Apoquel

• Apoquel Indications
• Lus ceeb toom thiab ceeb toom rau Apoquel
• Cov lus qhia thiab ntau npaum li cas rau Apoquel

Apoquel

• Cov dev

(oclacitinib ntsiav tshuaj)

3.6mg ib

5,4mg ib

16 mg o

Immunomodulator

Rau qhov ncauj siv rau dev xwb

Apoquel Ceev faj

Tsoom Fwv Teb Chaws (USA) Txoj Cai txwv cov tshuaj no siv los ntawm lossis raws li kev txiav txim ntawm tus kws kho tsiaj muaj ntawv tso cai.

Kev piav qhia

APOQUEL (oclacitinib maleate) yog ib qho hluavtaws Janus Kinase (JAK) inhibitor. Cov tshuaj muaj pes tsawg leeg ntawm APOQUEL yog N-methyl [trans-4-(methyl-7H-pyrrolo[2,3-d] pyrimidin-4-ylamino) cyclohexyl] methanesulfonamide (2Z)-2-butenedioate.

Cov qauv tshuaj ntawm oclacitinib maleate yog:

Apoquel Indications

Kev tswj cov kab mob pruritus cuam tshuam nrog kev tsis haum dermatitis thiab kev tswj cov kab mob atopic dermatitis hauv dev tsawg kawg yog 12 lub hlis.

Dosage thiab Administration

Dosing Chart

Ceeb toom

APOQUEL tsis yog siv rau cov dev uas muaj hnub nyoog qis dua 12 lub hlis (saib Tsiaj Kev Nyab Xeeb ).

APOQUEL modulates lub cev tiv thaiv kab mob.

APOQUEL tsis yog siv rau cov dev uas muaj mob hnyav.

APOQUEL tuaj yeem ua rau muaj kev kis kab mob, suav nrog demodicosis, thiab exacerbation ntawm neoplastic tej yam kev mob (saib Kev Ceeb Toom, Kev Tsis Pom Zoo, Kev Pom Zoo Tom Qab Kev Pom Zoo thiab Kev Nyab Xeeb Tsiaj ).

Cov mob neoplastic tshiab (benign thiab malignant) tau pom nyob rau hauv cov dev kho nrog APOQUEL thaum lub sij hawm soj ntsuam thiab tau tshaj tawm nyob rau hauv lub sij hawm tom qab kev pom zoo (saib Kev Tsis Pom Zoo thiab Kev Pom Zoo Tom Qab Kev Pom Zoo ).

Xav txog qhov txaus ntshai thiab cov txiaj ntsig ntawm kev kho mob ua ntej pib APOQUEL hauv cov dev uas muaj keeb kwm ntawm kev kis mob hnyav lossis rov tshwm sim demodicosis lossis neoplasia (saib Kev Tsis Pom Zoo, Kev Pom Zoo Tom Qab Kev Pom Zoo , thiab Tsiaj Kev Nyab Xeeb ).

Khaws APOQUEL rau hauv qhov chaw ruaj ntseg kom tsis txhob ncav cuag cov dev, miv, thiab lwm yam tsiaj kom tsis txhob muaj kev sib tsoo los yog siv tshuaj ntau dhau.

Tib neeg ceeb toom:

Cov khoom no tsis yog siv rau tib neeg. Khaws qhov no thiab tag nrho cov tshuaj kom deb ntawm menyuam yaus. Siv rau hauv cov dev xwb. Ntxuav tes tam sim ntawd tom qab tuav cov ntsiav tshuaj. Yog tias qhov muag tsis pom kev, yaug tam sim nrog dej lossis ntsev kom tsawg li 15 feeb thiab tom qab ntawd mus rau kev kho mob. Nyob rau hauv cov ntaub ntawv ntawm kev huam yuaj, nrhiav kev kho mob tam sim ntawd.

Cov kev ceev faj

Cov dev tau txais APOQUEL yuav tsum tau saib xyuas kev txhim kho ntawm cov kab mob, suav nrog demodicosis, thiab neoplasia.

