natgillin/translations-raw huggingface dataset:
VELCADE kombineret med melphalan og prednison er indiceret til behandling af patienter med tidligere ubehandlet myelomatose, som er uegnede til højdosis kemoterapi med knoglemarvstransplanation.
VELCADE in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with bone marrow transplant.
VELCADE er indiceret til monoterapi af progressiv myelomatose, hos patienter som tidligere har modtaget mindst én behandling og som allerede har gennemgået eller er uegnet til en knoglemarvstransplantation.
VELCADE is indicated as monotherapy for the treatment of progressive multiple myeloma in patients who have received at least 1 prior therapy and who have already undergone or are unsuitable for bone marrow transplantation.
Den anbefalede startdosis bortezomib er 1, 3 mg/ m2 kropsareal to gange om ugen i to uger (dag 1, 4, 8 og 11) efterfulgt af en 10- dages pause (dag 12- 21).
Posology for monotherapy The recommended starting dose of bortezomib is 1.3 mg/ m2 body surface area twice weekly for two weeks (days 1, 4, 8, and 11) followed by a 10-day rest period (days 12-21).
Denne 3- ugers periode kaldes en behandlingscyklus.
This 3-week period is considered a treatment cycle.
Der skal gå mindst 72 timer mellem de efterfølgende doser VELCADE.
At least 72 hours should elapse between consecutive doses of VELCADE.
Det anbefales, at patienter med bekræftet, komplet respons får yderligere to cyklusser med VELCADE efter en bekræftelse.
It is recommended that patients with a confirmed complete response receive 2 additional cycles of VELCADE beyond a confirmation.
I øjeblikket er der begrænsede data vedrørende genbehandling med VELCADE.
Currently there are limited data concerning re-treatment with VELCADE.
4. 4).
Dose adjustments during treatment and re-initiation of treatment for monotherapy VELCADE 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).
Når toksicitetssymptomerne er forsvundet, kan behandlingen med VELCADE genoptages i 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 mg/ m2).
Once the symptoms of the toxicity have resolved, VELCADE treatment may be re-initiated at a 25% reduced dose (1.3 mg/ m2 reduced to 1.0 mg/ m2; 1.0 mg/ m2 reduced to 0.7 mg/ m2).
4. 4).
2 Patients who experience bortezomib-related neuropathic pain and/ or peripheral neuropathy are to be managed as presented in Table 1 (see section 4.4).
Patienter med præ- eksisterende, svær neuropati må kun behandles med VELCADE efter en omhyggelig vurdering af risici og fordele.
Patients with pre-existing severe neuropathy may be treated with VELCADE only after careful risk/ benefit assessment.
Anbefalede * dosisændringer ved bortezomib- relateret neuropati
Recommended* posology modifications for bortezomib-related neuropathy.
Sværhedsgrad af perifer neuropati Grad 1 (paræstesi, svækkelse og/ eller tab af reflekser) uden smerter eller funktionstab
Severity of neuropathy Grade 1 (paraesthesia, weakness and/ or loss of reflexes) with no pain or loss of function
Dosisændringer Ingen ændring
Posology modification No action
Grad 1 med smerter eller grad 2 (funktionsforstyrrelser, som ikke påvirker de daglige gøremål)
Grade 1 with pain or Grade 2 (interfering with function but not with activities of daily living)
Reduceres til 1, 0 mg/ m2
Reduce to 1.0 mg/ m2
Grad 2 med smerter eller grad 3 (påvirker de daglige gøremål)
Grade 2 with pain or Grade 3 (interfering with activities of daily living)
VELCADE- behandlingen seponeres, indtil toksicitetssymptomerne er forsvundet.
Withhold VELCADE treatment until symptoms of toxicity have resolved.
Når toksiciteten er forsvundet, gives VELCADE igen, dosis reduceres til 0, 7 mg/ m2, og behandlingsplanen ændres til en gang om ugen.
When toxicity resolves re-initiate VELCADE treatment and reduce dose to 0.7 mg/ m2 and change treatment schedule to once per week.
