natgillin/translations-raw huggingface dataset:
Hos dyr hæmmede carfilzomib proteasom-aktiviteten i blod og væv og forsinkede tumorvæksten i myelomatosemodeller. 
In animals, carfilzomib inhibited proteasome activity in blood and tissue and delayed tumour growth in models of multiple myeloma.
Studiets kriterier for egnethed tillod, at en lille delgruppe af patienter med myelom, som var refraktært over for bortezomib (n = 118) eller lenalidomid (n = 57), kunne deltage. 
Study eligibility criteria allowed a small subset of patients with myeloma refractory to bortezomib (n = 118) or lenalidomide (n = 57) to be enrolled.
Studiet nåede ikke det primære effektendemål: påvisning af Kyprolis' superioritet som monoterapi i forhold til den aktive kontrolarm for så vidt angår samlet overlevelse (HR = 0,975 [95 % CI: 0,760-1,249]). 
The study did not meet its primary efficacy endpoint of demonstrating superiority of Kyprolis monotherapy over the active control arm in overall survival (HR = 0.975 [95% CI: 0.760-1.249]).
Den øvre grænse for 1-sidet 95 % konfidensinterval (CI) for forventet virkning på QTcF ved Cmax var 4,8 ms. Med Bazetts korrektion (QTcB-interval) var den øvre grænse for 1-sidet 95 % konfidensinterval for forventet virkning på QTcB ved Cmax 5,9 ms. 
The upper bound of one-sided 95% confidence interval (CI) for predicted effect on QTcF at Cmax was 4.8 msec. With Bazett's correction (QTcB interval), the upper bound of one-sided 95% confidence interval (CI) for predicted effect on QTcB at Cmax was 5.9 msec.
Cmax og AUC efter en 2-10 minutters intravenøs infusion af 27 mg/m2 var henholdsvis 4.232 ng/ml og 379 ng•t/ml. 
The Cmax and AUC following a 2 to 10 minute intravenous infusion of 27 mg/m2 was 4,232 ng/mL and 379 ng•hr/mL, respectively.
25 mg dagligt Cyklus 13 og fremefter 
25 mg daily Cycles 13 on
95 % CI af ORR 1-sidet p-værdib 
95% CI of ORR 1-sided p-valueb
Studiets kriterier for egnethed tillod, at patienter, som tidligere var blevet behandlet med carfilzomib (n = 3) eller bortezomib (n = 502), kunne deltage, så længe de som et minimum havde partiel respons (PR) på tidligere behandling med en proteasomhæmmer; ikke var taget ud af behandling med en proteasomhæmmer på grund af toksicitet og som et minimum havde haft et 6-måneders interval uden behandling med en proteasomhæmmer siden sidste dosis. 
Study eligibility criteria allowed patients previously treated with carfilzomib (n = 3) or bortezomib (n = 502) to be enrolled as long as patients had at least a partial response (PR) to prior proteasome inhibitor therapy, were not removed from proteasome inhibitor therapy due to toxicity, and had at least a 6-month proteasome inhibitor treatment-free interval from last dose.
Kyprolis kan medføre stigning i serum-aminotransferaser (se pkt. 
Kyprolis can cause elevations of serum transaminases (see section 4.8).
Carfilzomib metaboliseres primært gennem peptidase- og epoxidhydrolase-aktivitet, og carfilzomibs farmakokinetiske profil vil derfor sandsynligvis ikke blive påvirket af samtidig administration af cytochrom P450-hæmmere og -induktorer. 
Carfilzomib is primarily metabolised via peptidase and epoxide hydrolase activities, and as a result, the pharmacokinetic profile of carfilzomib is unlikely to be affected by concomitant administration of cytochrome P450 inhibitors and inducers.
Patienterne havde fået 1 til 3 tidligere behandlingsforløb (median 2), herunder tidligere behandling med bortezomib (66 %), thalidomid (44 %) og lenalidomid (20 %). 
Subjects had received 1 to 3 prior lines of therapy (median of 2), including prior treatment with bortezomib (66%), thalidomide (44%) and lenalidomide (20%).
• Smerter i arme, ben, hænder eller fødder 
• Pain in limbs, hands or feet
Der er opstået tilfælde af hypertensiv krise (akut alvorlig hypertension [urgency] og akut hypertensiv krise [emergency]) efter administration af Kyprolis. 
