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SERVICE D'H?MATO-ONCOLOGIE
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Amivantamab ? Programme acc?s de Janssen, n?cessit? m?dicale particuli?re (NMP)
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Cancer du poumon non ? petites cellules (CPNPC) avec mutation EGFR insertion exon 20Crit?res d?utilisation FORMCHECKBOX CPNPC m?tastatique ou non r?s?cable avec mutation EGFR insertion exon 20
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FORMCHECKBOX A progress? pendant ou apr?s une chimioth?rapie ? base de platine; si patient non ?ligible aux platines, doit
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avoir re?u un traitement alternatif (ex?: mobocertinib, un ITK anti EGFRexon20)
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FORMCHECKBOX Cas pr?sent? au comit? des tumeurs et recommandation des pairs
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FORMCHECKBOX Formulaire compl?t? pour demande au programme du fabricant (Janssen)
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FORMCHECKBOX Formulaire compl?t? pour demande de n?cessit? m?dicale particuli?re au comit? de pharmacologie
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(MOSAIQ, PM EXPRESS, onglet chimioth?rapie?: *CdePMed.Particul-T) Aux commis ? la planification : attendre ok de la pharmacie avant de planifier le premier traitement Laboratoires De base?: FSC et Biochimie N16 (Acide urique, Albumine, AST, ALT, Phos Alc, Bili tot, Ca, Cr?atinine,
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Glucose, K, Na, LD, Lipase, Mg, Phosphore, Ur?e)
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Dans les 96 heures avant chaque cycle?: FSC, Albumine, AST, ALT, phos Alc, Bili tot, Ca, Cr?atinine,
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Glucose, K, Na, Mg, phosphore
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Traiter selon balises CHUM-ONCO et si ALT e t p h o s . A l c a l i n e d" 5 x l i m i t e s u p ? r i e u r e n o r m a l e ( L S N ) P r ? m ? d i c a t i o n A d m i n i s t r e r 6 0 m i n u t e s a v a n t l a p e r f u s i o n ? : A c ? t a m i n o p h ? n e 9 7 5 m g p o e t d i p h e n h y d r a m i n e 5 0 m g p o
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C y c l e 1 j o u r s 1 e t 2 s e u l e m e n t ? : D e x a m ? t h a s o n e 1 0 m g I V
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F O R M C H E C K B O X A u t r e ? : F O R M T E X T T r a i t e m e n t M ? d i c a m e n t D o s e f i x e s e l o n l e p o i d s
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V o i r n i v e a u x d a j u s t e m e n t p a g e 3 A d m i n i s t r a t i o n N B ? : l a d o s e e s t b a s ? e s u r l e p o i d s i n i t i a l d u p a t i e n t , m ? m e s i son poids varie ult?rieurementPerfusion par voie p?riph?rique pour les 3 premi?res doses (m?me si voie centrale pr?sente)
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Surveillance x 30 minutes post-perfusion pour les 3 premi?res doses Cycle 1 jours 1 et 2Amivantamab FORMCHECKBOX < 80 kg : 350 mg jour 1
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700 mg jour 2Dans 250 mL de NaCl 0,9 %
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IV en 4 ? 6 heures par voie p?riph?rique
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D?bit variable, voir page 2
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Par tubulure avec filtre 0,2 micron
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Surveillance x 30 minutes post perfusion FORMCHECKBOX e" 8 0 k g : 3 5 0 m g j o u r 1
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1 0 5 0 m g j o u r 2 C y c l e 1 j o u r s 8 , 1 5 e t 2 2 A m i v a n t a m a b F O R M C H E C K B O X < 8 0 k g : 1 0 5 0 m g D a n s 2 5 0 m L d e N a C l 0 , 9 %
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I V e n 2 ? 4 h e u r e s
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D ? b i t v a r i a b l e , v o i r p a g e 2
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P a r t u b u l u r e a v e c f i l t r e 0 , 2 m i c r o n
