natgillin/translations-raw huggingface dataset:
Bivirkninger inkluderede behandlingskrævende hændelser af alle årsager, der indtraf ved eller efter cyklus 1, dag 1, inden for 42 dage efter sidste dosis BESPONSA, men inden start på ny kræftbehandling (inklusive HSCT).
Adverse reactions included treatment-emergent, all-causality events that commenced on, or after Cycle 1 Day 1 within 42 days after the last dose of BESPONSA, but prior to the start of a new anticancer treatment (including HSCT).
Skema 8 viser opbevaringstider og -forhold for rekonstituering, fortynding og administration af BESPONSA.
Table 8 shows the storage times and conditions for reconstitution, dilution, and administration of BESPONSA.
Nedenstående skema viser de anbefalede doseringsregimer.
The table below shows the recommended dosing regimens.
De primære målorganer hos dyr inkluderede leveren, knoglemarven og lymfoide organer med associerede hæmatologiske ændringer, nyrerne og nervesystemet.
In animals, the primary target organs included the liver, bone marrow and lymphoid organs with associated haematological changes, kidney, and nervous system.
Total bilirubin > 1,5 × ULN og ASAT/ALAT > 2,5 × ULN
Total bilirubin > 1.5 × ULN and AST/ALT > 2.5 × ULN
Behandlingen skal seponeres permanent, hvis der forekommer VOD/SOS (se pkt.
Treatment should be permanently discontinued if VOD/SOS occurs (see section 4.2).
Andre observerede ændringer inkluderede påvirkning af reproduktionsorganerne hos hanner og hunner (se nedenfor) og præneoplastiske og neoplastiske leverlæsioner (se nedenfor).
Other observed changes included male and female reproductive organ effects (see below) and preneoplastic and neoplastic liver lesions
Farmakoterapeutisk klassifikation: Antineoplastiske midler, andre antineoplastiske stoffer, monoklonale antistoffer, ATC-kode: L01XC26.
Pharmacotherapeutic group: Antineoplastic agents, other Antineoplastic agent, monoclonal antibodies, ATC code: L01XC26.
Relevansen for mennesker af disse fund hos dyr kendes ikke.
The relevance of these animal findings to humans is uncertain.
Hos mennesker var det totale fordelingsvolumen af inotuzumab ozogamicin ca. 12 liter.
In humans, the total volume of distribution of inotuzumab ozogamicin was approximately 12 L.
Den maternelle toksiske dosis (ca. 2,3 gange den kliniske eksponering hos mennesker baseret på AUC) resulterede også i væksthæmning hos fosteret, herunder lavere fostervægt og forsinket ossifikation af skelettet.
The maternally toxic dose (approximately 2.3 times the human clinical exposure based on AUC) also resulted in foetal growth retardation, including decreased foetal weights and delayed skeletal ossification.
Det lille molekyle, N-acetyl-gamma-calicheamicin, er et cytotoksisk produkt.
The small molecule, N-acetyl-gamma-calicheamicin, is a cytotoxic product.
Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med BESPONSA i en eller flere undergrupper af den pædiatriske population i behandlingen af recidiverende eller refraktær ALL (se pkt.
The European Medicines Agency has deferred the obligation to submit the results of studies with BESPONSA in 1 or more subsets of the paediatric population for the treatment of relapsed or refractory ALL (see section 4.2 for information on paediatric use).
- Beskyttes mod lys.
- Protect from light.
Hos patienter, der blev testet positive for antistoffer mod inotuzumab ozogamicin, blev der ikke detekteret nogen indvirkning på clearance af BESPONSA baseret på populationsfarmakokinetisk analyse.
In patients who tested positive for anti-inotuzumab ozogamicin antibodies, no effect on clearance of BESPONSA was detected based on population-pharmacokinetic analysis.
INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT OTHER
Hovedpine (28 %)
Headache (28%)
Infusionsrelaterede reaktioner forekom generelt i cyklus 1 og kort efter endt infusion af inotuzumab ozogamicin, og de forsvandt spontant eller med medicinsk behandling.
Infusion related reactions generally occurred in Cycle 1 and shortly after the end of the inotuzumab ozogamicin infusion and resolved spontaneously or with medical management.
Den primære analyse af CR/CRi og MRD-negativitet blev foretaget hos de første 218 randomiserede patienter, og analyse for OS, PFS, DoR, og HSCT-rate blev foretaget hos alle 326 randomiserede patienter.
