The use of Acthar as an alternative for treating acute exacerbations in a relapse-remitting multiple sclerosis (RRMS) patient

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1 ACTUAL PATIENT CASE STUDY T f v f g xb p-g p (RRMS) p I HP G (p p j) f f xb f p C v w b ffv pg f xb f p Hwv, v ff Cb b M Fp, PD, RN, BSN, Ng Sp Sg C, L, NE PATIENT 2-- f M w 1 F pv, p p MEDICAL HISTORY Dg w RRMS g 21 TREATMENT HISTORY O -fg p (DMT) f 4 Ipv g, x, N p p w DMT Spp DMT w pg pg MS RELAPSE SIGNS AND SYMPTOMS Sgf p 6 f ppg DMT Op V b (2/ 2/); g b Rg g wk w f p RELAPSE TREATMENT IV p (IVMP) ACTHAR TREATMENT IS PRESCRIBED MS p p pv f f Eg pv, b p Wk pv MS p p f pv f 1 f V [2/ g (OD), 2/2 f (OS)] S pp v S ff g w S p b Wg g P xp ff (- p), w pp f p T b g p b f pv f v p pp b f b w p f f xb f p SELECTED IMPORTANT SAFETY INFORMATION C v b v A f v v v p vg ppv f w g f p f p w, p, fg f, p px, g, f p f pp, gv f, p, p ff, pf v p f p g P Ip Sf If bk v

2 ACTUAL PATIENT CASE STUDY v p MS p f 1 WHEN YOUR PATIENTS NEED ANOTHER OPTION, CONSIDER ACTHAR bv v b -f pp 2-7 * D p p v p 8-1 * W x f f kw, f vg bg T f b, p bf kw T x f f ACTH kw Sf pf b v A g f pp v f p L b p-p/pc IMPORTANT SAFETY INFORMATION C v b v A f v v v p vg ppv f w g f p f p w, p, fg f, p px, g, f p f pp, gv f, p, p ff, pf v p f p g Wg P T v ff f p g ff pb w f v f f Spp p-px (HPA) fwg pg p w p f ff f ww A ff b z b pg w g Dg v f g p b p f (g g) b f M p f ff f HPA pp f ppg Cg g p b g v f p pp M p f g p v f b p, w, pk B p, p v b f b kg p f / M p f g f p fwg p GI bg g T k f pf p w g M f g f bg b w v ff gg f p,, b, wg, p g, v p, p Exg b ggv P w b v w C b w pbg p w b gv Pg f p, g f M f g p g pg f k f pv Nzg b w f g ACTH v T ff p w p w v Lg- v gv ff gw p vp M p p D b B b f p g- p Pg C C: b w v b ff b g pg f p bf jf p k f Av R C v f f f, g, v b p, bv g, pp wg g Spf v p IS f 2 f g : f, p, b, Cg p, p,, vg, px, wg g, pp, pp, g,,, pp Cv w p, b b g b IS p pg f f z IS k z, w b vb p f IS v O v v p f Pbg If f pk Rf: 1 HP G [pkg ] Hzw, MO: Mk ARD I; 21 2 B SA, H ZM Ig () p-msh b EAE J N 28;19(1-2): B SA, H ZM Ig () ACTH b EAE J N 211;22(1-2): R DS, Rgwk MA S- x-v GABA(A) p f z pb J N 22;22(9):79-8 Hw MA, C D, Bk LH, A p ffv f p (HP G) p p b pp Np D Tp 214;29(8): B KL, K N, Egb-A M, B TZ Cp (ACTH) g w-g p-g g xp A N 21;49(): Pz MR, C KY, Mx M, T ED, A TJ Cbp f ACTH p: ff p P N 2;(2): R AS, Kz JW, Kzk JF, Nw NS, Sb WA, T WW Cpv v p p : ACTH v pb f p Ng 197;2():1-9 9 Rw MD, Lvg LA, Gfb G T f bb w p L 1966;2(7472): Rw MD, Lvg LA T f bb w p L 1969;2(761):222 Mk, M b k Mk P g k f Mk p O b k f Mk p pv w 217 Mk ARDUS/1-1/417/18 M 217

