BEFORE USING PRODUCT, READ THE FOLLOWING

Transcription

1 Cution: Federl (USA) lw restricts this device to sle y or on the order of licensed physicin or properly licensed prctitioner. BEFORE USING PRODUCT, READ THE FOLLOWING INFORMATION THOROUGHLY. 1. DEVICE DESCRIPTION injectle gel is sterile, iodegrdle, non-pyrogenic, viscoelstic, cler, colorless, homogeneous gel implnt. It consists of cross-linked hyluronic cid (HA) produced y Streptococcus species of cteri, formulted to concentrtion of 15 mg/ml nd 0.3 w/w lidocine in physiologic uffer. 2. INTENDED USE/INDICATIONS injectle gel is indicted for injection into the lips for lip ugmenttion nd for correction of periorl rhytids in dults over the ge of CONTRAINDICATIONS is contrindicted for ptients with severe llergies mnifested y history of nphylxis or history or presence of multiple severe llergies. contins trce mounts of Grm-positive cteril proteins nd is contrindicted for ptients with history of llergies to such mteril. contins lidocine nd is contrindicted for ptients with history of llergies to such mteril. 4. WARNINGS The product must not e injected into lood vessels. Introduction of injectle gel into the vsculture my led to emoliztion, occlusion of the vessels, ischemi, or infrction. Tke extr cre when injecting soft-tissue fillers, for exmple, fter insertion of the needle, nd just efore injection, the plunger rod cn e withdrwn slightly to spirte nd verify the needle is not intrvsculr, inject the product slowly, nd pply the lest mount of pressure necessry. Rre, ut serious, dverse events ssocited with the intrvsculr injection of soft-tissue fillers in the fce hve een reported nd include temporry or permnent vision impirment, lindness, cererl ischemi or cererl hemorrhge leding to stroke, skin necrosis, nd dmge to underlying fcil structures. Immeditely stop the injection if ptient exhiits ny of the following symptoms, including chnges in vision, signs of stroke, lnching of the skin, or unusul pin during or shortly fter the procedure. Ptients should receive prompt medicl ttention nd possily evlution y n pproprite helth cre professionl specilist should n intrvsculr injection occur (see HEALTH CARE PROFESSIONAL INSTRUCTIONS #12). Product use t specific sites in which n ctive inflmmtory process (skin eruptions such s cysts, pimples, rshes, or hives) or infection is present should e deferred until the underlying process hs een controlled. site responses consist minly of short-term inflmmtory symptoms strting erly fter tretment nd lsting 30 dys. Refer to the ADVERSE EVENTS section for detils. 5. PRECAUTIONS injectle gel is pckged for single-ptient use. Do not resterilize. Do not use if pckge is opened or dmged. In order to minimize the risks of potentil complictions, this product should only e used y helth cre professionls who hve pproprite trining, experience, nd who re knowledgele out the ntomy t nd round the site of injection. Helth cre professionls re encourged to discuss ll potentil risks of soft-tissue injection with their ptients prior to tretment nd ensure tht ptients re wre of signs nd symptoms of potentil complictions. Bsed on preclinicl studies, ptients should e limited to 20 ml of ny JUVÉDERM injectle gel per 60 kg (130 ls) ody mss per yer. The sfety of injecting greter mounts hs not een estlished. The sfety nd effectiveness for the tretment of ntomic regions other thn the lips nd periorl re hve not een estlished in controlled clinicl studies. of more thn 6.0 ml of injectle gel hs not een studied for lip ugmenttion nd correction of periorl rhytids. As with ll trnscutneous procedures, derml filler implnttion crries risk of infection. Stndrd precutions ssocited with injectle mterils should e followed. injectle gel is to e used s supplied. Modifiction or use of the product outside the Directions for Use my dversely impct the sterility, homogeneity, nd performnce of the product. The sfety for use during pregnncy, in restfeeding femles, or in ptients under 22 yers hs not een estlished. The sfety in ptients with known susceptiility to keloid formtion, hypertrophic scrring, nd pigmenttion disorders hs not een studied. injectle gel should e used with cution in ptients on immunosuppressive therpy. Ptients who re using sustnces tht cn prolong leeding (such s spirin, nonsteroidl nti-inflmmtory drugs, nd wrfrin) my, s with ny injection, experience incresed ruising or leeding t injection sites. Ptients my experience lte onset dverse events with use of derml fillers, including. Refer to ADVERSE EVENTS section for detils. After use, tretment syringes nd needles re iohzrds. Hndle nd dispose of these items in ccordnce with ccepted medicl prctice nd pplicle locl, stte, nd federl requirements. injectle gel is cler, colorless gel without visile prticultes. In the event tht the content of syringe shows signs of seprtion nd/or ppers cloudy, do not use the syringe; notify Allergn Product Support t should only e used y helth cre professionls who hve pproprite experience nd who re knowledgele out the ntomy nd the product for use in the lips nd periorl re. If lser tretment, chemicl peeling, or ny other procedure sed on ctive derml response is considered fter tretment with, there is possile risk of eliciting n inflmmtory rection t the implnt site. An inflmmtory rection is lso possile if the product is dministered efore the skin hs heled completely fter such procedure. Filure to comply with the needle ttchment instructions could result in needle disenggement nd/or product lekge t the LUER-LOK nd needle hu connection.