Kev siv APOQUEL tsis tau raug soj ntsuam ua ke nrog glucocorticoids, cyclosporine, lossis lwm yam tshuaj tiv thaiv kab mob.

APOQUEL tsis yog siv rau hauv kev yug menyuam dev, lossis cev xeeb tub lossis lactating bitches.

Kev Phem Tsis Zoo

Kev tswj ntawm Atopic Dermatitis

Hauv kev tshawb nrhiav daim npog ntsej muag txhawm rau txheeb xyuas qhov ua tau zoo thiab kev nyab xeeb ntawm oclacitinib rau kev tswj cov kab mob atopic dermatitis hauv dev, 152 tus dev kho nrog APOQUEL thiab 147 tus dev kho nrog cov placebo (tswj tsheb) tau soj ntsuam kev nyab xeeb. Feem ntau ntawm cov dev hauv pawg placebo tau thim tawm ntawm 112-hnub txoj kev tshawb fawb los ntawm Hnub 16. Cov kev tshwm sim tsis zoo qhia (thiab feem pua ​​​​ntawm cov dev cuam tshuam) thaum Hnub 0-16 suav nrog raws plab (4.6% APOQUEL, 3.4% placebo), ntuav (3.9%) APOQUEL, 4.1% placebo), anorexia (2.6% APOQUEL, 0% placebo), cov tawv nqaij tshiab los yog subcutaneous (2.6% APOQUEL, 2.7% placebo), thiab lethargy (2.0% APOQUEL, 1.4% placebo). Feem ntau, raws plab, ntuav, anorexia, thiab lethargy tau daws nws tus kheej nrog kev noj tshuaj ntxiv. Cov dev ntawm APOQUEL tau txo qis leukocytes (neutrophil, eosinophil, thiab monocyte suav) thiab cov ntshav globulin, thiab nce cov roj cholesterol thiab lipase piv rau cov placebo pab pawg tab sis pab pawg txhais tau tias tseem nyob hauv qhov qub. Qhov nruab nrab lymphocyte suav tau nce ntxiv nyob rau hnub 14 hauv pawg APOQUEL.

Cov dev uas tau tshem tawm ntawm qhov kev kawm uas npog qhov ncauj qhov ntswg tuaj yeem nkag mus rau qhov kev kawm uas tsis tau npog qhov twg txhua tus dev tau txais APOQUEL. Nyob nruab nrab ntawm txoj kev kawm npog ntsej muag thiab tsis npog ntsej muag, 283 tus dev tau txais tsawg kawg ib koob tshuaj APOQUEL. Ntawm 283 tus dev no, ob tug dev tau raug tshem tawm los ntawm kev kawm vim qhov xav tias muaj kev cuam tshuam txog kev kho mob: ib tus dev uas muaj qhov khaus khaus khaus khaus thiab mob hnyav thib ob pyoderma tom qab 19 hnub ntawm kev tswj hwm APOQUEL, thiab ib tus dev uas tsim kev demodicosis tom qab. 28 hnub ntawm APOQUEL kev tswj hwm. Ob tug dev lwm tus ntawm APOQUEL raug tshem tawm ntawm txoj kev kawm vim yog qhov xav tau lossis paub tseeb tias mob neoplasia thiab tom qab ntawd euthanized, suav nrog ib tus dev uas tsim cov cim cuam tshuam nrog lub plawv loj tom qab 21 hnub ntawm kev tswj hwm APOQUEL, thiab ib tus dev uas tsim qib III mast cell qog. tom qab 60 hnub ntawm APOQUEL kev tswj hwm.

Ib qho ntawm 147 tus dev hauv pab pawg placebo tau tsim cov qog qog ntshav Qib I thiab tau raug tshem tawm los ntawm kev kawm npog ntsej muag. Cov dev ntxiv uas tau txais APOQUEL tau mus pw hauv tsev kho mob rau kev kuaj mob thiab kho mob ntsws (ib tus dev), ntuav los ntshav thiab quav (ib tus dev), thiab cystitis nrog urolithiasis (ib tus dev).