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J o u r 8 s e u l e m e n t ? : p a r v o i e p ? r i p h ? r i q u e
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e t s u r v e i l l a n c e x 3 0 m i n u t e s p o s t p e r f u s i o n F O R M C H E C K B O X e" 8 0 k g : 1 4 0 0 m g
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S E R V I C E D ' H ? M A T O - O N C O L O G I E
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A m i v a n t a m a b P r o g r a m m e a c c ? s d e J a n s s e n , n ? c e s s i t ? m ? d i c a l e p a r t i c u l i ? r e ( N M P )
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C a n c e r d u p o u m o n n on ? petites cellules (CPNPC) avec mutation EGFR insertion exon 20 Traitement (suite)M?dicamentDose fixe selon le poidsAdministration A d?buter 7 jours apr?s Cycle 1 jour 22?:
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Cycle 2 et suivants: jours 1 et 15Amivantamab FORMCHECKBOX < 80 kg : 1050 mgDans 250 mL de NaCl 0,9 %
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IV en 2 heures
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Par tubulure avec filtre 0,2 micron FORMCHECKBOX e" 8 0 k g : 1 4 0 0 m g R ? p ? t e r c h a q u e c y c l e a u x 2 8 j o u r s x F O R M T E X T c y c l e s
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T r a i t e m e n t c o n d i t i o n n e l a u r e n d e z - v o u s m ? d i c a l ? : F O R M C H E C K B O X p o u r c h a q u e c y c l e ( s ) F O R M C H E C K B O X ? t o u s l e s F O R M T E X T c y c l e s D ? b i t d e p e r f u s i on selon le calendrier et la doseCycle de 28 joursDoseD?bit initialD?bit suivantDur?e totale d?administration< 80 kg : 1050 mg Cycle 1 Jour 1350 mg50 mL/h x 2 heures75 mL/h x 2 heures4 heuresJour 2700 mg50 mL/h x 2 heures75 mL/h x 2 heures4 heuresJour 81050 mg85 mL/h3 heures Jour 151050 mg125 mL/h2 heures Jour 221050 mg125 mL/h2 heures Cycle 2
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Jours 1 et 151050 mg125 mL/h2 heures e" 8 0 k g : 1 4 0 0 m g C y c l e 1 J o u r 1 3 5 0 m g 5 0 m L / h x 2 h e u r e s 7 5 m L / h x 2 h e u r e s 4 h e u r e s J o u r 2 1 0 5 0 m g 3 5 m L / h x 2 h e u r e s 5 0 m L / h x 3 h 3 6 m i n 5 h 3 6 m i n J o u r 8 1 4 0 0 m g 6 5 m l / h 4 h e u r e s J o u r 1 5 1 4 0 0 m g 8 5 m L / h 3 h e u r e s J o u r 2 2 1 4 00 mg125 mL/h2 heures Cycle 2
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Jours 1 et 151400 mg125 mL/h2 heures
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SERVICE D'H?MATO-ONCOLOGIE
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Amivantamab ? Programme acc?s de Janssen, n?cessit? m?dicale particuli?re (NMP)
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Cancer du poumon non ? petites cellules (CPNPC) avec mutation EGFR insertion exon 20 Surveillance des r?actions d'hypersensibilit? La majorit? des r?actions (fi?vre ou frisson, naus?es ou vomissement, dyspn?e, inconfort thoracique, mal de t?te, hypertension l?g?re) surviennent au Cycle 1 jour 1 dans les premi?res 90 mi n u t e s d e l a p e r f u s i o n ( 8 4 % ) .
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S u i v i d e s s i g n e s v i t a u x : P A , p o u l s , s a t u r a t i o n O 2 , f r ? q u e n c e r e s p i r a t o i r e e t T p C
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A u x j o u r s 1 , 2 e t 8 : a v a n t d e d ? b u t e r p u i s a u x 3 0 m i n j u s q u ' ? 3 0 m i n u t e s a p r ? s l a f i n d e l a p e r f u s i o n
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A u t r e s j o u r s d u c y c l e : avant de d?buter puis aux 30 minutes
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Apr?s 3 traitements sans r?action, cesser la p?riode d?observation post perfusion
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Si r?action d'hypersensibilit?: interrompre la perfusion et initier l'OC INF. 0044
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Grade 1 ? 3 : R?action l?g?re ? s?v?re
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Suspendre la perfusion, surveiller le patient ad r?solution des sympt?mes
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Administrer m?dicaments de soutien si besoin.