Hypertensive crises (hypertensive urgency or hypertensive emergency) have occurred following administration of Kyprolis.
Carfilzomibs farmakokinetik er ikke undersøgt hos patienter med svært nedsat leverfunktion (bilirubin > 3 x ULN og vilkårlig ASAT). 
The pharmacokinetics of carfilzomib has not been studied in patients with severe hepatic impairment (bilirubin > 3 x ULN and any AST).
Beregn dosis (mg/m2) og det nødvendige antal hætteglas med Kyprolis på baggrund af patientens BSA ved baseline. 
Calculate the dose (mg/m2) and number of vials of Kyprolis required using the patient's BSA at baseline.
Patienter med moderat eller svært nedsat nyrefunktion deltog i Kyprolis-dexamethasonkombinationsstudier, men blev udelukket fra Kyprolis-lenalidomid-kombinationsstudier. 
Patients with moderate or severe renal impairment were enrolled in Kyprolis-dexamethasone combination studies, but were excluded from Kyprolis-lenalidomide combination studies.
Doser på 2 mg/kg/dosis til rotter er cirka det halve af den anbefalede humane dosis på 27 mg/m2 baseret på BSA. 
The dose of 2 mg/kg/dose in rats is approximately half the recommended dose in humans of 27 mg/m2 based on BSA.
Da der er øget risiko for venøse tromboemboliske hændelser forbundet med carfilzomib, bør kvindelige patienter desuden undlade at bruge hormonelle kontraceptiva, der er forbundet med risiko for trombose, under behandling med carfilzomib (se pkt. 
In addition, due to an increased risk of venous thromboembolic events associated with carfilzomib, females should avoid the use of hormonal contraceptives that are associated with a risk of thrombosis during treatment with carfilzomib (see sections 4.4 and 4.8).
Efter initialdoser af carfilzomib på 20 mg/m2 blev dosis øget til 27 mg/m2 i studie PX-171-009 og til 56 mg/m2 i studie 2011-003 (se pkt. 
Following initial doses of carfilzomib at 20 mg/m2, the dose was increased to 27 mg/m2 in study PX-171-009 and to 56 mg/m2 in study 2011-003 (see section 5.1).
• En bivirkning, der kaldes for tumorlysesyndrom, som skyldes den hurtige nedbrydning af kræftceller og kan medføre uregelmæssig hjerterytme, nyresvigt eller unormale blodprøveresultater 
• A side effect called tumour lysis syndrome, which can be caused by the rapid breakdown of tumour cells and may cause irregular heartbeat, kidney failure or abnormal blood test results
Carfilzomibs mulige virkninger på hjertefunktionen blev undersøgt ved en central, blindet vurdering af tre ekg-optagelser fra hver af 154 patienter med fremskredne maligniteter, herunder myelomatose. 
An evaluation of possible effects of carfilzomib on cardiac function was performed by analysing, via central blind reading, triplicate ECG in 154 subjects with advanced malignancies, including multiple myeloma.
Du må ikke bruge Kyprolis, hvis du ammer. 
Do not take Kyprolis if you are breast-feeding.
Serumkalium skal monitoreres månedligt eller oftere under behandling med Kyprolis, alt efter klinisk indikation og afhængigt af de kaliumniveauer, der er målt inden behandlingens start, samtidigt givne behandlinger (fx lægemidler, der vides at øge risikoen for hypokaliæmi) og associerede komorbiditeter. 
Serum potassium levels should be monitored monthly, or more frequently during treatment with Kyprolis as clinically indicated and will depend on the potassium levels measured before the start of treatment, concomitant therapy used (e.g. medicinal products known to increase the risk of hypokalaemia) and associated comorbidities.
Lungeinfektion Influenza Herpes zoster* Urinvejsinfektion Bronkitis Gastroenteritis Virusinfektion Nasofaryngitis Rhinitis 
Lung infection Influenza Herpes zoster* Urinary tract infection Bronchitis Gastroenteritis Viral infection Nasopharyngitis Rhinitis
Rekonstitution og klargøring til intravenøs administration Hætteglassene med Kyprolis indeholder ingen antimikrobielle konserveringsmidler og er kun beregnet til engangsbrug. 
Reconstitution and preparation for intravenous administration Kyprolis vials contain no antimicrobial preservatives and are intended for single use only.
Stop behandling med Kyprolis, indtil TLS er svundet (se pkt. 
