Clinical experience of a patient with new-onset multiple sclerosis (MS) exacerbation treated with Acthar 1

Transcription

1 ACTUAL PATIENT CASE STUDY C xp f p w w- p (MS) xb w 1 I H.P. G (py p j) f f xb f p. C v w b ffv pg f xb f p. Hwv, v ff y. Cb by Sv Q. Np, MD, M D, C MS I, Fxb, MA PATIENT 49-y- f M w D yg F pvy, p p. INITIAL CLINICAL ASSESSMENT ER v f yp By/b v S p B Pq w MS P p g y fy y f MS Rp b f b g 9 Ng x A/ x M INO f Sg x w wkg EDSS: 2. MRI v B MRI yp f p Sv pq, g g f N b b N Cv MRI g f yg T MRI w pb yg pq T-T4 Dg w w- MS xb TREATMENT INITIATED IV yp (IVMP) 1 g/y f y v v MS p w f -fyg py (DMT) T b g p b fy pv f v p pp. N y vb pfy xg ffy f p w MS xb w fy p. SELECTED IMPORTANT SAFETY INFORMATION C v b vy. A f v v v p vg ppv f. w g f p f. p w, p, y fg f, p px, gy, y f p f pp, gv f, yp, py ffy, ypf vy p f p g. P Ip Sfy If bk v.

2 ACTUAL PATIENT CASE STUDY Rp IVMP 7 y p-ivmp Nw p RELAPSE PERSISTS, NEW LESION DISCOVERED PRESENTATION 7 y f IVMP I v C MS I Syp : F wk G by Dg ASSESSMENT Ng x M b INO M g f wk Cp wk Affg f (py B p) B fg- x EDSS:. MRI Nw p w (gy g) N b Sggv f ff Sp f y 6 g b CSF 2 g b CONDITION WORSENS FOLLOW-UP 11 y f IVMP, w N wkg EDSS: 6. TREATMENT Nw G 8 U b j f v y w g py bz p w f DMT W y, p IVMP. I y p pb. Sv Q. Np, MD P Ip Sfy If bk v.

3 p- R p CLINICAL SYMPTOMS IMPROVE WITH ACTHAR FIRST ACTHAR FOLLOW-UP Fw-p 7 y f g w C yp pv V pv Fg ; q F wk pv EDSS:. Rp bz w f zb DMT pv f b yp, f wk. Sv Q. Np, MD LONG-TERM FOLLOW-UP: IMPROVED MRI AND EDSS w g zb Ng x N v f INO Fg-- G ; -- wkg EDSS: SELECTED IMPORTANT SAFETY INFORMATION S Wg P T v ff f py g ff. pby w f v f f. Spp yp-py-x (HPA) fwg pg py w p f ffy f ww. A ffy b z by pg w g. Dg vy g p b p f (.g. gy) by f. M p f ff f HPA pp f ppg. T b g p b fy pv f v p pp. N y vb pfy xg ffy f p w MS xb w fy p.

4 ACTUAL PATIENT CASE STUDY v p MS p f 2 WHEN YOUR PATIENTS NEED ANOTHER OPTION, CONSIDER ACTHAR bv v b y -fy pp -8 * D p p vy p 9-11 * W x f f kw, f vg bg. T f b, p bf kw. T x f f ACTH kw. Sfy pf b v y A g f pp v f y p L b p-p./pc IMPORTANT SAFETY INFORMATION C v b vy. A f v v v p vg ppv f. w g f p f. p w, p, y fg f, p px, gy, y f p f pp, gv f, yp, py ffy, ypf vy p f p g. Wg P T v ff f py g ff. pby w f v f f. Spp yp-pyx (HPA) fwg pg py w p f ffy f ww. A ffy b z by pg w g. Dg vy f g p b p f (.g. gy) by f. M p f ff f HPA pp f ppg. Cg y g py b gy v f py pp. M p f g yp. v f b p, w, ypk. B p, p v b. f by kg yp f /. M p fy g f p fwg py. GI bg g. T k f pf p w g. M f g f bg. b w v y ff gg f p,, by, wg, py g, v p, py. Exg b ggv. P w b v w. C b w pbg p w b y gv. Pg f p, g y f. M f g yp. g pg f k f ypvy. Nzg b w f g ACTH vy. T ff p w ypy w v. Lg- v gv ff gw py vp. M p p. D b y. B y b f p g- py. Pgy C C: b w v by ff b g pgy y 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 y f g : f, yp, by, Cg yp, p,, vg, pyx, wg g, pp, pp, g,,, yppy. Cv w p, b y 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. A f y, D. Np pkg y p w Q P, p Mk ARD I. Rf: 1. Np S. ACTH g f p xb: y. I M C Rp J. 21;8: H.P. G [pkg ]. Hzw, MO: Mk ARD I; 21.. 