natgillin/translations-raw huggingface dataset:
Kombinationsbehandling med bortezomib, melphalan og prednison (VMP) hos patienter, som ikke er kandidater til autolog stamcelletransplantation:
Combination treatment with bortezomib, melphalan and prednisone (VMP) in patients ineligible for autologous stem cell transplant:
I visse tilfælde kan den allergiske reaktion være alvorlig og omfatte hævelser af ansigtet, læberne, munden, tungen eller svælget, synke- eller vejrtrækningsbesvær eller kløende udslæt (nældefeber).
In some cases you may have a severe allergic reaction which may include a swollen face, lips, mouth, tongue or throat, difficulty swallowing or breathing or an itchy rash (hives).
Oversigt over indlægssedlen Virkning og anvendelse Det skal du vide, før du får DARZALEX Sådan får du DARZALEX Bivirkninger
What DARZALEX is and what it is used for What you need to know before you are given DARZALEX How DARZALEX is given
Kombinationsbehandling med lenalidomid og dexamethason hos patienter, som ikke er kandidater til autolog stamcelletransplantation:
Combination treatment with lenalidomide and dexamethasone in patients ineligible for autologous stem cell transplant:
I denne undergruppe blev median PFS ikke nået i D-VMP-gruppen, og den var 17,9 måneder i VMP-gruppen (HR = 0,56; 95 % CI: 0,42, 0,75; p < 0,0001).
In this subgroup, median PFS was not reached in the DVMP group and was 17.9 months in the VMP group (HR=0.56; 95% CI: 0.42, 0.75); p<0.0001).
2-estimat af den fælles oddsratio anvendes.
A Chi-Squared estimate of the common odds ratio is used.
Mindre hyppige symptomer var hvæsende vejrtrækning, allergisk rhinitis, pyrexi, ubehag i brystkassen, pruritus og hypotension (se pkt.
Less common symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus and hypotension (see section 4.8).
Del 1 sammenlignede induktions- og konsolideringsbehandling med 16 mg/kg DARZALEX i kombination med bortezomib, thalidomid og dexamethason (D-VTd) med behandling med bortezomib, thalidomid og dexamethason (VTd) hos patienter med nydiagnosticeret myelomatose, som var kandidater til ASCT.
Part 1 compared induction and consolidation treatment with DARZALEX 16 mg/kg in combination with bortezomib, thalidomide and dexamethasone (D-VTd) to treatment with bortezomib, thalidomide and dexamethasone (VTd) in patients with newly diagnosed multiple myeloma eligible for ASCT.
Der blev udført fire individuelle farmakokinetiske populationsanalyser hos patienter, som fik daratumumab som monoterapi eller forskellige kombinationsbehandlinger (analyse 1-4) med i alt 1.404 patienter med normal leverfunktion (total-bilirubin [TB] og aspartataminotransferase [ASAT] ≤ øvre grænse for normal [ULN]), 189 med let nedsat leverfunktion (TB 1,0 x til 1,5 x ULN eller ASAT > ULN) og 8 patienter med moderat (TB > 1,5 x til 3,0 x ULN; n = 7) eller svært (TB > 3,0 x ULN; n = 1) nedsat leverfunktion.
Four individual population PK analyses were performed in patients receiving daratumumab monotherapy or various combination therapies (Analyses 1-4), and included a total of 1404 patients with normal hepatic function (total bilirubin [TB] and aspartate aminotransferase [AST] ≤ upper limit of normal [ULN]), 189 with mild hepatic impairment (TB 1.0 x to 1.5 x ULN or AST >ULN) and 8 patients with moderate (TB > 1.5 x to 3.0 x ULN; n=7), or severe (TB > 3.0 x ULN; n=1) hepatic impairment.
Du kan føle dig træt, når du har fået DARZALEX, og det kan påvirke din evne til at færdes i trafikken og din arbejdssikkerhed.
Driving and using machines You may feel tired after taking DARZALEX which may affect your ability to drive or use machines.
Skema for dosering i kombination med lenalidomid (regime med 4-ugers serier) og for monoterapi: Den anbefalede dosis er 16 mg DARZALEX pr. kg legemsvægt administreret som en intravenøs infusion i henhold til doseringsskemaet i tabel 1.
Dosing schedule in combination with lenalidomide (4-week cycle regimen) and for monotherapy: The recommended dose is DARZALEX 16 mg/kg body weight administered as an intravenous infusion according to the following dosing schedule in Table 1.
