natgillin/translations-raw huggingface dataset:
10 ml klart type I-hætteglas med grå chlorbutyl gummiprop og blå aluminiumshætte med flip-off indeholdende 3,5 mg bortezomib.
10 ml clear Type I glass vial with grey chlorobutyl rubber stopper and blue aluminium flip-off over seal, containing 3.5 mg bortezomib.
Både BR-CAP og R-CHOP var mindre veltolereret hos patienter ≥ 75 år, og hyppigheden af alvorlige bivirkninger var i BR-CAP-gruppen 68 % sammenlignet med 42 % i R-CHOP-gruppen.
Although in patients aged ≥ 75 years, both BR-CAP and R-CHOP were less tolerated, the serious adverse event rate in the BR-CAP groups was 68%, compared to 42% in the R-CHOP group.
Tabel 1: Anbefalede* dosisjusteringer for bortezomibrelateret neuropati Sværhedsgrad af neuropati
Table 1: Recommended* posology modifications for bortezomib-related neuropathy Severity of neuropathy
Den normale startdosis af bortezomib er 1,3 mg/m legemsoverflade to gange om ugen.
The usual starting dose of bortezomib is 1.3 mg/m body surface area twice a week.
Bemærk: OR > 1 tyder på en fordel for bortzomib-indeholdende induktionsterapi
Note: An OR > 1 indicates an advantage for bortezomib-containing induction therapy
Tabel 16: Effektresultater fra studie LYM-3002 Effektmål
Table 16: Efficacy results from study LYM-3002 Efficacy endpoint
Den samlede opbevaringstid for det rekonstituerede lægemiddel må ikke overstige 96 timer (hvis opbevaret ved 25⁰C) og 8 dage (hvis opbevaret ved 2-8⁰C) inden administration.
The total storage time for the reconstituted medicinal product should not exceed 96 hours (if stored at 25°C) and 8 days (if stored at 2-8 °C) prior to administration.
I fase III-studiet, hvor bortezomib administreret intravenøst versus subkutant blev sammenlignet, var forekomsten af hændelser med ≥ grad 2 perifer neuropati 24 % i gruppen, der fik subkutane injektioner, og 41 % i gruppen der fik intravenøse injektioner (p=0,0124).
In the Phase III study comparing bortezomib administered intravenously versus subcutaneously, the incidence of grade ≥ 2 peripheral neuropathy events was 24% for the subcutaneous injection group and 41% for the intravenous injection group (p=0.0124).
Ved anvendelse af thalidomid er det nødvendigt at være særligt opmærksom på behovet for graviditetstests og prævention (se pkt.
When thalidomide is used, particular attention to pregnancy testing and prevention requirements is needed (see section 4.6).
Der er i sjældne tilfælde rapporteret mulige immunkompleksmedierede reaktioner, f.eks. serumsygetypereaktioner, polyarthritis med udslæt og proliferativ glomerulonefritis.
Potentially immunocomplex-mediated reactions, such as serum-sickness-type reaction, polyarthritis with rash and proliferative glomerulonephritis have been reported uncommonly.
Det primære effektmål for studiet var post-induktions- og post-transplantations-responsrater (CR+nCR).
The primary efficacy endpoints of the study were post-induction and post-transplant response rates (CR+nCR).
Når symptomerne er forsvundet, genstartes behandling med bortezomib og reducér dosis til 0,7 mg/m én gang om ugen.
When toxicity resolves re-initiate bortezomib treatment and reduce dose to 0.7 mg/m once per week
Almindelig Urinvejsinfektion*
Urinary tract infection*
Bortezomib-kombinationsbehandling med dexamethason 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 matched-pair-analyse for at sammenligne resultaterne fra den ikke-randomiserede arm med bortezomib i kombination med dexamethason (open-label fase II-studie MMY-2045) med resultaterne fra bortezomib-monoterapiarmene fra forskellige randomiserede fase III-studier (M34101-039 [APEX] og DOXIL MMY-3001) med samme indikation.
Bortezomib combination treatment with dexamethasone 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.
Neutrofiltallet 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.