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Apr?s r?solution des sympt?mes, reprendre la perfusion ? 50 % du d?bit pr?c?dent
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Si tol?r? apr?s 30 minutes, reprendre l'augmentation du d?bit ? partir du palier le plus proche
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Administrer dexam?thasone 10 mg IV en pr?m?dication
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Grade 3 r?currente ou Grade 4 (r?action potentiellement mortelle)
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Arr?ter la perfusion et cesser le traitement de fa?on d?finitiveAjustement des doses en cas de r?action ind?sirable de grade 3 ou 4 En cas de r?action de grade 3 ou 4, interrompre le traitement jusqu?? r?solution d" g r a d e 1
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S i i n t e r r u p t i o n e s t d" 7 j o u r s ? : r e p r e n d r e ? l a m ? m e d o s e
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t ???6? ? ?????? ? ? ? 4? 4? 4? a???p?
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? ? ytpFz d? ? $If gd0c R kd + $$If ? 4?(? ???& ?????
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? ? ytpFz d? ? $If gd0c R kdt, $$If ? 4?(? ???& ?????
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t ???6? ? ?????? ? ? ? 4? 4? 4? a???p?
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? ? ytpFz 8' G' R' Z' [' z' ?' ?' ?' ?' B( F( ?( ?( ) ) ) ,) <) >) |) ~) ?) ?) * ? f? j? ?? ?? 6? 8? :? <? ?? ??????ɺޣ????ɺ????????????xa -hRj hpFz B*CJ OJ PJ QJ ^J aJ ph )h|v? hpFz B*CJ OJ PJ QJ ^J ph U'hpFz B*CJ OJ PJ QJ ^J aJ ph -h eT hpFz B*CJ OJ PJ QJ ^J aJ ph h|v? hpFz B*PJ ^J ph (heFQ hpFz 5?B*OJ PJ QJ ^J ph "hpFz 5?B*OJ PJ QJ ^J ph h|v? h0c B*PJ ^J ph "?' ?' ( ?( ) ) ~) ? ? ? ? P E ? $If gd?b? R kdr. $$If ? 4?(? ???& ?????
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t ???6? ? ?????? ? ? ? 4? 4? 4? a???p?
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? ? ytpFz ? $If gd?F& R kd?- $$If ? 4?(? ???& ?????
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t ???6? ? ?????? ? ? ? 4? 4? 4? a???p?
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? ? ytpFz ~) ?) 8? ?? 8? :? <? ? ? ? ? R G ? $If gd?F& P kd?/ $$If ? ?(? ???&??????
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t ???6? ? ?????? ? ? ? 4? 4? 4? a???p?
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? ? ytpFz ? $If gdpFz P kd / $$If ? ??? ???&??????
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t ???6? ? ?????? ? ? ? 4? 4? 4? a???p?
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? ? ytpFz u s q u ? r ? s o l u t i o n d" g r a d e 1
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S i i n t e r r u p t i o n e s t d" 7 j o u r s ? : r e p r e n d r e ? l a m ? m e d o s e
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S i i n t e r r u p t i o n > 7 j o u r s e s t n ? c e s s a i r e ? : r e p r e n d r e ? d o s e d i m i n u ? e N i v e a u x d a j u s t e m e n t d e s d o s e s d e a m i v a n t a m a b P o i d s i n i t i a l D o s e i n i t i a l e N i v e a u - 1 N i v e a u - 2 N i v e a u - 3 < 8 0 k g 1 0 5 0 m g 7 0 0 m g 3 5 0 m g c e s s e r e" 8 0 k g 1 4 0 0 m g 1 0 5 0 m g 7 0 0 m g T h ? r a p i e d e s o u t i e n ( f a i r e o r d o n n a n c e s e x t e r n e s ) A v i s e r l e p a t i e n t d e n e p a s s e x p o s e r a u s o l e i l p e n d a n t l e t r a i t e m e n t e t p e n d a n t 2 m o i s s u i v a n t l a r r ? t
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E n c a s d e t o x i c i t ? c u t a n ? e ? :
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C o n s i d ? r e r c o r t i c o s t ? r o ? d e s t o p i q u e s e t a n t i b i o t i q u e s o r a u x o u t o p i q u e s ( f a i r e o r d o n n a n c e s e x t e r n e s )