Grad 4 (invaliderende sensorisk neuropati eller motorisk neuropati, som er livstruende eller medfører lammelse) og/ eller autonom svær neuropati
Grade 4 (sensory neuropathy which is disabling or motor neuropathy that is life threatening or leads to paralysis) and/ or severe autonomic neuropathy
* Baseret på dosisændringer i fase II - og III- forsøg vedrørende multipelt myelom og erfaring efter markedsføring.
*Based on posology modifications in Phase II and III multiple myeloma studies and post-marketing experience.
5. 1 og 5. 2).
Paediatric patients VELCADE is not intended for use in children below 18 due to lack of data on safety and efficacy (see sections 5.1 and 5.2).
4. 8).
Elderly patients There is no evidence to suggest that dose adjustments are necessary in the patients over 65 years of age (see section 4.8).
Det er derfor ikke nødvendigt at justere doseringen til disse patienter.
Renal impairment The pharmacokinetics of bortezomib are not influenced in patients with mild to moderate renal impairment (CrCL (Creatinine Clearance) > 20 ml/ min/ 1.73 m2); therefore, dose adjustments are not necessary for these patients.
Det er uvist, om bortezomibs farmakokinetik bliver påvirket hos patienter med svært nedsat nyrefunktion, som ikke er i dialyse (CrCL < 20 ml/ min/ 1, 73 m2).
It is unknown if the pharmacokinetics of bortezomib are influenced in patients with severe renal impairment not undergoing dialysis (CrCL < 20 ml/ min/ 1.73 m2).
5. 2).
Since dialysis may reduce bortezomib concentrations, VELCADE should be administered after the dialysis procedure (see section 5.2).
VELCADE er ikke undersøgt til patienter med nedsat leverfunktion.
Hepatic impairment VELCADE has not been studied in patients with impaired hepatic function.
Signifikant nedsat leverfunktion kan indvirke på eliminationen af bortezomib og kan øge sandsynligheden for interaktioner med andre aktive stoffer.
Significant hepatic impairment may have an impact on the elimination of bortezomib and may increase the likelihood of interactions with other active substances.
4. 3 og 4. 4).
Patients with impaired liver function should be treated with extreme caution and a dose reduction should be considered (see sections 4.3 and 4.4).
VELCADE (bortezomib) indgives som en intravenøs bolusinjektion kombineret med oral melphalan og oral prednison i ni 6- ugers behandlingscyklusser som vist i tabel 2.
Posology for combination therapy VELCADE (bortezomib) is administered in combination with oral melphalan and oral prednisone for nine 6-week treatment cycles as shown in Table 2.
I cyklus 1- 4 indgives VELCADE to gange om ugen (dag 1, 4, 8, 11, 22, 25, 29 og 32).
In Cycles 1-4, VELCADE is administered twice weekly (days 1, 4, 8, 11, 22, 25, 29 and 32).
I cyklus 5- 9 indgives VELCADE en gang om ugen (dag 1, 8, 22 og 29).
In Cycles 5-9, VELCADE is administered once weekly (days 1, 8, 22 and 29).
Melphalan og prednison bør begge gives oralt på dag 1, 2, 3 og 4 i den første uge af hver cyklus.
Melphalan and prednisone should both be given orally on days 1, 2, 3 and 4 of the first week of each cycle.
3 Tabel 2- Anbefalet dosering for VELCADE i kombination med melphalan og prednison til patienter med tidligere ubehandlet myelomatose VELCADE to gange om ugen (cyklus 1- 4)
Table 2: Recommended posology for VELCADE in combination with melphalan and prednisone for patients with previously untreated multiple myeloma Twice weekly VELCADE (cycles 1-4)
dag dag dag
-- Day Day 8 Day
hvile
rest Day Day Day Day
dag
rest
dag dag dag
(
4 8
4
25 29 32
25
M (9 mg/ m2) P (60 mg/ m2)
M (9 mg/ m2)
dag dag dag dag 1 2 3
Day Day Day
hvile -- -- -- --
-- -- rest -- -- -- --
hvile
rest
VELCADE en gang om ugen (cyklus 5- 9)
P (60 mg/ m2)
Uge
1 2 3 4 period
-- --
period
dag hvile dag
period
dag
Once weekly VELCADE (cycles 5-9)
hvile
Week
8 22
Day 8
M (9 mg/ m2) P (60 mg/ m2)
1.3 mg/ m2)
dag dag 1
1
dag dag 2 3
(9 mg/ m2) (60 mg/ m2)
4
Day 1
-- hvile --
Day Day Day 2 3 4
hvile
rest period
Vc = VELCADE; M = melphalan, P = prednison
Vc = VELCADE; M = melphalan, P=prednisone
Dosisændringer ved kombinationsbehandling
Dose adjustments for combination therapy
Dosisændringer og genoptagelse af behandling, når VELCADE indgives i kombination med melphalan og prednison.