Mediantid til respons [måneder (interval)] Median responsvarighed [måneder (95 % CI)]
Median Duration of Response [months (95% CI)]
hver tredje uge (i alt 16 doser)
every three weeks (total of 16 doses)
• i kombination med lenalidomid og dexamethason eller bortezomib og dexamethason til behandling af voksne patienter med myelomatose, som tidligere har fået mindst én behandling.
• in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
Der er ikke udført formelle studier af daratumumab hos patienter med nedsat leverfunktion.
No formal studies of daratumumab in patients with renal impairment have been conducted.
Lenalidomid (25 mg oralt en gang dagligt på dag 1-21 i gentagne serier på 28 dage [4 uger]) blev givet sammen med 40 mg/uge lavdosis-dexamethason (eller en reduceret dosis på 20 mg/uge for patienter > 75 år eller med BMI < 18,5).
Lenalidomide (25 mg once daily orally on Days 1-21 of repeated 28-day [4-week] cycles) was given with low dose dexamethasone at 40 mg/week (or a reduced dose of 20 mg/week for patients >75 years or BMI <18.5).
Lægemidler efter infusion
Post-infusion medication
Fortæl det til den person, der tager blodprøven, at du får DARZALEX.
DARZALEX can affect the results of this blood test. Tell the person doing the test that you are using DARZALEX.
50 ml/time hver time
500 mL 50 mL/hour 50 mL/hour every hour
95 % CI (%) Oddsratio med 95 % CI
95% CI (%) Odds ratio with 95% CI
Medianalderen var 71 år (interval: 40 til 93 år), og 30 % af patienterne var ≥ 75 år.
The median age was 71 (range: 40-93) years, with 30% of the patients ≥75 years of age.
En ml koncentrat indeholder 20 mg daratumumab.
One mL of concentrate contains 20 mg daratumumab.
Bortezomib blev administreret som subkutan injektion eller intravenøs infusion i en dosis på 1,3 mg/m2 to gange om ugen i to uger (dag 1,
Bortezomib was administered by subcutaneous (SC) injection at a dose of 1.3 mg/m2 body surface area twice weekly at
hver tredje uge (i alt 5 doser)
every three weeks (total of 5 doses)
Alvorlige bivirkninger var pneumoni, bronchitis, infektion i øvre luftveje, pulmonalt ødem, influenza, pyrexi, dehydrering, diarré og atrieflimren.
Serious adverse reactions were pneumonia, bronchitis, upper respiratory tract infection, pulmonary oedema, influenza, pyrexia, dehydration, diarrhoea and atrial fibrillation.
På dagene med infusion af DARZALEX blev 20 mg af dexamethasondosen givet før infusionen, og resten blev givet dagen efter infusionen.
On DARZALEX infusion days, 20 mg of the dexamethasone dose was given as a pre-infusion medication and the remainder given the day after the infusion.
Med en samlet median opfølgning på 7,4 måneder (95 % CI: 0,0; 14,9) var hazard ratio for OS 0,77 (95 % CI: 0,47; 1,26; p = 0,2975).
Median OS was not reached for either treatment group.With an overall median follow-up of 7.4 months (95% CI: 0.0, 14.9), the hazard ratio for OS was 0.77 (95% CI: 0.47, 1.26; p=0.2975).
Meget almindelig 10
Very Common 10
Skema for dosering i kombination med med bortezomib, thalidomid og dexamethason (regime med 4-ugers serier) til behandling af nydiagnosticerede patienter, som er kandidater til autolog stamcelletransplantation (ASCT):
Dosing schedule in combination with bortezomib, thalidomide and dexamethasone (4-week cycle regimens) for treatment of newly diagnosed patients eligible for autologous stem cell transplant (ASCT):
Meget almindelig 16
Very Common 16
Daratumumab er et humant monoklonalt IgG kappa-antistof, som kan påvises med såvel SPE-analyser (serumproteinelektroforese) som IFE-analyser (immunfiksering), der anvendes til klinisk monitorering af endogent M-protein (se pkt.
Interference with determination of Complete Response Daratumumab is a human IgG kappa monoclonal antibody that can be detected on both, the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein (see section 4.5).