2 6. ADVERSE EVENTS A. US Pivotl Study of In the multicenter, doule-lind, rndomized, controlled clinicl tril to evlute the sfety nd effectiveness of JUVÉDERM VOLBELLA XC versus Restylne-L (control) for lip ugmenttion nd correction of periorl rhytids, sujects were rndomized nd treted in 3:1 rtio with either (N = 168) or control (N = 56). Sujects used preprinted diry forms to record specific signs nd symptoms of injection site responses (ISRs) experienced during the 30 dys fter initil tretment, touch-up tretment (if performed), nd repet tretment. Sujects were instructed to rte ech ISR listed on the diry s, Moderte, Severe, or None. ISRs were defined s wreness of sign or symptom ut esily tolerted. Moderte ISRs were defined s discomfort enough to cuse interference with usul ctivity. Severe ISRs were defined s incpcitting with inility to work or do usul ctivity. The severity nd durtion of ll ISRs reported y > 5 of sujects who completed post-tretment diry forms fter initil tretment re summrized in Tle 1 nd Tle 2, respectively. Tle 3 shows the severity nd durtion of ll ISRs fter repet tretment reported y > 5 of sujects. The mjority of ISRs were mild or moderte in intensity, nd their durtion ws short lsting (30 dys or less). There were no significnt differences in ISRs reported etween nd control. The incidence, severity, nd durtion of ISRs reported fter the touch-up nd repet tretments were generlly lower thn those reported fter initil tretment. Tle 1. s y Severity After Initil Tretment Occurring in > 5 of Treted Sujects Lumps/Bumps Pin Discolortion Totl (n/n ) 97.4 (150/154) 92.9 (143/154) 89.6 (138/154) (135/154) 83.1 (128/154) 80.5 (124/154) 41.6 (64/154) 30.5 (47/154) 5.2 (8/154) Moderte Severe Totl (n/n ) (45/51) (25/51) 37.3 (19/51) 3.9 (2/51) Moderte Severe N denotes the numer of sujects who recorded responses in the diries fter initil tretment. Mximum reported severity in the diry. The percentges y severity re sed on the numer of sujects Tle 2. s y Durtion After Initil Tretment Occurring in > 5 of Treted Sujects Lumps/ Bumps Pin Discolortion Totl (n/n ) 97.4 (150/154) 92.9 (143/154) 89.6 (138/154) (135/154) 83.1 (128/154) 80.5 (124/154) 41.6 (64/154) 30.5 (47/154) 5.2 (8/154) 1-3 Totl (n/n ) (45/51) (25/51) 37.3 (19/51) 3.9 (2/51) N denotes the numer of sujects who recorded responses in the diries fter initil tretment. Mximum durtion reported in the diry. The percentges y durtion re sed on the numer of sujects Tle 3. s y Severity nd Durtion After Repet Tretment with Occurring in > 5 of Treted Sujects Lumps/Bumps Pin Discolortion Totl (n/n ) 90.2 (111/123) 87.8 (108/123) 83.7 (103/123) 80.5 (99/123) 79.7 (98/123) 77.2 (95/123) 72.4 (89/123) 69.9 (86/123) 30.9 (38/123) 26.0 (32/123) Severity Moderte Severe 1-3 Dys Dys Durtion c Dys Dys N denotes the numer of sujects who recorded responses in the diries fter repet tretment. Mximum severity reported in the diry. The percentges y severity re sed on the numer of sujects c Mximum durtion reported in the diry. The percentges y durtion re sed on the numer of sujects ISRs tht lsted eyond the 30-dy diries were considered dverse events (AEs). AEs were lso reported y the Evluting Investigtor t follow-up visits. After initil tretment (or touch-up tretment, if performed), tretment-relted AEs were reported in 50.0 (84/168) of sujects treted with JUVÉDERM VOLBELLA XC nd 51.8 (29/56) of sujects treted with control. The severity nd durtion of tretment-relted AEs reported y > 5 of sujects fter initil tretment (or touch-up tretment) re summrized in Tle 4 nd Tle 5. All AEs with n incidence > 5 were tretment-relted.

