natgillin/translations-raw huggingface dataset:
In vitro-studier viser, at bortezomib er en svag hæmmer af cytochrom P450 CYP-isozymer 1A2, 2C9, 2C19, 2D6 og 3A4.
In vitro studies indicate that bortezomib is a weak inhibitor of the cytochrome P450 (CYP) isozymes 1A2, 2C9, 2C19, 2D6 and 3A4.
• for at minde patienter, der modtager Bortezomib Accord sammen med thalidomid, om, at de skal overholde det svangerskabsforebyggende program for thalidomid, og med reference til produktresuméet for thalidomid for yderligere oplysninger.
• to remind that patients receiving Bortezomib Accord in combination with thalidomide should adhere to the pregnancy prevention programme of thalidomide, with reference to the SmPC of thalidomide for additional information.
• Trombocyttal skal være ≥ 70 x 109/l, og absolut neutrofiltal skal være ≥ 1,0 x 109/l
• Platelet counts should be ≥ 70 x 109/l and the absolute neutrophils count should be ≥ 1.0 x 109/l
• et redskab til beregning af dosis, hvor den ordinerende læge kan indlæse patientens højde og vægt for ud fra disse at beregne arealet af legemsoverfladen og derved fastsætte en passende dosering af Bortezomib Accord.
• a dose-calculation tool that enables prescribers to input a patient's height and weight in order to calculate the body surface area (BSA) and thereby to determine the appropriate Bortezomib Accord dose.
198 (82 %) og 208 (87 %) patienter i henholdsvis VDDx og BzDx-gruppen fik autolog stamcelletransplantation.
Autologous stem cell transplants were received by 198 (82%) patients and 208 (87%) patients in the VDDx and BzDx groups respectively; the majority of patients underwent one single transplant procedure.
Tabel 1: Anbefalede* dosisændringer ved Bortezomib Accord-relateret neuropati
Table 1: Recommended* posology modifications for Bortezomib Accord -related neuropathy
I et studie, hvor bortezomib-behandling blev gentaget hos 130 patienter med recidiverende myelomatose, som tidligere havde opnået mindst partielt respons med et regime, der omfattede bortezomib, var de hyppigste bivirkninger af alle grader, der indtraf hos mindst 25 % af patienterne, trombocytopeni (55 %), neuropati (40 %), anæmi (37 %), diaré (35 %) og obstipation (28 %).
In a study in which bortezomib retreatment was administered in 130 patients with relapsed multiple myeloma, who previously had at least partial response on a bortezomib-containing regimen, the most common all-grade adverse events occurring in at least 25% of patients were thrombocytopenia (55%), neuropathy (40%), anaemia (37%), diarrhoea (35%), and constipation (28%).
- Godartede cyster - En alvorlig, reversibel tilstand i hjernen, der omfatter krampeanfald, højt blodtryk, hovedpine,
• A severe reversible brain condition which includes seizures, high blood pressure, headaches,
Bortezomibs farmakokinetik blev karakteriseret efter intravenøs bolus-administration af 1,3 mg/m2 to gange om ugen hos 104 pædiatriske patienter (2-16 år) med akut lymfoblastær leukæmi (ALL) eller akut myeloid leukæmi (AML).
The pharmacokinetics of bortezomib were characterized following twice weekly intravenous bolus administration of 1.3 mg/m2 doses to 104 paediatric patients (2-16 years old) with acute lymphoblastic leukaemia (ALL) or acute myeloid leukaemia (AML).
Dosisjusteringer i behandlingsforløbet og ved genoptagelse af behandling ved monoterapi
Dose adjustments during treatment and re-initiation of treatment for monotherapy
Bortezomib Accord skal rekonstitueres af sundhedspersonale (se pkt.
Bortezomib Accord must be reconstituted by a healthcare professional (see section 6.6).
Bortezomib Accord er kun til engangsbrug.
Bortezomib Accord is for single use only.
Reducer Bortezomib Accord til 1,0 mg/m2
Reduce Bortezomib Accord to 1.0 mg/m2
Bortezomib Accord-behandlingen skal indstilles, indtil symptomerne på toksicitet er bedret til grad 2 eller bedre.
Bortezomib Accord therapy should be withheld until symptoms of the toxicity have resolved to Grade 2 or better.