Efterfølgende infusioner (uge 3 og derefter, 16 mg/kg)
Subsequent (Week 3 onwards, 16 mg/kg) infusions
Der blev udført fire individuelle farmakokinetiske populationsanalyser på grundlag af eksisterende data for nyrefunktionen hos patienter, der fik daratumumab som monoterapi eller forskellige kombinationsbehandlinger (analyse 1-4), som omfattede i alt 441 patienter med normal nyrefunktion (kreatinin-clearance [CrCl] ≥ 90 ml/min), 621 patienter med let nedsat nyrefunktion (CrCl < 90 og ≥ 60 ml/min), 523 patienter med moderat nedsat nyrefunktion (CrCl <60 og ≥ 30 ml/min) og 27 patienter med svært nedsat nyrefunktion eller nyresygdom i terminalstadiet (CrCl < 30 ml/min) indgik i analysen.
Four individual population PK analyses were performed based on pre-existing renal function data in patients receiving daratumumab monotherapy, or various combination therapies (Analyses 1-4), and included a total of 441 patients with normal renal function (creatinine clearance [CRCL] ≥90 mL/min), 621 with mild renal impairment (CRCL <90 and ≥60 mL/min), 523 with moderate renal impairment (CRCL <60 and ≥30 mL/min), and 27 with severe renal impairment or end stage renal disease
VGPR eller bedre (sCR + CR + VGPR) p-værdi
VGPR or better (sCR + CR + VGPR) p-value
Tabel 1: Skema for dosering af DARZALEX i kombination med lenalidomid (doseringsregime med 4-ugers serier) og monoterapi
Table 1: DARZALEX dosing schedule in combination with lenalidomide (4-week cycle dosing regimen) and monotherapy
Tabel 6: Bivirkninger hos patienter med myelomatose behandlet med DARZALEX 16 mg/kg
Table 6: Adverse reactions in multiple myeloma patients treated with DARZALEX
I 36 % af tilfældene blev infusionen ændret som følge af en reaktion.
The incidence of infusion modifications due to reactions was 36%.
injektion med en dosis på 1,3 mg/m2 legemsoverfladeareal to gange om ugen i to uger (dag 1, 4, 8 og 11) i gentagne serier på 28 dage (4 uger) med induktionsbehandling (serie 1-4) og to konsolideringsserier (serie 5 og 6) efter ASCT efter serie 4.
Bortezomib was administered by SC injection or IV injection at a dose of 1.3 mg/m2 body surface area twice weekly for two weeks (Days 1, 4, 8, and 11) of repeated 28 day (4-week) induction treatment cycles (Cycles 1-4) and two consolidation cycles (Cycles 5 and 6) following ASCT after Cycle 4.
Kombinationsbehandling med bortezomib, thalidomid og dexamethason (VTd) hos patienter, som er kandidater til autolog stamcelletransplantation (ASCT):
Combination treatment with bortezomib, thalidomide and dexamethasone (VTd) in patients eligible for autologous stem cell transplant (ASCT):
Meget almindelig 25
Very Common 25
Sjældne symptomer (kan forekomme hos op til 1 ud af 1.000 patienter):
Rare (may affect up to 1 in 1,000 people):
Den mediane PFS blev ikke nået i DRd-armen og var 33,8 måneder i Rd-armen (HR = 0,56; 95 % CI: 0,44; 0,71; p < 0,0001).
Median PFS was not reached in the DRd arm and was 33.8 months in the Rd arm (HR=0.56; 95% CI: 0.44, 0.71; p<0.0001).
Medianalderen var 73 (interval: 45-90 år), og 44 % af patienterne var ≥ 75 år.
The median age was 73 (range: 45-90) years, with 44% of the patients ≥75 years of age.
Alvorlige infusionsrelaterede reaktioner inkluderede bronkospasme, dyspnø, larynxødem, lungeødem, hypoxi og hypertension.
Severe infusion-related reactions included bronchospasm, dyspnoea, laryngeal oedema, pulmonary oedema, hypoxia, and hypertension.
ugentligt (i alt 9 doser)
weekly (total of 9 doses)
Meget almindelig 19
Very Common 19
• i kombination med lenalidomid og dexamethason eller med bortezomib, melphalan og prednison til behandling af voksne patienter med nydiagnosticeret myelomatose, som ikke er kandidater til autolog stamcelletransplantation.
• in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
• i kombination med bortezomib, thalidomid og dexamethason til behandling af voksne patienter med nydiagnosticeret myelomatose, som er kandidater til autolog stamcelletransplantation.
