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.
October 24, 2017
Answer: Number of Kybella treatments required 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!
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October 24, 2017
Answer: Number of Kybella treatments required 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!
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October 19, 2017
Answer: How many #Kybella treatments? 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
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October 19, 2017
Answer: How many #Kybella treatments? 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
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