Fra et mikrobiologisk synspunkt bør den rekonstituerede opløsning anvendes umiddelbart efter tilberedning, med mindre metoden til åbning/rekonstitution/fortynding udelukker risikoen for mikrobiel forurening.
From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the reconstituted solution should be used immediately after preparation.
Kun IV.
IV only
Ved efterfølgende doser lå de gennemsnitlige maksimale observerede plasmakoncentrationer på 67-106 ng/ml for en dosis på 1,0 mg/m2 og på 89-120 ng/ml for en dosis på 1,3 mg/m2.
In subsequent doses, mean maximum observed plasma concentrations ranged from 67 to 106 ng/ml for the 1.0 mg/m2 dose and 89 to 120 ng/ml for the 1.3 mg/m2 dose.
Forekomsten af herpes zoster blandt patienter i Bz+M+P-behandlingsgruppen var 17 % hos patienter, der ikke havde fået antiviral profylakse, sammenlignet med 3 % hos patienter, der havde fået antiviral profylakse.
The incidence of herpes zoster among patients in the Bz+M+P treatment group was 17% for patients not administered antiviral prophylaxis compared to 3% for patients administered antiviral prophylaxis.
Hvis du ikke er blevet behandlet for myelomatose tidligere, og du ikke er egnet til at få transplantation med blodstamceller, vil du få Bortezomib Accord samtidig med to andre lægemidler; melphalan og prednison.
If you have not been treated before for multiple myeloma, and you are not suitable for blood stem cell transplantation you will receive Bortezomib Accord together with two other medicines; melphalan and prednisone.
Kombinationsbehandling med melphalan og prednison
Combination therapy with melphalan and prednisone
• at Bortezomib Accord 1 mg kun er til intravenøs anvendelse
• that Bortezomib Accord 1 mg is only for intravenous use
Hazard ratio-estimat er baseret på en Cox-model stratificeret efter IPI-risiko og sygdomsstadie.
b Hazard ratio estimate is based on a Cox's model stratified by IPI risk and stage of disease.
Patienter ≥ 75 år tolererede begge regimer dårligere, både BzR-CAP og R-CHOP (se pkt.
In patients aged ≥ 75 years, both regimens, BzR-CAP as well as R-CHOP, were less tolerated (see section 4.8).
Median for investigatorbedømt PFS var 30,7 måneder i BzR-CAP-gruppen og 16,1 måneder i R-CHOP-gruppen (Hazard ratio [HR]=0,51; p < 0,001).
Median PFS by investigator assessment was 30.7 months in the BzR-CAP group and 16.1 months in the R-CHOP group (Hazard Ratio [HR]=0.51; p < 0.001).
Der blev på grund af mangel på en direkte sammenligning af bortezomib og bortezomib i kombination med dexamethason hos patienter med progressiv myelomatose, gennemført en statistisk "matchet par"analyse for at sammenligne resultaterne fra den ikke-randomiserede arm med bortezomib i kombination med dexamethason (åbent fase II-studie MMY-2045) med resultaterne fra bortezomibmonoterapiarmene fra forskellige randomiserede fase III-studier (M34101-039 [APEX] og DOXIL MMY-3001) med samme indikation.
In the absence of any direct comparison between bortezomib and bortezomib in combination with dexamethasone in patients with progressive multiple myeloma, a statistical matched-pair analysis was conducted to compare results from the non randomised arm of bortezomib in combination with dexamethasone (Phase II open-label study MMY-2045), with results obtained in the bortezomib monotherapy arms from different Phase III randomised studies (M34101-039 [APEX] and DOXIL MMY-3001) in the same indication.
Varigheden af det samlede respons var 21,4 måneder længere i BzR-CAP-gruppen (median 36,5 måneder kontra 15,1 måneder i R-CHOP-gruppen).
The duration of overall response was 21.4 months longer in the BzR-CAP group (median 36.5 months versus 15.1 months in the R-CHOP group).
Kombinationsbehandling med pegyleret liposomal doxorubicin
Combination therapy with pegylated liposomal doxorubicin
Når toksiciteten er forsvundet, gives Bortezomib Accord igen, dosis reduceres til 0,7 mg/m2 en gang om ugen.
When toxicity resolves re-initiate Bortezomib Accord treatment and reduce dose to 0.7 mg/m2 once per week.
- Leverbetændelse - Alvorlig allergisk reaktion (anafylaktisk reaktion).