• Infektioner, herunder urinvejsinfektioner, influenza, herpes virusinfektioner, øreinfektion og cellulitis
• Infections including urinary tract infections, the flu, herpes virus infections, ear infection and cellulitis
Almindelig Vertigo*
Vertigo*
Tabel 7: Bivirkninger hos patienter med myelomatose behandlet med bortezomib i kliniske studier samt alle bivirkninger fremkommet efter markedsføring, uanset indikation Systemorganklasse
Table 7: Adverse reactions in patients with multiple myeloma treated with bortezomib in clinical trials and all post-marketing adverse reactions regardless of indication
I generelle toksicitetsstudier med flere cyklusser med rotter og aber omfattede de vigtigste målorganer mave-tarm-kanalen, hvilket resulterede i opkastning og/eller diarré; hæmatopoietisk og lymfatisk væv, hvilket resulterede i perifere blodcytopenier; lymfoidt vævsatrofi og hæmatopoietisk hypocellularitet i knoglemarven; perifer neuropati (set hos aber, mus og hunde) som involverer sensoriske nerveaxoner og mindre forandringer i nyrerne.
In multi-cycle general toxicity studies conducted in the rat and monkey, the principal target organs included the gastrointestinal tract, resulting in vomiting and/or diarrhoea; haematopoietic and lymphatic tissues, resulting in peripheral blood cytopenias, lymphoid tissue atrophy and haematopoietic bone marrow hypocellularity; peripheral neuropathy (observed in monkeys, mice and dogs) involving sensory nerve axons; and mild changes in the kidneys.
Hos patienter med fremskreden myelom var sværhedsgraden af trombocytopeni relateret til trombocyttallet før behandlingen: for trombocyttal ved baseline < 75.000/µl havde 90 % af 21 patienter et tal på ≤ 25.000/µl under studiet, herunder 14 % < 10.000/µl.
In patients with advanced myeloma the severity of thrombocytopenia was related to pre-treatment platelet count: for baseline platelet counts < 75,000/μl, 90% of 21 patients had a count ≤ 25,000/μl during the study, including 14% < 10,000/μl; in contrast, with a baseline platelet count > 75,000/μl, only 14% of 309 patients had a count ≤ 25,000/μl during the study.
Studiets primære effektmål var post-induktions-responsrate (CR+nCR).
The primary efficacy endpoint of the study was post-induction response rate (CR+nCR).
Seponér behandling med bortezomib, indtil symptomer på toksicitet er forsvundet.
Withhold bortezomib treatment until symptoms of toxicity have resolved.
Der blev observeret en statistisk signifikant forskel i CR+nCR til fordel for gruppen med bortezomib i kombination med dexamethason.
A statistically significant difference in CR+nCR was observed in favour of the bortezomib combined with dexamethasone group.
Patienterne i begge behandlingsarme fik i gennemsnit 6 cyklusser, hvor 14 % af patienterne i BR-CAP-armen og 17 % af patienterne i R-CHOP-armen fik yderligere 2 cyklusser.
A median of 6 cycles was received by patients in both treatment arms with 14% of subjects in the BR-CAP group and 17% of patients in the R-CHOP group receiving 2 additional cycles.
Analysen påviste forbedret ORR (CR+PR) (odds-ratio 3,769; 95 % CI 2,045-6,947; p < 0,001), PFS (hazard ratio 0,511; 95 % CI 0,309-0,845; p=0,008),
The analysis demonstrated improved ORR (CR+PR) (odds ratio 3.769; 95% CI 2.045-6.947; p < 0.001), PFS (hazard ratio 0.511; 95% CI 0.309-0.845; p=0.008), TTP (hazard ratio 0.385; 95% CI 0.212-0.698; p=0.001) for bortezomib in combination with dexamethasone over bortezomib monotherapy.
Samlet overlevelse* Hændelser (dødsfald) n (%) Median a
Overall survival* Events (deaths) n (%) Median a
Subkutan anvendelse: Tilsæt 1,4 ml natriumchlorid 0,9%, så den endelige koncentration bliver 2,5 mg/ml.
Subcutaneous use: Add 1.4 ml sodium chloride 0.9% to make 2.5 mg/ml final concentration.
