Kybella Cost, Side Effects, FDA Approval and Drug Information for Reducing Double Chin | Wing (Bernadette) Cheung, PharmD | RxEconsult
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Kybella (deoxycholic acid) Side Effects, Cost, Approval and Prescribing Information for Double Chin (Submental Fat) Category: Diet & Weight Loss by - May 3, 2015 | Views: 95629 | Likes: 1 | Comment: 1  

How effective is Kybella at improving double chin (submental fat)?

In a study of 506 patients who had moderate or severe (grade 2 or 3) submental fullness, patients received either KYBELLA (up to 6 treatments) or placebo at no less than 1-month intervals. The severity of submental fullness was based on a 5-point grading scale with 0 being none and 4 being extreme. At baseline, 51% had a clinician-rated submental fat severity of moderate and 49% had a severe submental fat rating. 0.2 mL was administered into the submental fat tissue with each injection site spaced 1 cm apart (2 mg/cm2). Maximum of 100 mg (10 mL) was permitted over the entire treatment area. 

The efficacy of Kybella was based on at least 1-Grade and 2-Grade improvements in submental fullness on the clinician-reported and patient-reported rating scales 12 weeks after the final treatment. 70% of Kybella treated patients versus 18.6% of patients that received placebo had at least 1-grade reduction on both the clinician-reported and patient-reported ratings of submental fat improvement. 13.4% of treated patients versus <0.1% patients that received placebo had at least a 2 grade reduction on both clinician-reported and patient-reported ratings of submental fat improvement. In a subset of patients, more Kybella treated patients (43%) achieved at least a 10% reduction in submental fat volume compared to placebo (5%) when evaluated by MRI. 

Interesting facts about Kybella

  • Kybella is the first FDA-approved submental contouring injectable drug.
  • Sixty-eight percent of consumers are bothered by fullness under their chin from a consumer survey by the American Society for Dermatologic Surgery.
  • Kybella is administered by injection into the fat under the chin and is not approved for use in other body areas.
  • Each in-office treatment session is typically 15-20 minutes. 

What are side effects of Kybella?

Common side effects reported with Kybella include:

Injection site swelling

Bruising (hematoma)

Pain

Numbness

Redness (erythema)

Hardening (induration)

Trouble swallowing (dysphagia)

Facial (marginal mandibular) nerve injury, resulting in an asymmetric smile or facial muscle weakness may occur.

 

Next: Dosage, Drug interactions, Warnings, Pregnancy, Breastfeeding, Cost

 


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