3 Most sujects treted with experienced mild (42.3, 71/168) or moderte (17.3, 29/168) tretment-relted AEs. Similr results were oserved fter tretment with control (41.1 [23/56] nd 23.2 [13/56] of sujects experienced mild nd moderte AEs, respectively). Regrdless of tretment group, the tretment-relted AEs generlly required no ction to e tken nd resolved without sequele. Tle 4. Tretment-Relted Adverse Events y Severity After Initil Tretment Occurring in > 5 of Treted Sujects Adverse Event Mss Pin Indurtion (N = 168) (N = 56) Sujects Moderte Severe Sujects Moderte Severe The percentges re sed on the numer of sujects who received tretment with the corresponding product. Tle 5. Tretment-Relted Adverse Events y Durtion After Initil Tretment Occurring in > 5 of Treted Sujects Adverse Event Mss Pin Indurtion Indurtion Events (n/n) 7 > 30 Not yet Resolved Events (n/n) 7 > 30 Not yet Resolved (100/345) (29/111) 15.9 (55/345) (20/111) 12.2 (42/345) (21/111) 12.5 (43/345) (7/111) (32/345) (17/111) 3.8 (13/345) (5/111) The percentges y durtion re sed on the numer of events for the corresponding tretment-relted dverse event. Tretment-relted AEs fter initil tretment (or touch-up tretment) occurring in 5 of sujects included chpped lips, dizziness, dry lips, generl physicl condition norml, hedche, lip disorder (lumps), lip injury, orl herpes, presyncope, wound, nd injection site discolortion, discomfort, edem, erythem, exfolition, hyperesthesi, hypoesthesi, lcertion, nodule, ppule, presthesi, pruritus, nd rection. In the clinicl study, 7 sujects hd lumps/umps or swelling tht occurred weeks to months fter tretment. All of these AEs were mild or moderte. ws treted with cetminophen or doxycycline, nd no tretment ws given for the lumps/umps. All of these events resolved without sequele. In the group, fter repet tretment with, tretment-relted AEs were reported in 13.7 (17/124) of sujects. site mss occurred in 7.3 (9/124) of sujects. Tretment-relted AEs occurring in 5 of sujects included chpped lips nd injection site ruising, edem, indurtion, nd pin. Tretment-relted AEs fter repet tretment occurred with lower incidence rtes, severity, nd durtion compred to initil/touch-up tretment. There were no tretment-relted serious dverse events reported. Lip sfety ssessments such s lip texture, functionl fetures of the lips, lip sensitivity nd senstion, Tyndll, nd speech nd rticultion were evluted t the screening visit nd throughout the study. None of the lip ssessments were remrkle or presented ny sfety concerns fter tretment with either JUVÉDERM VOLBELLA XC or control. On the vlidted Recovery Erly Life Impct module of the FACE-Q questionnire, suject reports showed tht tretment with (men score of 81.1) ws significntly less disruptive to norml dily ctivities thn tretment with control (men score of 73.1). B. Europen Clinicl Study In prospective, rndomized, multicenter study, 280 sujects desiring lip volume enhncement were rndomized 1:1 to receive tretment with or control. The sujects returned to the investigtionl sites t qurterly intervls for followup evlutions with the Treting Investigtor. Sujects could receive repet tretment with t months 6, 9, or 12 if the Investigtor determined tht the suject s Allergn Lip Fullness Scle (LFS) score hd returned to seline, or t month 12 if the suject s LFS score ws lower thn the tretment gol s ssessed y the Investigtor. At 1 month fter repet tretment, sujects returned for finl follow-up visit nd were then exited from the study. Common nd expected ISRs were collected vi 30-dy diries fter ech tretment. The incidence, severity, nd durtion of ISRs for sujects treted with fter initil tretment re