natgillin/translations-raw huggingface dataset:
Zejula hårde kapsler indeholder lactosemonohydrat.
Zejula hard capsules contain lactose monohydrate.
Niraparib er en type kræftmedicin, der kaldes PARPhæmmere.
Niraparib is a type of anti-cancer medicine called a PARP inhibitor.
Myelodysplastisk syndrom/akut myeloid leukæmi, herunder tilfælde med dødelig udgang, er indberettet hos nogle få patienter, som fik Zejula eller placebo.
Myelodysplastic syndrome/acute myeloid leukaemia (MDS/AML), including cases with fatal outcome, have been reported in a small number of patients who received Zejula or placebo.
Der er samlet indberettet myelodysplastisk syndrom/akut myeloid leukæmi hos 7 ud af 751 (0,9 %) patienter, der blev behandlet med Zejula i kliniske studier.
Overall, MDS/AML has been reported in 7 out of 751 (0.9 %) patients treated with Zejula in clinical studies.
Der er ikke udført karcinogenicitetsstudier med niraparib.
Carcinogenicity studies have not been conducted with niraparib.
Der er ikke gennemført studier med pædiatriske patienter.
Paediatric population No studies have been conducted in paediatric patients.
• Følelse af bekymring, nervøsitet eller utryghed
• Feeling of worry, nervousness, or unease
Du må ikke tage Zejula, hvis du ammer, da man ikke ved, om det udskilles i mælken.
Zejula should not be taken if you are breast-feeding as it is not known if it passes into breast milk.
For at være egnet til niraparibbehandling bør patienten have udvist respons (komplet eller delvis) efter fuldførelse af den sidste platin-baserede kemoterapi.
To be eligible for niraparib treatment, the patient should be in response (CR or PR) following completion of last platinum based chemotherapy.
Data for patientrapporterede resultater fra validerede undersøgelsesværktøjer (FOSI og EQ-5D) tyder på, at niraparib-behandlede patienter ikke oplevede nogen forskel i forhold til placebo, når de blev adspurgt om forhold vedrørende livskvaliteten.
Patient-reported outcome (PRO) data from validated survey tools (FOSI and EQ-5D) indicate that niraparib-treated patients reported no difference from placebo in measures associated with quality of life (QoL).
Hæmatologisk bivirkning, der kræver støtte i form af transfusion eller hæmatopoietisk vækstfaktor
Haematologic adverse reaction requiring transfusion or haematopoietic growth factor support
Seponer Zejula permanent.
• Permanently discontinue Zejula.
Manglende dosis
Missing dose
84 × 1 hårde kapsler 56 × 1 hårde kapsler 28 × 1 hårde kapsler
84 × 1 hard capsules 56 × 1 hard capsules 28 × 1 hard capsules
I en farmakokinetisk populationsanalyse var niraparibs tilsyneladende totale clearance (CL/F) 16,2 l/h hos cancerpatienter.
In a population pharmacokinetic analysis, the apparent total clearance (CL/F) of niraparib was 16.2 L/h in cancer patients.
• Forhøjede blodprøveværdier
• Elevated blood tests
• Hurtig puls kan medføre svimmelhed, brystsmerter eller åndenød
• Fast heart beat may cause dizziness, chest pain or breathlessness
gBRCAmut ikke-gBRCAmut
gBRCAmut non-gBRCAmut
Urinvejsinfektion, bronkitis
Urinary tract infection, bronchitis
Afbrydelse på grund af trombocytopeni-hændelser (trombocytopeni og nedsat antal trombocytter) skete hos ca. 3 % af patienterne.
Discontinuation due to thrombocytopenia events (thrombocytopenia and platelet count decreased) occurred in approximately 3 % of the patients.
Et samtidigt måltid med højt fedtindhold havde ingen signifikant indvirkning på niraparibs farmakokinetik efter administration af 300 mg niraparib.