Stop Kyprolis until TLS is resolved (see section 4.2).
Der er opstået akut lungesvigt (ARDS), akut respirationsinsufficiens og akut diffus infiltrativ lungesygdom såsom pneumonitis og interstitiel lungesygdom hos patienter, der fik Kyprolis. 
Acute respiratory distress syndrome (ARDS), acute respiratory failure, and acute diffuse infiltrative pulmonary disease such as pneumonitis and interstitial lung disease have occurred in patients receiving Kyprolis.
Carfilzomib har udvist antiproliferativ og proapoptotisk aktivitet i prækliniske modeller i hæmatologiske tumorer. 
Carfilzomib had antiproliferative and proapoptotic activities in preclinical models in haematologic tumours.
• Smerter eller hævelser på ben eller arme (som kan være et symptom på blodpropper i de dybe vener i benet eller armen), brystsmerter eller stakåndethed (som kan være et symptom på blodpropper i lungerne) 
• Leg or arm pain or swelling (which could be a symptom of blood clots in the deep veins of the leg or arm), chest pain or shortness of breath (which may be a symptom of blood clots in the lungs)
På baggrund af det store antal tilfælde, den plausible mekanisme og risikoens alvorsgrad, foreslås det at tilføje hepatitis B som en bivirkning i produktresuméet og indlægssedlen. 
Based on high number of cases, plausible mechanism and seriousness of the risk, hepatitis B reactivation is proposed to be added as an adverse drug reaction in the SmPC and PL. A relevant warning should also be included.
De hyppigste bivirkninger (forekom hos > 20 % af patienterne) var: anæmi, træthed, trombocytopeni, nausea, diaré, pyreksi, dyspnø, luftvejsinfektion, hoste og neutropeni. 
The most common adverse reactions (occurring in > 20% of subjects) were: anaemia, fatigue, thrombocytopenia, nausea, diarrhoea, pyrexia, dyspnoea, respiratory tract infection, cough and neutropenia.
Carfilzomib var ikke mutagent i en in vitro bakteriel tilbagemutationstest (Ames' test) og var ikke klastogent i en in vivo mikronukleusanalyse i knoglemarv fra mus. 
Carfilzomib was not mutagenic in the in vitro bacterial reverse mutation (Ames) test and was not clastogenic in the in vivo mouse bone marrow micronucleus assay.
Angst Konfusionstilstand 
Anxiety Confusional state
Kyprolis administreres i kombination med andre lægemidler, og der henvises til de andre lægemidlers produktresuméer for information om yderligere kontraindikationer. 
As Kyprolis is administered in combination with other medicinal products, refer to their summaries of product characteristics for additional contraindications.
Hvert hætteglas indeholder 10 mg, 30 mg eller 60 mg carfilzomib. 
Each vial contains 10 mg, 30 mg or 60 mg of carfilzomib.
Patienter med hjerteinsufficiens NYHA- (New York Heart Association) klasse III og IV, nyligt myokardieinfarkt og ledningsforstyrrelser, der ikke kontrolleres med lægemidler, kunne ikke deltage i de kliniske studier. 
Patients with New York Heart Association (NYHA) Class III and IV heart failure, recent myocardial infarction, and conduction abnormalities uncontrolled by medicinal products were not eligible for the clinical trials.
Dosis af Kyprolis bør reduceres, hvis hypertensionen ikke kan kontrolleres. 
If the hypertension cannot be controlled, the Kyprolis dose should be reduced.
Der var en stigning på cirka 8 %, 23 % og 34 % i hæmningen af henholdsvis delenhed LMP7, MECL1 og LMP2 ved en dosis på 56 mg/m2 sammenlignet med doser på 15 til 20 mg/m2. 
There was an approximately 8%, 23% and 34% increase in the inhibition of LMP7, MECL1, and LMP2 subunits respectively at the dose of 56 mg/m2 compared to those at 15 to 20 mg/m2.
Carfilzomib var klastogent i in vitro kromosomaberrationstesten i lymfocytter fra perifert blod. 
Carfilzomib was clastogenic in the in vitro chromosomal aberration test in peripheral blood lymphocytes.
Der er indberettet tilfælde af leverinsufficiens, herunder dødelige tilfælde. 
Cases of hepatic failure, including fatal cases, have been reported.
Der er observeret hypertension, herunder hypertensiv krise og akut svær hypertension, i forbindelse med behandling med Kyprolis. 
