natgillin/translations-raw huggingface dataset:
In placebo-controlled studies with background DMARDs, for up to 12/14 weeks, increases in CPK values were observed.
V študijah, ki so bile kontrolirane s placebom in v katerih so bolniki kot osnovo prejemali DMARD, so v obdobju do 12/14 tednov opažali zvišanje vrednosti CPK.
Across the Phase 3 studies, the efficacy seen with upadacitinib 15 mg QD was generally similar to that observed with upadacitinib 30 mg QD.
V študijah 3. faze je bila učinkovitost 15 mg upadacitiniba enkrat na dan na splošno podobna uspešnosti 30 mg upadacitiniba enkrat na dan.
The proportion of patients with no radiographic progression (mTSS change ≤ 0) was significantly higher with upadacitinib 15 mg in both studies.
(sprememba mTSS ≤ 0) je bil s 15 mg upadacitiniba v obeh študijah značilno večji.
Week 24b/26c
24. tedenb/26c
Blood CPK increased ALT increased AST increased Weight increased * URTI includes: acute sinusitis, laryngitis, nasopharyngitis, oropharyngeal pain, pharyngitis, pharyngotonsillitis, rhinitis, sinusitis, tonsillitis, viral upper respiratory tract infection ** Herpes simplex includes oral herpes
Povečanje telesne mase *Okužbe zgornjih dihal vključujejo: akutni sinuzitis, laringitis, nazofaringitis, orofaringealno bolečino, faringitis, faringotonzilitis, rinitis, sinuzitis, tonzilitis, virusno okužbo zgornjih dihal.
Physical function response and health-related outcomes Treatment with upadacitinib 15 mg, alone or in combination with csDMARDs, resulted in a significantly greater improvement in physical function compared to all comparators as measured by HAQ-DI (see Table 6).
Zdravljenje s 15 mg upadacitiniba samega ali v kombinaciji s csDMARD je doseglo značilno večje izboljšanje telesnega delovanja, merjeno s HAQ-DI, kot vsa primerjalna zdravila (glejte preglednico 6).
In clinical trials, upadacitinib was administered without regard to meals (see section 4.2).
V kliničnih preskušanjih so upadacitinib uporabljali ne glede na obroke (glejte poglavje 4.2).
Remove the cap from the bottle by pushing down and while still pushing, turn the cap anti-clockwise.
Pokrovček odstranite s plastenke tako, da ga pritisnete navzdol in ga med pritiskanjem zasučete v smeri, nasprotni urinemu kazalcu.
If you stop taking RINVOQ
Če ste prenehali jemati zdravilo RINVOQ
Malignancies were observed in clinical studies of upadacitinib.
V kliničnih študijah upadacitiniba so opažali maligne bolezni.
Absolute Neutrophil Count (ANC)
Absolutno število nevtrofilcev (AŠN)
RINVOQ 15 mg prolonged-release tablets
RINVOQ 15 mg tablete s podaljšanim sproščanjem
Treatment with upadacitinib was associated with decreases from baseline in mean hsCRP levels as early as Week 1 which were maintained with continued treatment.
Zdravljenje z upadacitinibom je bilo povezano z znižanjem povprečne ravni hsCRP od izhodišča že po
Upadacitinib should not be given to patients with active TB (see section 4.3).
Bolniki z aktivno TB ne smejo dobiti upadacitiniba (glejte poglavje 4.3).
Upadacitinib had no effect on fertility in male or female rats at doses up to 50 mg/kg/day in males and 75 mg/kg/day in females in a fertility and early embryonic development study.
V študiji plodnosti in zgodnjega embrionalnega razvoja upadacitinib ni vplival na plodnost podganjih samcev ali samic v odmerkih do 50 mg/kg/dan pri samcih in do 75 mg/kg/dan pri samicah.
PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING Bottle Label
PODATKI NA VMESNI OVOJNINI Nalepka na plastenki
Upadacitinib should not be used in patients with severe (Child Pugh C) hepatic impairment (see section 4.3).