Dose modification and re-initiation of therapy when VELCADE is administered in combination with melphalan and prednisone
Før påbegyndelse af en ny behandlingscyklus: • Trombocyttal skal være ≥ 70 x 109/ l, og absolut neutrofiltal skal være ≥ 1, 0 x 109/ l • Ikke- hæmatologiske, toksiske hændelser skal være vurderet til grad 1 eller baseline
Prior to initiating a new cycle of therapy: • Platelet counts should be ≥ 70 x 109/ l and the absolute neutrophils count should be ≥ 1.0 x 109/ l • Non-haematological toxicities should have resolved to Grade 1 or baseline
Toksicitet
Table 3: Posology modifications during subsequent cycles:
Dosisændring eller udsættelse
Toxicity Haematological toxicity during a cycle
Hæmatologisk toksicitet i løbet af en cyklus:
Posology modification or delay
Overvej reduktion af melphalandosis med 25% i den næste cyklus.
Consider reduction of the melphalan dose by 25% in the next cycle.
• Hvis trombocyttallet er ≤ 30 × 109/ l eller ANC - værdien ≤ 0, 75 x 109/ l på en VELCADE - dosisdag (bortset fra dag 1)
• If platelet counts ≤ 30 × 109/ l or ANC ≤ 0.75 x 109/ l on a VELCADE dosing day (other than Day 1)
VELCADE- behandling skal tilbageholdes
VELCADE therapy should be withheld
• Hvis flere VELCADE- doser i en cyklus tilbageholdes (≥ 3 doser under indgift to gange om ugen eller ≥ 2 doser under indgift en gang om ugen)
• If several VELCADE doses in a cycle are withheld (≥ 3 doses during twice weekly administration or ≥ 2 doses during weekly administration)
VELCADE- dosis skal reduceres med 1 dosisniveau (fra 1, 3 mg/ m2 til 1 mg/ m2 eller fra 1 mg/ m2 til 0, 7 mg/ m2) VELCADE- behandlingen skal tilbageholdes, indtil
VELCADE dose should be reduced by 1 dose level (from 1.3 mg/ m2 to 1 mg/ m2, or from 1 mg/ m2 to 0.7 mg/ m2) VELCADE therapy should be withheld until
Ikke- hæmatologiske, toksiske hændelser af grad ≥ 3
Grade ≥ 3 non-haematological toxicities
symptomerne på toksiciteten er vurderet til grad 1 eller baseline.
symptoms of the toxicity have resolved to Grade 1 or baseline.
VELCADE kan så genoptages med reduktion af et dosisniveau (fra 1, 3 mg/ m2 til 1 mg/ m2 eller fra 1 mg/ m2 til 0, 7 mg/ m2).
Then, VELCADE may be reinitiated with one dose level reduction (from 1.3 mg/ m2 to 1 mg/ m2, or from 1 mg/ m2 to 0.7 mg/ m2).
I tilfælde af VELCADE- relateret neuropatisk smerte og/ eller perifer neuropati holdes og/ eller modificeres VELCADE som beskrevet i tabel 1.
For VELCADE-related neuropathic pain and/ or peripheral neuropathy, hold and/ or modify VELCADE as outlined in Table 1.
Indgivelsesmåde Den rekonstituerede 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.
Method of administration The 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.
Overfølsomhed over for bortezomib, bor eller et eller flere af hjælpestofferne.
Hypersensitivity to bortezomib, boron or to any of the excipients.
4. 4).
Severe hepatic impairment (see section 4.4).
Akut diffus infiltrativ lunge - og perikardial sygdom.