The primary analysis of CR/CRi and MRD negativity was conducted in the initial 218 randomised patients and the analysis of OS, PFS, DoR, and HSCT rate was conducted in all 326 randomised patients.
Farmakokinetisk/farmakodynamisk populationsanalyse indikerede, at der var en korrelation mellem forøgede serumkoncentrationer af inotuzumab ozogamicin og forlængelse af QTc-intervaller hos patienter med ALL og patienter med non-Hodgkin lymfom (NHL).
Population pharmacokinetic/pharmacodynamic evaluation suggested a correlation between increasing inotuzumab ozogamicin serum concentrations and prolongation of QTc intervals in ALL and non-Hodgkin's lymphoma (NHL) patients.
Bindingen in vitro af N-acetyl-gamma-calicheamicin dimethylhydrazid til humane plasmaproteiner er ca. 97 %.
In vitro, the binding of the N-acetyl-gamma-calicheamicin dimethylhydrazide to human plasma proteins is approximately 97%.
Brug ikke lægemidlet efter den udløbsdato, der står på hætteglassets etiket og kartonen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
Do not use this medicine after the expiry date which is stated on the vial label and carton after EXP.
• 1 hætteglas indeholdende en hvid til råhvid frysetørret kage eller pulver.
• 1 glass vial containing a white to off-white lyophilised cake or powder.
• Et lavere antal hvide blodlegemer, hvilket kan medføre generel svækkelse og en tendens til at udvikle infektion
• Reduced number of white blood cells which may result in general weakness and a tendency to develop infections
HIDAC, FLAG eller MXN/Ara-C (N = 109)
HIDAC, FLAG, or MXN/Ara-C (N=109)
2-sidet p-værdi < 0,0001 BESPONSA (N = 164)
2-sided p-value < 0.0001 BESPONSA (N=164)
Fem ud af de 18 VOD/SOS-hændelser, der indtraf efter HSCT, var letale (se pkt.
Five of the 18 VOD/SOS events that occurred post-HSCT were fatal (see section 5.1).
Der blev indberettet letale infektioner, herunder lungebetændelse, neutropenisk sepsis, sepsis, septisk shock og sepsis pseudomonas hos 8 (5 %) patienter.
Fatal infections, including pneumonia, neutropenic sepsis, sepsis, septic shock, and pseudomonal sepsis, were reported in 8 (5%) patients.
Inotuzumab ozogamicins farmakokinetik er velkarakteriseret af en 2-kompartmentmodel med lineære og tidsbestemte clearance-komponenter.
Inotuzumab ozogamicin pharmacokinetics were well characterised by a 2-compartment model with linear and time-dependent clearance components.
Spørg på apoteket, hvordan du skal bortskaffe medicinrester.
Ask your doctor how to throw away medicines you no longer use.
Hos patienter med serumbilirubin ≥ ULN inden HSCT må der kun fortsættes med HSCT efter behandling med BESPONSA efter nøje overvejelse af benefit/risk-forholdet.
In patients in whom the serum bilirubin is ≥ ULN prior to HSCT, HSCT post BESPONSA treatment should only be undertaken after careful consideration of the benefit/risk.
Der blev indberettet febril neutropeni, som kan være livstruende, hos 43 (26 %) patienter.
Febrile neutropenia, which may be life-threatening, was reported in 43 (26%) patients.
Patienter skal observeres under og i mindst 1 time efter endt infusion for symptomer på infusionsrelaterede reaktioner (se pkt.
Patients should be observed during, and for at least 1 hour after the end of infusion for symptoms of infusion related reactions (see section 4.4).
• Infusionsposen skal beskyttes mod lys ved hjælp af afskærmning, der beskytter mod ultraviolet lys (dvs. ravgule, mørkebrune eller grønne poser eller aluminiumsfolie) under infusion.
• Protect the intravenous bag from light using an ultraviolet light-blocking cover (i.e., amber, dark brown, or green bags or aluminium foil) during infusion.
Inotuzumab er et humaniseret immunoglobulin klasse G subtype 4 (IgG4) antistof, der specifikt genkender humant CD22.
Inotuzumab is a humanised immunoglobulin class G subtype 4 (IgG4) antibody that specifically recognises human CD22.