Upadacitiniba se pri bolnikih s hudo (Child-Pugh C) okvaro jeter ne sme uporabljati (glejte poglavje 4.3).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Blister Carton (Individual carton)
PODATKI NA ZUNANJI OVOJNINI Škatla s pretisnimi omoti (posamezna škatla)
In all studies, more patients treated with upadacitinib 15 mg achieved ACR20, ACR50, and ACR70 responses at 12 weeks compared to placebo, MTX, or adalimumab (Table 4).
V vseh študijah je odzive ACR20, ACR50 in ACR70 po 12 tednih doseglo več bolnikov, ki so prejemali 15 mg upadacitiniba, kot bolnikov, ki so prejemali placebo, MTX ali adalimumab
Upper respiratory tract infections (URTI)*
Okužbe zgornjih dihal*
• Low disease activity (DAS28-CRP)
• Nizka aktivnost bolezni (DAS28-CRP)
ACR20 (% of patients)
ACR20 (% bolnikov)
Hypercholesterolaemia Hypertriglyceridaemia
Hiperholesterolemija Hipertrigliceridemija
Treatment group MTX
Terapevts ka skupina MTX
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN (ODGOVORNI) ZA
Patients should be screened for tuberculosis (TB) before starting upadacitinib therapy.
Bolnikom je treba pred začetkom zdravljenja z upadacitinibom opraviti presejanje glede tuberkuloze
ACR70 (% of patients)
ACR70 (% bolnikov)
Upadacitinib was teratogenic in rats and rabbits with effects in bones in rat foetuses and in the heart in rabbit foetuses when exposed in utero.
Upadacitinib je bil pri podganah in kuncih teratogen ter je v primeru izpostavljenosti in utero vplival na kosti podganjih plodov in srce kunčjih plodov.
Package leaflet: Information for the patient RINVOQ 15 mg prolonged-release tablets upadacitinib This medicine is subject to additional monitoring.
RINVOQ 15 mg tablete s podaljšanim sproščanjem upadacitinib Za to zdravilo se izvaja dodatno spremljanje varnosti.
Silica, colloidal anhydrous Magnesium stearate
Silicijev dioksid, koloidni, brezvodni Magnezijev stearat
The overall long-term rate of serious infections for the upadacitinib 15 mg group across all five Phase 3 clinical studies was 3.8 events per 100 patient-years.
Celotni dolgoročni delež resnih okužb je bil v skupini s 15 mg upadacitiniba v vseh petih kliničnih študijah 3. faze 3,8 dogodka na 100 bolnik-let.
Patients who develop adverse reactions should receive appropriate treatment.
morajo biti deležni ustreznega zdravljenja.
In a clinical study, rosuvastatin and atorvastatin AUC were decreased by 33% and 23%, respectively, and rosuvastatin Cmax was decreased by 23% following the administration of multiple 30 mg once daily doses of upadacitinib to healthy subjects.
V klinični študiji se je po večkratnih dnevnih odmerkih 30 mg upadacitiniba enkrat na dan pri zdravih osebah AUC rosuvastatina zmanjšala za 33 % in AUC atorvastatina za 23 %, Cmax rosuvastatina pa se je zmanjšala za 23 %.
RINVOQ 15 mg prolonged-release tablets upadacitinib
RINVOQ 15 mg tablete s podaljšanim sproščanjem upadacitinib
Serious and sometimes fatal infections have been reported in patients receiving upadacitinib.
Pri bolnikih, ki so prejemali upadacitinib, so poročali o resnih okužbah, v nekaterih primerih s smrtnim izidom.
The use of upadacitinib has not been studied in subjects with end stage renal disease.
Uporaba upadacitiniba ni bila preučena pri preiskovancih s končno odpovedjo ledvic.
RINVOQ is not recommended for use in children and adolescents under 18 years of age.
Uporaba zdravila RINVOQ pri otrocih in mladostnikih, mlajših od 18 let ni priporočljiva, ker zdravilo v tej starostni skupini ni raziskano.