Hauv 283 tus dev uas tau txais APOQUEL, cov tsos mob hauv qab no tau tshaj tawm tom qab pib APOQUEL (feem pua ​​​​ntawm cov dev uas muaj tsawg kawg yog ib daim ntawv qhia txog kev kuaj mob raws li qhov tsis muaj nyob rau hauv qhov kev tshawb pom): pyoderma (12.0%), tsis tau teev tseg. dermal lumps (12.0%), otitis (9.9%), ntuav (9.2%), raws plab (6.0%), histiocytoma (3.9%), cystitis (3.5%), anorexia (3.2%), lethargy (2.8%), poov xab kab mob ntawm daim tawv nqaij (2.5%), pododermatitis (2.5%), lipoma (2.1%), polydipsia (1.4%), lymphadenopathy (1.1%), xeev siab (1.1%), nce qab los noj mov (1.1%), aggression (1.1%), thiab poob phaus (0.7).

Tswj Pruritus Associated with Allergic Dermatitis

Hauv kev tshawb fawb daim npog ntsej muag txhawm rau txheeb xyuas qhov ua tau zoo thiab kev nyab xeeb ntawm oclacitinib rau kev tswj cov kab mob pruritus cuam tshuam nrog kev ua xua rau cov dev, 216 tus dev kho nrog APOQUEL thiab 220 tus dev kho nrog cov placebo (tswj tsheb) tau soj ntsuam kev nyab xeeb. Thaum lub sijhawm kawm 30-hnub, tsis muaj neeg tuag thiab tsis muaj teebmeem tshwm sim uas xav tau kev saib xyuas hauv tsev kho mob. Cov tshuaj tiv thaiv tsis zoo tau tshaj tawm (thiab feem pua ​​​​ntawm cov dev cuam tshuam) thaum Hnub 0-7 suav nrog raws plab (2.3% APOQUEL, 0.9% placebo), ntuav (2.3% APOQUEL, 1.8% placebo), lethargy (1.8% APOQUEL, 1.4% placebo), anorexia (1.4% APOQUEL, 0% placebo), thiab polydipsia (1.4% APOQUEL, 0% placebo). Hauv feem ntau ntawm cov xwm txheej no, cov cim qhia tau daws nws tus kheej nrog kev siv tshuaj txuas ntxiv. Tsib APOQUEL pab pawg dev raug tshem tawm los ntawm kev kawm vim yog: qhov chaw tsaus ntawm daim tawv nqaij thiab pluab (1 tus dev); raws plab (1 dev); kub taub hau, lethargy thiab cystitis (1 dev); khaus khaus khaus thiab ntuav (1 aub); thiab raws plab, ntuav, thiab lethargy (1 aub). Cov dev hauv pawg APOQUEL tau txo qis me ntsis ntawm cov qe ntshav dawb suav (neutrophil, eosinophil, thiab monocyte suav) uas tseem nyob hauv qhov kev siv ib txwm muaj. Txhais tau tias lymphocyte suav rau cov dev hauv APOQUEL pawg tau nce ntawm Hnub 7, tab sis rov qab mus rau qib pretreatment los ntawm kev kawm kawg yam tsis tau so hauv APOQUEL kev tswj hwm. Cov roj (cholesterol) hauv cov ntshav nce ntxiv hauv 25% ntawm APOQUEL pab pawg dev, tab sis txhais tau tias cov roj cholesterol tseem nyob hauv qhov kev siv ntau yam.

