natgillin/translations-raw huggingface dataset:
N-acetyl-gamma-calicheamicin dimethylhydrazid in vitro er et substrat af P-glykoprotein (Pgp).
In vitro, N-acetyl-gamma-calicheamicin dimethylhydrazide is a substrate of P-glycoprotein (P-gp).
Patienter med recidiverende eller refraktær ALL, der havde fået 2 eller flere tidligere behandlingsregimer for ALL - Studie 2
Patients with relapsed or refractory ALL who have received 2 or more prior treatment regimens for ALL - Study 2
Sandsynligheden for overlevelse ved 24 måneder var 38,0 % (95% CI: 27,4-48,5) versus 35,5 % (95 % CI: 20,1-51,3) for henholdsvis BESPONSA og investigators valg af kemoterapi.
At month 24, the survival probability was 38.0% (95% CI: 27.4, 48.5) versus 35.5% (95% CI: 20.1, 51.3) for BESPONSA and Investigator's choice of chemotherapy, respectively.
+/- 2 dage (oprethold 6 dage mellem doser).
a +/- 2 days (maintain a minimum of 6 days between doses).
BESPONSA skal administreres med forsigtighed til patienter, der tidligere har haft eller er disponeret for forlænget QT-interval, som tager lægemidler kendt for at forlænge QT-intervallet (se pkt.
BESPONSA should be administered with caution in patients who have a history of, or predisposition to QT interval prolongation, who are taking medicinal products that are known to prolong QT interval (see section 4.5) and in patients with electrolyte disturbances.
• hvis du har en alvorlig leversygdom, fx skrumpelever (hvor leveren ikke fungerer ordentligt på grund af langvarige skader), eller sygdom med symptomer på grund af øget modstand ved blodets gennemstrømning gennem leveren (nodulær regenerativ hyperplasi), som kan være forårsaget af kronisk brug af lægemidler, eller aktiv leverbetændelse (en sygdom, hvor der er betændelsestilstand i leveren).
• have serious ongoing liver disease, e.g., cirrhosis (a condition in which the liver does not function properly due to long-term damage), nodular regenerative hyperplasia (a condition with signs and symptoms of portal hypertension that can be caused by chronic use of medicines), active hepatitis (a disease characterised by inflammation of the liver).
BESPONSA indeholder ikke bakteriostatiske konserveringsmidler.
BESPONSA contains no bacteriostatic preservatives.
Opbevaringstider og -forhold for rekonstitueret og fortyndet BESPONSA-opløsning
Storage times and conditions for reconstituted and diluted BESPONSA solution
I pivotalstudiet (N = 164) blev der målt maksimale stigninger i QT-interval korrigeret for hjertefrekvens vha. Fridericia-formlen (QTcF) ≥ 30 msek og ≥ 60 msek fra baseline hos henholdsvis 30/162 (19 %) og 4/162 (3 %) patienter.
In the pivotal study (N=164), maximum increases in QT interval corrected for heart rate using the Fridericia formula (QTcF) ≥ 30 msec and ≥ 60 msec from baseline were measured in 30/162 (19%) and 4/162 (3%) patient, respectively.
I pivotalstudiet (N = 164) blev der indberettet hyperbilirubinæmi og forhøjede transaminaser hos hhv. 35 (21 %) og 43 (26 %) patienter.
In the pivotal study (N=164), hyperbilirubinaemia and increased transaminases were reported in 35 (21%) and 43 (26%) patients, respectively.
Overvåg nøje alle patienter for symptomer på VOD/SOS, især efter HSCT.
Signs and symptoms of VOD/SOS should be monitored closely in all patients, especially post HSCT.
Afhængigt af hvor alvorlig reaktionen er, bør det overvejes at stoppe infusionen eller administrere steroid og antihistamin (se pkt.
Depending on the severity of the infusion related reaction, discontinuation of the infusion or administration of steroids and antihistamines should be considered (see section 4.2).