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F O R M C H E C K B O X I n i t i e r p r o t o c o l e E P I D E R M p a r p h a r m a c i e n
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S E R V I C E D ' H ? M A T O - O N C O L O G I E
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A m i v a n t a m a b P r o g r a m m e a c c ? s d e J a n s s e n , n ? c e s s i t ? m ? d i c a l e p a r t i c u l i ? r e ( N M P )
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C a n c e r d u p o u m o n n o n ? p e t i t e s c e l l u l e s ( C P N P C ) a v e c m u t a t i o n E G F R i n s e r t i o n e x o n 2 0 R ? f . : A d a p t ? d e M o n o g r a p h i e R y b r e v a n t U S ( D ? c 2 0 2 1 ) ; I n f o d e J a n s s e n C a n a d a ; B C C A t x p l a n N o v 2 0 2 1
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C r ? a t i o n ? : m a r s 2 0 2 2 L . B e s s e R ? v i s i o n ? : N R o m e r o . M a i 2 0 2 2 ( c h a n g e m e n t d e P A S ? c o m m e r c i a l i s ? )
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C o m m e n t a i r e s ? :
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F O R M T E X T
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O R D O N N A N C E M ? D I C A L E
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P o i d s ? : k g T a i l l e ? : c m
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S u r f a c e c o r p o r e l l e ( m ? ) :
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A l l e r g i e s / i n t o l ? r a n c e s ? : V o i r O a c i s { P a t i e n t . N a m e L F M } # { I d e n t . I D A } { A d m i n . P a t _ A d r 1 } { A d m i n . G e n d e r } { A d m i n . P a t _ C i t y } , { A d m i n . P a t _ S t a t e }
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{ A d m i n . P a t _ P o s t a l } { I d e n t . I D D }
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D D N ? : { A d m i n . B i r t h _ D a t e } ( { A d m i n . A g e } )
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D a t e d e l a v i s i t e ? : { O b j e c t . E n c o u n t e r _ D a t e } { A d m i n . P a t _ H o m e _ P h o n e } L o i d e V a n e s s a - R ? a c t i o n i n d ? s i r a b l e g r a v e a u x m ? d i c a m e n t s : c o m p o s e r l e 1 4 3 2 5
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A p p r o u v ? ? l e c t r o n i q u e m e n t p a r { O b j e c t . S a n c t _ I D * P n P . F i r s t _ N a m e @ M } { O b j e c t . S a n c t _ I D * P n P . L a s t _ N a m e @ M } , { O b j e c t . S a n c t _ I D * P n P . S u f f i x } ( { O b j e c t . S a n c t _ I D * P n P . L i c e n s e } ) l e { O b j e c t . S a n c t _ D a t e } { O b j e c t . S a n c t _ T i m e }
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F U M - 0 0 0 2 ( O R D O N N A N C E M ? D I C A L E ) P a g e P A G E \ * A r a b i c \ * M E R G E F O R M A T 1 d e N U M P A G E S \ * A r a b i c \ * M E R G E F O R M A T 4
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<? ?? ?? ?? ?? ?? ?? ?? ?? ? ? ? ? d ? ? ? ? ? ? ? ? kdl0 $$If ? 4?? ?F ??ob!?&?? ??
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??
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t ???6? ? ? ? ? ? ? ? 4? 4? 4? a???p? ? ? ? ? ? ? yt?F& ? $If gd?F& $? $If a$gd?F&
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?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ? ? ? ? &? (? 6? 8? D? F? R? T? `? d? f? h? v? x? ?? ?? ?? ?? ?? ?? ?? ?? ?? ? ???????????????خ??????????خ???????ɜ?q +h|v? h?b? 5?6?B*OJ PJ QJ ^J ph (h|v? h?b? 5?B*OJ PJ QJ ^J ph "h?b? 5?B*OJ PJ QJ ^J ph 4h? 1 hpFz 5?B*CJ OJ PJ QJ ^J mH ph sH h|v? hpFz B*PJ ^J ph )h|v? hpFz B*CJ OJ PJ QJ ^J ph #hpFz B*CJ OJ PJ QJ ^J ph (? ? ? kdm1 $$If ? 4?? ֞ ??o ?4?b!?&?? ?? ?? ?? ?? ?? ??