• Hvis toksiciteten forsvinder dvs. patienten har en ANC ≥ 750 celler/μl og et trombocyttal ≥ 25.000 celler/μl, kan bortezomib re-initieres ved en dosis, som er reduceret 1 dosisniveau (fra 1,3 mg/m til 1 mg/m 2, eller fra 1 mg/m til 0,7
- If toxicity resolves i.e. patient has an ANC ≥ 750 cells/μL and a platelet count ≥ 25,000 cells/μL, bortezomib may be reinitiated at a dose reduced by one dose level (from 1.3 mg/m to 1 mg/m 2, or from
Hvis du ikke tidligere er blevet behandlet for mantle-celle-lymfom, vil du få bortezomib 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 intravenously or subcutaneously together with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone.
Bortezomib Fresenius Kabi 3,5 mg rekonstitueret opløsning indgives subkutant i låret (højre eller venstre) eller abdomen (højre eller venstre side).
Bortezomib Fresenius Kabi 3.5 mg reconstituted solution is administered subcutaneously through the thighs (right or left) or abdomen (right or left).
Det gennemsnitlige distributionsvolumen (Vd) for bortezomib var 1.659-3.294 l efter indgift af enkeltdoser eller gentagne intravenøse doser på 1,0 mg/m eller 1,3 mg/m til patienter med myelomatose.
The mean distribution volume (Vd) of bortezomib ranged from 1,659 l to 3,294 l following singleor repeated-dose intravenous administration of 1.0 mg/m or 1.3 mg/m to patients with multiple myeloma.
Patienter tidligere behandlet for let kæde (AL) amyloidose Der blev udført et open-label, ikke-randomiseret fase I/II-studie for at bestemme bortezomibs sikkerhed og effekt hos patienter, der tidligere var blevet behandlet for AL-amyloidose.
Patients with previously treated light-chain (AL) Amyloidosis An open label non randomised Phase I/II study was conducted to determine the safety and efficacy of bortezomib in patients with previously treated light-chain (AL) Amyloidosis.
I studie IFM-2005-01 blev bortezomib i kombination med dexamethason [BDx, n=240] sammenlignet med vincristin-doxorubicin-dexamethason [VDDx, n=242].
In study IFM-2005-01 bortezomib combined with dexamethasone [BDx, n=240] was compared to vincristine-doxorubicin-dexamethasone [VDDx, n=242].
Almindelig Hypersensitivitet* Ikke almindelig Anafylaktisk reaktion
Hypersensitivity* Uncommon Anaphylactic reaction
For studiet LYM-3002, hvor bortezomib blev administreret sammen med rituximab, cyclophosphamid, doxorubicin og prednison (BR-CAP), præsenteres forekomsten af perifer neuropati i kombinationsregimerne i tabellen nedenfor:
In study LYM-3002 in which bortezomib was administered with rituximab, cyclophosphamide, doxorubicin, and prednisone (BR-CAP), the incidence of peripheral neuropathy in the combination regimens is presented in the table below:
Baseret på log-rank-test stratificeret efter IPI-risiko og sygdomsstadie.
d Based on Log rank test stratified with IPI risk and stage of disease.
Hos patienter med MCL (studie LYM-3002) var forekomsten af herpes zoster-infektion 6,7 % i BRCAP-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 BR-CAP arm and 1.2% in the R-CHOP arm (see section 4.8).
BILAG III
ANNEX I
Bortezomib-behandlingen skal indstilles, indtil symptomerne på toksiciteten er vurderet til grad 1 eller baseline.
Bortezomib therapy should be withheld until symptoms of the toxicity have resolved to grade 1 or baseline.
• Hvis toksiciteten ikke bedres, som beskrevet ovenfor efter bortezomib har været tilbageholdt, skal bortezomib seponeres.
- If, after bortezomib has been held, the toxicity does not resolve, as defined above, then bortezomib must be discontinued.
på dag 1, cyclophosphamid 750 mg/m i.v.
IV on day 1; cyclophosphamide 750 mg/m
Den gennemsnitlige eliminationshalveringstid (t½) for bortezomib efter gentagne doser var mellem 40193 timer.
