Safety guidelines for Isotretinoin dated 19.12.2018

.. • Patient Information/Informed Consent (for all patients): A. To be completed by patient (and parent or guardian if patient is under age 18) and signed by the doctor. Read each item below and initial in the space provided if you understand each item and agree to follow your doctor's instructions. A parent or guardian of a patient under age 18 must also read and understand each item before signing the agreement. Donot signthis agreementand donot take isotretinoin ifthere isanything that you do not understand about all the information you have received about using isotretinoin. 1. I, I (Patient's Name) Understand that isotretinoin is a medicine used to treat severe nodular acne that cannot be cleared up by any other acne treatments, including antibiotics. In severe nodular acne, many red, swollen, tender lumps form in the skin. If untreated, severe nodular acne can lead to permanent scars. Initials: _ 2. I understand that I must not get pregnant 1 month before, during the entire time of my treatment, and for 6 month after the end of my treatment with isotretinoin. My doctor has told me about my choices for treating my acne. Initials: _ 3. I understand that there are serious side effects that may happen while I am taking isotretinoin. These have been explained to me. These side effects include serious birth defects in babies of pregnant patients. (Note: There is a second Patient Information/Informed Consent About Birth Defects (for female patients who can get pregnant) Initials: _ 4. I understand that some patients, while taking isotretinoin or soon after stopping isotretinoin, have become depressed or developed other serious mental problems. Symptoms of depression include sad, "anxious" or empty mood, irritability, acting on dangerous impulses, anger, loss of pleasure or interest in social or sports activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down, or trouble concentrating. Some patients taking isotretinoin have had thoughts about hurting themselves or putting an end to their own lives (suicidal thoughts). Some people tried to end their own lives. And some people have ended their own lives. There were reports that some of these people did not appear depressed. There have been reports of patients on isotretinoin becoming aggressive or violent. No one knows jf isotretinoin caused these behaviors or if they would have happened even if the person did not take isotretinoin. Some people have had other signs of depression while taking isotretinoin (see #7 below).• • "a ~r Initials: _ 5. Before I start taking isotretinoin, I agree to tell my doctor if I have ever had symptoms of depression (see #7 below), been psychotic, attempted suicide, had any other mental problems, or take medicine for any of these problems. Being psychotic means having a loss of contact with reality, such as hearing voices or seeing things that are not there. Initials: _ 6. Before I start taking isotretinoin, I agree to tell my doctor if, to the best of my knowledge, anyone in my family has ever had symptoms of depression, been psychotic, attempted suicide, or had any . . . other serious mental problems. Initials: _ 7. Once I start takingisotretinoin~ I agree to stop using isotretinoin and tell my doctor rig~ht away if any of the following signs and symptoms of depression or psychosis happen. I: • Start to feel sad or have crying spells • Loseinterest inactivities 1once enjoyed • Sleep too much or have trouble sleeping • Become more irritable, angry, or aggressive than usual (for example, temper outbursts, thoughts of