A concomitant high-fat meal did not significantly affect the pharmacokinetics of niraparib after administration of 300 mg of niraparib.
• Åndenød, stor træthed, bleg hud eller hurtig puls - dette kan være tegn på et lavt antal røde blodlegemer (blodmangel (anæmi)).
• Being short of breath, feeling very tired, having pale skin, or fast heartbeat -- these may be signs of a low red blood cell count (anaemia).
Bronkitis, konjunktivitis
Bronchitis, conjunctivitis
Højt blodtryk
High blood pressure
Du kan føle dig svag, træt eller svimmel, når du tager Zejula, og det påvirker din evne til at føre motorkøretøj og betjene maskiner.
When you are taking Zejula it may make you feel weak, tired or dizzy and therefore influence your ability to drive and use machines.
Hovedpine, svimmelhed, dysgeusi
Headache, dizziness, dysgeusia
Hvis du tager Zejula ved sengetid, kan det hjælpe med til at undertrykke kvalme.
Taking Zejula at bedtime may help you to manage nausea.
Brug af anden medicin sammen med Zejula
Other medicines and Zejula
De sekundære endepunkter CFI, TFST og PFS2 viste en statistisk signifikant og vedvarende behandlingseffekt til fordel for niraparib-behandlingsarmen i gBRCAmut-kohorten og ikke-gBRCAmut-kohorten overordnet set (tabel 5).
The secondary endpoints CFI, TFST, and PFS2 demonstrated a statistically significant and persistent treatment effect in favour of the niraparib treatment arm in the gBRCAmut cohort and the overall non-gBRCAmut cohort (Table 5).
Afbrydelse på grund af neutropeni skete hos 2 % af patienterne.
Discontinuation due to neutropenia events occurred in 2 % of patients.
Der bør udvises forsigtighed, når niraparib kombineres med aktive stoffer, der er underlagt optagelsestransport via OCT1, f.eks. metformin.
Caution is recommended when niraparib is combined with active substances that undergo an uptake transport by OCT1 such as metformin.
Dosisnedsættelser kan gennemføres i forhold til bivirkninger.
Dose reductions may be implemented based on adverse reactions.
Titandioxid (E 171) Gelatine
Capsule shell Titanium dioxide (E 171) Gelatin
Øget niraparib-induceret cytotoksicitet sås i tumorcellelinjer med eller uden defekter i tumorsuppressorgenerne BReast CAncer (BRCA) 1 og 2.
Increased niraparib-induced cytotoxicity was observed in tumour cell lines with or without deficiencies in the BReast CAncer (BRCA) 1 and 2 tumour suppressor genes.
Efter flere orale doser niraparib på fra 30 mg til 400 mg én gang dagligt var akkumulationen af niraparib ca. 2 til 3 gange så stor.
Following multiple oral doses of niraparib from 30 mg to 400 mg once daily, accumulation of niraparib was approximately 2 to 3 folds.
Forsigtighed tilrådes derfor, når niraparib kombineres med substrater for BCRP (irinotecan, rosuvastatin, simvastatin, atorvastatin og methotrexat).
Caution is then recommended when niraparib is combined with substrates of BCRP (irinotecan, rosuvastatin, simvastatin, atorvastatin, and methotrexate).
• Blå mærker eller blødning, der varer længere end normalt, hvis du kommer til skade - dette kan være tegn på et lavt antal blodplader (trombocytopeni).
• Bruising or bleeding for longer than usual if you hurt yourself -- these may be signs of a low blood platelet count (thrombocytopenia).
Niraparib er en hæmmer af poly (ADP-ribose) polymerase-/PARP-enzymerne PARP-1 og PARP-2, der spiller en rolle i reparationen af DNA.
Niraparib is an inhibitor of poly(ADP-ribose) polymerase (PARP) enzymes, PARP-1 and PARP-2, which play a role in DNA repair.