• in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
Meget almindelig 45
Very Common 45
Andre almindelige symptomer (kan forekomme hos op til 1 ud af 10 patienter):
Other common symptoms (affecting up to 1 in 10 people) are:
Medianalderen var 65 år (34-89 år), og 11 % var ≥ 75 år.
The median patient age was 65 years (range 34 to 89 years) and 11% were ≥75 years.
Brug af anden medicin sammen med DARZALEX Fortæl det altid til lægen eller sygeplejersken, hvis du tager anden medicin, for nylig har taget anden medicin eller planlægger at tage anden medicin.
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Andre infusionsrelaterede bivirkninger omfattede tilstoppet næse, hoste, kulderystelser, irritation i svælget, opkastning og kvalme (se pkt.
Other adverse infusion-related reactions included nasal congestion, cough, chills, throat irritation, vomiting and nausea (see section 4.4).
Lenalidomid (25 mg en gang dagligt administreret oralt på dag 1-21 i gentagne serier på 28 dage [4 uger]) blev administreret sammen med oral eller intravenøs lavdosis dexamethason 40 mg/uge (eller en reduceret dosis på 20 mg/uge for patienter > 75 år eller med et BMI < 18,5).
Lenalidomide (25 mg once daily orally on Days 1-21 of repeated 28-day [4-week] cycles) was given with low dose oral or intravenous dexamethasone 40 mg/week (or a reduced dose of 20 mg/week for patients >75 years or body mass index [BMI] <18.5).
Lægen fastsætter den rette dosis DARZALEX og en doseringsplan.
Your doctor will work out your dose and schedule of DARZALEX.
Median PFS blev ikke nået i D-VMParmen og var 19,3 måneder i VMP-armen (HR = 0,46; 95 % CI: 0,36, 0,60; p < 0,0001).
Median PFS was not reached in the D-VMP arm and was 19.3 months in the VMP arm (HR=0.46; 95% CI: 0.36, 0.60; p<0.0001).
Alvorlige reaktioner, herunder bronkospasme, hypoxi, dyspnø, hypertension, larynxødem og lungeødem er forekommet.
Severe reactions have occurred, including bronchospasm, hypoxia, dyspnoea, hypertension, laryngeal oedema and pulmonary oedema.
Symptomerne omfattede fortrinsvis tilstoppet næse, hoste, irritation i svælget, kulderystelser, opkastning og kvalme.
Symptoms predominantly included nasal congestion, cough, throat irritation, chills, vomiting and nausea.
Infusionshastigheder
Infusion rates
Tabel 4: Skema for dosering af DARZALEX i kombination med bortezomib (doseringsregime med 3-ugers serier)
Table 4: DARZALEX dosing schedule in combination with bortezomib (3-week cycle dosing regimen)
Stringent komplet respons (sCR) [n(%)] Komplet respons (CR) [n(%)] Meget godt delvist respons (VGPR) [n(%)] Delvist respons (PR) [n(%)] MRD-negativitetsrate (95% CI)
Stringent complete response (sCR) [n (%)] Complete response (CR) [n] Very good partial response (VGPR) [n (%)] Partial response (PR) [n (%)] Clinical Benefit Rate (ORR+MR) [n (%)]
På dage med infusion af DARZALEX blev dexamethason-dosen administreret intravenøst som en præ-infusionsmedicinering.
On the days of DARZALEX infusion, the dexamethasone dose was administered intravenously as a pre-infusion medication.
Tabel 3: Skema for dosering af DARZALEX i kombination med bortezomib, thalidomid og dexamethason ([VTd]; doseringsregime med 4-ugers serier) Behandlingsfase
Table 3: DARZALEX dosing schedule in combination with bortezomib, thalidomide and dexamethasone ([VTd]; 4-week cycle dosing regimen)
Interferens med indirekte antiglobulintest (indirekte Coombs test) Daratumumab binder til CD38, der findes i lavt niveau på erytrocytter, hvilket kan medføre en positiv indirekte Coombs test.
Interference with Indirect Antiglobulin Test (Indirect Coombs Test) Daratumumab binds to CD38 found at low levels on red blood cells (RBCs) and may result in a positive indirect Coombs test. Daratumumab-mediated positive indirect Coombs test may persist for up to 6 months after the last daratumumab infusion.
hver anden uge (i alt 4 doser)
every two weeks (total of 4 doses)
• udpræget træthedsfølelse
• feeling very tired
Den anbefalede dosis er 16 mg DARZALEX pr. kg legemsvægt administreret som intravenøs infusion i henhold til doseringsskemaet i tabel 3.