Upadacitinib metabolism is mediated by CYP3A4 with a potential minor contribution from CYP2D6.
Presnova upadacitiniba poteka s posredovanjem CYP3A4 in z možnim majhnim prispevkom
98 prolonged-release tablets.
98 tablet s podaljšanim sproščanjem.
• Upadacitinib 30 mg
• 30 mg upadacitiniba
47h Abbreviations: ACR20 (or 50 or 70) = American College of Rheumatology ≥20% (or ≥50% or ≥70%)
Okrajšave: ACR20 (ali 50 ali 70) = izboljšanje za ≥ 20 % (ali ≥ 50 % ali ≥ 70 %) po American College of Rheumatology, ADA = adalimumab, CDAI = indeks klinične aktivnosti bolezni (Clinical Disease Activity
The overall longterm rate of opportunistic infections for the upadacitinib 15 mg group across all five Phase 3 clinical studies was 0.6 events per 100 patient-years.
Celotni dolgoročni delež oportunističnih okužb je bil v skupini s 15 mg upadacitiniba v vseh petih kliničnih študijah 3. faze 0,6 dogodka na 100 bolnik-let.
• increased levels of triglycerides (a type of fat in the blood) as shown in tests
• zvišana koncentracija trigliceridov (vrsta maščob v krvi); pokaže se na preiskavah krvi
Treatment should be interrupted if ANC is < 1,000 cells/mm3 and may be restarted once ANC returns above this value
Zdravljenje je treba prekiniti, če se AŠN zmanjša na < 1.000 celic/mm3, in ga je mogoče znova začeti, ko se AŠN
Upadacitinib was not mutagenic or genotoxic based on the results of in vitro and in vivo tests for gene mutations and chromosomal aberrations.
Upadacitinib glede na rezultate testov za genske mutacije in kromosomske aberacije in vitro in in vivo ni bil mutagen ali genotoksičen.
Treatment should be interrupted if ALC is < 500 cells/mm3 and may be restarted once ALC returns above this value
< 500 celic/mm3, in ga je mogoče znova začeti, ko se AŠL vrne nad to vrednost.
How to take RINVOQ
Kako jemati zdravilo RINVOQ
c SELECT-EARLY, SELECT-NEXT, SELECT-COMPARE, SELECT-BEYOND d SELECT-MONOTHERAPY e SELECT-EARLY f SELECT-COMPARE g multiplicity controlled p≤0.001 upadacitinib vs placebo or MTX comparison h nominal p≤0.001 upadacitinib vs placebo or MTX comparison i nominal p≤0.01 upadacitinib vs adalimumab comparison
a SELECT-NEXT, SELECT-EARLY, SELECT-COMPARE, SELECT-BEYOND b SELECT-MONOTHERAPY c SELECT-EARLY d SELECT-COMPARE
Absolute Lymphocyte Count (ALC)
Absolutno število limfocitov (AŠL)
The most commonly reported adverse drug reactions (ADRs) are upper respiratory tract infections (13.5%), nausea (3.5%), blood creatine phosphokinase (CPK) increased (2.5%) and cough (2.2%).
(3,5 %), zvišanje kreatin-fosfokinaze (CPK) v krvi (2,5 %) in kašelj (2,2 %).
Each prolonged-release tablet contains upadacitinib hemihydrate, equivalent to 15 mg of upadacitinib.
Ena tableta s podaljšanim sproščanjem vsebuje upadacitinibijev hemihidrat, kar ustreza 15 mg upadacitiniba.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Intermediate carton of 84 tablet multipack (without Blue Box)
PODATKI NA ZUNANJI OVOJNINI Notranja škatla za skupno pakiranje s 84 tabletami (brez modrega okenca)
Use of live, attenuated vaccines during or immediately prior to upadacitinib therapy is not recommended.
Tik pred zdravljenjem z upadacitinibom in med zdravljenjem z njim ni priporočljivo uporabljati živih, oslabljenih cepiv.