3 HIGHLIGHTS OF PRESCRIBING INFORMATION T gg f HP G f ffv S f pbg f f HP G HP G (p p j) INJECTION, GEL f INTRAMUSCULAR SUBCUTANEOUS I US Appv: INDICATIONS AND USAGE HP G p (ACTH) g p f f f p f 2 f g (11) HP G f f xb f p (12) HP G b f fwg : ; g; g; g ; p; p; (1 19) DOSAGE AND ADMINISTRATION I f f p, 1 U/ 2 v w j f 7 U/ 2 Af 2 wk f, g b g p v 2-wk p (21) I f xb f p, b f 8-12 f 2- wk b I b p (22) I f, g w b vz pg p I b p (2) DOSAGE FORMS AND STRENGTHS L - v g 8 USP p L () CONTRAINDICATIONS HP G v b gv v HP G p w, p, fg f, p px, g, f p f pp, gv f, p, v p f p g A f v v v p vg ppv f HP G HP G 2 f g w p g f (4) T f w INDICATIONS AND USAGE w p b p ff pf (4) WARNINGS AND PRECAUTIONS If: I pb w f k f xb, v f f Sg p f f b k (1) A Iff f Pg Tp: M f ff f pp-x pp f ppg (2) Cg S: M f pg p M f g p (2) Ev B P, S W R Hpk: M b p p v () V: D v v v p ppv (4) Mkg f Sp f O Ug D/D M p f g f g / b k () G Pf Bg: T k f g bg T k f pf p w GI Sg p b k M f g f pf bg (6) Bv M Db: M p,, wg, p g, v p p Exg b ggv (7) Cb D: Sp f b gv b w w (8) Op Eff: M f, f g (9) Ig P: Nzg b w f g ACTH v (1) U P w Hp Lv C: M ff (11) Ngv Eff Gw P Dvp: M p p g p (12) D B D: M f p p g p (1) U Pg: Eb ff App w f p f (14) ADVERSE REACTIONS C v f HP G f f, g, v b p, bv g, pp wg g (6) Spf v g f g 2 f g k f f, p, b, Cg p, pp wg g (611) T p SUSPECTED ADVERSE REACTIONS, Mk FDA 1-8-FDA-188 wwwfgv/w DRUG INTERACTIONS HP G w p (7) USE IN SPECIFIC POPULATIONS Pg: HP G b w v b ff b g pg f p bf jf p k f (81) P U: Pg G b k gw If, b gv w f bv (12 84) S 17 f P Cg If FDA-ppv M G Rv: J 217 FULL PRESCRIBING INFORMATION: CONTENTS* FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 11 If p: 12 Mp S: 1 R D: 14 Cg D: 1 Dg D: 16 Ag S: 17 Op D: 18 Rp D: 19 E S: 2 DOSAGE AND ADMINISTRATION 21 Spf R Dg Rg f If 22 Sp If C U 2 Y f Ag R Dg Rg f T f 2 A Exb A w Mp S R Dg Rg f O I f A C Ov 2 Y f Ag 24 Pp DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS WARNINGS AND PRECAUTIONS 1 If 2 Cg S A Iff Up Ww Ev B P, S W R Hpk 4 V Mkg Sp f O D 6 G Pf Bg 7 Bv M Db 8 Cb D 9 Op Eff 1 Ig P 11 U P w Hp Lv C 12 Ngv Eff Gw P Dvp 1 D B D 14 U Pg 6 ADVERSE REACTIONS 61 C S Exp 611 Av R If C U 2 Y f Ag 62 Pkg Exp 621 Ag R 622 Cv 62 Dg 624 E 62 G 626 G 627 Mb 628 Mk 629 Ng 6 Pb A Sg Eff 61 Dg 62 E 6 Mb 64 Mk 6 Ng 66 Op 7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS 81 Pg 8 Ng M 84 P U 1 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 121 M f A 1 NONCLINICAL TOXICOLOGY 11 Cg, Mg, Ip f F 14 CLINICAL STUDIES 16 HOW SUPPLIED / STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION *S b f f pbg f