Hos de patienter, som fortsatte direkte til HSCT, var mediantiden mellem sidste dosis af inotuzomab ozogamicin og HSCT 4,8 uger (interval: 1-19 uger).
In those patients who proceeded directly to HSCT, there was a median gap of 4.8 weeks (range: 1-19 weeks) between the last dose of inotuzumab ozogamicin and HSCT.
Der blev indberettet forhøjet amylase og lipase af grad ≥ 3 hos hhv. 3 (2 %) og 7 (4 %) patienter.
Increases in Grade ≥ 3 amylase and lipase were reported in 3 (2%) and 7 (4%) patients, respectively.
Baseret på in vitro-data vil samtidig administration af inotuzumab ozogamicin og hæmmere eller inducere af cytokrom P450 (CYP) eller uridindiphosphat-glucuronosyltransferase (UGT) sandsynligvis ikke ændre eksponeringen for N-acetyl-gamma-calicheamicin-dimethylhydrazid.
Based on in vitro data, coadministration of inotuzumab ozogamicin with inhibitors or inducers of cytochrome P450 (CYP) or uridine diphosphate-glucuronosyltransferase (UGT) drug metabolising enzymes are unlikely to alter exposure to N-acetyl-gamma-calicheamicin dimethylhydrazide.
I pivotalstudiet (N = 164) blev der indberettet forhøjet amylase og lipase hos hhv. 8 (5 %) og 15 (9 %) patienter.
In the pivotal study (N=164), increases in amylase and lipase were reported in 8 (5%) and 15 (9%) patients, respectively.
Egnede patienter var ≥ 18 år med recidiverende eller refraktær B-celle prækursor ALL.
Eligible patients were ≥ 18 years of age with relapsed or refractory B-cell precursor ALL.
Opbevaringsforhold og holdbarhed
Storage conditions and shelf life
Risikorate [95 % CI] = 0,450 [0,348-0,581] 2-sidet p-værdi < 0,0001
Hazard ratio [95% CI] = 0.450 [0.348-0.581] 2-sided p-value < 0.0001
Alle patienter, der ikke opnår CR/CRi inden for 3 cyklusser, skal have seponeret behandlingen (se pkt.
Any patients who do not achieve a CR/CRi within 3 cycles should discontinue treatment.
Brug altid lægemidlet nøjagtigt efter lægens, apotekspersonalets eller sundhedspersonalets anvisning.
Always use this medicine exactly as your doctor, pharmacist, or nurse has told you.
Der blev indberettet grad 4 trombocytopeni og neutropeni hos hhv. 46 (28 %) og 45 (27 %) patienter.
Grade 4 thrombocytopenia and neutropenia were reported in 46 (28%) and 45 (27%) patients, respectively.
PFS blev defineret som tid fra randomiseringsdato til tidligste dato for følgende hændelser: død, sygdomsprogression (inklusive objektiv progression, recidiv fra CR/CRi, seponering af behandling pga. generel forringelse af helbredsstatus) og start på ny induktionsterapi eller HSCT efter behandlingen uden opnåelse af CR/CRi.
progressive disease (including objective progression, relapse from CR/CRi, treatment discontinuation due to global deterioration of health status), and start of new induction therapy or post-therapy HSCT without achieving CR/CRi.
Forhøjede leverenzymer kan nødvendiggøre dosisafbrydelse, -nedsættelse eller permanent seponering af BESPONA (se pkt.
Elevation of liver tests may require dosing interruption, dose reduction, or permanent discontinuation of BESPONSA (see section 4.2).
Se venligst produktresumeet for den fulde information om dosering og dosisjustering.
For full information on dosage and dose modifications please refer to the Summary of Product Characteristics.
Hyppigheden af følgende typer af specifikke infektioner var: sepsis og bakteriæmi (17 %), nedre luftvejsinfektion (12 %), øvre luftvejsinfektion (12 %), svampeinfektion (9 %), virusinfektion (7 %), gastrointestinal infektion (4 %), hudinfektion (4 %) og bakteriel infektion (1 %).