violence) • Have a change in my appetite or body weight • Have trouble concentrating • Withdraw from my friends or family • Feel like I have no energy • Have feelings of worthlessness or guilt • Start having thoughts about hurting myself or taking my own life (suicidal thoughts) • Start acting on dangerous impulses • Start seeing or hearing things that are not real Initials: --­ 8. I agree to return to see my doctor every month I take isotretinoin to get a new prescription for isotretinoin, to check my progress, and ito check for signs of side effects. Initials: _ 9. Isotretinoin will be prescribed just for me - I will not share isotretinoinwith other people because it may cause serious side effects, including birth defects. Initials: _ 10. I will not give blood while taking isotretinoin or for 1 month after I stop taking isotretinoin. I .~~ understand that if someone who is pregnant gets my donated blood, her baby may be exposed to isotretinoin and may be born with serious'birth defects. l ,:0 ! ',~, '• • Initials: _ 11. I have read the materials my provider gave me containing important safety information about isotretinoin. I understand all the information I received. Initials: _ B. Forfemale patientswhocanget pregnant 1. I understand that there is a very high chance that my unborn baby could have severe birth defects if I am pregnant or become pregnant while taking isotretinoin. This can happen with any amount and even if taken for short periods of time. This is why I must not be pregnant while taking isotretinoin. Initial: _ 2. I understand that I must not get pregnant 1 month before, during the entire time of my treatment, and for 6 months after the end of my treatment with isotretinoin. Initial: _ 3. I understand that I must avoid sexual intercourse completely, or I must use 2 separate, effective forms of birth control (contraception) at the same time. The only exceptions are if I have had surgery to remove the uterus (a hysterectomy) or both of my ovaries (bilateral oophorectomy), or my doctor has medically confirmed that I am post-menopausal. Initial: _ 4. I understand that hormonal birth control products are among the most effective forms of birth control. Combination birth control pills and other hormonal products include under-the-skin implants, vaginal rings, and intrauterine devices (IUDs). Any form of birth control can fail. That is why I must use 2 different birth control methods at the same time, starting 1 month before, during, and for 6 months after stopping therapy every time I have sexual intercourse, even if 1 of the methods I choose is hormonal birth control. Initial: --- 5. I understand that the following are effective forms of birth control: Primary forms Secondary forms • tying my tubes (tubal sterilization) Barrier: • partner's vasectomy • male latex condom with or without • intrauterine device spermicide • hormonal (combination birth control pills, • vaginal sponge (contains spermicide) under the-skin implants, or vaginal ring)e. • ., • I understand that at least 1 of my 2 forms of birth control must be a primary method. Initial: _ 6. I will talk with my doctor about any medicines including herbal products I plan to take during my isotretinoin treatment because hormonal birth control methods may not work if I am taking certain medicines or herbal products. Initial: _ 7. Imust begin usingthe birth control methods Ihavechosenasdescribedaboveat least1month before I start taking isotretinoin. Initial: --­ 8. Icannotget myfirst prescription for isotretinoin unlessmydoctor hastold me that Ihave2 negative pregnancy test results. The first pregnancy