Hæmatologiske bivirkninger (trombocytopeni, anæmi, neutropeni), herunder kliniske diagnoser og/eller laboratoriefund, forekom generelt tidligt i niraparib-behandlingen, og incidensen faldt med tiden.
Haematologic adverse reactions (thrombocytopenia, anaemia, neutropenia) including clinical diagnoses and/or laboratory findings generally occurred early during niraparib treatment with the incidence decreasing over time.
Niraparib er ikke et substrat for galdesalteksportpumpen (BSEP).
Niraparib is not a substrate of bile salt export pump (BSEP).
Hypertension var i de fleste tilfælde tilstrækkeligt kontrolleret med gængs antihypertensiv behandling med eller uden dosisjustering af Zejula (se pkt.
In most cases, hypertension was controlled adequately using standard antihypertensive treatment with or without Zejula dose adjustment (see section 4.2).
Hæmatologiske bivirkninger (trombocytopeni, anæmi, neutropeni) er indberettet hos patienter, der er behandlet med Zejula.
Haematologic adverse reactions (thrombocytopenia, anaemia, neutropenia) have been reported in patients treated with Zejula.
P-værdi gBRCAmut ikke-gBRCAmut
P value gBRCAmut non-gBRCAmut
Hypertension, herunder hypertensiv krise, er indberettet ved brug af Zejula.
Hypertension, including hypertensive crisis, has been reported with the use of Zejula.
I det internationale fase 3 pivotale studie (ENGOT-OV16) var der næsten samme forekomst af myelodysplastisk syndrom/akut myeloid leukæmi hos patienter, der fik niraparib (1,4 %), som hos patienter, der fik placebo (1,1 %).
In the pivotal Phase 3 international trial (ENGOT-OV16), the incidence of MDS/AML in patients who received niraparib (1.4 %) was similar to that in patients who received placebo (1.1 %).
Den vigtigste primære metabolit, M1, er ikke et substrat for P-gp, BCRP eller BSEP.
The major primary metabolite M1 is not a substrate of P-gp, BCRP, or BSEP.
Demografi, sygdomskarakteristika ved baseline og tidligere behandlingsanamnese var generelt velafbalanceret mellem niraparib- og placeboarmene i kohorterne gBRCAmut (n = 203) og ikke-gBRCAmut (n = 350).
Demographics, baseline disease characteristics, and prior treatment history were generally well balanced between the niraparib and placebo arms in the gBRCAmut (n = 203) and the non-gBRCAmut cohorts (n = 350).
Zejula hårde kapsler har en hvid uigennemsigtig underdel og en lilla uigennemsigtig overdel.
Zejula hard capsules have a white opaque body and a purple opaque cap.
Niraparibs sikkerhed og virkning som vedligeholdelsesbehandling blev undersøgt i et randomiseret, dobbeltblindet, placebokontrolleret internationalt fase 3-studie (ENGOT-OV16/NOVA) hos patienter med recidiv af fortrinsvis høj-grads serøs epitelial ovariecancer, tubacancer eller primær peritonealcancer, som var platinfølsom, defineret ved komplet respons (CR) eller delvis respons (PR) i mere end seks måneder på deres næstsidste platinbaserede terapi.
The safety and efficacy of niraparib as maintenance therapy was studied in a Phase 3 randomised, double-blind, placebo-controlled international trial (ENGOT-OV16 / NOVA) in patients with relapsed predominantly high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who were platinum sensitive, defined by complete response (CR) or partial response (PR) for more than six months to their penultimate (next to last) platinum-based therapy.
Hvis du ammer, skal du holde op, før du begynder at tage Zejula, og du må først begynde at amme igen 1 måned efter, at du har taget din sidste dosis.
If you are breast-feeding, you must stop before you start taking Zejula and you must not begin breast-feeding again until 1 month after taking your last dose.
• Genoptag Zejula i nedsat dosis (100 mg/dag).