The frequencies of specific infections were: sepsis and bacteraemia (17%), lower respiratory tract infection (12%), upper respiratory tract infection (12%), fungal infection (9%), viral infection (7%), gastrointestinal infection (4%), skin infection (4%), and bacterial infection (1%).
• Hvirvl forsigtigt glasset for at fremme opløsning.
• Gently swirl the vial to aid dissolution.
Inotuzumab ozogamicin var klastogent in vivo i knoglemarven hos hanmus.
Inotuzumab ozogamicin was clastogenic in vivo in the bone marrow of male mice.
Der anbefales præmedicinering med kortikosteroid, antipyretika og antihistamin inden dosering (se pkt.
Pre-medication with a corticosteroid, antipyretic, and antihistamine is recommended prior to dosing (see section 4.2).
Hvis trombocyttallet falder, skal næste cyklus afbrydes, indtil trombocyttallet ≥ 50 × 10
If platelet count decreases, interrupt the next cycle of treatment until platelet count recovers to ≥ 50 × 109/La.
Baseret på en populationsfarmakokinetisk analyse af 765 patienter var clearance af inotuzumab ozogamicin hos patienter med nedsat leverfunktion, defineret af National Cancer Institute Organ Dysfunction Working Group (NCI ODWG) kategori B1 (total bilirubin ≤ ULN og ASAT > ULN, n = 133) eller B2 (total bilirubin > 1,0-1,5 × ULN og ASAT af alle niveauer, n = 17) den samme som hos patienter med normal leverfunktion (total bilirubin/ASAT ≤ ULN, n = 611) (se pkt.
Based on a population pharmacokinetic analysis in 765 patients, the clearance of inotuzumab ozogamicin in patients with hepatic impairment defined by National Cancer Institute Organ Dysfunction Working Group (NCI ODWG) category B1 (total bilirubin ≤ ULN and AST > ULN; n=133) or B2 (total bilirubin > 1.0-1.5 × ULN and AST any level; n=17) was similar to patients with normal hepatic function (total bilirubin/AST ≤ ULN; n=611) (see section 4.2).
Der skal tages EKG og måles elektrolytter inden behandlingsstart samt periodisk under behandlingen (se pkt.
ECG and electrolytes should be obtained prior to the start of treatment and periodically monitored during treatment (see sections 4.8 and 5.2).
+ B-celle ALL, havde 1 patient fået en TKI tidligere og 1 patient havde ikke fået en TKI tidligere.
Of the 9 patients with Ph+ B-cell ALL, 1 patient had received 1 previous TKI and 1 patient had received no prior TKIs.
I pivotalstudiet (N = 164) blev der indberettet trombocytopeni og neutropeni hos hhv. 83 (51 %) og 81 (49 %) patienter.
In the pivotal study (N=164), thrombocytopenia and neutropenia were reported in 83 (51%) and 81 (49%) patients, respectively.
Inotuzumab ozogamicin er et antistof-lægemiddel-konjugat (ADC) sammensat af et rekombinant humaniseret IgG4 kappa CD22-rettet monoklonalt antistof (produceret i ovarieceller fra kinesisk hamster vha. rekombinant DNA-teknologi), der bindes kovalent til N-acetyl-gamma-calicheamicin dimethylhydrazid.
Inotuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of a recombinant humanised IgG4 kappa CD22-directed monoclonal antibody (produced in Chinese hamster ovary cells by recombinant DNA technology) that is covalently linked to N-acetyl-gamma-calicheamicin dimethylhydrazide.
I toksicitetsstudier med gentagne doser hos rotter inkluderede fund vedrørende reproduktion hos hanner degeneration af testiklerne associeret med hypospermi og atrofi af prostata og sædblæren.