shown in Tle 6. Most sujects reported n ISR fter tretment, with the most common eing swelling, tenderness, nd firmness. The mjority of ISRs were mild to moderte in severity nd resolved within 14 dys. The incidence of ISRs fter touch-up tretment ws lower thn tht fter initil tretment. The ISRs fter repet tretment were similr to those fter initil tretment. Tle 6. s y Severity nd Durtion After Initil Tretment with Occurring in > 5 of Treted Sujects Lumps/Bumps Pin Discolortion Totl (n/n ) 95.5 (126/132) 90.9 (120/132) 87.1 (115/132) 82.6 (109/132) 78.0 (103/132) 76.5 (101/132) 76.5 (101/132) 68.9 (91/132) 21.2 (28/132) 17.4 (23/132) Severity Moderte Severe 1-3 Dys Durtion c Dys Dys Dys N denotes the numer of sujects who recorded responses in the diries fter initil tretment. Mximum severity reported in the diry. The percentges y severity re sed on the numer of sujects c Mximum durtion reported in the diry. The percentges y durtion re sed on the numer of sujects ISRs lsting eyond the 30-dy diries were considered AEs. AEs were lso reported y the Investigtor t follow-up visits. Among the 139 sujects treted with t the initil tretment, 14 (10.1) experienced totl of 22 tretmentrelted AEs. The most common tretment-relted AE ws injection site mss (lumps/umps). Sujects treted with JUVÉDERM VOLBELLA XC experienced mild (7.9, 11/139) or moderte

4 (2.9, 4/139) tretment-relted AEs. In generl, the tretmentrelted AEs required no ction nd resolved without sequele. Among the 139 sujects who were treted with JUVÉDERM VOLBELLA XC t initil tretment nd received repet tretment with, 3 experienced totl of 4 tretment-relted AEs fter repet tretment. These AEs include 3 reports of injection site mss nd 1 report of orl herpes. None required tretment. Of the 4 AEs, 2 were mild (1 injection site mss [lumps/umps] nd 1 orl herpes), which resolved without sequele, nd 2 were reported with mximum severity of severe (oth events were injection site mss [lumps/umps] in 1 suject) nd then mild t the completion of the study. C. Postmrket Surveillnce The following reported dverse events were received from postmrket surveillnce on the use of JUVÉDERM VOLBELLA XC for lip ugmenttion outside the United Sttes nd were not oserved in the clinicl study. These dverse events, with frequency of 5 events or more, re listed in order of prevlence: inflmmtory rection, loss/lck of correction, hemtom, llergic rection, infection, presthesi, herpes, migrtion, ngioedem, nd necrosis. In mny cses the symptoms resolved without ny tretment. Reported tretments included the use of (in lpheticl order): nlgesics, ntiiotics, ntihistmines, nti-virl, rnic, dringe, hyluronidse, ice, lser tretment, mssge, NSAIDs, steroids, nd wrm compress. Outcomes for these reported events rnged from resolved to ongoing t the time of lst contct. In ddition, two reports of lurry vision fter injection into the perioritl re were received from postmrket surveillnce for used outside of the United Sttes. Reported tretment included nti-inflmmtories. The outcomes for these two reports were either ongoing or unknown t time of lst contct (see WARNINGS section). Adverse rections should e reported to Allergn Product Surveillnce Deprtment t CLINICAL STUDIES A. Pivotl Study of Pivotl Study Design A prospective, doule-lind, rndomized, controlled, multicenter clinicl study ws conducted to evlute the sfety nd effectiveness of versus control for injection into the lips nd periorl re (vermilion, vermilion order, philtrl columns, Cupid s Bow, periorl lines, nd/or orl commissures) for lip ugmenttion nd the correction of periorl rhytids. A totl of 224 sujects were rndomized nd underwent tretment with