Kev kawm txuas ntxiv mus

Tom qab ua tiav APOQUEL cov kev tshawb fawb, 239 tus dev tau tso npe rau hauv qhov tsis muaj qhov ncauj qhov ntswg (tsis muaj cov tshuaj placebo), kev tshawb fawb txuas ntxiv tau txais APOQUEL rau lub sijhawm tsis txwv. Lub sijhawm nruab nrab ntawm txoj kev tshawb no yog 372 hnub (ntau 1 txog 610 hnub). Ntawm 239 tus dev no, ib tus dev tsim demodicosis tom qab 273 hnub ntawm APOQUEL kev tswj hwm. Ib tus dev tsim cov kab mob dermal pigmented viral plaques tom qab 266 hnub ntawm APOQUEL kev tswj hwm. Ib tus dev tau tsim muaj mob hnyav hnyav tom qab 272 hnub ntawm APOQUEL kev tswj hwm; Tus kab mob no tau daws nrog kev kho mob antimicrobial thiab txiav APOQUEL ib ntus. Ib tus dev tau euthanized tom qab tsim lub plab ascites thiab pleural effusion ntawm tsis paub etiology tom qab 450 hnub ntawm APOQUEL kev tswj hwm. Rau tus dev tau euthanized vim xav tias malignant neoplasms: suav nrog thoracic metastatic, plab metastatic, splenic, frontal sinus, thiab intracranial neoplasms, thiab transitional cell carcinoma tom qab 17, 120, 175, 49, 141, thiab 286 hnub ntawm APO. Ob tug dev txhua tus tau tsim cov qog qog ntshav Qib II tom qab 52 thiab 91 hnub ntawm APOQUEL kev tswj hwm, raws li. Ib tus dev tsim cov qog ntshav qog ntshav qis B-cell tom qab 392 hnub ntawm kev tswj hwm APOQUEL. Ob tug dev txhua tus tsim ib lub qog apocrine adenocarcinoma (ib qho dermal, ib lub qhov quav) tom qab kwv yees li 210 thiab 320 hnub ntawm kev tswj hwm APOQUEL, raws li. Ib tus dev tau tsim cov qib qis ntawm qhov ncauj spindle cell sarcoma tom qab 320 hnub ntawm APOQUEL kev tswj hwm.

Tom qab kev pom zoo (2020) :

Cov xwm txheej tsis zoo hauv qab no yog ua raws li kev pom zoo tom qab kev pom zoo txog kev siv tshuaj tsis zoo rau APOQUEL. Tsis yog txhua qhov xwm txheej tsis zoo raug tshaj tawm rau FDA / CVM. Nws tsis yog ib txwm ua tau kom ntseeg tau tias kwv yees qhov tsis zoo tshwm sim ntau zaus lossis tsim kom muaj kev sib raug zoo rau cov khoom raug siv cov ntaub ntawv no.

Cov xwm txheej tsis zoo hauv qab no tau tshaj tawm hauv dev tau teev nyob rau hauv kev txo qis ntawm kev tshaj tawm zaus.

ntuav, lethargy, anorexia, raws plab, siab siab enzymes, dermatitis (xws li crusts, pododermatitis, pyoderma), qaug dab peg, polydipsia, thiab demodicosis.

Benign, malignant, thiab unclassified neoplasms, dermal masses (xws li papillomas thiab histiocytomas), lymphoma thiab lwm yam qog nqaij hlav tau raug tshaj tawm.

Kev tuag (nrog rau euthanasia) tau tshaj tawm.

Tiv tauj xov tooj:

Txhawm rau tshaj tawm cov xwm txheej tsis zoo, rau kev pab cuam lossis kom tau txais daim ntawv theej ntawm Kev Nyab Xeeb Cov Ntaub Ntawv, hu rau Zoetis Inc. ntawm 1-888-963-8471 lossis www.zoetis.com.

Yog xav paub ntxiv txog kev qhia txog cov tshuaj tsis zoo rau tsiaj txhu, hu rau FDA ntawm 1-888-FDA-VETS lossis online ntawm www.fda.gov/reportanimalae.

