KYBELLA kybeHa (deoxycholic acid) injection 20 mg/2 mL (10 mg/mL) for subcutaneous use only t) (7, Ha Single use Vials? Discard unused pomon? money/0m Four ready-to-use 00 not dilute. wig/yummy . Vim. . Rx ONLY Roger A. Dailey, MD, FACS Casey Aesthetic Facial Surgery Center Roger A. Dailey, MD, FACS Casey Aesthetic Facial Surgery Center Consumers Are Concerned About Their Submental Fullness According to "'Amer? 1 Dermatologic Surgery (ASDS) i Roger A. Dailey, MD, FACS Casey Aesthetic Facial Surgery Center Key Anatomic Landmarks of the Cervicomental Region Pre-platysmal Fat Through Destruction of Fat Cells When injected into subcutaneous fat, causes the destruction of fat cells. Once destroyed, those cells cannot store or accumulate fat. Before Treatment 7 Direct effects ?4 Lysis of Adipocytes Heanhy Adipocytes To avoid potential tissue damage, KYBELLATM shoulc not be injected into or in close proximity to vulnerable anatorr structures. Submental Fat ailey, MD, FACS sthetic Facial Surgery Centel +1 +3 +4 Week Weeks Weeks I I A After Multiple . Treatments Destruction of Fat Cells Macrophage In?ltratlon, Phagocytosis. and Fibroblast Recruitment Submental Fat t, - a. . . Lamb/rd Roger A. Dailey, MD, FACS Casey Aesthetic Facial Surgery Center 5 - . . ?12523.- Post-platysmal fat Pre-platysmal fat Pre-Treatment Post-Treatment Roger A. Dailey, MD, FACS Casey Aesthetic Facial Surgery Center KYBELLA Double Chin (Submental Fullness) Roger A. Dailey, MD, FACS Casey Aesthetic Facial Surgery Center The Safety Pro?le of KYBELLATM (deoxycholio acid) Injection ls Well?Characterized Most Common Adverse Reactions Were Primarily Associated With the Treatment Area* soveese REACTIONS (?Kgs?g'l'n?n?xm Injection site reactions 492 411 edemalswelling 448 218 hematomalbruising 388 02%) 353 pain . 358 00%) I 180 numbness 341 29 erythema 138 91 induration 12D 13 "Adverse reactions that occurred in a20% treated subjects and at greater incidence than placebo Adverse reactionsthat occurred in <20% of subjectsincluded paresthesia, nodule, pruritus, skin tightness. site warmth. nerve injury, headache. oropharvngeal pain, hypertension, nausea, and Other adverse reactions associated with the use of KYBELLA include: injection site hemorrhage, injection site discoloration. injection site urticaria, and neck pain. Inrorn'atlc-n Elsa?Ia'maceullcals rt: Eljliv Roger A. Dailey, MD, FACS Casey Aesthetic Facial Surgery Center SELECT Dose Determine KYBELLATM (deoxycholic acid) Injection Dose Determine number of 1 mL syringes needed - Count the number of dots in the treatment area and divide by 5 - Ignore any dots that fall outside of the pre?marked treatment area SELECT KYBELLATM (deoxycholic acid) Injection Dose Count the Number of Dots in the Pre-De?ned Treatment Area Number of Total Dose Number of Dots Number of 1-mL Syringes KYBELLA Vials 'In clinical trials the average total dose was 4 to 6 mL or between 2 to 3 of administered in a Single treatment seSSion No more than 10 mL or 5- wals of per lreatnient sessmn is recommended Discard unused portions of Roger A. Dailey, MD, FACS Casey Aesthetic Facial Surgery Center Individual results may vary. Roger A. Dailey, MD, FACS Casey Aesthetic Facial Surgery Center Kythera Study Patient Roger A. Dailey, MD, FACS Casey Aesthetic Facial Surgery Center Kythera Study Patient Roger A. Dailey, MD, FACS Casey Aesthetic Facial Surgery Center Kythera Study Patient Roger A. Dailey, MD, FACS Casey Aesthetic Facial Surgery Center Kythera Study Patient Roger A. Dailey, MD, FACS Casey Aesthetic Facial Surgery Center Kythera Study Patient Roger A. Dailey, MD, FACS Casey Aesthetic Facial Surgery Center Kythera Study Patient Roger A. Dailey, MD, FACS Casey Aesthetic Facial Surgery Center Kythera Study Patient Roger A. Dailey, MD, FACS Casey Aesthetic Facial Surgery Center Kythera Study Patient THE FIRST AND ONLY FDA APPROVED INJECTABLE DRUG THAT CONTOURS AND IMPROVES THE APPEARANCE 0F SUBMENTAL FULLNESS CLINICAL PROGRAM 7 9 TOPLINE RESULTS of patients treated with KYBELLATM reported DOSING satisfaction with their appearance in association PATIENT SATISFACTION their. face and Chin* The most commonly reported adverse reactions in the pivotal clinical trials were: injection site edema/swelling, hematoma/ bruising, pain, numbness, erythema, and induration. ?In response to the question. ?Considering your appearance in association with your face and chin. how satis?ed do you feel with your appearance at the present time whether or not in yourjudgment it IS due entirely to treatment Tull-1??; "4 Arr-Mm: Amman:- . .i im'. .rzzii :i~l"Il -"ll ?lI r: "an" .372; 'i N, 1 in. ti vii aim: m? 'ttiz?u?x in ~11"min 1'1 ?In Roger A. Dailey, MD, FACS Casey Aesthetic Facial Surgery Center