Anyone using kybella more than the recommended 6 treatments?

Question

I could not find any study information as to why only 6 treatments are approved. Has anyone needed to treat someone >6 times and if so any adverse outcomes or lack of effect? I assume if there is still fat in the treatment area and patient is willing to continue to pay for treatment, it can be done.

Edward P. Miranda, MD, FACS · Answer

Thank you for your question.  Kybella was approved for up to 6 treatments in the submental area and a patient can theoretically have more than 6 treatments if there is treatable areas, but this begs the question of if this would be financially responsible when there are alternatives such as Coolsculpting or even liposuction which may be cheaper overall.  Kybella is a very effective tool, but there are alternatives to help achieve your personal goals.

Jonathan Kulbersh, MD · Answer

The studies submitted were for results after 6 treatments and that is what the FDA approved. Theoretically, you could have more treatments, but neck liposuction is a great option for patients with good skin elasticity and excess fat in the neck, chin and around the jawline and would be more effective. Liposuction is great at removing this excess fat and stimulating the skin to contract over time to create improved angulation and definition along the jawline. I hope this helps!

Michael I. Echavez, MD · Answer

I believe the reason that Kybella is only approved for up to 6 treatment sessions is that the scientific study that was presented to the FDA for the approval of Kybella only had up to 6 treatment sessions.  In my opinion, if there is still some fat present after 6 treatments, additional treatments could be done and should not cause any increase in adverse events.

Alex Eshaghian, MD, PhD · Answer

Thank you for your question jenoch. I understand your concern. Kybella is the first
and thus-far only FDA-approved non-surgical injectable treatment for the double
chin. The double chin can be formed by various factors including age, weight
gain, and genetics.
The pivotal studies demonstrated that most
people require two to four treatments, sometimes up to six treatments. The
pivotal studies used two vials per treatment, which is what I use for my
patients. Some doctors use more or less than this amount, which is fine. The
more product is used the more swelling can be expected after the treatment.
Although some people see results after a single treatment, for my patients I
recommend starting with at least two treatments because many people do not see
a significant improvement after only one treatment. Each vial contains 2 mL of
product and 0.2 mL aliquots are used for each injection per the manufacturer’s
guidelines; therefore, one vial would be enough for 10 injections using this
method.
Although in the studies up to six treatments were performed, more treatments can be performed off label. This is more common when a lower dose is used in each treatment. For example the manufacturer recommends using two vials per session. But some doctors only use one vial per session. If such a protocol is used, certainly more than six treatments may be performed. Usually, however, when two (or even three) vials are used, significant results are seen after six treatment sessions.
Please consult with a doctor for specific
recommendations. Good luck!

Sheryl D. Clark, MD, FAAD · Answer

Dear jenoch:The reason Kybella was approved for six treatments is that the studies submitted to the FDA included patients that were treated up to six times without any serious side effects. That does not mean that you cannot have more than six treatments.However, in my experience, more than six treatments is never necessary. I have had one patient who needed a sixth and possibly will need a seventh treatment, but only because she had had five treatments with very small amounts of Kybella prior to seeing me, and had a very large amount of fat under the chin and on the sides of the neck and lower neck at the start of treatment. She was the type of patient who would have had a quicker response to liposuction, but she had decided she did not want to have surgery.My approach to patients who would benefit from reduction of fat under the jawline as well as under the chin is to offer any additional Kybella needed over the standard two vials at cost. In that way, the patient can get quicker results with fewer treatments and see remodeling of the entire neck with improvement in the definition of the jawline.I do hope this answers your question.All the best,  Dr. Clark

Edsel Antonio, DO - Account Suspended · Answer

Yes the company and the studies submitted to the FDA showed the outcomes for a max of 6 treatments and that doesn't mean you can only have 6 BUT the more important question is why would anyone need more than 6?  Your Kybella provider has to properly assess you and a realistic goal for treating the submental fat.  That means age, body habitus, pre-existing conditions, etc come into play when they're considering giving that many treatments.  You also have to consider skin laxity playing a part.  Yes the Kybella dissolved that submental fat but there's still that remaining skin and Kybella won't address that issue.  If you need that many treatments is there really that much submental fat left to dissolve at treatment #7? Does the submental fat re-accumulate that fast? Highly unlikely.  Maybe an adjunct treatment would be to address the skin laxity.  Kybella is an effective treatment but when you're at #7, it may not be enough by itself.

Anyone using kybella more than the recommended 6 treatments?

Answers (6)

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