Belkyra-kybella

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BELKYRA ®


is an lipolytic or fat Dermal Filler Dissolving (Hyaluronidase) injection that has been in the UK since 2021. It is a only which acid and is used to fullness or double chins.


It is made by Allergan Aesthetics, the same manufacturers as the botulinum toxin brand, , and is as in the UK, Australia, Canada, and other European countries. It has been in the USA since April 2015 where it is under the brand name .


Prior to as a medicine in both the USA and the UK, it was known in clinical trials as ATX-101, thus many of the published papers about its safety and efficacy refer to it as ATX-101.


The active ingredient is 20 mg of acid in each 2ml vial of solution. There are 4 x 2ml vials in each per patient box of BELKYRA® which should be enough to treat a single patient over the course of several sessions.


Each vial also water for injection, sodium chloride, sodium hydroxide (for dissolution and pH adjustment), phosphate anhydrous, and hydrochloric acid (for pH adjustment). The pH of the is 8.3, making it slightly alkaline and on a level with sea water.


The note that deoxycholic acid is a drug. When it is into the subcutaneous layer where the fat sits, its mechanism of action is to disrupt the cell membrane of the fat cells or adipocytes. By the fat cell walls and making them leak out their liquid fat content, or lipids, this stimulates a wound healing response in the body, which sets about eliminating the debris through the natural metabolism and ridding the body of the excess fat which has been for . It also the production of new collagen in the area as a to the trauma with tightens and contours the area.


During treatment, your will inject 0.2 ml (2 mg) per site into the subcutaneous level below the skin where the fat resides, points are spaced 1 cm apart under your chin and will be marked out prior to treatment. You will usually need more than one for optimal results.


To ensure comfort, the is usually using either anaesthetic cream or local injection to numb the area being treated. A cold compress may also be .


BELKYRA® became widely available and licensed in the UK in 2021 following several years of trial amongst UK physicians.


BELKYRA® is licensed in the UK and indicated for "the treatment of moderate to severe convexity or fullness associated with submental fat in adults when the presence of submental fat has an important psychological impact for the patient". 


The U.S. Food and Drug Administration in America approved the in April 2015 under the brand name KYBELLA® for the "improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults".


The is not recommended for use in anyone under 18 years of age.


Appropriately trained and members of the medical profession only. 
Currently only available on prescription through .


is indicated for to severe submental fat, more known as a double chin.


The idea patient is either male or female and is bothered by the area under their chin, they feel it makes them look older or in appearance, and despite eating well and the double chin or does not reduce.


Because treatment with under the clinical trial name AXT-101 and the brand name of has been available for longer in the USA, the long-term results from treatment have been more thoroughly assessed. From the trials, a subset of those have to be followed-up for further study and this has the of for up to 5 years.


Very commonly reported side effects following treatment with include, redness, pain, swelling, itching, or at the sites. Other common side effects include headache, nausea, a feeling of tightness or warmth to the skin in the area . Most common reactions swelling and discomfort resolve within days.


More severe and rare complications include nerve injuries, which can take a few months to resolve.


You can take pain to ease discomfort after each .


and breast-feeding women, or the under 18s.


Should not be used in anyone with a known to deoxycholic acid or any of the other within the product. 


cannot take place if there is an active infection in the area to be .


Due to the of salt within the product, patients on a controlled sodium diet may not be suitable for treatment.


You will be recommended to have 2-4 sessions up to a maximum of 6. These will be spaced at least 4 weeks apart.


The cost of on the size of the area being and the amount of required. Be for prices to be between £750-£1,000 per .


The have performed various randomised, double-blind, trials at multi-centres across the USA, Canada, and Europe over the last decade to gather pivotal data required for medicines approval in the various territories. The U.S. and Phase III trials were known as REFINE-1 and REFINE-2 (Randomised Double-blind Evaluation of Submental Fat Reduction IN ATX-101 TrEated Patients) and enrolled more than 1,000 patients who were treated with ATX-101 or placebo, in 70 centres. Similar trials were conducted in Europe.


The various trials have demonstrated results which show that 68.2% of subjects treated with KYBELLA experienced a ≥1-grade with the use of the product to 20.5% of subjects; this was based upon and patient measurements. 16% of patients a ≥2- grade improvement, compared to 2% of patients who to . Similarly, KYBELLA treatment resulted in high patient – 79% of reported with their appearance in association with their face and chin. Patients also reported in the visual and impact of fat when asked how happy, bothered, self-conscious, embarrassed, old, and overweight they felt following treatment in to the amount of their fat.


in Contour Up to 3 Years After ATX-101: and Safety Follow-Up of the Phase 3 REFINE Trials.
Humphrey S, Cohen JL, Bhatia AC, Green LJ, Green JB, Bowen B.
Aesthet Surg J. 2021 Feb 22:sjab100. 


