Kybella

Introducing Kybella - Kybella (deoxycholic acid) Injection. Kybella is the first and only FDA approved injectable drug that contours and improves the appearance of submental fullness.

1. What is Kybella?

2. What is the FDA approved indication for Kybella?

3. What are some of the clinical study results with Kybella?

4. Can I use Kybella to reduce fatty deposits in other areas of my body such as my arms or stomach?

5. What are the most common adverse reactions associated with Kybella?

6. What are some of the risks and potential complications associated with Kybella injections?

7. How is Kybella supplied to the Physician?

8. How does Dr. Mitchell perform the Kybella procedure?

9. How long does it take to perform a Kybella procedure?

10. What can I expect following a Kybella treatment? Is the procedure painful?

11. Will Kybella therapy help to tighten my loose neck skin?

12. How many individual injections are needed during a Kybella treatment?

13. How many separate treatments are needed to achieve my desired result?

14. How long is the "down time" following a Kybella treatment?

15. What is the cost of a Kybella treatment?

Answers

1. Kybella is the first and only FDA approved injectable drug that reduces fat and clinically improves the appearance of submental (beneath the chin) fullness. Kybella is deoxycholic acid and is identical to the deoxycholic acid that is produced in the body. Deoxycholic acid produced in the body is a bile acid secreted by the liver. The acid causes adipocytolysis, which is the rupture of the fat cells leading to reabsorption in the body. When the fat cell is exposed to the deoxycholic acid properly, the fat cell dies and is gone forever.

2. Kybella is indicated for application to the submental region of the neck. The submental area is also known physically as the submental triangle (or suprahyoid triangle). In addition to fat, there are muscles and ligaments in the deep region of the submental area. Kybella is not indicated for injection into any muscle or fat deep to the neck muscles. Kybella is only FDA approved and indicated to treat the fat in the submental region, deep to the skin but above the neck muscles that also are located in the submental triangle. Some people have an abundance of fat beneath the platysma muscle in the submental area. The fat below the platysma muscle is not indicated to be injected with Kybella. If this fat is injected either inadvertently or purposely, there are reports of patients experiencing dysphasia (difficulty swallowing). This adverse effect should be temporary but nonetheless is potentially dangerous and concerning to the patient.

3. More than 20 clinical studies, involving more than 2600 patients of whom more than 1600 treated with Kybella have been conducted regarding the use of deoxycholic acid and fat reduction. In the pivotal phase 3 clinical trials, 68.2 % of subjects treated with Kybella were responders. Many patients' experienced visible results in two to four treatment sessions spaced at least one-month apart. 79% of patients treated with Kybella reported satisfaction with their appearance in association with their face and chin. This data is on file at Kythera Biopharmaceuticals.

4. Kybella is FDA approved for injection into the submental region of the neck only. While other areas of the body such as the arms and stomach can be injected with Kybella (deoxycholic acid); these injections are considered an off-label use (not approved by the FDA). Also, Kybella is supplied from the manufacturer in a small quantity (2 ml per vial) and if an area larger than the neck, such as the arms or stomach were injected with Kybella, the amount of Kybella needed would be very large and cost prohibitive. The reality however is that deoxycholic acid has been used for many years on all fatty areas of the body for fat reduction but was not FDA approved. Injectable drugs including deoxycholic acid injected for fat dissolving is called mesotherapy among other terms found in the literature. This technique for fat destruction has been around for well over a decade and used by many physicians for the same indication as Kybella. Compounded deoxycholic acid is inexpensive to manufacture. However, this form of deoxycholic acid therapy is not FDA approved and is considered an off-label use.

5. The most common adverse reactions following the injection of Kybella were primarily associated with the treatment area and injection sites and include edema (swelling), hematoma (bruising), pain, numbness, erythema (redness) and induration (firmness of the injected area). Most of these reactions were mild (81%), moderate (17.4%), or severe (1.6%).

6. When adverse reactions to a medication or procedure occur, the severity occurs on a continuum from mild reactions to more severe episodes. In order to better understand the risks involved using Kybella, let's call more severe adverse reactions of the Kybella procedure as complications. Two temporary potential complications that may occur following Kybella injection are nerve injury and swallowing difficulties. The marginal mandibular nerve is a motor nerve that courses near the submental area. The submental area of the neck is the region where Kybella is injected. If the marginal mandibular nerve is affected by Kybella, some degree of loss of normal movement of the lower lip will be observed. This will typically affect only one side of the lower lip as there are both a left and a right marginal mandibular nerve supplying movement to their respective sides of the lower lip. It would be much more common to have a partial and temporary paresis (muscular weakness or partial paralysis) of the lower lip than a complete paralysis. No cases of complete lower lip paralysis have been reported from the use of Kybella. In order to provide the patient with the safest injection procedure, it is critical that the injecting physician be intimately familiar with the anatomy of the neck and marginal mandibular nerve branch of the facial nerve in particular. During clinical trials of Kybella cases of transient paresis of the marginal mandibular nerve were observed. The median duration of paresis was 44 days (range 1-298 days). All cases of marginal mandibular nerve paresis resolved spontaneously without permanent muscle weakness. Another possible adverse occurrence following the injection of Kybella is dysphasia (difficulty swallowing). Patients who have pre-existing dysphagia (trouble swallowing) should avoid Kybella use as using Kybella may exacerbate the condition. The cause of difficulty swallowing following Kybella injection is not well understood but is likely due to the swelling from the Kybella reaction itself or if the Kybella is injected into the muscle or on the muscle, muscular inflammation ensues and difficulty swallowing will occur. If either lip weakness or difficulty swallowing occur, the patient should expect a full recovery.

