Off-Label Injectables: Sculptra and Compounded Kybella

Written by Erin Lucie, DNP, FNP-C

Being able to offer treatments that are safe, effective, and affordable for clients is always top priority. Sometimes, as injectors, we need to use our artistic license and go off-label in order to make that happen. Off-label product use is entirely legal and very common. In fact, about one in five medications is prescribed off-label and is an integral part of modern cosmetic medicine. Sculptra is an FDA-approved injectable for increasing the volume in the mid-face, thereby reducing wrinkles, folds, and skin creases. It is made from poly-L-lactic acid (PLLA) microparticles. PLLA is a synthetic, bio-identical, and biodegradable polymer that induces collagen production. It can be used off-label on many body areas, but one very common area is the knees. The knees are an area that age similar to the neck and decolletage due to the amount of sun exposure and flexural movement. Sculptra is typically injected in a series of three treatments performed at one month intervals. The client will have gradual improvement over several weeks, with maximum results at six months after last treatment, and results will last up to two years. One of the downsides of the injections is that you do have to wait for visible results. Another option to receive the immediate benefits of PLLA is with thread-lifts. Thread-lifts pull up sagging skin by implanting threads into the subcutaneous layer of the skin. The threads made of PLLA regenerate collagen in that area while they are dissolving, keeping the lift in place. Both options provide natural results with minimal downtime.

Another off-label treatment is the use of compounded Kybella. Kybella, which is deoxycholic acid, is the first and only FDA-approved injectable treatment to reduce fat under the chin. This designation can make the price of deoxycholic acid very steep and, sometimes, unaffordable for clients. Before Kybella was patented, sterile compounding pharmacies could make deoxycholic acid for localized fat reduction. Now, these same pharmacies are making PC/DC or phosphatidylcholine (PC) with sodium deoxycholate (DC) for mesotherapy. PC creates fat cell lysis and DC aids in dissolving or disintegrating the remainder of the fat cell. Both are natural substances that our bodies already have in our tissue and there are no known allergies. PC is used in over 600 cosmetic formulations sold in the United States today as a nutritional supplement for cognitive function. While Kybella is FDA-approved for submittal fat under the chin, it is being used off-label all over the body. Localized fat reduction with injections, mesotherapy, can be safely done with PC/DC if it is made by an approved, sterile, compounding pharmacy. And, while PC/DC can cost 10 times less than brand name products, that does not mean you can use more product at one time. The indications are still the same and injections are performed in small areas at six-week intervals in a series of three to five treatments. Client safety is always first and foremost, but, when safe, more affordable alternatives are available, it is worth a second look and deeper conversation with your client.

Erin LucieErin Lucie, DNP, FNP-C, owner of Luminate Clinic and an Oklahoma native, is family nurse practitioner and licensed cosmetologist with over 15 years’ experience in the aesthetic industry. Known in Tulsa as an expert cosmetic injector, she completed her Botox and filler training in Beverly Hills, California in 2011 and has attended many advanced trainings since. She has further specialized in optimizing and balancing the hormone dysfunction created by stress and the overwhelming life management issues relating to all professionals by providing clients with integrative options in health, lifestyle, medication, and appearance enhancement. Lucie is a member of the American Academy of Anti-Aging Medicine.

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