Clinical Pharmacology

Mechanism ntawm Action

Oclacitinib inhibits kev ua haujlwm ntawm ntau yam pruritogenic cytokines thiab pro-inflammatory cytokines, nrog rau cytokines koom nrog kev ua xua uas nyob ntawm JAK1 lossis JAK3 enzyme kev ua. Nws muaj me ntsis cuam tshuam rau cytokines koom nrog hauv hematopoiesis uas nyob ntawm JAK2. Oclacitinib tsis yog corticosteroid lossis antihistamine.

meloxicam tab 15 mg

Pharmacokinetics

Hauv cov dev, oclacitinib maleate yog sai thiab zoo absorbed tom qab kev tswj qhov ncauj, nrog lub sij hawm lub sij hawm mus rau siab kawg plasma concentrations (T._max) tsis pub dhau 1 teev. Tom qab kev tswj hwm qhov ncauj ntawm 0.4-0.6 mg oclacitinib / kg rau 24 tus dev, qhov nruab nrab (90% kev ntseeg siab txwv [CL]) qhov siab tshaj plaws (C_max) yog 324 (281, 372) ng / mL thiab thaj tsam nruab nrab nyob rau hauv plasma concentration-lub sij hawm nkhaus ntawm 0 thiab extrapolated rau infinity (AUC_{0-inf ib}) yog 1890 (1690, 2110) ng•hr/mL. Lub xeev prandial ntawm dev tsis cuam tshuam rau tus nqi lossis qhov nqus ntawm qhov nqus. Qhov tseeb bioavailability ntawm oclacitinib maleate yog 89%.

Oclacitinib muaj protein ntau khi nrog 66.3-69.7% khi nyob rau hauv fortified canine plasma ntawm nominal concentrations xws li 10-1000 ng / mL. Qhov tseeb txhais tau tias (95% CL) ntim ntawm kev faib tawm ntawm lub xeev ruaj khov yog 942 (870, 1014) mL / kg lub cev hnyav.

Oclacitinib yog metabolized hauv tus dev mus rau ntau yam metabolites thiab ib qho loj oxidative metabolite tau txheeb xyuas hauv cov ntshav thiab zis. Zuag qhia tag nrho txoj kev tshem tawm tseem ceeb yog cov metabolism hauv me me los ntawm kev tshem tawm lub raum thiab biliary. Inhibition ntawm canine cytochrome P450 enzymes los ntawm oclacitinib yog tsawg; inhibitory concentrations (IC_{50s ib}) yog 50 npaug ntau dua qhov pom C_maxtus nqi ntawm kev siv tshuaj.

Qhov nruab nrab (95% CL) tag nrho lub cev oclacitinib tshem tawm ntawm cov ntshav ntshav qis - 316 (237, 396) mL / h / kg lub cev hnyav (5.3 mL / min / kg lub cev hnyav). Tom qab IV thiab PO kev tswj hwm, lub davhlau ya nyob twg t_1/2tshwm sim zoo ib yam nrog qhov tseem ceeb ntawm 3.5 (2.2, 4.7) thiab 4.1 (3.1, 5.2) teev, feem.

Kev ua tau zoo

Kev tswj ntawm Atopic Dermatitis

Kev tshawb nrhiav ob lub ntsej muag, 112-hnub, kev tswj xyuas tau ua nyob rau ntawm 18 US cov tsev kho tsiaj tsiaj. Txoj kev tshawb no tau tso npe rau 299 tus neeg siv cov dev nrog atopic dermatitis. Cov dev tau randomized rau kev kho mob nrog APOQUEL (152 tus dev: ntsiav tshuaj noj ntawm ib koob ntawm 0.4-0.6 mg / kg ib koob ob zaug ib hnub rau 14 hnub thiab tom qab ntawd ib hnub ib zaug) lossis placebo (147 dev: kev tswj tsheb, cov ntsiav tshuaj siv tib lub sijhawm. ). Thaum txoj kev tshawb no, dev tsis tuaj yeem kho nrog lwm cov tshuaj uas tuaj yeem cuam tshuam rau kev ntsuas kev ua tau zoo, xws li corticosteroids, anti-histamines, lossis cyclosporine. Kev kho kom zoo rau pruritus rau txhua tus dev tau txhais tias tsawg kawg yog 2 cm txo los ntawm lub hauv paus ntawm 10 cm visual analog scale (VAS) nyob rau hauv pruritus, soj ntsuam los ntawm tus tswv, nyob rau hnub 28. Kev kho kom zoo rau daim tawv nqaij lesions tau txhais raws li ib tug 50. % txo qis los ntawm lub hauv paus ntawm Canine Atopic Dermatitis Extent and Severity Index (CADESI) qhab nia, soj ntsuam los ntawm Veterinarian, hnub 28. Qhov kwv yees feem pua ​​​​ntawm cov dev nrog Kev Kho Mob Ua Tau Zoo hauv Tus Tswv Cuab tau soj ntsuam pruritus VAS qhab nia thiab hauv Veterinarian-kuaj ntsuam xyuas CADESI tau qhab nia ntau dua. thiab sib txawv heev rau pawg APOQUEL piv rau pawg placebo.