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): Ry DS, Rgwk MA. S- xy-v GABA(A) p f z pby. J N. 22;22(9): Hw MA, C D, Bk LH,. A p y ffv f p (H.P. G) p y p b ppy. Np D Tp. 214;29(8): B KL, K N, Egb-A M, B TZ. Cp (ACTH) y yg w-g p-g g xp. A N. 21;49(): Pz MR, C KY, Mx M, T ED, A TJ. Cbp f ACTH py: ff py. P N. 2;(2): R AS, Kz JW, Kzk JF, Nw NS, Sby WA, T WW. Cpv y v py p : ACTH v. pb f p. Ngy. 197;2(): 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 py. O b k f Mk py pv w. 217 Mk. ARDUS/1-1/417/17 My 217

5 HIGHLIGHTS OF PRESCRIBING INFORMATION T gg f H.P. G fy ffvy. S f pbg f f H.P. G. H.P. G (py p j) INJECTION, GEL f INTRAMUSCULAR SUBCUTANEOUS I U.S. Appv: INDICATIONS AND USAGE H.P. G p (ACTH) g py f f f p f 2 y f g. (1.1) H.P. G f f xb f p. (1.2) H.P. G b f fwg : ; g; g; g ; p; py;. (1. 1.9) DOSAGE AND ADMINISTRATION I f f p, 1 U/ 2 v w y j f 7 U/ 2. Af 2 wk f, g b gy p v 2-wk p. (2.1) I f xb f p, y b f 8-12 f 2- wk b. I b y p. (2.2) I f, g w b vz pg p. I b y p. (2.) DOSAGE FORMS AND STRENGTHS L - v g 8 USP p L () CONTRAINDICATIONS H.P. G v b gv vy. H.P. G p w, p, y fg f, p px, gy, y f p f pp, gv f, yp, vy p f p g. A f v v v p vg ppv f H.P G. H.P. G 2 y f g w p g f. (4) T f w INDICATIONS AND USAGE w y p by py ffy ypf. (4) WARNINGS AND PRECAUTIONS If: I pby w f k f xb, v f f. Sg yp f f b k. (.1) A Iffy f Pg Tpy: M f ff f yppy-x pp f ppg. (.2) Cg Sy: My f pg py. M f g yp. (.2) Ev B P, S W R Hypk: M b p p v. (.) V: D v v v p ppv. (.4) Mkg f Syp f O Uyg D/D. M p f g f yg / b k. (.) G Pf Bg: T k f g bg. T k f pf p w GI. Sg yp b k. M f g f pf bg. (.6) Bv M Db: My p,, wg, py g, v p py. Exg b ggv. (.7) Cb D: Syp f b y gv b w w. (.8) Op Eff: M f, f g. (.9) Igy P: Nzg b w f g ACTH vy. (.1) U P w Hypy Lv C: My ff. (.11) Ngv Eff Gw Py Dvp: M p p g py. (.12) D B Dy: M f p p g py. (.1) U Pgy: Eby ff. App w f p f. (.14) ADVERSE REACTIONS C v f H.P. G f f, g, v b p, bv g, pp wg g. (6) Spf v g f g 2 y f g k f f, yp, by, Cg yp, yppy wg g. (6.1.1) T p SUSPECTED ADVERSE REACTIONS, Mk FDA 1-8-FDA DRUG INTERACTIONS H.P. G y w py. (7) USE IN SPECIFIC POPULATIONS Pgy: H.P. G b w v by ff b g pgy y f p bf jf p k f. (8.1) P U: Pg G b k gw. If y, b gv y w f bv. ( ) S 17 f P Cg If FDA-ppv M G Rv: Jy 217 FULL PRESCRIBING INFORMATION: CONTENTS* FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 If p: 1.2 Mp S: 1. R D: 1.4 Cg D: 1. Dg D: 1.6 Ag S: 1.7 Op D: 1.8 Rpy D: 1.9 E S: 2 DOSAGE AND ADMINISTRATION 2.1 Spf R Dg Rg f If 2.2 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 2.4 Pp DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS WARNINGS AND PRECAUTIONS.1 If.2 Cg Sy A Iffy Up Ww. Ev B P, S W R Hypk.4 V. Mkg Syp f O D.6 G Pf Bg.7 Bv M Db.8 Cb D.9 Op Eff.1 Igy P.11 U P w Hypy Lv C.12 Ngv Eff Gw Py Dvp.1 D B Dy.14 U Pgy 6 ADVERSE REACTIONS 6.1 C S Exp Av R If C U 2 Y f Ag 6.2 Pkg Exp Ag R Cv 6.2. Dg E 6.2. G G Mb Mk Ng 6. Pb A Sg Eff 6..1 Dg 6..2 E 6.. Mb 6..4 Mk 6.. Ng 6..6 Op 7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS 8.1 Pgy 8. Ng M 8.4 P U 1 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 M f A 1 NONCLINICAL TOXICOLOGY 1.1 Cg, Mg, Ip f Fy 14 CLINICAL STUDIES 16 HOW SUPPLIED / STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION *S b f f pbg f

6 PRESCRIBING PRESCRIBING INFORMATION INFORMATION pk:m: M bbfullfull 4 4 CONTRAINDICATIONS CONTRAINDICATIONS IgP.1.1 Igy INDICATIONS ANDAND USAGE USAGE f v f v.. b H.P. A b H.P. v pp 1 1 INDICATIONS v If p: p: w w g g f f p p f. f. f yp k k f ypv M.M ppf f If (py (py p p j) j) py py f f bf g p bf g py k.. (.)(.) f f f f p p f f 2 y 2 y f g. f g. A A f v f v v v v v p p vg vg k fgg ppv ppv G.G. P UU P w p GI GI Mp S: S: T T ff g f pf g f pf Mp (py (py p p j) j) f f f f p p,, p, p, y y v.v. f p f p.. C C vv w w fg fg f, f, p p px, px, gy, gy, y y 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, yp, yp, py py Ngv Ngv Eff Eff xg g b b.. Hwv, Hwv, v v ff ff ffy, ffy, ypf ypf vy vy p p f p f p g. g. Lg- Lg- f H.P A y.. vp vp. vg vybywbw y ff b ff b WARNINGS WARNINGS ANDAND PRECAUTIONS PRECAUTIONS R R D: D: T ff T ff v g.. (.9)(.9) A jv py py f - f - ( ( p p vv py vp py vp f ya jv pp yyggffff.... p p xb) xb) : P : P ; ; R R,, g g jv jvttvvfffffh.pf.ha.p.ag G f v v v v b b bw bw vv bb ff ( ( q q w- w- py), py),n N y G,G, b b g g b xp b xp.. [[ Av Av R R (6.)](6.)] Akyg Akyg py. py. D B.1.1 D B D b f D b f pppp.1.1 If If Cg Cg D: D: g g (. H.P. H.P. G G k k f f w w y y pg, pg, g g xb xb py py f: y f: y p p f b f f b f gg. Dg py.pydg v,v, b, b, fg, fg, pz pz f. f. P P b b y, y, y y y y (pyy). (pyy). ( bb (y b b vy vy b b bv bv y, f py pg, y, f py pg,p, p, f. f. (.14)(.14) ppyx b. ppyx b Dg Dg D: D: vp f vp f Sv y y f, f, Sv-J Sv-J y. y. p p k Sv.2 Cg Sy A Iffy Up Ww.2 Cg Sy A Iffy Up Ww py, py, bb y f f T w H.P. G yp-py-x (HPA) pp T w H.P. G yp-py-x (HPA) pp Ag Ag S: S:,, v v b b C g y. T b p y w. C g y. T b p y w. S S k. k..14 U Pg.14 U Pgy wg wg g.g. (6) (6) bb 2y2yf gfg Spp HPAHPA fwg pg py p f f Spp fwg pg py p Op D: D: f. f. [[ U y,g Cg yp, yp, Op ffy ff ww. P b ffy ww. P b Sv Sv g g fy fy p p vvg vvg y y f ffy wk, yppg, wg,, yp f g f ffy wk, yppg, wg yp6 6 ADVERSE x x : k; : k;,, y, y, ff ff p p v v,, ppf g ADVERSE REA REACTI b p.p. b, ; ; g g f. f. k , P Av P ff Av R TT yp f ffy f f f p b bf yp f ffy f f f p Rpy Rpy D: D: f w w ff fy. TT yp -pf x, fg, ff fy. yp -pf x, fg,p Syp Syp.. p S S gy, wk, xv wg,, yp b p.p. I I gy, wk, xv wg yp b 2 y vv 2 y f g w py. py. (7) (7) p gv b w pby f ffy p gv b w pby f ffyg 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 y y w ww gz, yp. [[ P Cg If (17)](17)] gz, yp. P Cg If p p ypyp p p y. y. b yby ffff Tf v Tf v f jf jf p p2 2 DOSAGE TT vy g kk ff yy p b b vy g p DOSAGE ANDAND ADMINISTRATION ADMINISTRATION p ff (.g.