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t ???6? ? ? ? ?? ? ? ? ? 4? 4? 4? a???p?F ? ? ? ? ? ? ? ? ? ? ? ? ? ? yt?F& ? ? (? 8? F? T? b? d? ? ? ? ? ? ? ? $? $If a$gd?F& ? $If gd?F& d? f? ? kd?2 $$If ? 4?? ֞ ??o ?4?b!?&?? ?? ?? ?? ?? ?? ??
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t ???6? ? ? ? ?? ? ? ? ? ? 4? 4? 4? a???p?F ? ? ? ? ? ? ? ? ? ? ? ? ? ? yt?F& f? h? x? ?? ?? ?? ?? ?? ? ? ? ? ? ? ? $? $If a$gd?F& ? $If gd?F& ?? ?? ? kd?3 $$If ? 4?? ֞ ??o ?4?b!?&?? ?? ?? ?? ?? ?? ??
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t ???6? ? ? ? ? ?? ? ? 4? 4? 4? a???p?F ? ? ? ? ? ? ? ? ? ? ? ? ? ? yt?F& ?? ? ? ?? &? ?? n? ? ? ? ? ? ? ? $If gdpEE ? $If gd?b? P kd?4 $$If ? ?? ???&??
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t ???6? ? ? ? ? ? 4? 4? 4? a???p?
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? ? ytpEE ?
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d? ? $If ^?
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gdpEE ? ? ?? &? ?? ?? ? ? ? ? l? n? p? t? ?? ?? H? ???ީ?s???d?`K<*"h?>? 5?B*OJ PJ QJ ^J ph h|v? h?>? B*PJ ^J ph (h|v? h?>? 5?B*OJ PJ QJ ^J ph hpFz hI8? h?b? B*PJ ^J ph @?jX5 h|v? h?b? B*CJ OJ PJ QJ U^J mH ph sH )hpFz h?b? B*CJ OJ PJ QJ ^J ph :j h|v? h?b? B*CJ OJ PJ QJ U^J mH ph sH ,hpFz h?b? >*B*CJ OJ PJ QJ ^J ph #h?b? B*CJ OJ PJ QJ ^J ph h|v? h?b? B*PJ ^J ph n? p? t? ?? J? ?? ? ? ? ? s $?
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d? ? $If ^?
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a$gd?>? $? ? $If ]? a$gd?>? $? ? $If ]? a$gd?>? P kd?5 $$If ? ?G? ???&??
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t ???6? ? ? ? ? ? 4? 4? 4? a???p?
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? ? ytpEE H? J? ?? ?? ?? ?? ? ? ? J? b? ?? ?? ??³??q\G5#G #h?# B*CJ OJ PJ QJ ^J ph #h? B*CJ OJ PJ QJ ^J ph )h? h? B*CJ OJ PJ QJ ^J ph )h? hI8? B*CJ OJ PJ QJ ^J ph ,h|v? hI8? 6?B*CJ OJ PJ QJ ^J ph ,h|v? hI8? 5?B*CJ OJ PJ QJ ^J ph &hI8? 5?B*CJ OJ PJ QJ ^J ph hT~C hpFz B*PJ ^J ph 0hpFz hpFz 5?B*CJ OJ PJ QJ ^J aJ ph )h?>? h?>? B*CJ OJ PJ QJ ^J ph h|v? h?>? B*PJ ^J ph ?? ?? ?? ?? ?? ?? ?? ? ? ? G B B gd?Q P kd?6 $$If ? ?? ???&??
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t ???6? ? ? ? ? ? 4? 4? 4? a???p?
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? ? ytRj ? $If gd? ? $If gdI8? P kdX6 $$If ? ?? ???&??
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t ???6? ? ? ? ? ? 4? 4? 4? a???p?
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t ??0 ? ? ? ? ? ? ? 6? ? ?? ? ? ? ? ?4? 4?
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l a? yt?Q d? ? $If gd||
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