The recommended dose is DARZALEX 16 mg/kg body weight administered as an intravenous infusion according to the following dosing schedule in Table 3.
ugentligt (i alt 6 doser)
weekly (total of 6 doses)
Den mediane infusionsvarighed for 16 mg/kg infusioner i uge 1 og uge 2 og efterfølgende infusioner var henholdsvis ca. 7, 4 og 3 timer.
Week and subsequent infusions were approximately 7, 4 and 3 hours respectively.
Mediantid til respons [måneder (95 % CI)] Median responsvarighed [måneder (95 % CI)]
Median Time to Response [months (95% CI)] 1.0 (1.0, 1.1) Median Duration of Response [months (95% CI)]
95 % CI (%) Oddsratio med 95 % CI p-værdi
95% CI (%) Odds ratio with 95% CI p-value
ugentligt (i alt 8 doser)
weekly (total of 8 doses)
DVd = daratumumab- bortezomib-dexamethason; Vd = bortezomib-dexamethason; MRD = minimal restsygdom; CI = konfidensinterval; NE = kan ikke estimeres.
DVd=daratumumab- bortezomib-dexamethasone; Vd=bortezomib-dexamethasone; MRD=minimal residual disease; CI=confidence interval; NE=not estimable.
Skema for dosering i kombination med bortezomib (regime med 3-ugers serier): Den anbefalede dosis er 16 mg DARZALEX pr. kg legemsvægt administreret som intravenøs infusion i henhold til doseringsskemaet i tabel 4.
Dosing schedule in combination with bortezomib, melphalan and prednisone (6-week cycle regimens): The recommended dose is DARZALEX 16 mg/kg body weight administered as an intravenous infusion according to the following dosing schedule in Table 2.
Tabel 8: Yderligere effektresultater fra studie MMY3007
Table 8: Additional efficacy results from Study MMY3007
hver anden uge (i alt 8 doser)
every two weeks (total of 8 doses)
Infusion i uge 2 (16 mg/kg)
Week 2 (16 mg/kg)infusion
(grad 4), skal der straks iværksættes passende livreddende behandling.
If an anaphylactic reaction or life-threatening (Grade 4) infusion reaction occurs, appropriate emergency resuscitation should be initiated immediately.
Hvis du er gravid eller ammer, har mistanke om, at du er gravid eller planlægger at blive gravid, skal du spørge din læge eller sundhedspersonalet til råds, før du får DARZALEX.
Talk to your doctor or nurse before you are given DARZALEX if you are pregnant, think you might be pregnant or are planning to have a baby.
Tabel 7: Yderligere effektresultater fra studie MMY3008
Table 7: Additional efficacy results from Study MMY3008
Den anbefalede dosis er 16 mg DARZALEX pr. kg legemsvægt administreret som intravenøs infusion i henhold til doseringsskemaet i tabel 2.
The recommended dose is DARZALEX 16 mg/kg body weight administered as an intravenous infusion according to the following dosing schedule in Table 4.
Bivirkning efter markedsføring
Post-marketing adverse reaction
For oplysninger om dosis og doseringsskema for VMP ved administration sammen med DARZALEX henvises til pkt.
For information on the VMP dose and dosing schedule when administered with DARZALEX, see section 5.1.
Hvert hætteglas med 20 ml indeholder 400 mg daratumumab (20 mg daratumumab pr. ml).
Each 20 mL vial contains 400 mg of daratumumab (20 mg daratumumab per mL).
Første dosis i doseringsskemaet for hver 3. uge gives i uge 7 Første dosis i doseringsskemaet for hver 4. uge gives i uge 55
First dose of the every-3-week dosing schedule is given at Week 7 First dose of the every-4-week dosing schedule is given at Week 55
NK- (naturlige dræberceller)-celletal og T-celletal NK-celler vides at udtrykke høje niveauer af CD38 og er følsomme for daratumumab-medieret cellelyse.
NK cells are known to express high levels of CD38 and are susceptible to daratumumab mediated cell lysis.
DRd = daratumumab-lenalidomid-dexamethason; Rd = lenalidomid-dexamethason; MRD = minimal restsygdom; CI = konfidensinterval; NE = kan ikke estimeres.