• Resume Zejula at a reduced dose (100 mg/day).
I den farmakokinetiske populationsanalyse af data fra kliniske studier hos patienter havde eksisterende let nedsat nyrefunktion (ClCr < 90 - ≥ 60 ml/min) og moderat nedsat nyrefunktion (ClCr < 60 - ≥ 30 ml/min) ingen indflydelse på clearance af niraparib.
In the population pharmacokinetic analysis of data from clinical studies in patients, pre-existing mild (CLCr < 90 - ≥ 60 ml/min) and moderate (CLCr < 60 - ≥ 30 mL/min) renal impairment did not influence the clearance of niraparib.
• Betændelse i munden og/eller fordøjelseskanalen
• Inflammation of the mouth and/or digestive tract
Indeholder også lactose og tartrazin (E 102).
Also contains lactose and tartrazine (E 102).
På grund af risikoen for trombocytopeni skal antikoagulantia og lægemidler, der nedsætter trombocyttallet, anvendes med forsigtighed (se pkt.
Due to the risk of thrombocytopenia, anticoagulants and medicinal products known to reduce the thrombocyte count should be used with caution (see section 4.8).
• Følelse af tristhed, depression
• Feelings of sadness, depressed
Hæmning af CYP'er (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 og CYP3A4) Hverken niraparib eller M1 hæmmer nogen aktivt stof-metaboliserende CYP-enzymer, dvs. CYP1A1/2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 og CYP3A4/5.
Inhibition of CYPs (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4) Neither niraparib nor M1 is an inhibitor of any active substance-metabolising CYP enzymes, namely CYP1A1/2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4/5.
Ved ortotopiske xenografttumorer fra patienter med høj-grads serøs ovariecancer (PDX), der er dyrket i mus, er det påvist, at niraparib reducerer tumorvæksten i BRCA 1 og 2-mutant, BRCA-vildtype, men med HR-defekt (homolog rekombination-defekt), og i tumorer af BRCA-vildtype og uden detekterbar HR-defekt.
In orthotopic high-grade serous ovarian cancer patient-derived xenograft tumours (PDX) grown in mice, niraparib has been shown to reduce tumour growth in BRCA 1 and 2 mutant, BRCA wild-type but homologous recombination (HR) deficient, and in tumours that are BRCA wild-type and without detectable HR deficiency.
Afbrydelse på grund af anæmi skete hos 1 % af patienterne.
Discontinuation due to anaemia occurred in 1 % of patients.
Zejula 100 mg, hårde kapsler
Zejula 100 mg hard capsules
Dosis er 3 hårde kapsler a 100 mg 1 gang dagligt, svarende til en daglig dosis på i alt 300 mg.
The dose is three 100 mg hard capsules once daily, equivalent to a total daily dose of 300 mg.
Figur 1: Kaplan-Meier-kurve for progressionsfri overlevelse i gBRCAmut-kohorten baseret på IRC-vurdering (ITT-population, N = 203)
Figure 1: Kaplan-Meier plot for progression-free survival in the gBRCAmut cohort based on IRC assessment (ITT population, N = 203)
Efter administration af en enkelt dosis på 300 mg niraparib under faste kunne niraparib måles i plasma i løbet af 30 minutter, og den gennemsnitlige maksimale plasmakoncentration (Cmax) af niraparib blev nået på ca. 3 timer [804 ng/ml (% CV:50,2 %)].
Following a single-dose administration of 300 mg niraparib under fasting conditions, niraparib was measurable in plasma within 30 minutes and the mean peak plasma concentration (Cmax) for niraparib was reached in about 3 hours [804 ng/mL (% CV:50.2 %)].
• Genoptag Zejula ved nedsat dosis (200 mg/dag).
• Resume Zejula at a reduced dose (200 mg/day).
Hvis en patient udvikler svær vedvarende hæmatologisk toksicitet, herunder pancytopeni, der ikke forsvinder i løbet af 28 dages afbrydelse, skal Zejula seponeres.