Anti-TB therapy should be considered prior to initiation of upadacitinib in patients with previously untreated latent TB or in patients with risk factors for TB infection.
Pri bolnikih z latentno TB, ki predhodno ni bila zdravljena, ali pri bolnikih z dejavniki tveganja za TB je treba razmisliti o protituberkuloznem zdravljenju pred začetkom zdravljenja z upadacitinibom.
Upadacitinib, at exposures (based on AUC) approximately 4 and 10 times the clinical dose of 15 mg in male and female Sprague-Dawley rats, respectively, was not carcinogenic in a 2-year carcinogenicity study in Sprague-Dawley rats.
Dveletna študija kancerogenosti pri Sprague-Dawleyjevih podganah je pokazala, da upadacitinib pri izpostavljenosti (osnovani na AUC), ki je bila približno 4-krat (pri samcih Sprague-Dawleyjevih podgan) in 10-krat (pri samicah Sprague-Dawleyjevih podgan) tolikšna, kot je med uporabo kliničnega odmerka, ni bil kancerogen.
ACR50 (% of patients)
ACR50 (% bolnikov)
In MTX-controlled studies, for up to 12/14 weeks, ALT and AST elevations ≥ 3 x ULN in at least one measurement were observed in 0.8% and 0.4% of patients treated with upadacitinib 15 mg, compared to 1.9% and 0.9%, respectively, of patients treated with MTX.
V študijah upadacitiniba, ki so bile kontrolirane z MTX, so v obdobju do 12/14 tednov opažali zvišanje ALT in AST na ≥ 3-krat nad ZNM na vsaj enem merjenju pri 0,8 % (ALT) oz. 0,4 % (AST) bolnikov, ki so prejemali 15 mg upadacitiniba, in pri 1,9 % (ALT) oz. 0,9 % (AST) bolnikov, ki so prejemali MTX.
• Primary endpoint: clinical remission (DAS28-CRP) at week 12
• Primarni opazovani dogodek: klinična remisija (DAS28-CRP) po 12 tednih
A patient who develops a new infection during treatment with upadacitinib should undergo prompt and complete diagnostic testing appropriate for an immunocompromised patient; appropriate antimicrobial therapy should be initiated, the patient should be closely monitored, and upadacitinib therapy should be interrupted if the patient is not responding to antimicrobial therapy.
uvesti je treba ustrezno protimikrobno zdravljenje, bolnika skrbno spremljati, zdravljenje z upadacitinibom pa prekiniti, če se bolnik ne odzove na protimikrobno zdravljenje.
Name and address of the manufacturers responsible for batch release
SPROŠČANJE SERIJ Ime in naslov proizvajalca (proizvajalcev), odgovornega (odgovornih) za sproščanje serij
Lipid elevations
Zvišanje AST
RINVOQ contains the active substance upadacitinib.
Zdravilo RINVOQ vsebuje učinkovino upadacitinib.
Abbreviations: ADA = adalimumab; IR = inadequate responder; MTX = methotrexate; PBO = placebo; UPA= upadacitinib a All placebo data at week 48 derived using linear extrapolation b SELECT-EARLY c SELECT-COMPARE
Okrajšave: ADA = adalimumab, IR = neustrezno odziven (inadequate responder), MTX = metotreksat, PBO = placebo, UPA= upadacitinib.
On background MTX
Ob osnovnem MTX
If any of the above apply to you or you are not sure, talk to your doctor or pharmacist before taking RINVOQ.
Če kaj od naštetega velja za vas (ali ste negotovi), se posvetujte s svojim zdravnikom ali farmacevtom,
QR code to be included
Vstavite QR-kodo
No dose adjustment is required in patients aged 65 years and older.
Bolnikom, starim 65 let in več, odmerka ni treba prilagoditi.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for 84 tablet multipack (with Blue Box)
PODATKI NA ZUNANJI OVOJNINI Zunanja škatla za skupno pakiranje s 84 tabletami (z modrim okencem)
Patients 18 years of age and older were eligible to participate.
