoloration or blood under the skin in that area. It's a possible side effect of the injection.

Dysphagia

• Dysphagia means having difficulty swallowing.
• It has happened when people experienced reactions at the injection site, like pain, swelling, or firmness in the area under the chin.
• The good news is that in all cases, this difficulty with swallowing went away on its own.
• It took different amounts of time for it to get better, but most of the time, it improved in about 34 days, with some cases getting better faster (1 day) and some taking a bit longer (up to 81 days).

Nerve injury:

• Nerve injury, specifically involving the marginal mandibular nerve, which can cause things like an uneven smile or weakness in facial muscles, has been reported.
• The good news is that in all cases, these injuries got better on their own.
• It took different amounts of time for these issues to resolve, but on average, it took about 44 days, with some improving quite quickly (1 day) and others taking a bit longer (up to 298 days).
• To prevent such nerve injuries, it's important not to inject the treatment too close to or directly into the area where this nerve is located.

Ulceration and necrosis:

• Ulceration and necrosis, which are severe skin problems involving open sores and tissue death, have been reported at the injection site when the treatment is given too close to the skin's surface (dermis).
• To prevent this, it's essential not to give more injections into the same area until the skin has healed and these issues have gone away.
• This helps avoid making the skin problems worse.

Bleeding abnormalities

• If you have bleeding problems or are currently taking medications to prevent blood clotting, be cautious when using this treatment.
• It's possible that you might experience more bleeding or bruising in the treated area.
• So, it's essential to be careful if you have these conditions or are taking such medications.

Deoxycholic acid: Drug Interaction

Note: Drug Interaction Categories:

• Risk Factor C: Monitor When Using Combination
• Risk Factor D: Consider Treatment Modification
• Risk Factor X: Avoid Concomitant Use

Monitoring parameters:

• Submental Area Induration: Keep an eye on the area under the chin for any hardening or firmness.
• Pain or Swelling: Watch for any discomfort or swelling at the injection site.
• Marginal Mandibular Nerve Injury: Be alert to any signs of nerve-related issues, like an uneven smile or facial muscle weakness, which might indicate an injury to the marginal mandibular nerve.

How to administer Deoxycholic acid Injection (Kybella)?

For a SubQ (subcutaneous) injection of deoxycholic acid:

• Assess the Treatment Area: Before each treatment, feel the area under the chin to make sure there's enough submental fat for the procedure.
• Mark the Treatment Area: Use a surgical pen to outline the planned treatment area. Create a 1 cm grid of injection sites on the skin. Make sure not to inject outside of this marked area.
• Prepare the Syringe: Using a large bore needle, draw 1 mL of the solution into a sterile 1 mL syringe.
• Patient Tension: Ask the patient to tighten the platysma muscle under the chin.
• Injection Process: Pinch the submental fat and, using a 30 gauge (or smaller) 0.5-inch needle, inject 0.2 mL of the solution into the preplatysmal fat near each of the marked injection sites. Insert the needle straight down into the skin.
• Injection Depth: Inject into the fat tissue at a depth of about halfway into the subcutaneous fat layer, but avoid injecting into the postplatysmal fat.
• Manage Bleeding: After withdrawing the needle, apply pressure to each injection site as needed to reduce bleeding. You can also use an adhesive dressing if necessary.
• Pain Management: If needed, use ice/cold packs, topical anesthesia, or injectable local anesthesia (like lidocaine) to manage pain and discomfort during the procedure.
• Dispose of Unused Solution: Any remaining solution should be discarded properly after use.

Mechanism of action of Deoxycholic acid Injection (Kybella):

• Deoxycholic acid is a type of medication that, when injected into tissue, works by physically breaking down the cell membrane of the targeted cells.
• This process leads to the destruction of the cells through a mechanism called lysis.
• In the context of aesthetic medicine, deoxycholic acid is often used to break down and reduce fat cells in the submental (under the chin) area to improve the appearance of the jawline and reduce double chin.

Duration:

• After treatment, deoxycholic acid in the bloodstream returns to its normal levels within 24 hours.

Absorption:

• The medication is quickly absorbed into the body after it's injected under the skin (subcutaneous injection).

Protein Binding:

• About 98% of deoxycholic acid binds to proteins in the blood.

Metabolism:

• Deoxycholic acid doesn't undergo significant metabolic changes in the body.

Time to Peak:

• It reaches its highest concentration in the bloodstream approximately 18 minutes after injection.

Excretion:

• The body gets rid of deoxycholic acid mainly through the feces, and it's eliminated from the body without significant changes (intact drug).

International Brand Names of Deoxycholic acid Injection:

• Kybella
• Belkyra

Deoxycholic acid Injection Brand Names in Pakistan:

Not Available.