either (N = 168) or control (N = 56) t the outset of the study. An optionl touch-up tretment ws performed pproximtely 1 month fter the initil tretment, if deemed necessry to chieve optiml correction. The follow-up period consisted of sfety nd effectiveness follow-up visits t 1, 3, 6, 9, nd 12 months fter the lst tretment. Sujects were then eligile for repet tretment with, with post-tretment followup for 1 month fter repet tretment, t which time ll sujects completed the study. Study Endpoints The primry effectiveness mesure for the study ws the nlysis of non-inferiority of reltive to control in terms of chnge from seline to month 3 in men lip fullness sed on Evluting Investigtor ssessments using the vlidted 5-point Allergn Lip Fullness Scle (LFS). Secondry mesures included Evluting Investigtors ssessment of sujects periorl lines using the vlidted Periorl Lines Severity Scle (POLSS) nd sujects stisfction with their lips using the vlidted Stisfction with Lips module of the FACE-Q questionnire. Additionl effectiveness mesures included Evluting Investigtors ssessments of sujects upper nd lower lip fullness using the LFS, periorl lines severity t mximl contrction using the Periorl Lines t Mximl Contrction (POLM) scle, orl commissures severity using the Orl Commissures Severity Scle (OCSS), glol esthetic improvement using the Glol Aesthetic Improvement Scle (GAIS), nd ssessment of lip smoothness. Sujects performed self-ssessments of lip lines (using the Lip Lines module of the FACE-Q questionnire), lip hydrtion, nd nturl look nd feel of the lips. The Treting Investigtors lso ssessed injection ese nd product moldility. Sfety mesures included incidence, severity, nd durtion of ISRs nd AEs, sujects ssessments of procedurl pin nd of impct to dily ctivities using the Recovery Erly Life Impct module of the FACE-Q questionnire, nd Evluting Investigtors ssessments of Tyndll effect, lip senstion, fetures of the lip, nd chnges in pronuncition. Suject Demogrphics Suject demogrphics nd pretretment chrcteristics of the nd control groups re presented in Tle 7. Tle 7. Suject Demogrphics nd Pretretment Chrcteristics (N = 224) JUVÉDERM VOLBELLA XC (N = 168) (N = 56) (n/n) (n/n) Gender Femle 97.6 (164/168) 94.6 (53/56) Mle 2.4 (4/168) 5.4 (3/56) Age Medin Rnge Rce Cucsin 85.7 (144/168) 87.5 (49/56) Africn-Americn 8.9 (15/168) 10.7 (6/56) Asin 1.8 (3/168) 1.8 (1/56) Americn Indin or Alsk Ntive 1.2 (2/168) 0 (0/56) Other 2.4 (4/168) 0 (0/56) Fitzptrick Skin Type I/II 40.5 (68/168) 37.5 (21/56) Bseline Overll Lip Fullness (LFS) Score III/IV 47.0 (79/168) 50.0 (28/56) V/VI 12.5 (21/168) 12.5 (7/56) Very Mrked 0 (0/168) 0 (0/56) Mrked 1.8 (3/168) 5.4 (3/56) Moderte 35.1 (59/168) 26.8 (15/56) 43.5 (73/168) 48.2 (27/56) Miniml 19.6 (33/168) 19.6 (11/56) Tretment Chrcteristics The overll totl medin volume of JUVÉDERM VOLBELLA XC injected to chieve optiml outcomes ws 2.6 ml. Sujects received medin volume of 1.0 ml in the upper lip, 0.8 ml in the lower lip, 0.3 ml in the periorl lines, 0.5 ml in the orl commissures, nd 0.1 ml in the philtrl columns. volumes into the lips nd periorl re fter repet tretment tended to e lower, with the typicl totl medin injection volume to chieve optiml correction fter repet tretment eing pproximtely 1.6 ml. Similr injection volumes were used in sujects treted with the control device. In generl, injections into the vermilion ody of the upper nd lower lip were suderml, nd injections into the vermilion order, Cupid s ow, philtrl columns, periorl lines, nd orl commissures were intrderml. A tunneling technique, seril puncture technique, fnning technique, or comintion ws used to chieve optiml results.