The mean elimination half-life (t1/2) of bortezomib upon multiple dosing ranged from 40-193 hours.
Når toksicitetssymptomerne er forsvundet, kan behandlingen med bortezomib genoptages med en dosis, der er reduceret med 25 % (1,3 mg/m2 reduceret til 1,0 mg/m2; 1,0 mg/m2 reduceret til 0,7
Once the symptoms of the toxicity have resolved, bortezomib treatment may be re-initiated at a 25% reduced dose (1.3 mg/m reduced to 1.0 mg/m 2; 1.0 mg/m reduced to 0.7 mg/m 2).
Klinisk virkning hos tidligere ubehandlede myelomatose Et prospektivt, internationalt, randomiseret (1:1), open-label klinisk fase III-studie (MMY-3002 VISTA) med 682 patienter blev gennemført for at bestemme, om bortezomib (1,3 mg/m som intravenøs injektion) i kombination med melphalan (9 mg/m 2) og prednison (60 mg/m 2) medførte en forbedring i tid til progression (TTP) ved sammenligning med melphalan (9 mg/m2) og prednison (60
Clinical efficacy in previously untreated multiple myeloma A prospective Phase III, international, randomised (1:1), open-label clinical study (MMY-3002 VISTA) of 682 patients was conducted to determine whether bortezomib (1.3 mg/m injected intravenously) in combination with melphalan (9 mg/m 2) and prednisone (60 mg/m 2) resulted in improvement in time to progression (TTP) when compared to melphalan (9 mg/m 2) and prednisone
• Rådgivning om reduktion af risikoen for at forveksle sprøjter til i.v.
• advice on how to reduce the risk of mix-up of IV and SC reconstituted syringes
- Sammen med lægemidlerne dexamethason eller dexamethason sammen med thalidomid til patienter, hvis sygdom ikke tidligere er blevet behandlet, og før de får højdosis-kemoterapi med transplantation af blodstamceller (induktionsbehandling).
- in combination with the medicines dexamethasone or dexamethasone together with thalidomide, for patients whose disease has not been previously treated and before receiving high-dose chemotherapy with blood stem cell transplantation (induction treatment).
• Diarré, forstoppelse, kvalme eller kaster op
• diarrhoea, constipation, nausea or vomiting
Intravenøs anvendelse: Tilsæt 3,5 ml natriumchlorid 0,9%, så den endelige koncentration bliver 1 mg/ml.
Intravenous use: Add 3.5 ml sodium chloride 0.9% to make 1 mg/ml final concentration.
Hos patienter med MCL (studie LYM-3002) var der en højere forekomst (56,7 % versus 5,8 %) af grad ≥ 3 trombocytopeni i bortezomib-behandlingsgruppen (BR-CAP) sammenlignet med nonbortezomib-behandlingsgruppen (rituximab, cyclophosphamid, doxorubicin, vincristin og prednison (R-CHOP)).
In patients with MCL (study LYM-3002), there was a higher incidence (56.7% versus 5.8%) of grade ≥ 3 thrombocytopenia in the bortezomib treatment group (BR-CAP) as compared to the non-bortezomib treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]).
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 (BR-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 (BR-CAP), one of the most common haematologic toxicity was transient thrombocytopenia.
Responsrate ved 4 cyklusser n (%) ORR (CR+PR) p-værdi a
Response Rate at 4 cycles n (%) ORR (CR+PR) p-value a
Der blev observeret en statistisk signifikant forskel i CR+nCR til fordel for gruppen, der fik bortezomib i kombination med dexamethason og thalidomid.
A statistically significant difference in CR+nCR was observed in favour of the bortezomib combined with dexamethasone and thalidomide group.