Kwv yees li ntawm cov dev nrog kev kho kom zoo, Atopic Dermatitis

Piv nrog rau cov placebo pab pawg, txhais tau hais tias tus tswv-kev soj ntsuam pruritus VAS cov qhab nia (Hnub 1, 2, 7, 14, thiab 28) thiab Veterinarian-tseem ceeb CADESI cov qhab nia (Hnub 14 thiab 28) tau qis dua (kho kom zoo) hauv cov dev hauv APOQUEL pab pawg. Txog Hnub Tim 30, 86% (127/147) ntawm cov placebo pab pawg dev thiab 15% (23/152) ntawm APOQUEL pawg dev tau thim tawm ntawm txoj kev kawm npog ntsej muag vim tias cov tsos mob tshwm sim zuj zus, thiab muaj kev xaiv rau npe rau hauv ib qho kev kawm uas tsis muaj ntsej muag. thiab tau txais APOQUEL. Rau cov dev uas txuas ntxiv APOQUEL kev kho mob dhau ib hlis, qhov txhais tau hais tias Tus Tswv Cuab tau soj ntsuam pruritus VAS cov qhab nia thiab Veterinarian-kuaj ntsuam CADESI cov qhab nia txuas ntxiv txhim kho los ntawm kev kawm kawg ntawm Hnub 112.

Tswj Pruritus Associated with Allergic Dermatitis

Kev tshawb nrhiav ob lub ntsej muag, 30-hnub, kev tswj xyuas tau ua nyob rau ntawm 26 lub tsev kho tsiaj hauv Tebchaws Meskas. Txoj kev tshawb no tau tso npe rau 436 tus neeg siv cov dev uas muaj keeb kwm ntawm kev tsis haum tshuaj dermatitis vim yog ib lossis ntau dua ntawm cov xwm txheej hauv qab no: atopic dermatitis, flea allergy, zaub mov tsis haum, tiv tauj tsis haum, thiab lwm yam / tsis muaj kev tsis haum dermatitis. Cov dev tau randomized rau kev kho mob nrog APOQUEL (216 tus dev: ntsiav tshuaj noj ntawm ib koob ntawm 0.4-0.6 mg / kg ob zaug ib hnub) lossis placebo (220 tus dev: kev tswj tsheb, tshuaj ntsiav tshuaj ob zaug ib hnub). Thaum txoj kev tshawb no, dev tsis tuaj yeem kho nrog lwm yam tshuaj uas tuaj yeem cuam tshuam rau kev soj ntsuam ntawm pruritus lossis dermal o xws li corticosteroids, anti-histamines, lossis cyclosporine. Kev kho mob zoo rau txhua tus dev tau txhais tias tsawg kawg yog 2 cm txo los ntawm cov hauv paus hauv paus ntawm 10 cm visual analog scale (VAS) nyob rau hauv pruritus, soj ntsuam los ntawm tus tswv, tsawg kawg yog 5 ntawm 7 hnub ntsuam xyuas. Qhov kwv yees feem pua ​​​​ntawm cov dev nrog Kev Kho Mob Zoo yog ntau dua thiab sib txawv heev rau pawg APOQUEL piv rau pawg placebo.