Acute diffuse infiltrative pulmonary and pericardial disease.
Gastrointestinal toksicitet Gastrointestinal toksicitet, inklusive kvalme, diaré, opkastning og forstoppelse, er meget almindelig ved behandling med VELCADE.
Gastrointestinal toxicity Gastrointestinal toxicity, including nausea, diarrhoea, vomiting and constipation are very common with VELCADE treatment.
4. 8), og derfor skal patienter, som oplever forstoppelse, monitoreres omhyggeligt.
Cases of ileus have been uncommonly reported (see section 4.8); therefore patients who experience constipation should be closely monitored.
Hæmatologisk toksicitet Behandlingen med Velcade forbindes meget ofte med hæmatologisk toksicitet (trombocytopeni, neutropeni og anæmi).
Haematological toxicity VELCADE treatment is very commonly associated with haematological toxicities (thrombocytopenia, neutropenia and anaemia).
Den mest almindelige hæmatologiske toksicitet er forbigående trombocytopeni.
The most common haematologic toxicity is transient thrombocytopenia.
Trombocyttallet var lavest på dag 11 i hver behandlingscyklus med VELCADE.
Platelets were lowest at Day 11 of each cycle of VELCADE treatment.
Der var ingen tegn på kumulativ trombocytopeni, heller ikke i det udvidede fase II- forsøg.
There was no evidence of cumulative thrombocytopenia, including in the Phase II extension study.
40% af værdien ved baseline.
The mean platelet count nadir measured was approximately 40% of baseline.
I modsætning hertil havde kun 14% af 309 patienter med et trombocyttal på > 75. 000/ µl et tal på ≤25 x 109/ l under forsøget.
In patients with advanced myeloma the severity of thrombocytopenia was related to pre-treatment platelet count: for baseline platelet counts < 75,000/μ l, 90% of 21 patients had a count ≤ 25,000/ μ l 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 ≤25×109/l during the study.
Trombocyttallet skal monitoreres før hver dosis VELCADE.
Platelet counts should be monitored prior to each dose of VELCADE.
Behandlingen skal indstilles, når trombocyttallet er < 25. 000/ µl og påbegyndes igen med nedsat dosis efter resolution (se pkt.
Therapy should be held when the platelet count is < 25,000/μ l and re-initiated at a reduced dose after resolution (see section 4.2).
Derfor skal totale blodtællinger (CBC), inklusive trombocyttal, gennemføres hyppigt under behandlingen med VELCADE.
Therefore, complete blood counts (CBC) including platelet counts should be frequently monitored throughout treatment with VELCADE.
Perifer neuropati Behandling med VELCADE er meget ofte forbundet med perifer neuropati, som er overvejende sensorisk.
Peripheral neuropathy Treatment with VELCADE is very commonly associated with peripheral neuropathy, which is predominantly sensory.
Det anbefales, at patienter monitoreres omhyggeligt for symptomer på neuropati, f. eks. brændende fornemmelse, hyperæstesi, hypoæstesi, paræstesi, ubehag, neuropatiske smerter eller svækkelse.
It is recommended that patients be carefully monitored for symptoms of neuropathy such as a burning sensation, hyperesthesia, hypoesthesia, paraesthesia, discomfort, neuropathic pain or weakness.
4. 2).
Patients experiencing new or worsening peripheral neuropathy should undergo neurological evaluation and may require the dose and schedule of VELCADE to be modified (see section 4.2).
Neuropati er blevet håndteret med støttebehandling og andre behandlinger.
Neuropathy has been managed with supportive care and other therapies.
Bedring eller resolution af perifer neuropati blev rapporteret hos henholdsvis 51% af patienterne med ≥ grad 2 perifer neuropati i fase III - myelomatoseforsøget med monoterapi og 71% af patienterne med grad 3 eller 4 perifer neuropati eller perifer neuropati, der førte til seponering af behandlingen i fase II - forsøg.
Improvement in, or resolution of, peripheral neuropathy was reported in 51% of patients with ≥ Grade 2 peripheral neuropathy in the single-agent Phase III multiple myeloma study and 71% of patients with grade 3 or 4 peripheral neuropathy or peripheral neuropathy leading to discontinuation of treatment in Phase II studies, respectively.