In repeat dose toxicity studies in rats, male reproductive findings included testicular degeneration, associated with hypospermia, and prostatic and seminal vesicle atrophy.
Administrer den fortyndede opløsning som infusion over 1 time ved en hastighed på 50 ml/time ved stuetemperatur (20-25 °C).
Administer diluted solution as a 1-hour infusion at a rate of 50 mL/h at room temperature (20 °C-25 °C).
2,3 gange den kliniske eksponering hos mennesker baseret på AUC) inden parring og i løbet af den første gestationssuge resulterede i embryoføtal toksicitet, inklusive øget resorption og færre levedygtige embryoner.
Administration of inotuzumab ozogamicin to female rats at the maternally toxic dose (approximately 2.3 times the human clinical exposure based on AUC) prior to mating and during the first week of gestation resulted in embryo-foetal toxicity, including increased resorptions and decreased viable embryos.
Behandling med BESPONSA kan muligvis forårsage en alvorlig uregelmæssig hjerterytme (ændring i de elektriske impulser i hjertet, som kaldes forlængelse af QT-intervallet).
Treatment with BESPONSA may prolong QT interval (a change in electrical activity of the heart that can cause serious irregular heart rhythms).
Hyppigheden af følgende typer af specifikke blødning/hæmoragiske hændelser var: næseblod (15 %), øvre gastrointestinal blødning (6 %), nedre gastrointestinal blødning (4 %), blødning i centralnervesystemet (CNS) (1 %).
The frequencies of specific bleeding/haemorrhagic events were: epistaxis (15%), upper gastrointestinal haemorrhage (6%), lower gastrointestinal haemorrhage (4%), and central nervous system (CNS) haemorrhage (1%).
Dag 15
Day 15a
Der blev indberettet grad ≥ 3 hyperbilirubinæmi og forhøjede transaminaser hos hhv. 9 (6 %) og 11 (7 %) patienter.
Grade ≥ 3 hyperbilirubinaemia and increased transaminases were reported in 9 (6%) and 11 (7%) patients, respectively.
Der blev indberettet grad 3/4 blødning/hæmoragiske hændelser hos 8/164 (5 %) patienter.
Grade 3/4 bleeding/haemorrhagic events were reported in 8/164 (5%) patients.
-, ingen tidligere HSCT,  90 % positivitet for CD22 i leukæmiske blaster ved baseline, ingen perifere blaster ved baseline og baseline hæmoglobin ≥ 10 g/dl, baseret på eksplorativ analyse.
There was also a trend for better OS with BESPONSA for patients with other prognostic factors (Ph-, no prior HSCT, ≥ 90% leukaemic blasts CD22-positive at baseline, no baseline peripheral blasts, and baseline haemoglobin ≥ 10 g/dL, based on exploratory analyses).
Hos patienter, der skal fortsætte med hæmatopoietisk stamcelletransplantation (HSCT), anbefales 2 behandlingscyklusser.
For patients proceeding to haematopoietic stem cell transplant (HSCT), the recommended duration of treatment is 2 cycles.
• Unormalt højt indhold af lipase i blodet (et enzym, der er nødvendigt for, at kroppen kan fordøje fedt fra maden)
• Abnormally high levels of lipase (an enzyme needed to process dietary fat) in the blood
Inotuzumab ozogamicin er et ADC sammensat af et CD22-rettet monoklonalt antistof, der bindes kovalent til N-acetyl-gamma-calicheamicin dimethylhydrazid.
Inotuzumab ozogamicin is an ADC composed of a CD22-directed monoclonal antibody that is covalently linked to N-acetyl-gamma-calicheamicin dimethylhydrazide.