Tus tswv-Tshuaj ntsuam xyuas Pruritus VAS Kev Kho Mob Zoo, Kev Tiv Thaiv Kab Mob Dermatitis

Tom qab ib lub lim tiam ntawm kev kho mob, 86.4% ntawm APOQUEL pab pawg dev piv nrog 42.5% ntawm cov placebo pab pawg dev tau ua tiav qhov txo qis ntawm 2 cm ntawm 10 cm Tus tswv-kev soj ntsuam pruritus VAS. Nyob rau txhua hnub ntawm 7 hnub, txhais tau hais tias tus tswv-kev soj ntsuam pruritus VAS cov qhab nia qis dua hauv cov dev hauv pawg APOQUEL (Saib daim duab 1). Cov kws kho tsiaj tau siv 10 cm VAS nplai los ntsuas txhua tus dev dermatitis. Tom qab ib lub lim tiam ntawm kev kho mob, qhov txhais tau tias Veterinarian-kuaj ntsuam xyuas VAS dermatitis qhab nia rau cov dev hauv APOQUEL pawg tau qis dua ntawm 2.2 cm (kho los ntawm tus nqi hauv paus ntawm 6.2 cm) piv nrog cov placebo pab pawg txhais tau tias tau qhab nia ntawm 4.9 cm (los ntawm cov hauv paus ntsiab lus. tus nqi ntawm 6.2 cm). Rau cov dev uas txuas ntxiv APOQUEL kev kho mob dhau ib lub lis piam, Veterinarian-kuaj xyuas cov kab mob dermatitis tau txuas ntxiv txhim kho los ntawm kev kawm kawg ntawm Hnub 30.

Daim duab 1: Tus tswv tau soj ntsuam Pruritus VAS Cov qhab nia los ntawm kev kho mob rau Hnub 0-7

Tsiaj Kev Nyab Xeeb:

Margin of Safety nyob rau hauv 12 Lub Hlis Qub dev

Oclacitinib maleate tau siv rau kev noj qab haus huv, ib xyoos cov dev Beagle ob zaug ib hnub rau 6 lub lis piam, ua raws li ib hnub ib hnub rau 20 lub lis piam, ntawm 0.6 mg / kg (1X siab tshaj koob tshuaj, 8 tus dev), 1.8 mg / kg (3X, 8 tus dev), thiab 3.0 mg / kg (5X, 8 dev) oclacitinib rau 26 lub lis piam. Yim tus dev tau txais cov placebo (tsis muaj gelatin capsule) ntawm tib lub sijhawm noj. Cov kev soj ntsuam soj ntsuam uas tau txiav txim siab yuav muaj feem cuam tshuam nrog oclacitinib maleate suav nrog papillomas thiab kev siv tshuaj ntau ntxiv hauv tus lej thiab zaus ntawm interdigital furunculosis (cysts) ntawm ib lossis ntau ko taw thaum kawm. Kev soj ntsuam ntxiv yog feem ntau cuam tshuam nrog interdigital furunculosis thiab suav nrog dermatitis (lub zos alopecia, erythema, abrasions, scabbing / crusts, thiab edema ntawm ko taw) thiab lymphadenopathy ntawm peripheral nodes. Cov kev tshawb pom me me suav hais tias yog oclacitinib maleate-txog ntsig txog suav nrog txo qis cellularity (lymphoid) hauv Gut-Associated Lymphoid Tissue (GALT), spleen, thymus, cervical thiab mesenteric lymph node; thiab txo cellularity ntawm sternal thiab femoral pob txha pob txha. Lymphoid hyperplasia thiab mob rhiab heev tau pom nyob rau hauv cov qog nqaij hlav uas ntws tawm ko taw cuam tshuam nrog interdigital furunculosis. Tsib oclacitinib maleate-kho dev muaj cov pov thawj microscopic ntawm me me interstitial pneumonia.

Kev tshawb pom ntawm cov kab mob pathology suav tias yog oclacitinib txiv neej-hais txog suav nrog me me, koob tshuaj txo qis hauv hemoglobin, hematocrit, thiab reticulocyte suav thaum lub sijhawm noj ob zaug ib hnub nrog kev txo qis hauv leukocyte subsets ntawm lymphocytes, eosinophils, thiab basophils. Tag nrho cov proteins tau txo qis thaum lub sijhawm feem ntau vim yog qhov feem ntawm albumin.