HIDAC, FLAG eller MXN/Ara-C (N = 162)
HIDAC, FLAG, or MXN/Ara-C (N=162)
Hos 1 abe blev der detekteret ændring af et hepatocellulært focus ved ca. 3,1 gange den kliniske eksponering hos mennesker baseret på AUC ved afslutningen af den 26 uger lange doseringsperiode.
In 1 monkey, a focus of hepatocellular alteration was detected at approximately 3.1 times the human clinical exposure based on AUC at the end of the 26-week dosing period.
Hvis der ses partikler eller misfarvning, må det ikke bruges.
If particles or discolouration are observed, do not use.
Blandt de 79 patienter, som fortsatte med HSCT (hvoraf 8 fik yderligere behandling (salvage) efter behandling med BESPONSA inden fortsættelse med HSCT), blev der indberettet VOD/SOS hos 18 (23 %) patienter.
Among the 79 patients who proceeded to a subsequent HSCT (8 of whom received additional salvage therapy after treatment with BESPONSA before proceeding to HSCT), VOD/SOS was reported in 18 (23%) patients.
BESPONSA er kun til engangsbrug.
BESPONSA is for single use only.
• Vend forsigtigt infusionsbeholderen om for at blande den fortyndede opløsning.
• Gently invert the infusion container to mix the diluted solution.
Der blev indberettet grad 3/4 TLS hos 3 (2 %) patienter.
Grade 3/4 TLS was reported in 3 (2%) patients.
En stigning i QTcF intervallet på > 450 msek blev observeret hos 26/162 (16 %) patienter.
An increase in QTcF interval of > 450 msec was observed in 26/162 (16%) patients.
Baseret på populationsfarmakokinetisk analyse påvirker alder, race og køn ikke i betydelig grad fordelingen af inotuzumab ozogamicin.
Based on a population pharmacokinetic analysis, age, race, and gender did not significantly affect inotuzumab ozogamicin disposition.
a ikke-hæmatologisk toksicitet (BESPONSA-relateret)
Grade ≥ 2a non-haematological toxicity (BESPONSA-related)
Hyperbilirubinæmi (21 %) Forhøjede transaminaser (26 %) GGT-forhøjelse (21 %)
Hyperbilirubinaemia (21%) Increased transaminases (26%) Increased GGT (21%)
Populationsfarmakokinetisk analyse af 765 patienter indikerer, at legemsoverfladearealet påvirkede disposition af inotuzumab ozogamicin i betydelig grad.
Based on a population pharmacokinetic analysis in 765 patients, body surface area was found to significantly affect inotuzumab ozogamicin disposition.
BESPONSAs sikkerhed og virkning er ikke undersøgt hos patienter med nyresygdom i slutstadiet.
The safety and efficacy of BESPONSA have not been studied in patients with end-stage renal disease.
Dette inkluderer 70 og 18 patienter i henholdsvis BESPONSA-armen og i behandlingsarmen med investigators valgs af kemoterapi som fortsatte direkte til HSCT.
This included 70 and 18 patients in the BESPONSA and Investigator's choice of chemotherapy arm, respectively, who proceeded directly to HSCT.
Det er ikke nødvendigt at justere startdosis ud fra alder (se pkt.
No adjustment to the starting dose is required based on age (see section 5.2).
Alle patienter skal have målt deres levertal, inklusive ALAT, ASAT, total bilirubin og alkalisk fosfatase inden og efter hver dosis BESPONSA.
In all patients, liver tests should be monitored, including, ALT, AST, total bilirubin, and alkaline phosphatase, prior to and following each dose of BESPONSA.
I tilfælde af overdosering skal infusionen standses midlertidigt, og patienten skal kontrolleres for levertoksicitet og hæmatologisk toksicitet (se pkt.
In the event of an overdose, the infusion should be temporarily interrupted, and patients should be monitored for liver and haematological toxicities (see section 4.2).
- Patienter, der tidligere har haft bekræftet svær eller aktiv veno-okklusiv leversygdom/sinusoidalt obstruktionssyndrom (VOD/SOS).
- Patients who have experienced prior confirmed severe or ongoing venoocclusive liver disease/sinusoidal obstruction syndrome (VOD/SOS).
Lægen tager et EKG (elektrokardiogram) og blodprøver for at måle elektrolytterne i blodet (fx calcium, magnesium, kalium) inden den første dosis BESPONSA, og regelmæssigt under behandlingen.