Forhøjet amylase (5 %) Forhøjet lipase (9 %)
Common Increased lipase (9%)
Studie 1: Resultater hos patienter ≥18 år med recidiverende eller refraktær B-celle prækursor ALL, som har fået 1 eller 2 tidligere behandlingsregimer for ALL
Study 1: Efficacy results in patients ≥ 18 years of age with relapsed or refractory B-cell precursor ALL who received 1 or 2 prior treatment regimens for ALL
Studie 2: Resultater hos patienter ≥18 år med recidiverende eller refraktær B-celle prækursor ALL, som har fået 2 eller flere tidligere behandlingsregimer for ALL
Study 2: Efficacy results in patients ≥ 18 years of age with relapsed or refractory B-cell precursor ALL who received 2 or more prior treatment regimens for ALL
BESPONSA 1 mg pulver til koncentrat til infusionsvæske, opløsning inotuzumab ozogamicin
BESPONSA 1 mg powder for concentrate for solution for infusion inotuzumab ozogamicin
• Hvis behandlingen fungerer godt, og du skal have en stamcelletransplantation (se afsnit 2), får du 2 eller højst 3 behandlingsforløb.
• If the medicine works well and you are going to receive a stem cell transplant (see section 2),
Den anbefalede BESPONSA-dosis blev fastlagt til 1,8 mg/m 2/cyklus administreret ved en dosis på 0,8 mg/m 2 på dag 1 og 0,5 mg/m 2 på dag 8 og 15 i en cyklus på 28 dage med dosisnedsættelse efter opnåelse af CR/CRi.
The recommended BESPONSA dose was determined to be 1.8 mg/m2/cycle administered at a dose of 0.8 mg/m2 on Day 1 and 0.5 mg/m2 on Days 8 and 15 of a 28-day cycle with a dose reduction upon achieving CR/CRi.
• Højt indhold af leverenzymer i blodet (der kan være tegn på leverskade)
• High levels of liver enzymes (which can be indicators of liver injury) in the blood
N-acetyl-gamma-calicheamicin er kovalent forbundet med antistoffet med en syrelabil binding.
N-acetyl-gamma-calicheamicin is covalently attached to the antibody via an acid-cleavable linker.
• Lavt antal blodlegemer (neutrofile) sommetider ledsaget af feber, røde blodlegemer, hvide blodlegemer, lymfocytter eller et lavt antal blodplader (se afsnit 2), symptomerne kan være betændelse eller feber, eller at man let får blå mærker eller ofte får næseblod.
• low number of blood cells known as neutrophils, (sometimes accompanied with fever), red blood cells, white blood cells, lymphocytes, or low number of blood components known as platelets (see section 2); signs and symptoms include developing an infection or fever or bruising easily or getting nose bleeds on a regular basis.
Mænd med kvindelige partnere i den fertile alder skal anvende sikker kontraception under behandlingen med BESPONSA og i mindst 5 måneder efter sidste dosis.
Men with female partners of childbearing potential should use effective contraception during treatment with BESPONSA and for at least 5 months after the last dose.
4.4 vedrørende klinisk behandling af levertoksicitet, herunder VOD/SOS.
For clinical management of hepatotoxicity, including VOD/SOS, see section 4.4.
Forkortelser: ALL = akut lymfoblastær leukæmi, ANC = absolut neutrofiltal, CI = konfidensinterval, CR = komplet remission, CRi = komplet remission med delvis hæmatologisk restitution, DoR = varighed af remission, HSCT = hæmatopoietisk stamcelletransplantation, MRD = minimal residualsygdom, N/n = antal patienter, OS = samlet overlevelse, PFS = progressionsfri overlevelse.
Abbreviations: ALL=acute lymphoblastic leukaemia; ANC=absolute neutrophil counts; CI=confidence interval; CR=complete remission; CRi=complete remission with incomplete haematological recovery; DoR=duration of remission; HSCT=haematopoietic stem cell transplant; MRD=minimal residual disease; N/n=number of patients; OS=overall survival; PFS=progression-free survival.