4 PRESCRIBING PRESCRIBING INFORMATION INFORMATION pk:m: M bbfullfull 4 4 CONTRAINDICATIONS CONTRAINDICATIONS IgP 11 Ig INDICATIONS USAGE USAGE f v f v b HP A b HP v pp 1 1 INDICATIONS v If p: p: w w g g f f p p f f f p k k f pv M M ppf f11 11 If (p (p p p j) j) p p f f bf g p bf g p k ()() f f f f p p f f 2 2 f g f g A A f v f v v v v v p p vg vg k fgg ppv ppv GG P 1111 UU P w p GI GI Mp S: S: T T ff g f pf g f pf Mp (p (p p p j) j) f f f f p p,, p, p, vv f p f p C C vv w w fg fg f, f, p p px, px, g, g, f f p p f f,,, xb, wgw,gxb b ffv b ffv pg pg f f xb xb f p f ppp pp,, gv gv f, f, p, p, p p 1212 Ngv Ngv Eff Eff xg g b b Hwv, Hwv, v v ff ff ff, ff, pf pf v v p p f p f p g g Lg- Lg- f HP A vp vp vg vbwbw ff b ff b WARNINGS WARNINGS PRECAUTIONS PRECAUTIONS 1 1 R R D: D: T ff T ff v g (9)(9) A jv p p f - f - ( ( p p vv p vp p vp f A jv pp ggffff p p xb) xb) : P : P ; ; R R,, g g jv jvttvvfffffhpf HAPAG G f v v v v b b bw bw vv bb ff ( ( q q w- w- p), p),n N G,G, b b g g b xp b xp [[ Av Av R R (6)](6)] Akg Akg p p D B 11 D B D b f D b f pppp 1 1 If If Cg Cg D: D: g g ( HP HP G G k k f f w w pg, pg, g g xb xb p p f: f: p p f b f f b f gg Dg ppdg v,v, b, b, fg, fg, pz pz f f P P b b,, (p) (p) ( bb ( b b v v b b bv bv, f p pg,, f p pg,p, p, f f (14)(14) ppx b ppx b 1 1 Dg Dg D: D: vp f vp f Sv f, f, Sv-J Sv-J p p k Sv 2 Cg S A Iff Up Ww 2 Cg S A Iff Up Ww p, p, bb f f T w HP G p-p-x (HPA) pp T w HP G p-p-x (HPA) pp Ag Ag S: S:,, v v b b C g T b p w C g T b p w S S k k 14 U Pg 14 U Pg wg wg gg (6) (6) bb 22f gfg Spp HPAHPA fwg pg p p f f Spp fwg pg p p Op D: D: f f [[ U,g Cg p, p,17 17 Op ff ff ww P b ff ww P b Sv Sv g g f f p p vvg vvg f ff wk, ppg, wg,, p f g f ff wk, ppg, wg p6 6 ADVERSE x x : k; : k;,,,, ff ff p p v v,, ppf g ADVERSE REA REACTI b pp b, ; ; g g f f k , P Av P ff Av R TT p f ff f f f p b bf p f ff f f f p Rp Rp D: D: f w w ff f TT p -pf x, fg, ff f p -pf x, fg,p Sp Sp p S S g, wk, xv wg,, p b pp I I g, wk, xv wg p b 2 vv 2 f g w p p (7) (7) p gv b w pb f ff p gv b w pb f ffg E E S: S: g f f g b bv f, f, b b w g b bv b b T T f p f p p p w ww gz, p [[ P Cg If (17)](17)] gz, p P Cg If p p pp p p b b ffff Tf v Tf v f jf jf p p2 2 DOSAGE TT v g kk ff p b b v g p DOSAGE ADMINISTRATION ADMINISTRATION p ff (g(g g) b f g p g) b f