• Hypersensitivity (allergic reaction)
• Hvis trombocyttallet er ≤ 30 × 109/l eller ANC-værdien ≤ 0,75 x 109/l på en Bortezomib Accord-dosisdag (bortset fra dag 1)
• If platelet counts ≤ 30 x 109/l or ANC ≤ 0.75 x 109/l on a Bortezomib Accord dosing day (other than day 1)
Mantel-Haenszel-estimat af den fælles oddsratio for stratificerede tabeller er benyttet, med IPI-risiko og sygdomsstadie som stratifkationsfaktorer.
e Mantel-Haenszel estimate of the common odds ratio for stratified tables is used, with IPI risk and stage of disease as stratification factors.
• at kravene til rekonstitution er forskellige ved intravenøs og subkutan anvendelse
• different reconstitution requirements for intravenous or subcutaneous use
Forekomsten af herpes zoster blandt patienter i BzR-CAP-armen var 10,7 % hos patienter, der ikke havde fået antiviral profylakse, sammenlignet med 3,6 % hos patienter, der havde fået antiviral profylakse (se pkt.
The incidence of herpes zoster among patients in the BzR-CAP arm was 10.7% for patients not administered antiviral prophylaxis compared to 3.6% for patients administered antiviral prophylaxis (see section 4.4).
Bz= Bortezomib Accord; Dx=dexamethason; T=thalidomid a Thalidomid-dosis øges kun til 100 mg fra uge 3 i cyklus 1, hvis 50 mg tåles, og til 200 mg fra og med cyklus 2, hvis 100 mg tåles.
Bz= Bortezomib Accord; Dx=dexamethasone; T=thalidomide a Thalidomide dose is increased to 100 mg from week 3 of Cycle 1 only if 50 mg is tolerated and to 200 mg from cycle 2
OR; 95 % CI; P værdia
OR; 95% CI; P valuea
• rådgivning om reduktion af risikoen for at forveksle sprøjter til intravenøs og subkutan anvendelse
• advice on how to reduce the risk of mix-up of intravenous and subcutaneous reconstituted syringes
Overvej dosisøgning til 1,0 mg/m2 eller yderligere dosisreduktion til 0,5 mg/m2
Consider dose escalation to 1.0 mg/m2 or further dose reduction to 0.5 mg/m2
Pegyleret liposomal doxorubicin administreres i en dosis på 30 mg/ m2 på dag 4 af Bortezomib Accord behandlingscyklussen som en 1-times intravenøs infusion, der administreres efter Bortezomib Accordinjektionen.
Pegylated liposomal doxorubicin is administered at 30 mg/m2 on day 4 of the Bortezomib Accord treatment cycle as a 1 hour intravenous infusion administered after the Bortezomib Accord injection.
Neutrofiltal var lavest på dag 11 i hver cyklus af bortezomib-behandlingen og var typisk vendt tilbage til baseline-niveau ved næste cyklus.
Neutrophils were lowest at Day 11 of each cycle of bortezomib treatment and typically recovered to baseline by the next cycle.
Dosisjustering af kombinationsbehandling for patienter med progressiv myelomatose
Dose adjustments for combination therapy for patients with progressive multiple myeloma
Bortezomib Accord må ikke indgives via andre administrationsveje.
Bortezomib Accord should not be given by other routes.
Tabel 2: Anbefalet dosering for Bortezomib Accord i kombination med melphalan og prednison
Table 2: Recommended posology for Bortezomib Accord in combination with melphalan and prednisone
I fase III-studiet havde patienter, der fik bortezomib subkutant sammenlignet med som intravenøs administration en 13 % lavere samlet forekomst af behandlingsrelaterede bivirkninger i form af toksicitet af grad 3 eller derover, og en 5 % lavere forekomst af seponering af behandling med bortezomib.
In the Phase III study patients who received bortezomib subcutaneously compared to intravenous administration had 13% lower overall incidence of treatment emergent adverse reactions that were Grade 3 or higher in toxicity, and a 5% lower incidence of discontinuation of bortezomib.