Ud over perifer neuropati kan der forekomme autonom neuropati ved nogle bivirkninger, f. eks. postural hypotension og svær forstoppelse med ileus.
In addition to peripheral neuropathy, there may be a contribution of autonomic neuropathy to some adverse reactions such as postural hypotension and severe constipation with ileus.
Krampeanfald Der er rapporteret enkelte tilfælde af krampeanfald hos patienter, som ikke tidligere har oplevet sådanne anfald eller epilepsi.
5 Seizures Seizures have been uncommonly reported in patients without previous history of seizures or epilepsy.
Der skal udvises særlig forsigtighed, ved behandling af patienter med risikofaktorer over for kramper.
Special care is required when treating patients with any risk factors for seizures.
5 Hypotension Behandlingen med VELCADE forbindes almindeligvis med ortostatisk/ postural hypotension.
Hypotension VELCADE treatment is commonly associated with orthostatic/ postural hypotension.
De fleste uønskede virkninger er milde til moderate og ses i hele behandlingsperioden.
Most undesirable effects are mild to moderate in nature and are observed throughout treatment.
Patienter, der udvikler ortostatisk hypotension ved VELCADE viste ikke tegn på ortostatisk hypotension før behandlingen med VELCADE.
Patients developing orthostatic hypotension on VELCADE did not have evidence of orthostatic hypotension prior to treatment with VELCADE.
Ortostatisk/ postural hypotension var ikke akut relateret til bolusinjektion af VELCADE.
Orthostatic/ postural hypotension was not acutely related to bolus infusion of VELCADE.
Autonom neuropati kan relateres til bortezomib, eller bortezomib kan forværre en tilgrundliggende tilstand som f. eks. diabetisk eller amyloid neuropati.
Autonomic neuropathy may be related to bortezomib or bortezomib may aggravate an underlying condition such as diabetic or amyloidotic neuropathy.
Håndtering af ortostatisk/ postural hypotension kan omfatte justeringer af antihypertensiva, rehydrering eller indgift af mineralkortikosteroider og/ eller sympatomimetika.
Management of orthostatic/ postural hypotension may include adjustment of antihypertensive medicinal products, rehydration or administration of mineralocorticosteroids and/ or sympathomimetics.
Patienterne skal instrueres i at søge læge, hvis de oplever symptomer på svimmelhed, uklarhed eller besvimelse.
Patients should be instructed to seek medical advice if they experience symptoms of dizziness, light-headedness or fainting spells.
Hjertesvigt Der er rapporteret akut udvikling eller forværring af kongestiv hjerteinsufficiens og/ eller ny forekomst af nedsat ejektionsfraktion fra venstre ventrikel ved behandling med bortezomib.
Heart failure Acute development or exacerbation of congestive heart failure, and/ or new onset of decreased left ventricular ejection fraction has been reported during bortezomib treatment.
I et randomiseret, komparativt fase III- forsøg med monoterapi var forekomsten af hjerteinsufficiens i VELCADE - gruppen den samme som i dexamethason- gruppen.
In a single agent Phase III randomised, comparative study the incidence of heart failure in the VELCADE group was similar to that in the dexamethasone group.
EKG- undersøgelser Der har været enkeltstående tilfælde af forlængelse af QT- intervallet i kliniske forsøg; årsagssammenhængen er ikke fastlagt.
ECG investigations There have been isolated cases of QT-interval prolongation in clinical studies, causality has not been established.
4. 8).
Pulmonary disorders There have been rare reports of acute diffuse infiltrative pulmonary disease of unknown aetiology such as pneumonitis, interstitial pneumonia, lung infiltration, and acute respiratory distress syndrome (ARDS) in patients receiving VELCADE (see section 4.8).
Nogle af disse tilfælde har været uhelbredelige.
Some of these events have been fatal.
Et røntgen af brystet anbefales før behandling, for at bestemme om der er behov for yderligere diagnostiske procedurer og for at tjene som udgangspunkt for potentielle lungeforandringer efter behandling.
A pre-treatment chest radiograph is recommended to determine if any additional diagnostic measures are necessary and to serve as a baseline for potential post-treatment pulmonary changes.