If a patient develops severe persistent haematologic toxicity including pancytopenia that does not resolve within 28 days following interruption, Zejula should be discontinued.
Kemoterapifrit interval Median (95 %-KI) - mo
Chemotherapy-free interval Median (95 % CI) - mo
I NOVA-studiet havde patienter, som var egnede til Zejula-behandling, følgende hæmatologiske værdier ved baseline: absolut neutrofilttal (ANC) ≥ 1.500 celler/µl, trombocyttal ≥ 100.000 celler/µl og hæmoglobin ≥ 9 g/dl før behandling.
In the NOVA study, patients eligible for Zejula therapy had the following baseline haematologic parameters: absolute neutrophil count (ANC) ≥ 1,500 cells/µL; platelets ≥ 100,000 cells/µL and haemoglobin ≥ 9 g/dL prior to therapy.
• Aktivt stof: niraparib.
• The active substance is niraparib.
Median (95 %-KI) - mo
Median (95 % CI) - mo
• Tilbagehold Zejula i maksimalt 28 dage eller indtil bedring af bivirkning.
• Withhold Zejula for a maximum of 28 days or until resolution of adverse reaction.
Kontakt straks lægen, hvis du tager mere end din normale dosis.
If you take more than your normal dose, contact your doctor immediately.
Efter oral administration af en enkelt dosis [14C]-niraparib på 300 mg blev i gennemsnit 86,2 % (interval 71-91 %) af dosis udskilt i urinen og fæces i løbet af 21 dage.
Following an oral administration of a single 300-mg dose of [14C]-niraparib, on average 86.2 % (range 71 % to 91 %) of the dose was recovered in urine and feces over 21 days.
Det komplette blodtal bør derfor overvåges ugentligt i behandlingens første måned, og dosis skal justeres efter behov.
It is therefore recommended to monitor complete blood counts (CBCs) weekly during the first month of treatment and modify the dose as needed.
Figur 2: Kaplan-Meier-kurve for progressionsfri overlevelse i ikke-gBRCAmut-kohorten overordnet set baseret på IRC-vurdering (ITT-population, N = 350)
Figure 2: Kaplan-Meier plot for progression-free survival in the non-gBRCAmut cohort overall based on IRC assessment (ITT population, N = 350)
Hård kapsel på ca. 22 × 8 mm, hvid underdel med "100 mg" trykt med sort blæk og lilla overdel med "Niraparib" trykt med hvidt blæk.
Hard capsule of approximately 22 mm × 8 mm; white body with “100 mg” printed in black ink and purple cap with “Niraparib” printed in white ink.
In vitro er niraparib en svag hæmmer af organisk kationtransportør 1 (OCT1) med en IC50 på 34,4 µm.
In vitro, niraparib weakly inhibits the organic cation transporter 1 (OCT1) with an IC50 = 34.4 µM.
En følsomhedsanalyse af investigator-PFS viste følgende resultater for gBRCA-mut-kohorten: HR 0,27 (95 %-KI*, 0,182-0,401; p < 0,0001); median PFS 14,8 måneder (95 %-KI*, 12,0-16,6) for niraparib og median PFS 5,5 måneder (95 %-KI*, 4,9-7,2) for placebo, og for ikke-gBRCA-mutkohorten: HR 0,53 (95 %-KI*, 0,405-0,683; p < 0,0001); median PFS 8,7 måneder (95 %-KI*, 7,3-10,0) for niraparib og median PFS 4,3 måneder (95 %-KI*, 3,7-5,5) for placebo.