test should be done when my doctor decides to prescribe isotretinoin. The second pregnancy test must be done in a lab during the first 5 days of my menstrual period right before starting isotretinoin therapy treatment, or as instructed by my doctor. I will then have 1 pregnancy test; in a lab. • every month during treatment • at the end oftreatment • and 1 month after stopping treatment I must not start taking isotretinoin until I am sure that I am not pregnant, have negative results from 2 pregnancy tests, and the second test has been done in a lab. Initial: --- 9. I have read and understand the materials my doctor has given to me. I was told about a private counselling line that I may call for more information about birth control. I have received information on emergency birth control. Initial: --­ 10. I must stop taking isotretinoin right away and call my doctor if I get pregnant, miss my expected menstrual period, stop using birth control, or have sexual intercourse without using my 2 birth control methods at any time. --- Initial: _• • 11. My doctor has answered all my questions about isotretinoin and I understand that it is my responsibility not to get pregnant 1 month before, during isotretinoin treatment, or for 6 months after I stop taking isotretinoin. Initial: _ 12. My doctor and I have decided I should take isotretinoin. I understand that I must be qualified to have my prescription filled each month. I understand that I can stop taking isotretinoin at any time. I agree to tell my doctor if I stop taking isotretinoin. Initials: _ I now allow/authorize my doctor to begin my treatment with isotretinoin. Patient Signature: Date: _ Parent/Guardian Signature (if under age 18): Date: _ Patient Name (print) _ Patient Address Telephone ( _ I have: - Fully explained to the patient, , the nature and purpose of isotretinoin treatment, including its benefits and risks, risks to female patients of child bearing potential. -Given the patient the appropriate educational materials, and asked the patient if he/she has any questions regarding his/her treatment with isotretinoin - Answered those questions to the best of my ability Doctor Signature: _ Date: _EJ~(l. :I]-.:~il/J~-DC From; Tht :D/:"'ol[;.S Contl"oller GellOn.(1 (!ttd/:l) Dk. G6ll/lcul of H(1altJ1 SnvJce;; // ," .,...-'~ :1(1['I~"' (h.'" D<lbJ, d:C1(':,J'Ti'''j'''-'f(!:'{ \ I'--'-"~' . ,,_•.1 _ '.: ••.• 11 ,LlJ I ~ f'''(-..:,a,· :'..'dL-:: i j h~£l..tL.1J!!frl ~\lb:;,~qbcnL mPJ ce .tl u1 uJe [/ wre tli Je rr c t oo f IE -y :o C -u 'fr n ~:I iI i'; !L .) ..' ,i .f" .) ., ~r . !ud .a .C .t .le .< _.~dE . ~-UI!-n:!.- ; -n-S­f> & I' cOfrc5jJO!lchiJ.c/; ng'lJ'iiih!.! rire fonnul~II tion Pi;rrni.$doh is hereby g-nJJlt6d to the mll1lufacture of tfhOeI lOwjn~ .mentioned above U!ld:;;r Rule 12:2-I-> Qfrhe Drugs & Cosmetics RUles subject 10'the condirions;_ I I. The product ahl11l have the.toUowing compo5itiou:_ .EacL !loft gelatillt: CapsHJe$Cotilalnll:_' II VSP Ts""rlnoln - -:-I 0'" /20mg F~SIh~"ing ,ond"'t~d Y'~rl 2. '"",oill",,, "'dy 'h'll be dunul iuitialperiodoftwo or mlln'.ertng or tho new j1Ug formulation after gcu:Jl'Ig .rJJt;pi n Y(.0co} Ilnd .the. name.s or. by 'he ''''-'''iga[o, duly 'ppmv,.d theLic,n,lng Auth"ity 3, This Direct lo Jlr ca lT ife ~n should be intimated as and Wlkt!l tile said tbnnl!lEition is launched by you in the Mllrket and submit 5i!lc: IJc('.k COllf1ll11illg <)Lc; li1iitof t.he m:::dieiTl<:: pr~tler. ~WillJ:\i~ ~!;!