g,, g bbkk SpS p f p f pfrfr DD grggr gf IffIfSpS p IfIf g, g, w f f bv bv C C U U 2 Y 2 Y f Ag f Ag T ff b z f b pg f T ff b z f b pg f I I fff fp p, HP, HAPAG G bb C SE C S 2 (v 2 (v g w g T T g g f 1 f 1 U/U/ w w w B B 2) 2) j j f 7 f U/ 7 U/ vv 2-wk 2-wk p p Dg Dg bv bv M G G p f Cg g p b b g Sg p f Cg g p g b g b g p p vv 2-wk 2-wk p p v v ff ffsg f f 2 2 ff p pp P b f f g v p pp P b g fwg fwg gg gg pg pg : : U/ U/ g g f f; ;v Rv: Rv: JJ T T 2 2 g 2 2 g 2 v 2 v p f p (g,(g, f,f,611611av p p f p 1 U/ 1 U/ g f f ; ; 1 U/ 1 U/ g f f ; ; 1 U/ 1 U/ p Av R R b),, bb, bb z, b),, bb, z,w g g f 6- f 6- W p f v p f v wg g,g, wk, pg, p wg wk, pg, p f p f p p p b b b b f f (BSA) (BSA) F F f f b ff b ff bb f f,, fwg fwg f f Ev B P, SS W R Hpk Ev B P, W R Hpk p p 2 Y f Ag 2 Y f Ag v f b p, w, pf v f b p, w, pf b b f x f p D p x f p D p pp b C b f p pp b C b f pp p p, gv f, ff p, gv f, ff p 4 4 V V TABLE: TABLE: I I (%) RR DD grggr gf f TT f AfA ExExbb A f v v v p vg A f v v v p vg G (p G (p A A Mp Mp S S ppv GG K v v b b ppv K v v TT b b f 8-12 f 8-12 f f; wv, p v b p O ; wv, p v b p O 2- wk 2- wk f f xb xb b k p ww vg z p b k p vg z p G,G, p w gg, b pb p w, b pb DD ggb bvvzzgg f fppz z f g p kk f b p f g p f b p S S Og Og C C Fq Fq gg b b b g b g v v p p p p Mkg Sp f O D Mkg Sp f O D C C f b kg p f / w f b kg p f / w Ag Ag gg p p,, ww ww ffg / P b f g / P b f C C Hpp Hp pg pg ff ff p p w w k k g f f p fwg p f f g f f, g p fwg p g f f, ff ff p p I I b b p p b E f, p, pg, g b wg E b f, p, pg, g b wg j j v v g g ff b b Cg Cg 2 2 RR DD grggr gf O foi If A fa CC G G 6 6 G Pf Bg G Pf Bg OvOv 2 Y 2 Y f Ag f Ag GI bg g T k k GI bg g T Cp Cp Dg Dg b vz b vz g g p g Sg f g f pf p g Sg f g g g f f p p Fq Fq gg b bf pf D D p, b k b p UU pf, p, b k b p b g b g v v p p p ppf, w pb f pg pf, b pg w pb f pg pf, b pg Vg Vg v, f, v pp f, v, f, v pp TT gv gv b bf, G G v v Bv M Db Bv M Db Ib Ib b v ff gg b v ff gg Ag Ag gg p p,, ww ww ffuu p,, b (p f), wg, p p,, b (p f), wg, p Px Px pg pg ff ff p p w w k k ff g, v p, fk p f xg v p, fk p f A,A, xg ff ff p p I I b b p p g, If If f f b p b ggv b p b ggv j j v v g g If* If* Cb D 8 8 Cb D Pp Pp Ivg P b w C P b vv w C b b Ivg b w b w p p bf bf g g w pbg p b gv w pbg p b gv Wg Wg gg C C b k b k v-pz v-pz v v pp wwg wwg p p Mb Mb Op Eff 9 9 Op Eff DOSAGE DOSAGE FORMS FORMS STRENGTHS STRENGTHS Pg p p bp, g Pg p p bp, g I I pp pp pb g p p v b f pb g v b f D D pp pp L - L - v v g g 8 USP 8 USP U U p p L L f fg v f fg v