7. Kybella is supplied to the Physician in a box containing four (4) 2 milliliter bottles of Kybella. In addition, a marking pen and a grid is supplied to assist the physician with pre-injection patient marking and properly spaced injections.

8. The Kybella procedure is performed in an office based setting. The patient will have pre-procedure photographs taken. The patients neck will be cleaned and marked in a sitting position. Topical anesthetic cream will be applied to the treatment area and left in place for approximately 15 minutes. Cold compresses may be used prior to the procedure, during and after the procedure for additional comfort. Also, prior to Kybella injection, a small volume of local anesthetic (Lidocaine) will be injected using a small 30 gauge, 1/2 inch needle into the treatment area. It has been found that this extra step significantly reduces the discomfort of the Kybella treatment. The treatment is actually quite tolerable. It should not be particularly painful when proper time and care is used for the procedure using the above stated technique.

9. The Kybella treatment takes approximately 15 minutes. However, we do not rush any procedure. First, photos will be taken. Then I will mark your neck appropriately and apply a topical anesthetic. The topical anesthetic will be allowed to take effect for a few minutes and the local anesthetic is infiltrated during this time. This will take about 2 minutes. The Kybella injections will take approximately 5 minutes but is dependent on how many Kybella injections the patient has agreed to. Each 2 ml of Kybella will cover 10 injection sites. From my current experience, most patients will benefit from 4 ml (2 bottles of Kybella), 20 injection sites per treatment session.

10. Following a Kybella treatment, the patient can expect the injected area to become warm, pink to red and swollen. This may last for 2 days or longer. The patient should expect their neck to have some swelling and redness for up to a week. It is very important to take this into consideration prior to undergoing a Kybella treatment because it may not be so easy to cover up the neck in public. Also, please realize that just because this is a minimally invasive procedure it does not necessarily equate into minimal treatment reaction. As indicated above, the treatment area is going to be swollen, warm to the touch and tender. The pain after the injection is not severe. The pain will likely only be mild or a moderate irritation. No prescription pain medications are indicated and over the counter Acetaminophen (Tylenol) or Ibuprofen will be sufficient to control any discomfort experienced from this treatment.

11. There is no guarantee that Kybella will tighten lo se skin in the submental area. Kybella is indicated to reduce the fat within the submental region. There may be associated skin retraction as time passes or after multiple treatments but no guarantee of skin tightening is made or should be expected. If skin laxity (loose neck skin) is your primary concern, it is imperative to discuss your concern with your surgeon to discuss all of your treatment possibilities. For loose neck skin, there is not an excellent substitute for a well executed lower face and neck lift to improve or rid the neck of extra, loose, hanging neck skin.

12. Besides the small amount of local anesthetic (lidocaine) that is injected for comfort, each Kybella treatment session will involve a minimum of 10 injections. Each 2 ml bottle of Kybella will cover ten injection sites placed 1 cm apart. Each injection will have 0.2 ml of Kybella. Ten (10) injections times 0.2 ml = 2 ml. As discussed in an earlier question, many patients seeking this treatment option for submental fullness reduction, will benefit from 20 injection sites or 4 ml of Kybella. Four (4)ml of Kybella is 2 bottles of Kybella. Kybella is sold in 1 bottle (2 ml) increments.

13. The number of individual treatment sessions to obtain your desired result cannot be determined exactly. Also, keep in mind that as with any treatment, if your expectations are unreasonable, you may not ever achieve your desired result. In the Kybella clinical trials, the average dose of Kybella injected per individual treatment session, was 4-6 ml. That translates into 2-3 vials per treatment session. Also, the clinical study participants underwent between 2-4 treatments spaced approximately 4 weeks apart. Individual results will vary. Also, I believe that choosing your injector wisely as with any surgery or procedure is paramount to obtaining a good result. By choosing a surgeon that is intimately familiar with the anatomy of the head and neck, you should expect a more precise treatment and a potentially better outcome.

14. The downtime following a Kybella treatment will be based on many factors including individual variations on healing capacity, number of injection sites and operator technique. The treated area is expected to be swollen and pink to red to some degree. The treatment area will feel warm to the touch for 24-48 hours. The swelling may last 4-7 days or possibly longer. For patients that work with the public, you may choose to not work for 4-7 days. Of course if you do not mind being seen with a swollen neck, work can be resumed in 24-48 hours. A turtle neck shirt or scarf may cover the area sufficiently in order to hide the treated area. Physical exercise may be resumed as the patient sees fit. the treated area will be hot, red and swollen for 4-7 days and any jarring action or jumping or bouncing may be found to be sensitive to the neck. Walking may be resumed within 24 hours. Let pain be your guide as to when you feel comfortable resuming your normal activities and workouts.

15. The cost of Kybella is going to vary between treatment providers. The prices I am stating here may change without notice and this cost is only an average. Each bottle of Kybella (2cc) will cost $600 to the patient. One 2cc bottle will cover 10 injection sites. As explained in earlier answers, many patients may desire or be good candidates for 2 bottles of Kybella per treatment session (4ml). Therefore most initial treatments and subsequent treatments will cost $1200.

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