5 Effectiveness Results The primry endpoint of the study ws met. The men chnge from seline to month 3 on the Allergn Lip Fullness Scle (LFS) ws 1.1 for sujects treted with nd 1.0 for sujects treted with control, with 80.3 (122/152) of sujects treted with nd 70.8 (34/48) of sujects treted with control showing 1-point improvement in overll lip fullness. Throughout the follow-up period, continued to provide cliniclly significnt improvement in lip fullness ( 1-point men improvement on the LFS), with mjority of sujects treted with demonstrting improvement through 1 yer (Tle 8). Tle 8. Effectiveness Results Through 1 Yer (n/n) 1 Month 86.2 (131/152) 3 Months 80.3 (122/152) 6 Months 71.1 (106/149) 9 Months 65.1 (95/146) 1 Yer 61.8 (76/123) At 3 months, improvements in periorl lines severity t rest were oserved in 65.4 (53/81) of sujects treted with JUVÉDERM VOLBELLA XC. At 1 yer, 66.2 (45/68) of sujects treted with mintined improvement in periorl lines severity t rest. At 3 months, 96.1 (147/153) of sujects treted with JUVÉDERM VOLBELLA XC reported improvement in stisfction with their lips, sed on the Stisfction with Lips module of the FACE-Q questionnire, with the men score incresing from 38.5 t seline to At 1 yer, 79.7 (98/123) of sujects reported improved stisfction with their lips over seline, with men score of Through 1 yer in the group, improvements in upper nd lower lip fullness were similr to the improvements seen in overll lip fullness. Sujects treted with in the periorl lines nd orl commissures lso sw improvement in periorl lines severity t mximl contrction nd orl commissures severity through 1 yer. On the GAIS t 3 months, 92.9 (143/154) of sujects in the group were scored s improved or much improved in ppernce. At 1 yer, the percentge of sujects scored s improved or much improved ws 58.5 (72/123) in the group. At 1 yer, 74.8 (92/123) of sujects treted with JUVÉDERM VOLBELLA XC reported improvement in stisfction with their lip lines sed on the Stisfction with Lip Lines module of the FACE-Q, with the men score incresing from 37.5 t seline to Follow-up After Repet Tretment Repet tretment with ws dministered to 124 sujects in the JUVÉDERM VOLBELLA XC rndomiztion group. The effectiveness profile fter repet tretment ws similr to tht fter initil tretment. At 1 month fter repet tretment, the responder rte ws similr to tht fter initil tretment, with 94.3 (115/122) of sujects showing t lest 1-point improvement in lip fullness, sed on the Evluting Investigtor ssessment. 8. INSTRUCTIONS FOR USE A. To Attch Needle to Syringe STEP 1: Remove tip cp Hold syringe nd pull tip cp off the syringe s shown in Figure A. Figure A STEP 2: Insert needle Hold the syringe ody nd firmly insert the hu of the needle (provided in the JUVÉDERM pckge) into the LUER-LOK end of the syringe. STEP 3: Tighten the needle Tighten the needle y turning it firmly in clockwise direction (see Figure B) until it is seted in the proper position s shown in Figure C. NOTE: If the position of the needle cp is s shown in Figure D, it is not ttched correctly. Continue to tighten until the needle is seted in the proper position. STEP 4: Remove the needle cp Hold the syringe ody in one hnd nd the needle cp in the other. Without twisting, pull in opposite directions to remove the needle cp s shown in Figure E. B. Helth Cre Professionl Instructions Figure B Figure C Figure D Figure E 1. injectle gel is highly crosslinked, soft, smooth gel formultion tht cn e injected using fine guge (e.g., 30-G) needle into the lips nd periorl re to dd fullness nd improve the shpe of the lips, nd to smooth periorl rhytids. 2. Prior to tretment, the ptient s medicl history should e otined, nd the ptient should e fully pprised of the indictions, contrindictions, wrnings, precutions, tretment responses, dverse rections, nd method of dministrtion. Ptients lso should e dvised tht supplementl touch-up tretments my e required to chieve nd mintin mximum correction. 3. The ptient s tretment gols should e chrcterized with regrd to proper proportion of upper nd lower lip, verticl height, horizontl length, vermilion fullness, contouring of the vermilion order, Cupid s ow, nd philtrl columns, s well s periorl lip rhytids nd orl commissures. Pretretment photogrphs re recommended. 4. Supplementry nesthesi my e used for dditionl pin mngement during nd fter injection.