Za sodelovanje so bili primerni bolniki, stari 18 let in več.
Hepatic transaminases
Jetrne transaminaze
• HDL cholesterol ≥ 1.03 mmol/L (40 mg/dL): 89% vs. 61%, in the upadacitinib 15 mg and placebo groups, respectively
• holesterol HDL ≥ 1,03 mmol/l (40 mg/dl): 89 % v skupini s 15 mg upadacitiniba in 61 % v skupini s placebom,
Treatment should not be initiated in patients with an absolute lymphocyte count (ALC) that is < 500 cells/mm3, an absolute neutrophil count (ANC) that is < 1,000 cells/mm3 or who have haemoglobin (Hb) levels that are < 8 g/dL (see sections 4.4 and 4.8).
absolutnim številom nevtrofilcev (AŠN) < 1.000 celic/mm3 ali hemoglobinom (Hb) < 8 g/dl (glejte poglavji 4.4 in 4.8).
• you are at high risk of developing skin cancer, your doctor may recommend preventive measures such as regular skin examinations while taking RINVOQ.
• če imate visoko tveganje za razvoj raka kože; zdravnik vam lahko med jemanjem zdravila
• infection of the lung (pneumonia), which may cause shortness of breath, fever, and a cough with mucus
• pasovec ali boleč kožni izpuščaj z mehurji (herpes zoster) • okužba pljuč (pljučnica), ki lahko povzroči težko dihanje, zvišano telesno temperaturo in kašelj s sluzjo
Absolute Neutrophil Count (ANC) < 1 x 109 cells/L, Absolute Lymphocyte Count (ALC) < 0.5 x 109 cells/L and haemoglobin < 8 g/dL were reported in ≤1 % of patients in clinical trials (see section 4.8).
x 109 celic/l in o hemoglobinu < 8 g/dl so v kliničnih preskušanjih poročali pri ≤ 1 % bolnikov (glejte poglavje 4.8).
49 prolonged-release tablets.
49 tablet s podaljšanim sproščanjem.
• Language for HCPs to inform patients of the importance of the PAC
• Informacije za zdravstvene delavce o seznanjanju bolnikov s pomenom opozorilne kartice za bolnika.
Purple 14 x 8 mm, oblong biconvex prolonged-release tablets imprinted on one side with ‘a15'.
tableta s podaljšanim sproščanjem Vijoličaste, podolgovate, bikonveksne tablete s podaljšanim sproščanjem, velike 14 x 8 mm, ki imajo na eni strani vtisnjeno oznako "a15".
• Triglycerides ≥ 2.26 mmol/L (200 mg/dL): 25% vs. 15%, in the upadacitinib 15 mg and placebo groups, respectively
• trigliceridi ≥ 2,26 mmol/l (200 mg/dl): 25 % v skupini s 15 mg upadacitiniba in 15 % v skupini s placebom.
• increased levels of cholesterol (a type of fat in the blood) as shown in tests
• zvišana koncentracija holesterola (vrsta maščob v krvi); pokaže se na preiskavah krvi
Store in original blister or bottle with the lid tightly closed to protect from moisture.
Shranjujte v originalnem pretisnem omotu ali plastenki; pokrovček plastenke naj bo tesno zaprt za zagotovitev zaščite pred vlago.
In placebo-controlled studies with background DMARDs, for up to 12/14 weeks, alanine transaminase (ALT) and aspartate transaminase (AST) elevations ≥ 3 x upper limit of normal (ULN) in at least one measurement were observed in 2.1% and 1.5% of patients treated with upadacitinib 15 mg, compared to 1.5% and 0.7%, respectively, of patients treated with placebo.