5 p vg p, f p f w HP pg, g w b p pg, x (HPA) pp w p f b g, p p b x, fg, p I ff v f, b b p b g pg p b g f g (g, f, b z, w, p f p p vg v b O w vg pb / w b f g f f, b wg k g f g p U pg ff gg wg, p A, xg C b, g b f 1 Ig P HP G g L vb gg p vp b HP G f f g ACTH HP G v Pg G k f pv Sv p p b bf g p g f p 11 U P w Hp Lv C T ff p w p w v 12 Ngv Eff Gw P Dvp Lg- G v gv ff gw p vp Cg pp w HP G p, w ff bg fq p T ff vb HP G p pp Gw p vp f p p pg p b f 1 D B D D b f b p b g ff g ( g bp g x) b f b f T, g w p x b ( p b) x p, b f b gw vp f p g Sp b gv p k f p (, pp w) bf g p, b b p g p 14 U Pg HP G b w v b ff App w f p f [ U Spf Pp (81)] 6 ADVERSE REACTIONS P f Av R If C U 2 Y f Ag (S 611) f w g p w If Sp T v p S 62 p pv f v 2 f g, b v b w g f 2 f g HP G f g f g Tf v ff kw w v w HP G w C v f, g, v b p, bv g, pp wg g 61 C S Exp B w vg, v bv f g b p f g, f bv p 611 Av R If C U 2 Y f Ag W p f v f g 2 f f p p, fq v b ff v g g f, g, p g g Bw f v pf b f v f pv vw 2 f g f f p T b f p w fw pv gf p gf p gp TABLE: I (%) f T Eg Av Ev Og 2% G (p p j) If C 2 f Ag S Og C R 7 U/2 b =122, (%) 1 U/2 q =7 (%) C C Hpp R 7 U/2 b =122, (%) 1 U/2 q =7 (%) 12 1 A 14 R S Og C Nv Cv Rp, N Cg Sk b V Hp *Spf f 2% w,, p pp p f I f If Sp, p f z/v b p w f p pg f f z (f xp, Lx-G S) A p k z p v f, z b vb T v b v 2 f g w f pp w ff g 62 Pkg Exp T fwg v w G v b f f pkg xp w HP G O v v bv v v p f pv vw -p w bg, B v p v f pp f z, w pb fq b p w HP G Ev gz b g U w v v v b p f, 621 Ag R Ag p v p zz, k ( ) 622 Cv Nzg g ( ) gv f 62 Dg Sk g ( ), f wg ( ) 624 E D b (f ) 62 G P ( ), b v pg 626 G Ij ( ) 627 Mb Hpk k (f ) 628 Mk M wk vb p f (f ) 629 Ng H ( ), vg ( ), b, g ( ), vb b kg ( p) (f ) 6 Pb A Sg Eff B g ff G v v b xp pg ff f T v v b v b p f HP G : Dg Ip w g, b, p, pp f k Cp 62 E M g D 14 Vg 6 Mb Ngv g b p b Ib Mk L f p f f Px I pp F g-g v b pf D pp HP G w p E Cg G G If f If* Ivg Wg g Mb 6 Ng I p w pp, (p- b) f, b ff 66 Op Exp 7 DRUG INTERACTIONS

6 8 USE IN SPECIFIC POPULATIONS 81 Pg Pg C C: HP G b w v b ff T q w- pg w HP G b g pg f p bf jf p k f 8 Ng M I kw w g x k B g x k b p f v g f f HP G, w g g, b w g g, g k bf 84 P U HP G p f f f p f 2 f g B v pp Wg Av R If C U 2 Y f Ag [ S 611] T ff G f f f p f 2 f g w v z, g b (v EEG p b) v ppv [ C S (14)] A pg p w f vg b p f p f p Sf p pp f f p w v b pv vw f -p [ Av R (611)] W p f v f 2 f g f f p p, fq v b ff v g g f, g, p g g Eff gw f p [ Wg P (12)] S v bv [ Wg P ()] 1 OVERDOSAGE W xp HP G g b w v f p v ff, xp g g, v v g, p f v ff p T v b p f v p f