6 5. After ensuring tht the ptient hs thoroughly wshed the tretment re with sop nd wter, the re should e swed with lcohol or other ntiseptic. Prior to injecting, depress the plunger rod until the product flows out of the needle. 6. After the first smll mount of mteril hs een injected into the ptient, wit full 3 seconds to llow the lidocine to tke effect efore proceeding with the rest of the injection. 7. The injection technique my vry with regrd to the ngle nd orienttion of the evel, the depth of injection, nd the quntity dministered. A tunneling technique, seril puncture technique, fnning technique, or comintion hs een used to chieve optiml results. Injecting the product too superficilly my result in visile lumps nd/or discolortion. 8. Inject y pplying slow nd even pressure on the plunger rod. It is importnt tht the injection e stopped efore the needle is pulled out of the skin to prevent mteril from leking out or eing plced too superficilly in the skin. 9. If the needle is locked, do not increse the pressure on the plunger rod. Insted, stop the injection nd replce the needle. 10. The typicl volume injected into the lips nd periorl re to chieve optiml correction ws pproximtely 2.6 ml, which my vry depending on the gols the ptient wishes to chieve. volumes into the lips nd periorl re fter repet tretment tended to e lower, with the typicl totl injection volume to chieve optiml correction eing pproximtely 1.6 ml. 11. Correct to 100 of the desired volume effect. Do not overcorrect. The degree nd durtion of the correction depend on the chrcter of the defect treted, the tissue stress t the implnt site, the depth of the implnt in the tissue, nd the injection technique. Mrkedly indurted defects my e difficult to correct. 12. If immedite lnching occurs, the injection should e stopped nd the re mssged until it returns to norml color. Blnching my represent vessel occlusion. If norml skin coloring does not return, do not continue with the injection. Tret in ccordnce with Americn Society for Dermtologic Surgery guidelines, which include hyluronidse injection When injection is completed, the treted site should e gently mssged so tht it conforms to the contour of the surrounding tissues. If overcorrection occurs, mssge the re etween your fingers or ginst n underlying superficil one/teeth to otin optiml results. 14. With ptients who hve loclized swelling, the degree of correction is sometimes difficult to judge t the time of tretment. In these cses, it is etter to invite the ptient ck to the office for touch-up tretment. 15. After the initil tretment, n dditionl touch-up tretment my e necessry to chieve the desired level of correction. If further tretment is needed, the sme procedure should e repeted until stisfctory result is otined. The need for n dditionl tretment my vry from ptient to ptient nd is dependent upon vriety of fctors such s tretment gols, lip fullness, periorl lines severity, skin elsticity, nd derml thickness t the tretment site. 16. Ptients my hve mild to moderte injection site responses fter tretment in the lips nd periorl re, which typiclly resolve within 14 dys. Ice my e pplied for rief period following tretment to minimize swelling nd reduce pin. 17. The helth cre professionl should instruct the ptient to promptly report to her/him ny evidence of prolems possily ssocited with the use of. C. Ptient Instructions It is recommended tht the following informtion e shred with ptients: Within the first 24 hours, ptients should void strenuous exercise, extensive sun or het exposure, nd lcoholic everges. Exposure to ny of the ove my cuse temporry redness, swelling, nd/or itching t the injection sites. To report n dverse rection, phone the Allergn Product Support Deprtment, HOW SUPPLIED injectle gel is supplied in individul tretment syringes with 30-G needles for single-ptient use nd redy for injection (implnttion). The volume in ech syringe is s stted on the syringe lel nd on the crton. The contents of the syringe re sterile nd non-pyrogenic. Do not resterilize. Do not use if pckge is opened or dmged. 10. SHELF LIFE AND STORAGE injectle gel must e used prior to the expirtion dte printed on the lel. Store t room temperture (up to 25 C/77 F). DO NOT FREEZE. injectle gel hs cler ppernce. In the event tht syringe contins mteril tht is not cler, do not use the syringe; notify Allergn Product Support immeditely t To plce n order, contct Allergn t Irvine, CA USA Mde in Frnce 2016 Allergn. All rights reserved. All trdemrks re the property of their respective owners. Ptented. See: 1 Alm M, Gldstone H, Krmer EM, et l. ASDS guidelines of cre: injectle fillers. Dermtol Surg. 2008;34(suppl 1):S115-S /