V študijah upadacitiniba, ki so bile kontrolirane s placebom in v katerih so bolniki kot osnovo prejemali DMARD, so v obdobju do 12/14 tednov opažali zvišanje alanin-aminotransferaze (ALT) in aspartat-aminotransferaze (AST) na ≥ 3-krat nad zgornjo normalno mejo (ZNM) na vsaj enem merjenju pri 2,1 % (ALT) oz. 1,5 % (AST) bolnikov, ki so prejemali 15 mg upadacitiniba, in pri 1,5 %
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton of 98 tablets
PODATKI NA ZUNANJI OVOJNINI Zunanja škatla z 98 tabletami
In placebo-controlled clinical studies with background DMARDs, the frequency of infection over 12/14 weeks in the upadacitinib 15 mg group was 27.4% compared to 20.9% in the placebo group.
V kliničnih študijah z osnovnimi imunomodulirajočimi antirevmatiki (DMARD), nadzorovanih s placebom, je bila pogostnost okužb v 12/14 tednih v skupini s 15 mg upadacitiniba 27,4 % in v skupini s placebom 20,9 %.
Store in the original bottle and keep the bottle tightly closed in order to protect from moisture.
Shranjujte v originalni plastenki, ki mora biti tesno zaprta za zagotovitev zaščite pred vlago.
30 prolonged-release tablets
30 tablet s podaljšanim sproščanjem
• Total cholesterol ≥ 5.17 mmol/L (200 mg/dL): 62% vs. 31%, in the upadacitinib 15 mg and placebo groups, respectively
• celokupni holesterol ≥ 5,17 mmol/l (200 mg/dl): 62 % v skupini s 15 mg upadacitiniba in 31 % v skupini s placebom,
Abbreviations: ADA = adalimumab; HAQ-DI = Health Assessment Questionnaire Disability Index; IR = inadequate responder; MTX = methotrexate; PBO = placebo; UPA = upadacitinib a Data shown are mean b Health Assessment Questionnaire-Disability Index: 0=best, 3=worst; 20 questions; 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities.
Okrajšave: ADA = adalimumab, HAQ-DI = indeks Health Assessment Questionnaire Disability Index, IR = neustrezno odziven (inadequate responder), MTX = metotreksat, PBO = placebo, UPA = upadacitinib.
Store in the original blister or bottle in order to protect from moisture.
Shranjujte v originalnem pretisnem omotu ali plastenki za zagotovitev zaščite pred vlago.
Consider alternatives to strong CYP3A4 inhibitor medications when used in the long-term.
Med dolgoročno uporabo razmislite o alternativah zdravilom, ki so močni zaviralci CYP3A4.
In placebo-controlled studies with background DMARDs, for up to 12/14 weeks, decreases in neutrophil counts below 1,000 cells/mm3 in at least one measurement occurred in 1.1% and <0.1% of patients in the upadacitinib 15 mg and placebo groups, respectively.
V študijah, ki so bile kontrolirane s placebom in v katerih so bolniki kot osnovo prejemali DMARD, so v obdobju do 12/14 tednov opažali znižanje števila nevtrofilcev pod 1.000 celic/mm3 na vsaj enem merjenju pri 1,1 % bolnikov, ki so prejemali 15 mg upadacitiniba, in pri < 0,1 % bolnikov, ki so prejemali placebo.
bDMARD = biologic disease-modifying anti-rheumatic drug, CRP = C-Reactive Protein, DAS28 = Disease Activity Score 28 joints, mTSS = modified Total Sharp Score, csDMARD = conventional synthetic diseasemodifying anti-rheumatic drug, HAQ-DI = Health Assessment Questionnaire Disability Index, SF-36 PCS = Short Form (36) Health Survey (SF-36) Physical Component Score, CDAI = Clinical Disease Activity Index, FACIT-F = Functional Assessment of Chronic Illness Therapy-Fatigue score, IR = inadequate responder, MTX = methotrexate, n = number randomised a. Patients were naïve to MTX or received no more than 3 weekly MTX doses b Patients had inadequate response to MTX c Patients who had an inadequate response to csDMARDs; patients with prior exposure to at most one bDMARD were eligible (up to 20% of total number of patients) if they had either limited exposure (<3 months) or had to discontinue the bDMARD due to intolerability d Patients who had an inadequate response to MTX; patients with prior exposure to at most one bDMARD (except adalimumab) were eligible (up to 20% of total study number of patients) if they had either limited exposure (<3 months) or had to discontinue the bDMARD due to intolerability e Patients who had an inadequate response or intolerance to at least one bDMARD
d Bolniki, ki se niso ustrezno odzvali na MTX; bolniki, predhodno izpostavljeni največ enemu bDMARD (razen adalimumaba), so bili primerni (do 20 % celotnega števila bolnikov v študiji), če so bili ali izpostavljeni krajši čas (< 3 mesece) ali so morali bDMARD prenehati uporabljati zaradi neprenašanja.