Forkortelser: ALL = akut lymfoblastær leukæmi, ANC = absolut neutrofiltal, Ara-C = cytarabin, CI = konfidensinterval, CR = komplet remission, CRi = komplet remission med delvis hæmatologisk restitution, DoR = varighed af remission, EAC = Endpoint Adjudication Committee, FLAG = fludarabin + cytarabin + granulocytkolonistimulerende faktor, HIDAC = højdosis cytarabin, HSCT = hæmatopoietisk stamcelletransplantation,
Abbreviations: ALL=acute lymphoblastic leukaemia; ANC=absolute neutrophil counts; Ara-C=cytarabine; CI=confidence interval; CR=complete remission; CRi=complete remission with incomplete haematological recovery; DoR=duration of remission; EAC=Endpoint Adjudication Committee; FLAG=fludarabine + cytarabine + granulocyte colony-stimulating factor; HIDAC=high dose cytarabine; HSCT=haematopoietic stem cell transplant; ITT=intent-to-treat; MRD=minimal residual disease; MXN=mitoxantrone; N/n=number of patients; OS=overall survival; PFS=progression-free survival.
4.4 vedrørende regelmæssig måling af EKG og elektrolytter.
For periodic monitoring of ECG and electrolyte levels, see section 4.4.
Hvis ANC falder, skal næste cyklus afbrydes, indtil ANC 9/l.
If ANC decreases, interrupt the next cycle of treatment until recovery of ANC to ≥ 1 × 109/L.
Centrale og lokale laboratorietest viste ≥70% CD22-positive leukæmiske blaster ved baseline hos henholdsvis 231/253 (91,3%) og 130/253 (51,4%) af patienterne.
By central and local laboratory tests, 231/253 (91.3%) patients and 130/253 (51.4%) patients, respectively, had ≥ 70% CD22-positive leukaemic blasts at baseline.
Risikorate [95 % CI] = 0,751 [0,588-0,959] 2-sidet p-værdi = 0,0210
[4.7 to 8.3] Hazard ratio [95% CI] = 0.751 [0.588-0.959] 2-sided p-value = 0.0210
USA
United States (USA)
Opbevaringsforhold efter rekonstitution og fortynding, se pkt.
For storage conditions after reconstitution and dilution, see section 6.3.
Mænd skal bruge sikker prævention under behandlingen og i mindst 5 måneder efter sidste dosis.
Men must use effective contraception during treatment and for at least 5 months after the last dose of treatment.
• hvis du tidligere har haft en sygdom, hvor blodkarrene i leveren var beskadiget og tilstoppet af blodpropper (veno-okklusiv sygdom), eller du har det nu.
• have previously had severe venoocclusive disease (a condition in which the blood vessels in the liver become damaged and blocked by blood clots) which was confirmed or have ongoing venoocclusive disease.
Baseret på populationsfarmakokinetiske analyser af 765 patienter var clearance af inotuzumab ozogamicin hos patienter med let nedsat nyrefunktion (CLcr 60-89 ml/min, n = 237), moderat nedsat nyrefunktion (CLcr 30-59 ml/min, n = 122) eller svært nedsat nyrefunktion (CLcr 15-29 ml/min, n = 4) den samme som hos patienter med normal nyrefunktion (CLcr ≥ 90 ml/min, n = 402) (se pkt.
Based on population pharmacokinetic analysis in 765 patients, the clearance of inotuzumab ozogamicin in patients with mild renal impairment (CLcr 60-89 mL/min; n=237), moderate renal impairment (CLcr 30-59 mL/min; n=122), or severe renal impairment (CLcr 15-29 mL/min; n=4) was similar to patients with normal renal function (CLcr ≥ 90 mL/min; n=402) (see section 4.2).
Det anbefales at bruge infusionsslanger fremstillet af PVC (med eller uden DEHP), polyolefin (polypropylen og/eller polyethylen) eller polybutadien.
Infusion lines made of PVC (DEHP or non-DEHP-containing), polyolefin (polypropylene and/or polyethylene), or polybutadiene are recommended.