Hypertension, including hypertensive crisis and hypertensive emergency, has been observed with Kyprolis.
Pulver i hætteglas (uåbnet) 
Powder vial (unopened)
Kyprolis' farmakokinetik er ikke blevet undersøgt hos patienter med svært nedsat leverfunktion. 
The pharmacokinetics of Kyprolis has not been evaluated in patients with severe hepatic impairment.
En passende reduktion af initialdosis af lenalidomid hos patienter med nedsat nyrefunktion ved baseline bør overvejes i overensstemmelse med anbefalingerne i produktresuméet for lenalidomid. 
Appropriate dose reduction for the starting dose of lenalidomide in patients with baseline renal impairment should be considered according to the recommendations in the lenalidomide summary of product characteristics.
Desuden medførte carfilzomib 20 mg/m2 hæmning af det latente membranprotein 2 (LMP2) og multikatalytiske, endopeptidase-kompleks-lignende 1 (MECL1)-delenheder af immunproteasomet henholdsvis inden for intervallet 26 % til 32 % og 41 % til 49 %. 
In addition, carfilzomib administration resulted in inhibition of the latent membrane protein 2 (LMP2) and multicatalytic endopeptidase complex-like 1 (MECL1) subunits of the immunoproteasome ranging from 26% to 32% and 41% to 49%, respectively, at 20 mg/m2.
Sammenlignelige proteasomhæmninger blev opnået efter 2-10-minutters og 30-minutters infusion af carfilzomib ved de to dosisniveauer (20 og 36 mg/m2), det blev undersøgt ved. 
Similar proteasome inhibition by carfilzomib was achieved with 2 to 10 minute and 30 minute infusions at the 2 dose levels (20 and 36 mg/m2) at which it was tested.
• Trombocyttal < 10 x109/l eller tegn på blødning med trombocytopeni (se pkt. 
• Platelet count < 10 x 109/L or evidence of bleeding with thrombocytopenia (see section 4.4)
Nyrefunktionen skal monitoreres mindst hver måned eller i henhold til retningslinjerne for accepteret klinisk praksis, især hos patienter med lavere kreatininclearance ved baseline. 
Renal function should be monitored at least monthly or in accordance with accepted clinical practice guidelines, particularly in patients with lower baseline creatinine clearance.
Kyprolis i kombination med enten lenalidomid og dexamethason eller med dexamethason alene er indiceret til behandling af voksne patienter med myelomatose, der har fået mindst én tidligere behandling (se pkt. 
Kyprolis in combination with either lenalidomide and dexamethasone or dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (see section 5.1).
Carfilzomib kan nedsætte virkningen af orale kontraceptiva (se pkt. 
Carfilzomib may decrease the efficacy of oral contraceptives (refer to section 4.5).
Nyrefunktionen skal vurderes ved behandlingsstart og monitoreres mindst hver måned eller i henhold til accepterede retningslinjer for klinisk praksis, især hos patienter med lav kreatininclearance ved baseline (CrCL < 30 ml/min). 
Renal function should be assessed at treatment initiation and monitored at least monthly or in accordance with accepted clinical practice guidelines, particularly in patients with lower baseline creatinine clearance (CrCL < 30 mL/min).
Lymfopeni Leukopeni 
Lymphopenia Leukopenia
Der er rapporteret om tilfælde af progressiv multifokal leukoencefalopati (PML) hos patienter i behandling med carfilzomib, som tidligere har været eller er i samtidig behandling med immunsuppressiva. 
Cases of Progressive Multifocal Leukoencephalopathy (PML) have been reported in patients receiving carfilzomib who have had prior or concurrent immunosuppressive therapy.
Dosisændringer under behandling med Kyprolis 
Dose modifications during Kyprolis treatment
Dehydrering Hyperkaliæmi Hypomagnesiæmi Hyponatriæmi Hyperkalcæmi Hypokalcæmi Hypofosfatæmi Hyperurikæmi Hypoalbuminæmi 
Dehydration Hyperkalaemia Hypomagnesaemia Hyponatraemia Hypercalcaemia Hypocalcaemia Hypophosphataemia Hyperuricaemia Hypoalbuminaemia
• Reaktivering af skoldkoppevirus (helvedesild), der kan medføre hududslæt og smerter (herpes zoster) 
• Reactivation of the chicken pox virus (shingles) that can cause a skin rash and pain (herpes zoster)
Urinsyresænkende lægemidler bør overvejes til patienter, som har stor risiko for TLS. 