(.g. gy) by f g p gy) by f g,, g ybbkk 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 ffy b z f by pg f T ffy b z f by pg f I I fff fp p, H.P,.HA.P.AG G bb y.y. C SE C S 2 (v 2 (v g. w g. T T g g y y f 1 f 1 U/U/ w w yy 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 yp f Cg y g py b b gy Sg yp f Cg y g py gy b gy b gy p p vv 2-wk 2-wk p p v v ffy. ffy.sg f f 2 2 ff py pp. P b f f g v py pp. P b g fwg fwg gg gg pg pg : : U/ U/ g g f fy; y;v Rv: Rv: JyJy T T 2 2 g 2 2 g 2 vy 2 vy p f p (.g.,(.g., f,f, av yp p f p 1 U/ 1 U/ g f f y; y; 1 U/ 1 U/ g f f y; y; 1 U/ 1 U/ yp Av R R by),, yy bby, bb z, by),, bby, z,w g g f 6-y. f 6-y. W yp f v yp f v wg g,g, wk, ypgy, yp. wg wk, ypgy, yp. f p f p ypy ypy b b by by f f (BSA). (BSA). F F f f b ff b ff byby f f,, fwg fwg f f.. Ev B P, SS W R Hypk Ev B P, W R Hypk py py 2 Y f Ag 2 Y f Ag v f b p, w, pfy v f b p, w, pfy b b f x f p. Dy p x f p. Dy p pp b y. C b f p pp b y. C b f pp p yp, gv f, ffy. yp, gv f, ffy. 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 (py G (p A A Mp Mp S S ppv G.G. K v v b b ppv K v v TT y y 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, py w gg, b pb py w, b pb DD ggb bvvzzgg f fpp.z. z f g p kk f by p. f g p f by p. Sy Sy Og Og C C Fqy Fqy gg b b by g by g vy vy p p p. p... Mkg Syp f O D Mkg Syp f O D C C f by kg yp f / w f by kg yp f / w Ag Ag gg p p,, ww ww ffg /. P b fy g /. P b fy C C Hypp Hyp pg pg ffy ffy yp yp w w k k g f f p fwg py f f g f f, g p fwg py g f f, ff ff p p.. I I b y b y p p b E f, yp, ypgy, g by wg E b f, yp, ypgy, g by wg j j v v gy gy.. ff b.. b Cg Cg 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. Fqy Fqy gg b bf pf D D p, b k by py. UU pf, p, b k by py. by g by g vy vy p p p. p.pf, w pby f pg pf, b pyg w pby f pg pf, b pyg Vg Vg v, f, v pp. f, v, f, v pp. TT gv gv y y by byf, G G vy vy Bv M Db Bv M Db Iby Iby b v y ff gg b v y ff gg Ag Ag gg p p,, ww ww ffuu p,, by (py f), wg, py p,, by (py f), wg, py Pyx Pyx pg pg ffy ffy yp yp w w k k ff g, v p, fk py f. xg v p, fk py f. A,A, xg ff ff p p.. I I b y b y p p g, If If f f by py b ggv. by py b ggv. j j v v gy gy.. 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 y gv. w pbg p b y 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 ANDAND STRENGTHS STRENGTHS Pg p p bp, g Pg p p bp, g I I pp pp pb g p p v b f y pb g v b f y 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.