Uncommon Adverse of Deoxycholic Acid for Fullness: Beyond the Clinical Trials.
Metzger KC, EL, Kadlubowska D, Gooderham MJ.
J Cutan Med Surg. 2020 Nov/Dec;24(6): . Epub 2020 Aug 5.


Deoxycholic acid in the fat reduction: A review of properties, adverse effects, and complications.
Farina GA, Cherubini K, de Figueiredo MAZ, Salum FG.
J Cosmet Dermatol. 2020 Oct;19(10): . Epub 2020 Jul 29.


and safety of ATX-101 as a for fullness: A retrospective analysis of two aesthetic .
Zarbafian M, Karavan M, Greene R, Fabi SG.
J Cosmet Dermatol. 2020 Jun;19(6): . Epub 2019 Sep 25.


ATX-101 (Deoxycholic Acid Injection) Leads to Clinically Improvement in Submental Fat: Final Data From .
Behr K, Kavali CM, Munavalli G, Teller CF, Yoelin S, Breshears L, Sangha S.
Dermatol Surg. 2020 May;46(5): .  


With 100 Patients Undergoing Neck With ATX-101 ( Acid): An Updated Report With A 2-Year Analysis.
SM.
Dermatol Surg. 2019 Oct;45(10): . 


ATX-101 (Deoxycholic Acid Injection) for Reduction of Fat: Results From a 12-Month Study.
Beer K, Weinkle SH, Cox SE, Rubin MG, A, C.
J Drugs Dermatol. 2019 Sep 1;18(9): .


The Use of Deoxycholic Acid for the Reduction of Excess Submental Fat in Indian Patients.
Shome D, Khare S, Kapoor R.
J Drugs Dermatol. 2019 Mar 1;18(3): .


and Safety of ATX-101 by Treatment Session: Pooled Analysis of Data From the Phase 3 REFINE Trials.
Dayan SH, Schlessinger J, Beer K, Donofrio LM, Jones DH, S, Carruthers J, Lizzul PF, Gross TM, FC 3rd, Somogyi C.
Aesthet Surg J. 2018 Aug 16;38(9): .


ATX-101 (Deoxycholic Acid Injection) Treatment in Men: From Our Clinical Experience.
Shridharani SM, Behr KL.
Dermatol Surg. 2017 Nov;43 Suppl 2:S225-S230. 


The development, evidence, and use of ATX-101 for the treatment of fat.
C, Lipner SR.
J Cosmet Dermatol. 2017 Jun;16(2): . Epub 2017 Apr 21.


Prevention and of Injection-Related Adverse Effects in Facial Aesthetics: for ATX-101 (Deoxycholic Acid Injection) .
Fagien S, McChesney P, Subramanian M, Jones DH.
Dermatol Surg. 2016 Nov;42 Suppl 1:S300-S304. 


of Patient Experience With ATX-101 ( Acid Injection) for Reduction of Submental Fat.
Dover JS, Kenkel JM, Carruthers A, Lizzul PF, Gross TM, Subramanian M, FC 3rd.
Surg. 2016 Nov;42 Suppl 1:S288-S299. 


Overview of ATX-101 ( Acid Injection): A Nonsurgical for Reduction of Fat.
Dayan SH, Humphrey S, Jones DH, Lizzul PF, Gross TM, K, Beddingfield FC 3rd.


Dermatol Surg. 2016 Nov;42 Suppl 1:S263-S270. 


REFINE-1, a Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial With ATX-101, an Drug for Submental Fat .
Jones DH, J, Joseph JH, Callender VD, Walker P, Lee DR, M, Lizzul PF, Gross TM, Beddingfield FC 3rd.
Dermatol Surg. 2016 Jan;42(1):38-49.


[The use of deoxycholic acid (ATX-101) in aesthetic medicine: A promising treatment].
Hersant B, Calmon A, JP.
Rev Stomatol Chir Maxillofac Chir Orale. 2015 Dec;116(6):350-2. doi: 10.1016/j.revsto.2015.09.003. Epub 2015 Dec 1.


Results from a pooled of two European, randomized, placebo-controlled, phase 3 studies of ATX-101 for the reduction of excess submental fat.
McDiarmid J, Ruiz JB, Lee D, Lippert S, Hartisch C, Havlickova B.
Aesthetic Plast Surg. 2014 Oct;38(5):849-60. Epub 2014 Jul 2.


Efficacy, outcomes and safety of ATX-101 (deoxycholic acid), an injectable drug for the reduction of unwanted submental fat: results from a phase III, randomized, study.
Ascher B, Hoffmann K, Walker P, S, U, Havlickova B.
J Eur Acad Dermatol Venereol. 2014 Dec;28(12): . Epub 2014 Mar 8.


of fat with ATX-101 (deoxycholic acid), an adipocytolytic treatment: results from a phase III, randomized, study.
Rzany B, T, Walker P, Lippert S, McDiarmid J, B.
Br J Dermatol. 2014 Feb;170(2):445-53.



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