DRd=daratumumab-lenalidomide-dexamethasone; Rd=lenalidomide-dexamethasone; MRD=minimal residual disease; CI=confidence interval; NE=not estimable.
Tabel 2: Skema for dosering af DARZALEX i kombination med bortezomib, melphalan og prednison ([VMP]; doseringsregime med 6-ugers serier)
DARZALEX dosing schedule in combination with bortezomib, melphalan and prednisone ([VMP]; 6-week cycle dosing regimen)
På dage med infusion af DARZALEX blev dexamethasondosen givet som præinfusionsmedicinering.
On DARZALEX infusion days, the dexamethasone dose was given as a pre-infusion medication.
På dagene med infusion af DARZALEX blev 20 mg af dexamethason-dosen administreret før infusionen.
On the days of DARZALEX infusion, 20 mg of the dexamethasone dose was administered as a pre-infusion medication.
Studie MMY3007, et åbent, randomiseret, aktivt kontrolleret fase III-studie, sammenlignede behandling med 16 mg/kg DARZALEX i kombination med bortezomib, melphalan og prednison (D-VMP) med behandling med VMP hos patienter med nydiagnosticeret myelomatose.
Study MMY3007, an open-label, randomised, active-controlled Phase III study, compared treatment with DARZALEX 16 mg/kg in combination with bortezomib, melphalan and prednisone (D-VMP), to treatment with VMP in patients with newly diagnosed multiple myeloma.
Infektion i øvre luftveje Urinvejsinfektion
Upper respiratory tract infection
Fremstiller Janssen Biologics B.V.
Manufacturer Janssen Biologics B.V. Einsteinweg 101
Første dosis i doseringsskemaet for hver 3. uge gives i uge 10 Første dosis i doseringsskemaet for hver 4. uge gives i uge 25
First dose of the every-3-week dosing schedule is given at Week 10 First dose of the every-4-week dosing schedule is given at Week 25
Hvert hætteglas med 20 ml koncentrat indeholder 400 mg daratumumab (20 mg/ml).
Each vial of 20 mL concentrate contains 400 mg of daratumumab (20 mg/mL).
Trombocytopeni Anæmi
Thrombocytopenia
Hvis en IRR forekommer, skal infusion af DARZALEX straks afbrydes og symptomerne behandles, uanset graden/sværhedsgraden af IRR'en.
For IRRs of any grade/severity, immediately interrupt the DARZALEX infusion and manage symptoms.
Yderligere effektresultater fra studie MMY3004 præsenteres i tabel 12 nedenfor.
Additional efficacy results from Study MMY3004 are presented in Table 12 below.
Rygsmerter
Haemolysis
Håndtering af infusionsrelaterede reaktioner Der skal administreres lægemidler før infusion af DARZALEX for at reducere risikoen for IRR'er.
Pre-infusion medications should be administered to reduce the risk of infusion-related reactions (IRRs) prior to treatment with DARZALEX.
Første dosis i doseringsskemaet for hver 2. uge gives i uge 9 Første dosis i doseringsskemaet for hver 4. uge gives i uge 25
First dose of the every-2-week dosing schedule is given at Week 9 First dose of the every-4-week dosing schedule is given at Week 25
• lungebetændelse
• lung infection (pneumonia)
Baseret på den farmakokinetiske populationsanalyse af daratumumab som monoterapi (analyse 1) nås steady state for daratumumab cirka 5 måneder inde i perioden med en dosis hver 4. uge (ved infusion nr. 21), og middelforholdet (SD) mellem Cmax ved steady state og Cmax efter første dosis var 1,6 (0,5).
Based on the population PK analysis of daratumumab monotherapy (Analysis 1), daratumumab steady state is achieved approximately 5 months into the every 4-week dosing period (by the 21
Studie MMY3008, et åbent, randomiseret, aktivt kontrolleret fase III-studie, sammenlignede behandling med 16 mg/kg DARZALEX i kombination med lenalidomid og lavdosis dexamethason (DRd) med behandling med lenalidomid og lavdosis dexamethason (Rd) hos patienter med nydiagnosticeret myelomatose.
Study MMY3008, an open-label, randomized, active-controlled Phase III study, compared treatment with DARZALEX 16 mg/kg in combination with lenalidomide and low-dose dexamethasone (DRd) to treatment with lenalidomide and low-dose dexamethasone (Rd) in patients with newly diagnosed multiple myeloma.
• svaghedsfornemmelse
• chest discomfort