A sensitivity analysis of investigator PFS showed the following results for the gBRCAmut cohort: HR 0.27 (95 % CI*, 0.182, 0.401; p < 0.0001); median PFS 14.8 months (95% CI*, 12.0, 16.6) for niraparib and median PFS 5.5 months (95% CI*, 4.9, 7.2) for placebo, and for the non-gBRCAmut cohort: HR 0.53 (95 % CI*, 0.405, 0.683; p < 0.0001); median PFS 8.7 months (95 % CI*, 7.3, 10.0) for niraparib and median PFS 4.3 months (95% CI*, 3.7, 5.5) for placebo.
Angst, depression
Anxiety, depression
Zejula er indiceret som monoterapi til vedligeholdelsesbehandling af voksne patienter med recidiv af platinfølsom høj-grads serøs epitelial ovariecancer, tubacancer eller primær peritonealcancer, som udviser (fuldstændig eller delvis) respons på platinbaseret kemoterapi.
Zejula is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
Hver hård kapsel indeholder niraparibtosylatmonohydrat svarende til 100 mg niraparib.
Each hard capsule contains niraparib tosylate monohydrate equivalent to 100 mg niraparib.
Zejula 100 mg, hårde kapsler niraparib
Zejula 100 mg hard capsules niraparib
Nedsat leverfunktion
Estimated Survival Function
Myelodysplastisk syndrom/akut myeloid leukæmi
Myelodysplastic syndrome/acute myeloid leukaemia
Shellac (E 904) Propylenglycol (E 1520) Kaliumhydroxid (E 525) Sort jernoxid (E 172) Natriumhydroxid (E 524) Povidon (E 1201)
Shellac (E 904) Propylene glycol (E 1520) Potassium hydroxide (E 525) Black iron oxide (E 172) Sodium hydroxide (E 524) Povidone (E 1201)
Hvis trombocyttallet på noget tidspunkt er < 75.000/μl,
• If platelet count is < 75,000/μL at any time, resume at a reduced dose.
De anbefalede dosisnedsættelser er først fra 3 hårde kapsler dagligt (300 mg) til 2 hårde kapsler dagligt (200 mg).
The recommended dose reductions are first from three hard capsules daily (300 mg) to two hard capsules daily (200 mg).
• Unormal smag i munden
• Abnormal taste in mouth
Studiet opfyldte sit primære formål med statistisk signifikant forbedret PFS ved vedligeholdelsesmonoterapi med niraparib sammenlignet med placebo i gBRCAmut-kohorten (HR 0,27, 95 %-KI* 0,173-0,410, p < 0,0001) samt i ikke-gBRCAmut-kohorten overordnet set (HR 0,45, 95 %-KI* 0,338-0,607, p < 0,0001).
The study met its primary objective of statistically significantly improved PFS for niraparib maintenance monotherapy compared with placebo in the gBRCAmut cohort (HR 0.27; 95 % CI* 0.173, 0.410; p < 0.0001) as well as in the overall non-gBRCAmut cohort (HR 0.45; 95 % CI* 0.338, 0.607; p < 0.0001).
• Øvrige indholdsstoffer: kapslens indhold: magnesiumstearat, lactosemonohydrat kapslens skal: titandioxid (E 171), gelatine, brilliant blue FCF (E 133), erythrosin (E 127), tartrazin (E 102) trykfarve: shellac (E 904), propylenglycol (E 1520), kaliumhydroxid (E 525), sort jernoxid (E 172), natriumhydroxid (E 524) og povidon (E 1201).
• The other ingredients (excipients) are: capsule content: magnesium stearate, lactose monohydrate capsule shell: titanium dioxide (E 171), gelatin, brilliant blue FCF (E 133), erythrosine (E 127), tartrazine (E 102) printing ink: shellac (E 904), propylene glycol (E 1520), potassium hydroxide (E 525), black iron oxide (E 172), sodium hydroxide (E 524), and povidone (E 1201).
Ca. 50 % af patienterne oplevede anæmi af alle grader, og 25 % oplevede anæmi af grad 3/4.
Approximately 50 % of patients experienced anaemia of any grade, and 25 % experienced Grade 3/4 anaemia.
