Deoxycholic acid Injection (Kybella) - Uses, Dose, Side effects, MOA

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:

  • It is administered as a subQ injection into the fatty tissues @ 2 mg/cm².
  • The maximum dose is 50 injections of 0.2 ml each (total 10ml) spaced at around 1 cm apart.
  • The maximum number of treatments is six treatments spaced at one months interval or more.

Use in Children:

Not indicated.   

Pregnancy Risk Category: N

  • Animal reproduction studies have shown adverse pregnancy outcomes.
  • Clinical trials excluded pregnant women and women with reproductive potential who were not using effective contraception from the clinical trials.

Use during breastfeeding:

  • It is unknown whether the drug can be excreted into breastmilk. Clinical studies excluded lactating mothers.
  • Manufacturers recommend that you weigh the risks to the baby and the benefits for the mother before you give any drug treatment.

Dose in Kidney Disease:

There are no dosage adjustments provided in the manufacturer's labeling.   

Dose in Liver disease:

  • There are no dosage adjustments provided in the manufacturer's labeling as it has not been studied in patients with hepatic impairment.
  • However, dosage adjustment is not required as the administered drug accounts for about 3% of the total body acid pool and is less likely to be affected by hepatic impairment.   

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 injection site
    • Urticaria at injection site
  • Gastrointestinal:
    • Dysphagia
    • Nausea
  • Hematologic & oncologic:
    • Lymphadenopathy
  • Local:
    • Injection site reaction
    • Swelling at injection site
    • Bruising at injection site
    • Hematoma at injection site
    • Pain at injection site
    • Injection site numbness
    • Erythema at injection site
    • Induration at injection site
    • Injection site nodule
    • Warm sensation at injection site
    • Bleeding at injection site
  • Neuromuscular & skeletal:
    • Neck pain
  • Respiratory:
    • Oropharyngeal pain

Contraindications to Deoxycholic acid Injection (Kybella):

  • Infection at the injection site

Canadian labeling: Additional contraindications not in US labeling

  • Allergy to deoxycholic or any other component of the formulation

Warnings and precautions

  • Alopecia
    • Localized hair loss or alopecia may occur at the injection site. 
    • Hairloss can occur at any time, and it may take a different approach for each person.
    • If alopecia persists, you should not inject any more injections until the problem is resolved.
  • Nerve injury:
    • Marginal mandibular nerve injuries can cause injury to surrounding neurons, which may lead to facial paralysis and an asymmetric smile.
    • Neuronal injuries heal spontaneously in a median time of 44 days, with a range from 1 to 298 days.
    • You should not inject the injection in close proximity of the marginal mandibular branch or the facial nerve.
  • Necrosis and ulceration:
    • If intradermally administered, it can cause necrosis and ulcerations. 
    • You should not continue to administer the drug intradermally until the necrosis and ulcerations have subsided.
  • Bleeding abnormalities
    • The injection may cause bleeding or swelling at the injection site. 
    • Anticoagulants and antiplatelets patients should be cautious when using the drug.
  • Dysphagia
    • Dysphagia may be exacerbated by injections. 
    • Patients with dysphagia should avoid it, regardless of whether they have a history.
    • Dysphagia can be resolved spontaneously in between 34 and 81 days.

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

Risk Factor C (Monitor therapy).

Antiplatelet Agents (e.g. P2Y12 inhibitors NSAIDs, SSRIs etc.)

This may increase the toxic/adverse effects of Deoxycholic Acid. The risk of bleeding or bruising may increase in the treatment area.

Anticoagulants

This may increase the toxic/adverse effects of Deoxycholic Acid. The risk of bleeding or bruising may increase in the treatment area.

Monitoring parameters:

Monitor the patient for local induration, redness, pain, and swelling after the injection. Monitor for mandibular nerve injury.   

How to administer Deoxycholic acid Injection (Kybella)?

  • It is administered as a subQ injection.
  • It is advisable to palpate the submental area and ensure sufficient submental fat before administering the injection.
  • Before starting the therapy, outline the area using a 1 cm injection grid.
  • Mark the injection site and avoid injecting outside the predefined area.
  • Draw one ml of the solution into a sterile one ml syringe.
  • Ask the patient to tense the neck muscles (platysma) as in shaving.
  • Pinch the submental fats and inject into the preplatysmal fat using a 30 gauge or smaller needle of 0.5 inches.
  • Advance the needle perpendicularly and inject into the adjacent marked areas.
  • Avoid injecting into the postplatysmal fats. Apply pressure to minimize bleeding at the sites of the injection.
  • Adhesive dressings may be applied. For post injection pain at the site, topical anesthetics like lignocaine may be used.
  • Some patients may feel better with applying ice cold packs. Discard the remaining solution after use.   

Mechanism of action of Deoxycholic acid Injection (Kybella):

It is a cytolytic medication that causes cell lysis by destroying the cell membrane.

Time:

  • Within 24 hours of treatment, plasma levels of deoxycholic acids return to baseline.

Absorption:

  • Subcutaneous injections are quick to absorb it

Protein binding:

  • 98%

Metabolism:

  • It is not metabolized significantly.

Time to peak:

  • 18 minutes

Excretion:

  • It is excreted in feces as an intact drug.

International Brand Names of Deoxycholic acid Injection:

  • Kybella
  • Belkyra

Deoxycholic acid Injection Brand Names in Pakistan:

No Brands are available in Pakistan.  

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