Your doctor will take an electrocardiogram (ECG) and blood tests to measure electrolytes (e.g., calcium, magnesium, potassium) before the first dose of BESPONSA and repeat these tests during treatment.
Fund vedrørende CR/CRi- og MRD-negativitet fra de første 218 randomiserede patienter stemte overens med de resultater, der sås hos alle 326 randomiserede patienter.
CR/CRi and MRD negativity findings in the initial 218 randomised patients were consistent with those seen in all 326 randomised patients.
• har forhøjet indhold af amylase eller lipaseenzymer, hvilket kan være et tegn på problemer med bugspytkirtlen eller leveren og galdeblæren eller galdegangene.
• have elevations in amylase or lipase enzymes that may be a sign of problems with your pancreas or liver and gallbladder or bile ducts.
Behandling af svær infektion, blødning/hæmoragi og andre virkninger af myelosuppression, herunder svær neutropeni eller trombocytopeni, kan kræve midlertidig afbrydelse af behandlingen, nedsættelse af dosis eller seponering (se pkt.
Management of severe infection, bleeding/haemorrhage and other effects of myelosuppression, including severe neutropenia or thrombocytopenia, may require a dosing interruption, dose reduction, or discontinuation of treatment (see section 4.2).
Derfor bør man nøje overveje samtidig brug af inotuzumab ozogamicin og lægemidler, der er kendt for at forlænge QT-intervallet eller fremkalde Torsades de Pointes.
Therefore, the concomitant use of inotuzumab ozogamicin with medicinal products known to prolong QT interval or to induce Torsades de Pointes should be carefully considered.
I det kliniske pivotalstudie (N = 164) blev der indberettet VOD/SOS hos 23 (14 %) patienter herunder 5 (3 %) patienter under studiebehandlingen eller under opfølgning uden intervenerende HSCT.
In the pivotal clinical study (N=164), VOD/SOS was reported in 23 (14%) patients including 5 (3%) patients during study therapy or in follow-up without an intervening HSCT.
Der er ikke udført interaktionsundersøgelser (se pkt.
No formal clinical drug interaction studies have been performed (see section 5.2).
I toksicitetsstudier udviklede rotter ovalcellehyperplasi, ændrede hepatocellulære foci og hepatocellulære adenomer i leveren ved ca. 0,3 gange den kliniske eksponering hos mennesker baseret på AUC.
In toxicity studies, rats developed oval cell hyperplasia, altered hepatocellular foci, and hepatocellular adenomas in the liver at approximately 0.3 times the human clinical exposure based on AUC.
Skema 2 og Skema 3 viser retningslinjer for dosisændring ved hhv. hæmatologisk og ikkehæmatologisk toksicitet.
Table 2 and Table 3 show the dose modification guidelines for haematological and non-haematological toxicities, respectively.
I pivotalstudiet (N = 164) blev der indberettet infusionsrelaterede reaktioner hos 17 (10 %) patienter.
In the pivotal study (N=164), infusion related reactions were reported in 17 (10%) patients.
BESPONSA er indiceret som monoterapi til behandling af voksne med recidiverende eller refraktær CD22-positiv B-celle prækursor akut lymfoblastær leukæmi (ALL).
BESPONSA is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22positive B cell precursor acute lymphoblastic leukaemia (ALL).
Doseringsregime for cyklus 1 og efterfølgende cyklusser afhængig af respons på behandlingen
Dosing regimen for Cycle 1 and subsequent cycles depending on response to treatment
Dosisændring(er)
Dose modification(s)
Hos patienter, som fik en opfølgende HSCTbehandling, var den mediane OS 11,9 måneder (95% CI: 9,2-20,6) for BESPONSA versus 19,8 måneder (95% CI: 14,6-26,7) for investigators valg af kemoterapi.
In patients who underwent a follow-up HSCT, the median OS was 11.9 months (95% CI: 9.2, 20.6) for BESPONSA versus 19.8 months (95% CI: 14.6, 26.7) for Investigator's choice of chemotherapy.
Anvend aseptisk teknik under rekonstituering og fortynding.
Use appropriate aseptic technique for the reconstitution and dilution procedures.
Ingen patienter blev testet positiv for neutraliserende antistoffer mod inotuzumab ozogamicin.
No patients tested positive for neutralising anti-inotuzumab ozogamicin antibodies.