Den vigtigste primære metabolit, M1, synes ikke at være en hæmmer af P-gp, BCRP, BSEP eller MATE1/2.
The major primary metabolite M1 does not appear to be an inhibitor of P-gp, BCRP, BSEP, or MATE1/2.
Niraparib som substrat for effluxtransportører (P-gp, BCRP og MATE1/2) Niraparib er et substrat for P-glycoprotein (P-gp) og Breast Cancer Resistance Protein (BCRP).
Niraparib as a substrate of efflux transporters (P-gp, BCRP, and MATE1/2) Niraparib is a substrate of P-glycoprotein (P-gp) and Breast Cancer Resistance Protein (BCRP).
Forhøjet gammaglutamyltransferase, forhøjet ASAT, forhøjet kreatinin i blodet, forhøjet ALAT, forhøjet alkalisk fosfatase i blodet, vægttab
Gamma-glutamyl transferase increased, AST increased, blood creatinine increased, ALT increased, blood alkaline phosphatase increased, weight decreased
Hvis du er en kvinde, der kan blive gravid, skal du bruge sikker prævention, mens du tager Zejula, og du skal blive ved med at bruge sikker prævention i 1 måned, efter at du har taget den sidste dosis.
If you are a woman who could become pregnant you must use reliable contraception while you are taking Zejula, and you must continue to use reliable contraception for 1 month after taking your last dose.
Zejula anvendes til voksne kvinder til behandling af kræft i æggestokkene, æggelederne (den del af kvindens kønsorganer, der forbinder æggestokkene med livmoderen) eller bughinden (den hinde, der beklæder bugvæggens inderside).
Zejula is used in adult women for the treatment of cancer of the ovary, the fallopian tubes (part of the female reproductive system that connects the ovaries to the uterus), or the peritoneum (the membrane lining the abdomen).
I gBRCAmut-kohorten var det mediane antal behandlingscyklusser højere i niraparib-armen end i placeboarmen (hhv. 14 og 7 cyklusser).
In the gBRCAmut cohort, the median number of treatment cycles was higher in the niraparib arm than the placebo arm (14 and 7 cycles, respectively).
Nogle af patienterne havde også knoglemarvsdysplasi i anamnesen.
Some of the patients had a history of bone marrow dysplasia.
In vitro hæmmer niraparib P-gp meget svagt og BCRP med en IC50 på hhv. 161 µm og 5,8 µm.
In vitro, niraparib inhibits P-gp very weakly and BCRP with an IC50 = 161 µM and 5.8 µM, respectively.
Den mediane tid til starten af trombocytopeni, uanset grad, og trombocytopeni af grad 3/4, var hhv. 22 og 23 dage.
The median time to onset of thrombocytopenia regardless of grade and Grade 3/4 thrombocytopenia was 22 and 23 days, respectively.
Hæmning af effluxtransportører (P-gp, BCRP, BSEP og MATE1/2) Niraparib er ikke en BSEP-hæmmer.
Inhibition of efflux transporters (P-gp, BCRP, BSEP, and MATE1/2) Niraparib is not an inhibitor of BSEP.
I ikke-gBRCAmut-kohorten overordnet set var det mediane antal behandlingscyklusser højere i niraparib-armen end i placeboarmen (hhv. 8 og 5 cyklusser).
In the overall non-gBRCAmut cohort, the median number of treatment cycles was higher in the niraparib arm than in the placebo arm (8 and 5 cycles, respectively).
Efter intensiv dosisjustering i løbet af de første to måneder af behandling fra 4. cyklus var hyppigheden af nye forekomster af trombocytopeni 1,2 %.
The rate of new incidences of thrombocytopenia after intensive dose modifications were performed during the first two months of treatment from Cycle 4 was 1.2 %.
Niraparib elimineres primært via leveren/galdevejene og nyrerne.
Niraparib is eliminated primarily through the hepatobiliary and renal routes.