Hændelser (dødsfald) n (%) Mediana
Events (deaths) n (%) Mediana
Følgende lægemidler gives som intravenøse infusioner på dag 1 i hver 21-ugers behandlingscyklus med Bortezomib Accord:
The following medicinal products are given on day 1 of each Bortezomib Accord 21-day treatment cycle as intravenous infusions:
Både BzR-CAP og R-CHOP var mindre veltolereret hos patienter ≥ 75 år, og hyppigheden af alvorlige bivirkninger var i BzR-CAP-gruppen 68 % sammenlignet med 42 % i R-CHOP-gruppen.
Although in patients aged ≥ 75 years, both BzR-CAP and R-CHOP were less tolerated, the serious adverse event rate in the BzR-CAP groups was 68%, compared to 42% in the RCHOP group.
Den gennemsnitlige TTP var 6,5 måned for patienter i monoterapi med bortezomib sammenlignet med 9,3 måneder for patienter i kombinationsbehandling med bortezomib plus pegyleret liposomal doxorubicin.
The median TTP was 6.5 months for the bortezomib monotherapy patients compared with 9.3 months for the bortezomib plus pegylated liposomal doxorubicin combination therapy patients.
Yderligere oplysninger om Bortezomib Accord findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Dosering til patienter med tidligere ubehandlet mantle-celle-lymfom (MCL)
Posology for patients with previously untreated mantle cell lymphoma (MCL)
CRf n (%) PRf n (%) nCR n (%) CR+PRf n (%) p-værdid
CRf n (%) PRf n (%) nCR n (%) CR+PRf n (%) p-valued
Læs indlægssedlerne for alle de lægemidler, som du skal tage sammen med Bortezomib Accord, for at få oplysninger om disse lægemidler, før du begynder på behandlingen med Bortezomib Accord.
You must read the package leaflets of all medicinal products to be taken in combination with Bortezomib Accord for information related to these medicines before starting treatment with Bortezomib Accord.
BzR-CAP R-CHOP
BzR-CAP
(95 % CI) p-værdi c a Kaplan-Meier-estimat b Estimatet af Hazard ratio er baseret på Cox' proportionelle risikomodel justeret for stratifikationsfaktorer: β2-mikroglobulin, albumin og region.
b Hazard ratio estimate is based on a Cox proportional-hazard model adjusted for stratification factors: β2-microglobulin, albumin, and region.
• Trombocyttal skal være ≥ 75x 109 celler/l hos patienter med infiltreret knoglemarv eller sekvestration af milten.
• Platelet counts should be ≥ 75,000 cells/μL in patients with bone marrow infiltration or splenic sequestration
Det skal du vide, før du begynder at bruge Bortezomib Accord Brug ikke Bortezomib Accord:
What you need to know before you use Bortezomib Accord Do not use Bortezomib Accord
Bortezomib-behandling skal indstilles ved forekomst af ≥ grad 3 bortezomib-relateret ikke hæmatologisk toksicitet (undtagen neuropati) eller ≥ grad 3 hæmatologisk toksicitet (se også pkt.
Bortezomib treatment must be withheld at the onset of any ≥ Grade 3 bortezomib-related non-haematological toxicities (excluding neuropathy) or ≥ Grade 3 haematological toxicities (see also section 4.4).
Patienter med moderat eller alvorligt nedsat leverfunktion skal starte med en reduceret dosis af Bortezomib Accord på 0,7 mg/m2 pr. injektion i den første behandlingscyklus; efterfølgende dosisøgning til 1,0 mg/m2 eller yderligere dosisreduktion til 0,5 mg/m2 kan overvejes, afhængigt af patientens tolerabilitet (se Tabel 6 samt pkt.
Patients with moderate or severe hepatic impairment should be started on Bortezomib Accord at a reduced dose of 0.7 mg/m2 per injection during the first treatment cycle, and a subsequent dose escalation to 1.0 mg/m2 or further dose reduction to 0.5 mg/m2 may be considered based on patient tolerability (see Table 6 and sections 4.4 and 5.2).
Median OS var 30,8 måneder (95 % CI: 25,2-36,5 måneder) for patienter i monoterapi med bortezomib og 33,0 måneder (95 % CI: 28,9-37,1 måneder) for patienter i kombinationsbehandling med bortezomib plus pegyleret liposomal doxorubicin.
The median OS was 30.8 months (95% CI; 25.2-36.5 months) for the bortezomib monotherapy patients and 33.0 months (95% CI; 28.9-37.1 months) for the bortezomib plus pegylated liposomal doxorubicin combination therapy patients.