Der foreligger ingen data fra gravide kvinder, der bruger inotuzumab ozogamicin.
There are no data in pregnant women using inotuzumab ozogamicin.
Brug ikke BESPONSA:
Do not use BESPONSA if you:
Se skema 6 for definitioner (med undtagelsen at CR/Cri ikke var per EAC i studie 2)
a, b, c, d, e, f For definition, see Table 6 (with the exception that CR/CRi was not per EAC for Study 2)
a- eller CRi b-respons ifølge investigators vurdering til datoen for en PFS-hændelse eller censureringsdatoen, hvis der ikke blev dokumenteret en PFShændelse.
g Duration of remission was defined as the time since first response of CRa or CRib per Investigator's assessment to the date of a PFS event or censoring date if no PFS event was documented.
Clearance af inotuzumab ozogamicin ved steady state hos 234 patienter med recidiverende eller refraktær ALL var 0,0333 l/t, og den endelige halveringstid (t½) ved afslutningen af cyklus 4 var ca. 12,3 dage.
In 234 patients with relapsed or refractory ALL, the clearance of inotuzumab ozogamicin at steady state was 0.0333 L/h, and the terminal elimination half-life (t½) at the end of Cycle 4 was approximately 12.3 days.
Blandt alle 326 randomiserede patienter var sandsynligheden for overlevelse efter 24 måneder 22,8 % i inotuzumab BESPONSA-armen og 10 % i behandlingsarmen med investigators valg af kemoterapi.
Among all 326 randomised patients, the survival probability at 24 months was 22.8% in the BESPONSA arm and 10% in the Investigator's choice of chemotherapy arm.
Der blev ikke indberettet forlænget QT-interval af grad ≥ 3 eller Torsades de Pointes.
No Grade ≥ 3 QT interval prolongation or events of Torsades de Pointes were reported.
Aktivering af N-acetyl-gamma-calicheamicin dimethylhydrazid inducerer dobbeltstrengede brud på DNA, hvorefter stop af cellecyklus og apoptotisk celledød induceres.
Activation of N-acetyl-gamma-calicheamicin dimethylhydrazide induces double-stranded DNA breaks, subsequently inducing cell cycle arrest and apoptotic cell death.
Dette lægemiddel skal efterses visuelt for partikler og misfarvning før det gives.
This medicine should be inspected visually for particulate matter and discolouration prior to administration.
CD22-ekspression blev vurderet ved hjælp af flowcytometri baseret på knoglemarvsaspirat.
CD22 expression was assessed using flow cytometry based on bone marrow aspirate.
• Rekonstituér hvert 1 mg hætteglas med 4 ml vand til injektionsvæske for at få en engangsopløsning på 0,25 mg/ml BESPONSA.
• Reconstitute each 1 mg vial with 4 mL of water for injection, to obtain a single-use solution of 0.25 mg/mL of BESPONSA.
Hvis den fortyndede opløsning imidlertid filtreres, anbefales det at anvende polyethersulfon (PES)-, polyvinylidenfluorid (PVDF)- eller hydrofile polysulfon (HPS)-baserede filtre.
However, if the diluted solution is filtered, polyethersulphone (PES)-, polyvinylidene fluoride (PVDF)-, or hydrophilic polysulphone (HPS)-based filters are recommended.
+/- 2 dage (oprethold minimum 6 dage mellem doser).
a +/- 2 days (maintain minimum of 6 days between doses).
Afhængigt af hvor alvorlig den infusionsrelaterede reaktion er, bør det overvejes at stoppe infusionen eller at administrere steroider og antihistaminer.
Depending on the severity of the infusion related reaction, consider discontinuation of the infusion or administration of steroids and antihistamines.
2-sidet p-værdi = 0,0022
2-sided p-value = 0.0022
I forhold til andre risikofaktorer blev VOD/SOS rapporteret hos 6/11 (55 %) patienter, der fik et HSCT-konditionerende regime, der indeholdt 2 alkylerende midler og 9/53 (17 %) patienter, der fik et HSCT-konditionerende regime, der indeholdt 1 alkylerende middel, 7/17 (41 %) patienter, der var ≥ 55 år og 11/62 (18 %) patienter, der var < 55 år, og 7/12 (58 %) patienter med serumbilirubin ≥ ULN inden HSCT og hos 11/67 (16 %) patienter med serumbilirubin < ULN inden HSCT.
