FULL PRESCRIBING INFORMATION

Transcription

1 HIGHLIGHTS OF PRESCRIBING INFORMATION T gg f G f ffv S f pbg f f G G (p p j) INJECTION, GEL f INTRAMUSCULAR SUBCUTANEOUS I US Appv: INDICATIONS AND USAGE G p (ACTH) g p f f f p f 2 f g (11) G f f xb f p (12) G b f fg : ; g; g; g ; p; p; (1 19) DOSAGE AND ADMINISTRATION I f f p, 1 U/ 2 v j f 7 U/ 2 Af 2 k f, g b g p v 2-k p (21) I f xb f p, b f 8-12 f 2- k b I b p (22) I f, g b vz pg p I b p (2) DOSAGE FORMS AND STRENGTHS L - v g 8 USP p L () CONTRAINDICATIONS G v b gv v G p, 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 G 2 f g p g f (4) T f INDICATIONS AND USAGE p b p ff pf (4) WARNINGS AND PRECAUTIONS If: I pb 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 GI Sg p b k M f g f pf bg (6) Bv M Db: M p,, g, p g, v p p Exg b ggv (7) Cb D: Sp f b gv b (8) Op Eff: M f, f g (9) Ig P: Nzg b f g ACTH v (1) U P Hp Lv C: M ff (11) Ngv Eff G P Dvp: M p p g p (12) D B D: M f p p g p (1) U Pg: Eb ff App f p f (14) ADVERSE REACTIONS C v f G f f, g, v b p, bv g, pp g g (6) Spf v g f g 2 f g k f f, p, b, Cg p, pp g g (611) T p SUSPECTED ADVERSE REACTIONS, Mk FDA 1-8-FDA-188 fgv/ DRUG INTERACTIONS G p (7) USE IN SPECIFIC POPULATIONS Pg: G b v b ff b g pg f p bf jf p k f (81) P U: Pg G b k g If, b gv 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 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 W 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 Hp Lv C 12 Ngv Eff G 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

2 PRESCRIBING PRESCRIBING INFORMATION INFORMATION pk:m: M bbfullfull 4 4 CONTRAINDICATIONS CONTRAINDICATIONS IgP 11 Ig INDICATIONS USAGE USAGE f v f v b A b v pp 1 1 INDICATIONS v If p: p: 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 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 fg fg f, f, p p px, px, g, g, f f p p f f,,, xb, g,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 Hv, Hv, 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 vbb 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 b b vv bb ff ( ( q q - - 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 ( G G k k f f 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 W 2 Cg S A Iff Up W p, p, bb f f T G p-p-x (HPA) pp T G p-p-x (HPA) pp Ag Ag S: S:,, v v b b C g T b p C g T b p S S k k 14 U Pg 14 U Pg g g gg (6) (6) bb 22f gfg Spp HPAHPA fg pg p p f f Spp fg pg p p Op D: D: f f [[ U,g Cg p, p,17 17 Op ff ff P b ff P b Sv Sv g g f f p p vvg vvg f ff k, ppg, g,, p f g f ff k, ppg, g 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 ff f TT p -pf x, fg, ff f p -pf x, fg,p Sp Sp p S S g, k, xv g,, p b pp I I g, k, xv g p b 2 vv 2 f g p p (7) (7) p gv b pb f ff p gv b pb f ffg E E S: S: g f f g b bv f, f, b b g b bv b b T T f p f p p p 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, 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 g T T g g f 1 f 1 U/U/ B B 2) 2) j j f 7 f U/ 7 U/ vv 2-k 2-k 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-k 2-k p p v v ff ffsg f f 2 2 ff p pp P b f f g v p pp P b g fg fg 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 g g,g, k, pg, p g k, 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,, fg fg 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,, pf v f b p,, 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; v, p v b p O ; v, p v b p O 2- k 2- k f f xb xb b k p vg z p b k p vg z p G,G, p gg, b pb p, 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 / f b kg p f / Ag Ag gg p p,, ffg / P b f g / P b f C C Hpp Hp pg pg ff ff p p k k g f f p fg p f f g f f, g p fg p g f f, ff ff p p I I b b p p b E f, p, pg, g b g E b f, p, pg, g b g 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, pb f pg pf, b pg 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,, ffuu p,, b (p f), g, p p,, b (p f), g, p Px Px pg pg ff ff p p 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 C P b vv C b b Ivg b b p p bf bf g g pbg p b gv pbg p b gv Wg Wg gg C C b k b k v-pz v-pz v v pp g g 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

3 p vg p, f p f pg, g b p pg, x (HPA) pp 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,, p f p p vg v b O vg pb / b f g f f, b g k g f g p U pg ff gg g, p A, xg C b, g b f 1 Ig P G g L vb gg p vp b G f f g ACTH G v Pg G k f pv Sv p p b bf g p g f p 11 U P Hp Lv C T ff p p v 12 Ngv Eff G P Dvp Lg- G v gv ff g p vp Cg pp G p, ff bg fq p T ff vb G p pp G 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 p x b ( p b) x p, b f b g vp f p g Sp b gv p k f p (, pp ) bf g p, b b p g p 14 U Pg G b v b ff App f p f [ U Spf Pp (81)] 6 ADVERSE REACTIONS P f Av R If C U 2 Y f Ag (S 611) f g p If Sp T v p S 62 p pv f v 2 f g, b v b g f 2 f g G f g f g Tf v ff k v G C v f, g, v b p, bv g, pp g g 61 C S Exp B 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 B f v pf b f v f pv v 2 f g f f p T b f p f 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%,, p pp p f I f If Sp, p f z/v b p 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 f pp ff g 62 Pkg Exp T fg v G v b f f pkg xp G O v v bv v v p f pv v -p bg, B v p v f pp f z, pb fq b p G Ev gz b g U 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 g ( ) 624 E D b (f ) 62 G P ( ), b v pg 626 G Ij ( ) 627 Mb Hpk k (f ) 628 Mk M k 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 G : Dg Ip 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 G p E Cg G G If f If* Ivg Wg g Mb 6 Ng I p pp, (p- b) f, b ff 66 Op Exp 7 DRUG INTERACTIONS

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

5 P, gv f b f G k p f / g / T p b f g f p fg p f g f f, b f, p, pg, g b g, f b [ Wg P ()] I f If Sp, p f z b p f p pg f f z (f xp, Lx- G S) A p k z p v f G, z b vb P gv f p f 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 Hz, MO 642 USA PL6 Rv 7/217