Bortezomib Accord-behandlingen skal indstilles, indtil symptomerne på toksiciteten er vurderet til grad 1 eller baseline.
Bortezomib Accord therapy should be withheld until symptoms of the toxicity have resolved to Grade 1 or baseline.
Bortezomib Accord vil blive givet af sundhedspersonale, som har erfaring med behandling med cytostatika.
Bortezomib Accord will be administered by a health care professional experienced in the use of cytotoxic medicines.
- Aktivt stof: bortezomib.
The active substance is bortezomib.
Kun intravenøs anvendelse.
Intravenous use.
- Øvrige indholdsstoffer: Mannitol (E421).
The other ingredient is mannitol (E421).
Der er i kliniske studier rapporteret hypoglykæmi og hyperglykæmi som ikke almindelige og almindelige bivirkninger hos diabetes-patienter i behandling med orale hypoglykæmika.
During clinical trials, hypoglycaemia and hyperglycaemia were uncommonly and commonly reported in diabetic patients receiving oral hypoglycaemics.
Patienterne i begge behandlingsarme fik i gennemsnit 6 cyklusser, hvor 14 % af patienterne i BzR-CAP-armen og 17 % af patienterne i R-CHOP-armen fik 2 supplerende cyklusser.
A median of 6 cycles was received by patients in both treatment arms with 14% of subjects in the BzR-CAP group and 17% of patients in the R-CHOP group receiving 2 additional cycles.
• Ikke-hæmatologiske, toksiske hændelser skal være vurderet til grad 1 eller baseline
• Non-haematological toxicities should have resolved to Grade 1 or baseline
For studiet LYM-3002, hvor bortezomib blev administreret sammen med rituximab, cyclophosphamid, doxorubicin og prednison (R-CAP), præsenteres forekomsten af perifer neuropati i kombinationregimerne i tabellen nedenfor:
In study LYM-3002 in which bortezomib was administered with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CAP), the incidence of peripheral neuropathy in the combination regimens is presented in the table below:
Hvis du får Bortezomib Accord for myelomatose eller mantle-celle-lymfom, skal du straks kontakte din læge, hvis du oplever nogle af nedenstående bivirkninger: - muskelkramper, muskelsvaghed - forvirring, synstab eller -forstyrrelser, blindhed, krampeanfald, hovedpiner - åndenød, hævede fødder eller ændringer i din hjerterytme, højt blodtryk, træthed, besvimelse - hoste og vejrtrækningsbesvær eller trykken for brystet.
If you are given Bortezomib Accord for multiple myeloma or mantle cell lymphoma, tell your doctor straight away if you notice any of the following symptoms: - muscle cramping, muscle weakness - confusion, visual loss or disturbances, blindness, seizures, headaches - shortness of breath, swelling of your feet or changes in your heart beat, high blood pressure,
Hvis du ikke tidligere er blevet behandlet for mantle-celle-lymfom, vil du få Bortezomib Accord intravenøst eller subkutant sammen med lægemidlerne rituximab, cyclophosphamid, doxorubicin og prednison.
If you have not been treated before for mantle cell lymphoma, you will receive Bortezomib Accord intravenously or subcutaneously together with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone.
Patienter, som er egnede til stamcelletransplantation
Patients eligible for stem cell transplantation
Cushings syndrom*, hypertyroidisme*, uhensigtsmæssig produktion af antidiuretikahormon Sjælden Hypotyroidisme
Cushing's syndrome*, Hyperthyroidism*, Inappropriate antidiuretic hormone secretion
Patienterne fik administreret intravenøse doser bortezomib på 0,7 til 1,3 mg/m2 to gange ugentlig.
Patients were administered intravenous doses of 0.7 to 1.3 mg/m2 of bortezomib twice weekly.
Bemærk: OR > 1 tyder på en fordel for Bz-indeholdende induktionsterapi
Note: An OR > 1 indicates an advantage for Bz-containing induction therapy
Perifer neuropati ved kombinationsbehandlinger
Peripheral neuropathy in combination regimens
Forjustering af Bortezomib Accord-dosis: Retningslinjerne for dosisændringer som beskrevet for monoterapi skal følges.
For Bortezomib Accord dosage adjustments, dose modification guidelines described for monotherapy should be followed.
Du vil derfor få taget regelmæssige blodprøver før og under din behandling med Bortezomib Accord for at kontrollere niveauet af dine blodlegemer.