In the studies, a significantly higher proportion of patients treated with upadacitinib 15 mg achieved low disease activity (DAS28-CRP ≤3.2) and clinical remission (DAS28-CRP <2.6) compared to placebo, MTX or adalimumab (Table 4).
Remisija in nizka aktivnost bolezni V študijah je nizko aktivnost bolezni (DAS28-CRP ≤ 3,2) in klinično remisijo (DAS28-CRP < 2,6)
Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving JAK inhibitors including upadacitinib.
Pri bolnikih, ki so prejemali zaviralce JAK, vključno z upadacitinibom, so poročali o globoki venski trombozi (GVT) in pljučni emboliji (PE).
Time to onset of efficacy was rapid across measures with greater responses seen as early as week 1 for ACR20.
Čas do pojava učinkovitosti je bil pri vseh merah hiter in večji odzivi so bili za
In placebo-controlled clinical studies with background DMARDs, the frequency of serious infection over 12/14 weeks in the upadacitinib 15 mg group was 1.2% compared to 0.6% in the placebo group.
V kliničnih študijah z osnovnimi DMARD, nadzorovanih s placebom, je bila pogostnost resnih okužb v 12/14 tednih v skupini s 15 mg upadacitiniba 1,2 % in v skupini s placebom 0,6 %.
• LDL cholesterol ≥ 3.36 mmol/L (130 mg/dL): 42% vs. 19%, in the upadacitinib 15 mg and placebo groups, respectively
• holesterol LDL ≥ 3,36 mmol/l (130 mg/dl): 42 % v skupini s 15 mg upadacitiniba in 19 % v skupini s placebom,
28 prolonged-release tablets.
28 tablet s podaljšanim sproščanjem.
In placebo-controlled clinical studies with background DMARDs, the frequency of opportunistic infections over 12/14 weeks in the upadacitinib 15 mg group was 0.5% compared to 0.3% in the placebo group.
V kliničnih študijah z osnovnimi DMARD, nadzorovanih s placebom, je bila pogostnost oportunističnih okužb v 12/14 tednih v skupini s 15 mg upadacitiniba 0,5 % in v skupini s placebom
28 prolonged-release tablets
28 tablet s podaljšanim sproščanjem
No dose adjustment is recommended for CYP3A substrates or for rosuvastatin or atorvastatin when coadministered with upadacitinib.
Med sočasno uporabo z upadacitinibom prilagoditev odmerka substratov CYP3A ali rosuvastatina ali atorvastatina ni potrebna.
• Do not swallow the desiccant.
• Sušilnega sredstva ne smete zaužiti.
• medicines to treat seizures or fits (such as phenytoin)
• zdravila za zdravljenje napadov krčev (npr. fenitoin)
Upadacitinib should be used with caution in patients at high risk for DVT/PE.
Pri bolnikih z velikim tveganjem za GVT/PE je treba upadacitinib uporabljati previdno.
Upadacitinib AUC was 28% and 24% higher in subjects with mild and moderate hepatic impairment, respectively, compared to subjects with normal liver function.
večja in pri preiskovancih z zmerno okvaro jeter 24 % večja kot pri tistih z normalnim delovanjem jeter.