HP G pb T f k k v v w T p G f BSA f 4 2 w b 6 U/ Ug 1- g pp w HP G, x b j 8 U/j, w w- g 11 DESCRIPTION HP G g pf pp p 16% g pv pg f b j A % p, 1% (), x / j ph w f j ACTH 9 pp w fwg f: H- S- T- S- M- G- H- P- Ag- Tp- G L- P- V- G- L- L- Ag- Ag- P- V L- V- T- P- Ap- G- A- G- Ap- G L- A- G- A- P- P- L- G- P- OH CLINICAL PHARMACOLOGY 121 M f A T f G f f p kw HP G g ACTH x,,, b f wk g b Pg f g G pp pp x g p f, wk g T f g ACTH f v v g f p b gv fbk Ev p pp ACTH HP G p b p T p ff f g ACTH HP G x w b f pp b b AMP ACTH p pp f fwg v ; pp, p f-f b 1 T pk G v b q z T x ff f p g g v w p f g T, fx G w w g f f 1 NONCLINICAL TOXICOLOGY 11 Cg, Mg, Ip f F Aq w- v b H b w g [ Wg P (14) U Spf Pp (81)] 14 CLINICAL STUDIES T ffv G f f p w g b (v EEG p b) w p w z v 2 wk f w HP G (7 U/ 2 w ) p (1 g/kg b w ) T p w p b f p gp w w p, f p vg p pp f b p p f p v EEG pf 2 wk fwg, b vg b T f 1 p (867%) p HP G p 4 f 14 p (286%) gv p (p<2) T 2-wk w fw b 2-wk p f p Np p w gb v HP G Sv f 8 p (87%) p HP G f pg p S, 2 p p f HP G w gb v w p O 2 p (%) p p f pg HP G A ppv g-b, z pg g-, g- (1 U/ 2 f wk, =) G w w-, - (2 U f 2 wk, =29) f f f p w v f 2 f g Np (f pv b ) w- gp v 2 wk U N p g, p w, w bv f f p b f f p 16 HOW SUPPLIED / STORAGE AND HANDLING HP G (p p j) pp L - v ( ) g 8 USP U p L HP G (p p j) b w p bf g D v pz v p wwg p S HP G (p p j) fg bw 2 8 C (6 46 F) P b f p b w b 17 PATIENT COUNSELING INFORMATION Ck f p w f p b f vb f M G, b M G p g HP G P b k HP G pb T p b p P, gv f b v p f f g w g f HP G p f g pp P, gv f b v f p vp f fv p T b fv b p g f T p w pp w f z k f f w kg HP G [ Wg P (1) Av R (611)] P, gv f b v f p xp b p p [ Wg P () Av R (611)] P, gv f b v f p gv b g p p [ Wg P (6)] Cgv f f f w HP G b f p w g f b p b T ff vb HP G p pp [ Wg P (7) Av R (611)] P, gv f b v g pp, f g wg g, w HP G p, bg fq p T ff vb HP G p pp [ Wg P (12) Av R (611)] P, gv f b v p b f g f ff wk, fg, g, x, wg, p, b p ppg ( ) f pp S v g v f, p b p f f g b f g p f [ Wg P (2)] P b v b v w v v v g w HP G A, z p p f b w w b w p b k w w p kg HP G [ Wg P (4)] P, gv f b v pg G Cg v, b k gw, p b If pg, HP G b gv g w f bv [ Wg P (2), (12), (1) Av R (611)]

7 P, gv f b f HP G k p f / w g / T p w b f g f p fwg p f g f f, b f, p, pg, g b wg, f b [ Wg P ()] I f If Sp, p f z b p w f p pg f f z (f xp, Lx- G S) A p k z p v f w HP G, z b vb P gv f p f w f z ppp g b [ Av R (611)] Mk, M b k, Mk P g b k f Mk p 217 Mk Mf f: Mk ARD I Hzw, MO 642 USA PL6 Rv 7/217

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