Therefore, you will have to take regular blood tests before and during your treatment with Bortezomib Accord, to check your blood cell counts regularly.
Hvis du har brugt for meget Bortezomib Accord
If you are given too much Bortezomib Accord
Hvis du ikke er blevet behandlet for myelomatose tidligere, og du er egnet til at få transplantation med blodstamceller, vil du få Bortezomib Accord intravenøst eller subkutant samtidig med lægemidlerne dexamethason, eller dexamethason og thalidomid, som induktionsbehandling.
If you have not been treated before for multiple myeloma, and you are suitable for blood stem cell transplantation you will receive Bortezomib Accord intravenously or subcutaneously together with the medicines dexamethasone, or dexamethasone and thalidomide, as induction treatment.
Skift behandlingsplanen for Bortezomib Accord til 1,3 mg/m2 en gang om ugen
Change Bortezomib Accord treatment schedule to 1.3 mg/m2 once per week
Bemærk: OR > 1 tyder på en fordel for Bz-indeholdende induktionsterapi.
Note: An OR > 1 indicates an advantage for Bz-containing induction therapy.
Bortezomib Accord-behandlingen seponeres, indtil toksicitetssymptomerne er forsvundet.
Withhold Bortezomib Accord treatment until symptoms of toxicity have resolved.
Det er nødvendigt, at du får taget regelmæssige blodprøver før og under din behandling med Bortezomib Accord for at kontrollere niveauet af dine blodlegemer.
You will have to take regular blood tests before and during your treatment with Bortezomib Accord, to check your blood cell counts regularly.
Tabel 3: Dosisjusteringer under efterfølgende cyklusser med Bortezomib Accord i kombination med melphalan og prednison
Table 3: Posology modifications during subsequent cycles of Bortezomib Accord therapy in combination with melphalan and prednisone
Følgende lægemidler administreres som intravenøse infusioner på dag 1 i hver 3-ugers behandlingscyklus med bortezomib: rituximab 375 mg/m2, cyclophosphamid 750 mg/m2 og doxorubicin 50 mg/m2.
The following medicinal products are administered on day 1 of each bortezomib 3 week treatment cycle as intravenous infusions: rituximab at 375 mg/m2, cyclophosphamide at 750 mg/m2 and doxorubicin at 50 mg/m2.
n:ITT-patienter
n: ITT patients
Den normale startdosis Bortezomib Accord er 1,3 mg/m2 legemsoverflade to gange om ugen.
The usual starting dose of Bortezomib Accord is 1.3 mg/m2 body surface area twice a week.
• at kravene til rekonstitution af Bortezomib Accord 3,5 mg er forskellige ved intravenøs og subkutan anvendelse
• different reconstitution requirements for Bortezomib Accord 3.5 mg intravenous or subcutaneous use
Pakningsstørrelser og yderligere oplysninger Bortezomib Accord indeholder:
Contents of the pack and other information What Bortezomib Accord contains
Hos patienter med MCL (studie LYM-3002) var forekomsten af herpes zoster-infektion 6,7 % i BzRCAP-armen og 1,2 % i R-CHOP-armen (se pkt.
In patients with MCL (study LYM-3002), the incidence of herpes zoster infection was 6.7% in the BzR-CAP arm and 1.2% in the R-CHOP arm (see section 4.8).
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON 1 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 1 mg
I studie MMY-3010 blev induktionsbehandling med bortezomib i kombination med thalidomid og dexamethason [BzTDx, n=130] sammenlignet med thalidomid-dexamethason [TDx, n=127].
In study MMY-3010 induction treatment with bortezomib combined with thalidomide and dexamethasone [BzTDx, n=130] was compared to thalidomide-dexamethasone [TDx, n=127].
I studier med patienter med recidiverende myelomatose, som blev behandlet med bortezomib, og med patienter med tidligere ubehandlet MCL, som blev behandlet med bortezomib i kombination med rituximab, cyclophosphamid, doxorubicin og prednison (BzR-CAP), var en af de hyppigste hæmatologiske bivirkninger forbigående trombocytopeni.
In studies in patients with relapsed multiple myeloma treated with bortezomib and in patients with previously untreated MCL treated with bortezomib in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BzR-CAP), one of the most common haematologic toxicity was transient thrombocytopenia.