Maksimal tid fra rekonstitution til fuldendt administration ≤ 8 timer Rekonstitueret opløsning
Maximum time from reconstitution through the end of administration ≤ 8 hoursa Reconstituted solution
Hvert hætteglas indeholder 1 mg inotuzumab ozogamicin.
Each vial contains 1 mg inotuzumab ozogamicin.
Hvis den fortyndede opløsning opbevares i køleskab (2-8 °C), skal den stå ved stuetemperatur (20-25 °C) i ca. 1 time inden administration.
If the diluted solution is stored in a refrigerator (2 °C-8 °C), bring it to room temperature (20 °C-25 °C) for approximately 1 hour prior to administration.
Dosisændringer på grund af ikke-hæmatologisk toksicitet på ethvert tidspunkt i løbet af behandling
Dose modifications for non-haematological toxicities at any time during treatment Non-haematological toxicity Dose modification(s)
Der blev indberettet grad 3 trombocytopeni og neutropeni hos hhv. 23 (14 %) og 33 (20 %) patienter.
Grade 3 thrombocytopenia and neutropenia were reported in 23 (14%) and 33 (20%) patients, respectively.
Hvis den rekonstituerede opløsning ikke kan bruges med det samme, kan den opbevares i op til 4 timer i køleskab (2-8 °C).
If the reconstituted solution cannot be used immediately, it may be stored for up to 4 hours in a refrigerator (2 °C-8 °C).
21 dage Doseringsregime for efterfølgende cyklusser afhængig af respons på behandlingen Patienter, der har opnået CR c eller CRi
Dosing regimen for subsequent cycles depending on response to treatment Patients who have achieved a CRc or CRid:
Dag 8
Day 8a
Risikorate [95% CI] = 0,471 [0,366-0,606] 2-sidet p-værdi < 0,0001
[2.8 to 4.6] Hazard ratio [95% CI] = 0.471 [0.366-0.606] 2-sided p-value < 0.0001
MRD-negativitet c for patienter, der opnåede CR/CRi, frekvens d (%) [95 %
MRD negativityc for patients achieving CR/CRi; rated (%) [95% CI]
4.4. vedrørende regelmæssig monitorering af forhøjet amylase og lipase.
For periodic monitoring of increased amylase and lipase, see section 4.4.
I studiets fase 1 fik 37 patienter BESPONSA ved en total dosis på 1,2 mg/m 2 (n = 3) 1,6 mg/m
In the Phase 1 portion of the study, 37 patients received BESPONSA at a total dose of 1.2 mg/m2 (n=3), 1.6 mg/m2 (n=12), or 1.8 mg/m2 (n=22).
BESPONSA er et pulver til koncentrat til infusionsvæske, opløsning.
BESPONSA is a powder for concentrate for solution for infusion.
Afbryd behandlingen indtil restitution af total bilirubin til ≤ 1,5 × ULN og ASAT/ALAT til ≤ 2,5 × ULN inden hver dosis, medmindre det skyldes Gilberts syndrom eller hæmolyse.
Interrupt dosing until recovery of total bilirubin to ≤ 1.5 × ULN and AST/ALT to ≤ 2.5 × ULN prior to each dose unless due to Gilbert's syndrome or haemolysis.
Blødning/hæmoragi
Bleeding/haemorrhage
• Veno-okklusiv leversygdom (se afsnit 2), symptomerne kan være hurtig vægtstigning, smerter i den øverste højre side af maven, forstørret lever, væskeophobning som giver hævelse af maven, og blodprøver som viser forhøjet bilirubin og/eller leverenzymer (kan give gulfarvning af hud og øjne).
• venoocclusive liver disease (see section 2); signs and symptoms include rapid weight gain, pain in the upper right side of your abdomen, increase in the size of the liver, accumulation of fluid causing abdominal swelling, and increases in bilirubin and/or liver enzymes (that may result in yellowing of the skin or eyes).