Kybella Off-Label?

FDA cleared for the treatment of submental fat, Kybella® (Allergan) has quickly become a popular treatment, and demand is only expected to increase. Speaking at Cosmetic Surgery Forum last month, both Manjula Jegasothy, MD and Corey Maas, MD cautioned against widespread use of Kybella off-label. Says Dr. Jegasothy, “I think that the current off-label use of Kybella should be limited to key opinion leaders and the core aesthetic specialists who have had significant experience with fat reduction laser treatment and Kybella on the neck, as well as those who have followed Kybella’s precursor drug, LipoDissolve or Lipostabil in the European market over the past 15 years.”

However, the two diverged on the question of whether and how certain clinicians could use Kybella for “off-label” applications. The potential for the new drug is significant. As Dr. Jegasothy noted, “I think that the areas which have been most successfully treated by the fat freezing or melting lasers, such as CoolSculpting, Vanquish and Ultra shape—such as the love handles, the anterior abdomen, the circumferential sides, the circumferential upper arms—are the best potential areas for Kybella to broaden its scope of use.”

In her own practice, Dr. Jegasothy acknowledges positive results using Kybella in these areas. “Kybella certified in August of 2015. I have been using Kybella on other body areas than the neck on a very limited and selected group of patients. I also pay close attention to anatomical areas which may carry neurovascular bundles and avoid those,” Dr. Jegasothy says. “Typically I inject the ‘love handles,’ the saddlebags, occasionally the area around the waist, and occasionally the superficial fat on the anterior abdomen. Most of my ideal patients are within 10 to 15 percent of ideal body weight. I have found with people that are heavier than that, I have not had as good results.”

For Dr. Maas, “The greatest risk of using Kybella off label is having liability exposure if someone has an adverse event.” He points to the fact that the labeling for Kybella recommends against use beyond the approved indication. “Since the FDA specifically has language in the PI that states ‘use in area other than the neck is NOT recommended,’ not only will the trial lawyers have a field day, but liability carriers could deny coverage. Before using any drug that is not recommended, the physician should check with his or her liability carrier,” he says.

“This is quite different than Botox or fillers (and frankly most other drugs and devices) where there is no reference to areas not recommended,” Dr. Maas maintains. Those physicians interested in pursuing off-label uses, “should simply submit an IND to FDA, which is a short form, and inform their professional liability carrier of their intent to use a drug that is not recommended under an IND,” he says.

Dr. Jegasothy doesn’t see a significant hurdle in the recommendation against use of Kybella beyond the neck. “I have been speaking to regulatory people at the FDA who feel that despite Kybella’s current monograph being more restrictively worded than current neuromodulator/filler monographs, off-label Kybella use is still up to the medical discretion of the physician injecting it. Therefore the FDA does not really see this as a different category of off-label use than neuromodulator,” she says.

“I also have been speaking with The Doctors Company®, which is my malpractice insurer, and they feel currently that it is okay for us to demonstrate off-label use of Kybella in CME-approved courses and conferences. However, they will not cover individuals who are non-aesthetic physicians attempting to try this procedure. It is still unclear whether most malpractice carriers will cover the off-label use of Kybella before Allergan broadens the scope of its packet insert. The Doctors Company feels, as I do, that it is up to key opinion leaders like ourselves to generate the data which will then spur Allergan on to pursue uses for Kybella other than the neck and hopefully obtain FDA approval for these other areas too.”

At press time, Dr. Jegasothy had just received positive word from her malpractice carrier. “I was able to speak with them and provide data and get personally approved by my malpractice insurance carrier, The Doctors Company, so that I can inject Kybella on the body in areas other than the neck, at my medical discretion,” she says. n

Based on a presentation given at Cosmetic Surgery Forum 2015. Cosmetic Surgery Forum 2016 will be held November 30 to December 4, 2016. For information, visit CosmeticSurgeryForum.com.

Manjula Jegasothy, MD is in solo private practice at the Miami Skin Institute, in the heart of Coral Gables. Corey S. Maas, MD is a plastic surgeon in practice in San Francisco.