7 p vg p, y f p f y w H.P. y pg, g w b py pg, x (HPA) pp w p f b g, yp p b x, fg, p. I ffy v f, b b p b g y pg py b gy f g (.g., f, b z, w, p f p p vg v b O w vg pb / w b fy g f f, by wg k g f g py. U pyg y ff gg wg, py. A, xg. C b, g b f y.1 Igy P H.P. G g. L vb gg p vp b H.P. G f f g ACTH H.P. G vy. Pg G k f ypvy. Svy p p b bf g py g f yp..11 U P w Hypy Lv C T ff p w ypy w v..12 Ngv Eff Gw Py Dvp Lg- G v gv ff gw py vp. Cg pp w H.P. G py, w ff bg fq p. T ff vb H.P. G py pp. Gw py vp f p p pg py b fy..1 D B Dy D b f b p b g ff g (.. g bp g x) b f b f. T, g w p x b (y p b) x p, b f b gw vp f p y g. Sp b gv p k f p (.., pp w) bf g py, b y b p g py..14 U Pgy H.P. G b w v by ff. App w f p f. [ U Spf Pp (8.1)] 6 ADVERSE REACTIONS P f Av R If C U 2 Y f Ag (S 6.1.1) f w g p w If Sp. T v p S 6.2 py pv f v 2 y f g, b v b w g f 2 y f g. H.P. G f g f g. Tf v ff kw w v w H.P. G w. C v f, g, v b p, bv g, pp wg g. 6.1 C S Exp B wy vyg, v bv f g b y p f g, f bv p Av R If C U 2 Y f Ag W yp f v f g 2 f f p p, fqy vy b ff vy yg g f, yg, py g g. Bw y f v pfy b f v f pv vw 2 y 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 (py p j) If C 2 y f Ag Sy Og C R 7 U/2 b =122, (%) 1 U/2 q =7 (%) C C Hyppy R 7 U/2 b =122, (%) 1 U/2 q =7 (%) 12 1 A 14 R Sy Og C Nv y Cv Rpy, N Cg Sk b V Hyp *Spf f 2% w,, p pp py f. I f If Sp, yp f z/v b p w f p pg f f z (f xp, Lx-G Sy). Ay p k z p v f, z b vb. T v b v 2 y f g w f pp w ff g. 6.2 Pkg Exp T fwg v w G v b f f pkg xp w H.P. G. Oy v v bv v v p f pv vw -p w bg,. B v p vy f pp f z, wy pb fqy b p w H.P. G. Ev gz by y g. U w v v v b p f, Ag R Ag p v p zz, k ( y) Cv Nzg g ( y) gv f Dg Sk g ( y), f y wg ( y) E D by (f y) G P ( y), b v pg G Ij ( y) Mb Hypk k (f y) Mk M wk vb p f (f y) Ng H ( y), vg ( y), b, g ( y), vb b kg (y y yp) (f y). 6. Pb A Sg Eff B g ff G v v b xp pg ff f. T v v b v b p f H.P. G : Dg Ip w g, b, p y, pp f k. Cp 6..2 E M g. D 14 Vg 6.. Mb Ngv g b p b. Iby Mk L f p f f. Pyx I pp F g-g v b pf. D pp H.P. G y w py. E Cg G G If f If* Ivg Wg g Mb 6.. Ng I p w pp, (p- b) y f, b ff Op Exp. 7 DRUG INTERACTIONS

8 8 USE IN SPECIFIC POPULATIONS 8.1 Pgy Pgy C C: H.P. G b w v by ff. T q w- pg w. H.P. G b g pgy y 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 H.P. G, w g g, b w g g, g k bf. 8.4 P U H.P. G py f f f p f 2 y f g. B v pp Wg Av R If C U 2 Y f Ag [ S 6.1.1]. T ffy G f f f p f 2 y 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 ypy. Sfy p pp f f p w v by pv vw f -p [ Av R (6.1.1)]. W yp f v f 2 y f g f f p p, fqy vy b ff vy yg g f, yg, py g g. Eff gw f p [ Wg P (.12)]. S v bv [ Wg P ()]. 