Kev Tshawb Fawb Txog Tshuaj Tiv Thaiv

Kev tiv thaiv kab mob txaus (serology) los tua tus kab mob vwm (RV), hloov kho tus kab mob nyob canine distemper (CDV), thiab hloov kho cov tshuaj tiv thaiv kab mob parvovirus (CPV) tau ua tiav hauv yim 16-lub lim tiam cov tshuaj tiv thaiv tus menyuam dev uas tau txhaj tshuaj oclacitinib maleate ntawm 1.8. mg/kg oclacitinib (3X koob tshuaj ntau tshaj) ob zaug ib hnub twg rau 84 hnub. Rau kev hloov kho nyob tus kab mob canine parainfluenza (CPI),<80% (6 of 8) of the dogs achieved adequate serologic response. Clinical observations that were considered likely to be related to oclacitinib maleate treatment included enlarged lymph nodes, interdigital furunculosis, cysts, and pododermatitis. One oclacitinib maleate-treated dog (26-weeks-old) was euthanized on Day 74 after physical examination revealed the dog to be febrile, lethargic, with pale mucous membranes and frank blood in stool. Necropsy revealed pneumonia of short duration and evidence of chronic lymphadenitis of mesenteric lymph nodes. During the three month recovery phase to this study, one oclacitinib maleate-treated dog (32-weeks old) was euthanized on Day 28 due to clinical signs which included enlarged prescapular lymph nodes, bilateral epiphora, lethargy, mild dyspnea, and fever. The dog showed an elevated white blood cell (WBC) count. Necropsy revealed lesions consistent with sepsis secondary to immunosuppression. Bone marrow hyperplasia was consistent with response to sepsis.

Margin of Safety nyob rau hauv 6 Lub Hlis Qub Dos

Ib txoj kev tshawb fawb txog kev nyab xeeb hauv cov dev muaj hnub nyoog 6 hli raug txiav tawm tom qab plaub lub hlis vim yog kev loj hlob ntawm cov kab mob ntsws thiab cov kab mob demodex mange nyob rau hauv cov dev hauv cov koob tshuaj siab (3X thiab 5X) pab pawg kho mob, koob tshuaj ntawm 1.8 thiab 3.0 mg / kg oclacitinib ob zaug ib hnub twg, rau tag nrho cov kev kawm.

Kev cia khoom:

APOQUEL yuav tsum tau muab khaws cia rau hauv chav tswj kub ntawm 20 ° txog 25 ° C (68 ° txog 77 ° F) nrog rau kev mus ncig ntawm 15 ° txog 40 ° C (59 ° txog 104 ° F).

Yuav Ua Li Cas

APOQUEL ntsiav tshuaj muaj 3.6 mg, 5.4 mg, lossis 16 mg ntawm oclacitinib li oclacitinib maleate ib ntsiav tshuaj. Txhua ntsiav tshuaj muaj zog tau ntim rau hauv 100 thiab 250 suav fwj. Txhua lub ntsiav tshuaj tau qhab nia thiab cim nrog AQ thiab ib qho S, M, lossis L uas sib haum rau cov ntsiav tshuaj sib txawv ntawm ob sab.

Pom zoo los ntawm FDA raws li NADA #141-345

Distributed by: Zoetis Inc., Kalamazoo, MI 49007

Kho tshiab: Kaum Ob Hlis 2020

4 0033180

CPN: 3690363.3

Txhua qhov kev siv zog tau ua los xyuas kom meej qhov tseeb ntawm Apoquel cov ntaub ntawv luam tawm saum toj no. Txawm li cas los xij, nws tseem yog lub luag haujlwm ntawm cov neeg nyeem kom paub txog lawv tus kheej nrog cov ntaub ntawv cov khoom lag luam uas muaj nyob rau hauv Teb Chaws Asmeskas cov khoom lag luam lossis cov pob ntxig.

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