~.! fl1~~ 4. Th,e n.lnl; of,lh,e drug , of I &hll be pdl)tG,d or ""'fIIlen In rndehble nix.and ~s bh OVlt ll 'l l Jappear(0II mora conGplpJolli manntrtJlan the tratdh(~; nameif any, which shall be imnlcdiately afteror ll)ldertheprop'~ehricn.ahm!hte; em , cla Ob D.e tl ao inf et rh ie s lpnan?clrl~Udo:s.i contl .l ' lncr ofthe: ,dr -ug or eVt:IY , otlll,;r I!c 'ov .eril1 _g .i n 5. The label of tht:l_tl1llennostcontainer of-rhedrag llYn.di:e'vfet;jT~y~ Uo~t.hoc:rncC.:.l.vteher.i:nJg~f tI-nsi dew.hich the container-is packed -shrtiJpJ!ar__<t Q,onspiJ::uous n:dl:'; -~ T'Jntling ~~UI.,.Jw.~~~",_.;.~_ d,1 l· s· t\ W,,,,J b.. i. n,\ g,l. l t' i" lf eJ - cre ia-1 ),: ,i !& 'cf oy n:, d, -« i -t= i -ot -h n ,e s- ,l.t phden.lr"~"i1.lv 4 r- li n-c . ~ tb h $ .. ~ .f . f ~i ,a _U ~ ~ cI ;'o ; , o [.t 0 tJemJe cs 1s . iI t1 iJ sll t ( j p1 rI em eql1 :l pi :Lll Q' w -.Aid ~l'/l an d wi/boll[ _-- - .- . _ .. -. ...c.:..:-'c:.:.--..;;'-;;;.'-;.;:--;;..-;;.;;--~-;:;..'-;';'-;;;:-;:;-';;;;--";;--'-~, ~-_-_"-';;_~,_'-"_-_-_-__ ~-_--_-_-_-_ --- .- --- .;..---:,;:..:::.;;-~~----------- - _..­­ . C(rntd ell ~)t::g;<.l •• -<i 1. /; " '~on 6. The label the immediate contalner of the drug as well es tlii: packing il~ w/)ic:i1 the. container is enclosed should conlll.iil the: following wnmil1g:- WARNINGi "To be sold by I'dllil VI! jllq;re~t:I'il}tiOIl r~f 11. ~Ylll~I().!Qt.l~ or,ly 7. The drug will be required 10 be wi\hdl'DWll from ;;1iI<1 f,';)!), lh,:. lnC1i'k,~i ill·e,:IS2 zny UI10eO'iI'iIL'oli.• reactions dueto its !lledication is brcught to ligllt 1\1 <In)' W~2r;. This Direcrorute ~I\onld be iufor.ued of adverse reaction on the drug. if n:ly. 8. The preparation shall be- ii1dicllktl jn rr..alll1CIH t\r~:y~g~!l1.!.0.3.0..!dx~!~!;1~.1~Cli';~':':"'~:tu_~,~~t~~,ci~ ~!lg.J!illS::'~!.'Ji~!l[i1)0.uull/:n~,\):G 9. No claims cl:ccpt lht),e tnelliiOl'lr.d above ~hi:Jl be; rm;(il.:(or !Ili.s drug. wiU'(1u( lilt prior. approval of lhi5 ])i;:tCIOl'rj!<:; 10 No rd'"rcnce ill the f\clvtflis~mcil[ or rntdi(~,1/ literature 'is JnBdr::j'hi>! the Government has approved thc dcug. i J I. Drafts (If the carton labels, package insert or all)' other promotional li{-':I'utl:re etc. l~l!!t will be . lidoj.1tcd by YO\1 for rn,irkcting this drug in the c\I!J1~try should be .got approved from this Directorate before (he druns is marketed. i . ~ I 12. This permission is no way relieves you of the rt:5¢.OI1~ihility of complying \.\I;1h .all other proviaions of the Drugs and Cosmetics Act ii~d the RJles thereunder. I 13. Package Insert should (~arry a ,bo~ warning &1 a pron\iljelltplace about potential risk. Involved In usage of Isotretinoin and /l diagran) warmng pregnant women against taking Isotretlnoin. I . I· 1<1. P,,-ck should elir!)! following box wru-f1ing:- ....JI.. r WARNING-TO F[I\1ALl£ PATII,ti'[S:­ rins IVIED/CINE MA.Y CAUSE S~~ERE BIRTJI Dt~ECTS. YOU IvlUST C,<' NOT TAKE THIS MEDIC1NE IF YOU ARE PI'(EONr\NT OR tviA Y LIKELY BECOME PREGNANT DUHING TR.EATMENT. ~o~:p.i.:~:~1..rss$,!16-Ul.d.Y.J~b~.C.Olli;~ltJOl'm RSP~!li1¢-t!lJ~io5urc 15.,..... lL s before tli'-dertoki l1g tilt ,i *~tlJle:nt~eU~j:[etlnoltt_·-F ' .: ,. . . ~!~~;Y_J)~{e 'ii~~-'e!'- .. ",Itl,~ ~,"'"'~ . that permission gCB.l1tedilbove is ~a.v LJL< '''llilUIU__'I •'•V _I I ;'1l' 'O--Ii:T, VI UI..... ,.....l" .I" l 1, 1/ ..1: I, \!; ., ... .., .., .." . ~ stipulated above are not complied \\lith Dpart frolTI~U1)C...Qther~acllorr:thnl'it1!lrt)t l6ken under _ _ --------pc..r-o'-v--is~jo-nuuhe.Drug,..~eosm~tlcsAc.t 194 . 0 and [he Rul ,e s _ t .h _e re .u -n :-d ......e ;.r .. : c-"--y.(Hit§·(:l.T. Hd, 11_ I_ t yd -;d -­ ----""_- .--~.":-:'= c..l , .'. ~c -,~.;;-~_.",-~.:;...-..--=-~ ~-!~--~ ~ __, ,- . c::(A-~\~hi'Riil~'u"r / . .: ) / Drug-oS Controller G(OlJt::n:1 [l ndla) \ \I (I. }>,) ~. ,! (, .2!~