Uric acid lowering medicinal products should be considered in patients at high risk for TLS.
Der er forekommet ny eller forværret hjerteinsufficiens (fx kongestiv hjerteinsufficiens, lungeødem, nedsat ejektionsfraktion), myokardieiskæmi og myokardieinfarkt efter administration af Kyprolis. 
New or worsening cardiac failure (e.g. congestive cardiac failure, pulmonary oedema, decreased ejection fraction), myocardial ischaemia and infarction have occurred following administration of Kyprolis.
• Hævede hænder, fødder eller ankler 
• Swelling of the hands, feet or ankles
• Nyreproblemer, herunder nyresvigt 
• Kidney problems, including kidney failure
Da Kyprolis gives i kombination med lenalidomid, skal du følge programmet for graviditetsforebyggelse (se lenalidomids indlægsseddel for information om graviditetsforebyggelse og tal med lægen, sundhedspersonalet eller apotekspersonalet om det). 
Lenalidomide is expected to be harmful to the unborn child. As Kyprolis is given in combination with lenalidomide, you must follow the Pregnancy Prevention Programme (see package leaflet for lenalidomide for information on pregnancy prevention and discuss with your doctor, pharmacist or nurse).
Kyprolis administreres med en initialdosis på 20 mg/m2 (maksimumdosis 44 mg) på dag 1 og 2 i cyklus 1. 
Kyprolis is administered at a starting dose of 20 mg/m2 (maximum dose 44 mg) in cycle 1 on days 1 and 2.
Leverenzymer og bilirubin skal monitoreres ved behandlingens start og månedligt under behandling med carfilzomib - uanset værdierne ved baseline. 
Liver enzymes and bilirubin should be monitored at treatment initiation and monthly during treatment with carfilzomib, regardless of baseline values.
Efter rekonstitution indeholder 1 ml opløsning 2 mg carfilzomib. 
After reconstitution, 1 mL of solution contains 2 mg of carfilzomib.
Hvis du bliver gravid, mens du får Kyprolis, skal du straks informere lægen eller sundhedspersonalet om det. 
If you become pregnant while taking Kyprolis, notify your doctor or nurse immediately.
Anbefalet håndtering 
Recommended action
Der er indberettet tilfælde af posteriort reversibelt encefalopati-syndrom (PRES) hos patienter, der fik Kyprolis. 
Cases of posterior reversible encephalopathy syndrome (PRES) have been reported in patients receiving Kyprolis.
Hvis det administreres i en infusionspose, brug kun en 21 gauge eller større gauge nål (0,8 mm eller mindre udvendig diameter nål) til at trække den beregnede dosis op af hætteglasset og fortynde i en 50 eller 100 ml infusionspose med 5 % glucoseinjektionsvæske. 
When administering in an intravenous bag, use only a 21-gauge or larger gauge needle (0.8 mm or smaller external diameter needle) to withdraw the calculated dose from the vial and dilute into a 50 or 100 mL intravenous bag containing 5% glucose solution for injection.
Kd = Kyprolis plus dexamethason; Vd = bortezomib og dexamethason; CI = konfidensinterval; NE = kan ikke estimeres; HR = hazard ratio; ORR = samlet responsrate; CR = komplet respons; VGPR = meget god partiel respons a. Disse endemål blev fastlagt af en uafhængig kontrolkomité (IRC) b. Statistisk signifikant c. Samlet respons defineres som opnåelse af en bedste samlet respons på PR, VGPR, CR eller sCR d. Statistisk signifikant, 1-sidet p-værdi = 0,0005 e. Statistisk signifikant, 1-sidet p-værdi = 0,0001 
Kd = Kyprolis plus dexamethasone; Vd = bortezomib and dexamethasone; CI = confidence interval; NE = not estimable; HR = Hazard Ratio; ORR = overall response rate; CR = complete response; VGPR = very good partial response a. These endpoints were determined by an Independent Review Committee b. Statistically significant c. Overall response is defined as achieving a best overall response of PR, VGPR, CR, or sCR d. Statistically significant, 1-sided p value = 0.0005 e. Statistically significant, 1-sided p value = 0.0001
Patienter med tegn eller symptomer på hjerteinsufficiens NYHA-klasse III eller IV, nyligt hjerteinfarkt (inden for de seneste 4 måneder) samt ukontrolleret angina eller arytmier bør gennemgå en omfattende kardiologisk vurdering, inden behandling med Kyprolis iværksættes. 