Tabel 5: Dosisjustering under behandlingen af patienter med tidligere ubehandlet mantlecellelymfom
Table 5: Dose adjustments during treatment for patients with previously untreated mantle cell lymphoma
Dissemineret intravaskulær koagulation, thrombocytose*, hyperviskositetssyndrom, uspecificeret påvirkning af thrombocytfunktionen, trombotisk mikroangiopati (herunder thrombocytopenisk purpura)
Disseminated intravascular coagulation, Thrombocytosis*, Hyperviscosity syndrome, Platelet disorder NOS, Thrombotic microangiopathy (including thrombocytopenic purpura)
Et enarmet, fase II, aktivitets-, sikkerheds- og farmakokinetikstudie udført af Children's Oncology Goup evaluerede virkningen af at tilføje bortezomib til reinduktionskemoterapi med flere stoffer hos pædiatriske og unge voksne patienter med lymfoide maligne sygdomme (ALL), T-celle ALL og Tcelle lymfoblastisk lymfom (LL)).
A Phase II, single arm activity, safety, and pharmacokinetic trial conducted by the Children's Oncology Group assessed the activity of the addition of bortezomib to multi agent re induction chemotherapy in paediatric and young adult patients with lymphoid malignancies (pre-B cell acute lymphoblastic leukemia [ALL], T-cell ALL, and T-cell lymphoblastic lymphoma [LL]).
Patienterne fik administreret intravenøse doser bortezomib på 0,7 til 1,3 mg/m to gange ugentlig.
Patients were administered intravenous doses of 0.7 to 1.3 mg/m of bortezomib twice weekly.
Det er yderst vigtigt, at der anvendes aseptisk teknik under håndteringen af bortezomib, da det ikke indeholder konserveringsmiddel.
Aseptic technique must be strictly observed throughout the handling of bortezomib, since it contains no preservative.
Du vil derfor få taget regelmæssige blodprøver før og under din behandling med bortezomib for at kontrollere niveauet af dine blodlegemer.
Therefore, you will have to take regular blood tests before and during your treatment with bortezomib, to check your blood cell counts regularly.
Tabel 3: Dosisjusteringer under efterfølgende behandlingscyklusser med bortezomib i kombination med melphalan og prednison
Table 3: Posology modifications during subsequent cycles of bortezomib therapy in combination with melphalan and prednisone Toxicity
Der foreligger begrænsede oplysninger om bortezomib til behandling af recidiverende myelomatose.
Limited information on bortezomib retreatment in relapsed multiple myeloma is available.
Det er nødvendigt, at du får taget regelmæssige blodprøver før og under din behandling med bortezomib for at kontrollere niveauet af dine blodlegemer.
You will have to take regular blood tests before and during your treatment with bortezomib, to check your blood cell counts regularly.
Bortezomib Fresenius Kabi 3,5 mg rekonstitueret opløsning indgives som en intravenøs bolusinjektion af 3-5 sekunders varighed gennem et perifert eller centralt intravenøst kateter efterfulgt af skylning med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning.
Bortezomib Fresenius Kabi 3.5 mg reconstituted solution is administered as a 3-5 second bolus intravenous injection through a peripheral or central intravenous catheter followed by a flush with sodium chloride 9 mg/ml (0.9%) solution for injection.
Kemisk og fysisk brugsstabilitet af den rekonstituerede opløsning er påvist i koncentrationer på 1 mg/ml og 2,5 mg/ml i 96 timer ved 25 °C og 8 dage ved 2-8⁰C, når opbevaret i det originale hætteglas og/eller sprøjte.
The chemical and physical in-use stability of the reconstituted solution has been demonstrated at concentrations of 1 mg/ml and 2.5 mg/ml for 96 hours at 25°C and 8 days at 2-8°C, when stored in the original vial and/or a syringe.
Dosisjusteringer i behandlingsforløbet og ved genoptagelse af behandling ved monoterapi Bortezomib skal seponeres ved forekomst af enhver ikke-hæmatologisk grad 3-toksicitet eller enhver hæmatologisk grad 4-toksicitet med undtagelse af neuropati som beskrevet nedenfor (se pkt.
Dose adjustments during treatment and re-initiation of treatment for monotherapy Bortezomib treatment must be withheld at the onset of any grade 3 non-haematological or any grade 4 haematological toxicities, excluding neuropathy as discussed below (see also section 4.4).