Regarding other risk factors, VOD/ SOS was reported in 6/11 (55%) patients who received a HSCT conditioning regimen containing 2 alkylating agents and 9/53 (17%) patients who received a HSCT conditioning regimen containing 1 alkylating agent, 7/17 (41%) patients who were ≥ 55 years old and 11/62 (18%) patients who were < 55 years old, and 7/12 (58%) patients with a serum bilirubin ≥ ULN prior to HSCT and in 11/67 (16%) patients with a serum bilirubin < ULN prior to HSCT.
infusion efter rekonstituering og fortynding.
IV infusion after reconstitution and dilution.
Der sås en forbedring i OS for BESPONSA versus investigators valg af kemoterapiarm, hos patienter som fik HSCT.
The OS improvement for BESPONSA versus Investigator's choice of chemotherapy arm was seen in patients who underwent HSCT.
I følgende undergrupper var den rapporterede hyppighed af VOD/SOS post-HSCT ≥ 50 %: - Patienter, der fik HSCT-konditionerende regimer, der indeholdt 2 alkylerende midler - Patienter ≥ 65 år og - Patienter med serumbilirubin ≥ ULN forud for HSCT
In the following subgroups, the reported frequency of VOD/SOS post-HSCT was ≥ 50%: - Patients who received a HSCT conditioning regimen containing 2 alkylating agents; - Patients aged ≥ 65 years; and
I alt fik 79/164 (48,2 %) af patienterne i BESPONSA-armen og 36/162 (22,2 %) af patienterne i behandlingsarmen med investigators valg af kemoterapi opfølgende HSCT.
A total of 79/164 (48.2%) patients in the BESPONSA arm and 36/162 (22.2%) patients in the Investigator's choice of chemotherapy arm had a follow-up HSCT.
Der var en tendens til fordel for RESPONSA for estimerede gennemsnitlige efter-baseline-scorer, som blev målt vha. spørgeskemaet EuroQoL 5 Dimension (EQ-5D) (hhv. BESPONSA og investigators valg af kemoterapi) for EQ-5Dindekset (0,80 versus 0,76, minimal betydende forskel for kræft = 0,06).
There was a trend in favour of BESPONSA for estimated mean postbaseline scores from the EuroQoL 5 Dimension (EQ-5D) questionnaire, (BESPONSA and Investigator's choice of chemotherapy, respectively) for the EQ-5D index (0.80 versus 0.76, minimally important difference for cancer = 0.06).
De hyppigste årsager til ophør af behandlingen var: sygdomsprogression/recidiv (30 (41,7%)), resistent sygdom (4 (5,6%)), HSCT (18 (25,0%)) og bivirkninger (13 (18,1%)).
The most common reasons for treatment discontinuation were: disease progression/relapse (30 [41.7%)], resistant disease (4 [5.6%]); HSCT (18 [25.0%]), and adverse events
Patienter med tidligere leversygdom skal nøje evalueres (fx ved ultralydsscanning, test for viral hepatitis) inden behandling med BESPONSA for at udelukke alvorlig aktiv leversygdom (se pkt.
Patients with a history of liver disease should be carefully evaluated (e.g., ultrasound scan, viral hepatitis testing) prior to treatment with BESPONSA to exclude serious ongoing hepatic disease (see section 4.3).
I pivotalstudiet (N = 164) blev der indberettet infektioner, herunder alvorlige infektioner, hvoraf nogle var livstruende eller letale, hos 79 (48 %) patienter.
In the pivotal study (N=164), infections, including serious infections, some of which were life-threatening or fatal, were reported in 79 (48%) patients.
Pyreksi (32 %) Træthed (35%) Kulderystelser (11 %)
Pyrexia (32%) Fatigue (35%) Chills (11%)
Lægemidlerne kan omfatte binyrebarkhormoner (fx dexamethason), febernedsættende midler (antipyretika) og antihistaminer (mod allergiske reaktioner).
These may include corticosteroids (e.g., dexamethasone), antipyretics (medicines to reduce fever), and antihistamines (medicines to reduce allergic reactions).
Skema 5 viser de bivirkninger, der blev indberettet fra patienter med recidiverende eller refraktær ALL, som fik BESPONSA.
Table 5 shows the adverse reactions reported in patients with relapsed or refractory ALL who received BESPONSA.