Patients with signs or symptoms of NYHA Class III or IV cardiac failure, recent history of myocardial infarction (in the last 4 months), and in patients with uncontrolled angina or arrhythmias, should have a comprehensive cardiological assessment, prior to starting treatment with Kyprolis.
Samlet set var forekomsten af visse bivirkninger (herunder hjerteinsufficiens) i kliniske studier højere hos patienter ≥ 75 år end hos patienter < 75 år (se pkt. 
Overall, the subject incidence of certain adverse events (including cardiac failure) in clinical trials was higher for patients who were ≥ 75 years of age compared to patients who were < 75 years of age (see section 4.4).
Sammenlignelige PFS-resultater blev observeret hos patienter, som havde fået tidligere behandling med bortezomib (HR 0,56; 95 % CI: 0,44; 0,73), og patienter, der ikke havde fået tidligere behandling med bortezomib (HR 0,48; 95 % CI: 0,36; 0,66). 
Similar PFS results were observed in patients who had received prior treatment with bortezomib (HR 0.56, 95% CI: 0.44, 0.73) and patients who had not received prior treatment with bortezomib (HR 0.48, 95% CI: 0.36, 0.66).
Patienter, der blev behandlet med KRd, rapporterede forbedret generel helbredsstatus med højere scorer for generel helbredsstatus/livskvalitet (Quality of Life [QoL]) sammenlignet med Rd-behandling i 18 behandlingscyklusser (multiplicitet ikke justeret, 1-sidet p-værdi = 0,0001), målt med EORTC QLQ-C30 - et værktøj, der er valideret ved myelomatose. 
Patients treated with KRd reported improved Global Health Status, with higher Global Health Status/Quality of Life (QoL) scores compared with Rd over 18 cycles of treatment (multiplicity unadjusted 1-sided p-value = 0.0001) measured with the EORTC QLQ-C30, an instrument validated in multiple myeloma.
Akut nyreinsufficiens blev indberettet hyppigere hos patienter med fremskreden recidiveret og refraktær myelomatose, der fik monoterapi med Kyprolis. 
Acute renal failure was reported more frequently in patients with advanced relapsed and refractory multiple myeloma who received Kyprolis monotherapy.
Kyprolis i kombination med dexamethason til behandling af patienter med recidiveret myelomatose - studie 2011-003 (ENDEAVOR) 
Kyprolis in combination with dexamethasone for the treatment of patients with relapsed multiple myeloma - study 2011-003 (ENDEAVOR)
Kyprolis i kombination med lenalidomid og dexamethason til behandling af patienter med recidiveret myelomatose - studie PX-171-009 (ASPIRE) 
Kyprolis in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed multiple myeloma - study PX-171-009 (ASPIRE)
Det første studie blev gennemført med 50 patienter med myelomatose med normal nyrefunktion (CrCL > 80 ml/min, n = 12), let (CrCL 50-80 ml/min, n = 12), moderat (CrCL 30-49 ml/min, n = 10) og svært (CrCL < 30 ml/min, n = 8) nedsat nyrefunktion samt patienter i kronisk dialyse (n = 8). 
The first study was conducted in 50 multiple myeloma patients with normal renal function (CrCL > 80 mL/min, n = 12), mild (CrCL 50-80 mL/min, n = 12), moderate (CrCL 30-49 mL/min, n = 10), and severe (CrCL < 30 mL/min, n = 8) renal impairment, and patients on chronic dialysis (n = 8).
Der er indberettet infusionsreaktioner, herunder livstruende reaktioner, hos patienter, der fik Kyprolis. 
Infusion reactions, including life-threatening reactions, have been reported in patients who received Kyprolis.
Der er indberettet akut indtræden af kulderystelser, hypotension, nyreinsufficiens, trombocytopeni og lymfopeni efter en dosis Kyprolis på 200 mg, der blev givet ved en fejl. 
Acute onset of chills, hypotension, renal insufficiency, thrombocytopenia and lymphopenia has been reported following a dose of 200 mg of Kyprolis administered in error.
Der er indberettet pulmonal hypertension hos patienter, der blev behandlet med Kyprolis. 
Pulmonary hypertension has been reported in patients treated with Kyprolis.