I studie MMY-3010 blev induktionsbehandling med bortezomib i kombination med thalidomid og dexamethason [BTDx, n=130] sammenlignet med thalidomid-dexamethason [TDx, n=127].
In study MMY-3010 induction treatment with bortezomib combined with thalidomide and dexamethasone [BTDx, n=130] was compared to thalidomide-dexamethasone [TDx, n=127].
Tid til progression hændelser n (%) Median a
Time to progression Events n (%) Median a
Median varighed Dage (måneder) Tid til respons CR+PR (dage)
Time to response CR+PR (days)
Forkortelser: SGOT = serum-glutamin-oxalsyre-transaminase, ASAT = aspartat-aminotransferase, ULN = øvre grænse for normalområdet.
AST=aspartate aminotransferase; ULN=upper limit of the normal range.
1.3 Kemisk og fysisk brugsstabilitet af den rekonstituerede opløsning er påvist i koncentrationer på 1 mg/ml og 2,5 mg/ml i 96 timer ved 25 °C og 8 dage ved 2-8⁰C, når opbevaret i det originale hætteglas og/eller sprøjte.
1.3 The chemical and physical in-use stability of the reconstituted solution has been demonstrated at concentrations of 1 mg/ml and 2.5 mg/ml for 96 hours at 25°C and 8 days at 2-8°C, when stored in the original vial and/or a syringe.
I studie LYM-3002 fik 78 % af patienterne i BR-CAP-armen og 61 % af patienterne i R-CHOP-armen support med kolonistimulerende faktor.
In study LYM-3002, colony stimulating factor support was given to 78% of patients in the BR-CAP arm and 61% of patients in the R-CHOP arm.
Dosisjustering af kombinationsbehandling for patienter med progressiv myelomatose Dosisjustering for bortezomib ved kombinationsbehandling skal følge retningslinjerne, der er beskrevet under monoterapi ovenfor.
Dose adjustments for combination therapy for patients with progressive multiple myeloma For bortezomib dosage adjustments for combination therapy follow dose modification guidelines described under monotherapy above.
Den samlede forekomst af hepatitis B-infektion var sammenlignelig hos patienter i BR-CAParmen og patienter i R-CHOP-armen (henholdsvis 0,8 % vs. 1,2 %).
The overall incidence of hepatitis B infections was similar in patients treated with BR-CAP or with R-CHOP (0.8% vs 1.2% respectively).
Hver karton af Bortezomib Fresenius Kabi 3,5 mg pulver til injektionsvæske, opløsning indeholder et 10 ml klart hætteglas med grå gummiprop og blå aluminiumshætte med flip-off indeholdende 3,5 mg bortezomib.
Each carton of Bortezomib Fresenius Kabi 3.5 mg powder for solution for injection contains a 10 ml clear glass-vial with grey rubber stopper and aluminium blue flip-off over seal, containing 3.5 mg bortezomib.
Estimatet af hazard ratio er baseret på en Cox-model justeret for stratifikationsfaktorer: ISS-score og antal tidligere behandlinger.
Hazards ratio estimate is based on a Cox model adjusted for stratification factors: ISS staging and number of prior lines.
Der findes yderligere information i produktresuméet for rituximab.
Refer to the Summary of Product Characteristics of rituximab for more information.
• Tidligere har haft problemer med følelsesløshed, følelse af prikken eller smerte i hænder eller fødder (neuropati)
• numbness, tingling, or pain in the hands or feet (neuropathy) in the past
Almindelig Kløe*, dermatitis*, udslæt*
Pruritus*, Dermatitis*, Rash*
Der er rapporteret meget sjældne tilfælde af John Cunningham-virusinfektion (JC-virus), der førte til PML og død, hos patienter behandlet med bortezomib.
Progressive multifocal leukoencephalopathy (PML) Very rare cases with unknown causality of John Cunningham (JC) virus infection, resulting in PML and death, have been reported in patients treated with bortezomib.
på dag 1 og prednison 100 mg/m2 oralt på dag 1 til og med dag 5 af bortezomib-behandlingscyklussens 21
IV on day 1; and prednisone 100 mg/m orally on day 1 through day 5 of the 21 day bortezomib treatment cycle.