1 OVERDOSAGE W xp H.P. G g b w vy f p v ff, xp g g, v v g, p f v ff p. T v b p f v yp f H.P. G pb. T f k ky v v w. T yp y G f BSA f.4 2 w b 6 U/y. Ug 1- yg pp w H.P. G, x b j 8 U/j, w w- g. 11 DESCRIPTION H.P. G gy pf pp p 16% g pv pg f b j. A.% p,.1% y (), yx / j ph w f j. ACTH 9 pp w fwg f: H- S- Ty- S- M- G- H- P- Ag- Tp- Gy Ly- P- V- Gy- Ly- Ly- Ag- Ag- P- V Ly- V- Ty- P- Ap- Gy- A- G- Ap- G L- A- G- A- P- P- L- G- P- OH CLINICAL PHARMACOLOGY 12.1 M f A T f G f f p kw. H.P. G g ACTH x,,, b f wky g b. Pg f g G ypp yppy x g p f, wk g. T f g ACTH f v y v gy f yp by gv fbk. Ev p pp ACTH. H.P. G p b p. T p ff f g ACTH H.P. G x w by f y pp b by y AMP. ACTH py pp f fwg v ; pp, p f-f b 1. T pk G v b qy z. T x ff f p g g v w p f g y. T, fx G w w g f f. 1 NONCLINICAL TOXICOLOGY 1.1 Cg, Mg, Ip f Fy Aq w- v b. H b w g. [ Wg P (.14) U Spf Pp (8.1)] 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 H.P. G (7 U/ 2 w y) p (1 g/kg by w y). T py w p b f p gp w w p, f p vg p pp f b p ypy f p y v EEG pf 2 wk fwg, by vg b. T f 1 p (86.7%) p H.P. G p 4 f 14 p (28.6%) gv p (p<.2). T 2-wk w fw by 2-wk p f p. Np p w gb v H.P. G. Sv f 8 p (87.%) p H.P. G f pg p. Sy, 2 p p f H.P. G w gb v w p. O 2 p (%) p p f pg H.P. G. A ppv g-b, z pg g-, g- (1 U/ 2 y f wk, =) G w w-, - (2 U y f 2 wk, =29) f f f p w v f 2 y f g. Np (f pvy b y) w- gp v 2 wk U y. N py g, p w, w bv f f p b f f ypy. 16 HOW SUPPLIED / STORAGE AND HANDLING H.P. G (py p j) pp L - v ( ) g 8 USP U p L. H.P. G (py p j) b w p bf g. D v pz v p wwg p. S H.P. G (py 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 vby f M G, y b M G p g H.P. G. P b k H.P. G y pb. Ty p y by py. P, gv f b v p f f g w g f H.P. G p f g pp. P, gv f b v f p vp f fv y py. Ty b fv y b p g f. T p y w pp w f z k f f w kg H.P. G. [ Wg P (.1) Av R (6.1.1)] P, gv f b v f p xp b p y py. [ Wg P (.) Av R (6.1.1)] P, gv f b v f p gv b g p y py. [ Wg P (.6)] Cgv f f f w H.P. G b f p w g f by p b. T ff vb H.P. G py pp. [ Wg P (.7) Av R (6.1.1)] P, gv f b v g pp, f g wg g, w H.P. G py, bg fq p. T ff vb H.P. G py pp. [ Wg P (.12) Av R (6.1.1)] P, gv f b v p b f g f ffy wk, fg, gy, x, wg, yp, b p yppg ( y) f pp. S vy g v f y, p b p f f gy by f g p f. [ Wg P (.2)] P b v b v w v v v g w H.P. G. Ay, z p p fy b w w b w p b k w w p kg H.P. G. [ Wg P (.4)] P, gv f b v pg G Cg y v, b k gw, p b y. If pg y, H.P. G b gv y g w f bv. [ Wg P (.2), (.12), (.1) Av R (6.1.1)]

9 P, gv f b f H.P. G k yp f / w g /. T p w b fy g f p fwg py f g f f, b f, yp, ypgy, g by wg, f b. [ Wg P (.)] I f If Sp, yp f z b p w f p pg f f z (f xp, Lx- G Sy). Ay p k z p v f w H.P. G, z b vb. P gv f py f y w f z ppp g b. [ Av R (6.1.1)] Mk, M b k, Mk P g b k f Mk py. 217 Mk. Mf f: Mk ARD I. Hzw, MO 642 USA PL6 Rv 7/217