I tilfælde af ny eller forværring af lungesygdom (f. eks. hoste, dyspnø) er det nødvendig med en hurtig diagnosticering og at patienterne behandles i overensstemmelse hermed.
In the event of new or worsening pulmonary symptoms (e. g. cough, dyspnoea), a prompt diagnostic evaluation should be performed and patients treated appropriately.
Forholdet mellem fordele og risici skal overvejes før behandlingen med VELCADE fortsætter.
The benefit/ risk ratio should be considered prior to continuing VELCADE therapy.
Patienterne fik højdosis cytarabin (2 g/ m2 dagligt) ved kontinuerlig infusion over en periode på 24 timer med daunorubicin og VELCADE for recidiverende akut myeloid leukæmi (AML).
In a clinical trial, two patients (out of 2) given high-dose cytarabine (2 g/ m2 per day) by continuous infusion over 24 hours with daunorubicin and VELCADE for relapsed acute myelogenous leukaemia died of ARDS early in the course of therapy, and the study was terminated.
Derfor frarådes det at anvende dette regime ved samtidig administration af højdosis cytarabin (2 g/ m2 dagligt) ved kontinuerlig infusion over en periode på 24 timer.
Therefore, this specific regimen with concomitant administration with high-dose cytarabine (2 g/ m2 per day) by continuous infusion over 24 hours is not recommended.
Nedsat nyrefunktion Nyrekomplikationer er hyppige hos patienter med myelomatose.
Renal impairment Renal complications are frequent in patients with multiple myeloma.
(se punkt 4. 2 og 5. 2)
Such patients should be monitored closely (see sections 4.2 and 5.2).
4. 2, 4. 3 og 5. 2).
Hepatic impairment Patients with hepatic impairment should be treated with extreme caution and a dose reduction should be considered (see sections 4.2, 4.3 and 5.2).
6 Leverreaktioner Der er rapporteret sjældne tilfælde af akut leversvigt hos patienter, der tager flere forskellige slags medicin samtidig og med alvorlige tilgrundliggende helbredsproblemer.
6 Hepatic reactions Rare cases of acute liver failure have been reported in patients receiving multiple concomitant medications and with serious underlying medical conditions.
4. 8).
Such changes may be reversible upon discontinuation of bortezomib (see section 4.8).
Tumorlysessyndrom Da bortezomib er et cytotoksisk stof, som hurtigt kan dræbe maligne plasmaceller, kan der opstå komplikationer i form af tumorlysesyndrom.
Tumour lysis syndrome Because bortezomib is a cytotoxic agent and can rapidly kill malignant plasma cells, the complications of tumour lysis syndrome may occur.
Amyloidose Virkningen af bortezomibs proteasomhæmning ved sygdomme forbundet med proteinakkumulation, f. eks. amyloidose, kendes ikke.
Amyloidosis The impact of proteasome inhibition by bortezomib on disorders associated with protein accumulation such as amyloidosis is unknown.
Der skal udvises forsigtighed ved behandling af disse patienter.
Caution is advised in these patients.
Samtidig behandling med andre lægemidler Patienterne skal monitoreres omhyggeligt, når der gives bortezomib sammen med kraftige CYP3A4 - hæmmere.
Concomitant medicinal products Patients should be closely monitored when given bortezomib in combination with potent CYP3A4-inhibitors.
4. 5).
Caution should be exercised when bortezomib is combined with CYP3A4- or CYP2C19 substrates (see section 4.5).
4. 5).
Normal liver function should be confirmed and caution should be exercised in patients receiving oral hypoglycemics (see section 4.5).
Mulige immunkompleksmedierede reaktioner Der er i sjældne tilfælde rapporteret mulige immunkompleksmedierede reaktioner, f. eks. serumsyge, polyarthritis med udslæt og proliferativ glomerulonefritis.
Potentially immunocomplex-mediated reactions Potentially immunocomplex-mediated reactions, such as serum-sickness-type reaction, polyarthritis with rash and proliferative glomerulonephritis have been reported uncommonly.
In vitro- forsøg viser, at bortezomib er en svag hæmmer af cytokrom 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.