natgillin/translations-raw huggingface dataset:
- Du må ikke amme under behandling med Rubraca, og i to uger efter indtagelse af sidste dosis.
• Do not breast-feed during treatment with Rubraca, and for two weeks after taking the last dose.
Rucaparib hæmmer også marginalt P-gp i tarmen.
Rucaparib also marginally inhibits P-gp in the gut.
Hvis MDS/AML bekræftes efter undersøgelse for længerevarende hæmatologiske toksicitet, skal Rubraca seponeres.
If, following investigation for prolonged haematological toxicity, MDS/AML is confirmed, Rubraca should be discontinued.
Hvis en dosis glemmes, skal patienten tage Rubraca igen ved næste planlagte dosis.
Missed doses If a dose is missed, the patient should resume taking Rubraca with the next scheduled dose.
Øgede transaminaserb
Increased transaminasesb
Rucaparib havde ingen virkning på Cmax af koffein, men øgede moderat AUCinf af koffein med 2,55 gange (90 % CI: 2,12, 3,08).
Rucaparib showed no effect on Cmax of caffeine while moderately increasing AUCinf of caffeine by 2.55 fold (90% CI: 2.12, 3.08).
Er du i tvivl, så spørg lægen, apotekspersonalet eller sundhedspersonalet, før du tager Rubraca.
If you are not sure, talk to your doctor, pharmacist or nurse before taking Rubraca.
Bivirkninger CTCAE klasse 3 eller højere forekom hos 23 % (anæmi), 8 % (neutropeni) og 6 % (trombocytopeni) af patienterne.
Adverse reactions CTCAE Grade 3 or higher occurred in 23% (anaemia), 8% (neutropenia) and 6% (thrombocytopenia) of patients.
I en eksplorativ analyse i denne undergruppe blev der noteret respons hos 18 % (95 % CI 12 % - 26 %) af patienterne (n=26) på rucaparib sammenlignet med 8 % (95 % CI 3 % - 17 %) af patienterne (n=5) på placebo (to-sidet p-værdi = 0,0069), herunder 10 patienter (7 %) i rucaparibgruppen, der opnåede en komplet remission.
In an exploratory analysis in this subgroup, a response was noted in 18% (95% CI 12% - 26%) of patients (n=26) on rucaparib compared to 8% (95% CI 3% - 17%) of patients (n=5) on placebo (2-sided p-value = 0.0069), including 10 patients (7%) in the rucaparib group who achieved a complete remission.
Det anbefales at foretage en graviditetstest hos kvinder i den fødedygtige alder før behandlingspåbegyndelse.
A pregnancy test before initiating treatment is recommended in women of reproductive potential.
Fertile kvinder/prævention til kvinder
Women of childbearing potential/contraception in females
Fødedygtige kvinder skal anbefales at bruge effektiv prævention under behandling og i 6 måneder efter den sidste dosis Rubraca (se pkt.
Women of reproductive potential should be advised to use effective contraception during treatment and for 6 months following the last dose of Rubraca (see section 4.6).
Hos patienter med kræft var den gennemsnitlige steady state, efter rucaparib 600 mg to gange dagligt, Cmax 1940 ng/ml, og AUC0-12 t var 16900 t⋅ng/ml med Tmax på 1,9 timer.
In patients with cancer following rucaparib 600 mg taken twice daily, the mean steady-state Cmax was 1940 ng/mL and AUC0-12h was 16900 h⋅ng/mL with Tmax of 1.9 hours.
Der er ikke udført fertilitetsforsøg med rucaparib.
Fertility studies have not been conducted with rucaparib.
Ingen justering anbefales af startdosis for ældre patienter (≥ 65 år) (se pkt.
No adjustment is recommended to the starting dose for elderly patients (≥ 65 years of age) (see sections 4.8 and 5.2).
Ved samtidig indgivelse af lægemidler, som er CYP2C9substrater med et snævert terapeutisk indeks (f.eks. warfarin, phenytoin), kan dosisjusteringer overvejes, hvis klinisk indiceret.
When co-administering medicinal products that are CYP2C9 substrates with a narrow therapeutic index (e.g., warfarin, phenytoin), dose adjustments may be considered, if clinically indicated.
I ITT-populationen havde 38 % af patienterne (141/375) i rucaparibgruppen og 35 % af patienterne (66/189) i placebogruppen målbar sygdom ved baseline.
In the ITT population, 38% of patients (141/375) in the rucaparib group and 35% of patients (66/189) in the placebo group had measurable disease at baseline.
Behandling af BRCA-muteret ovariecancer efter to eller flere kemoterapiforløb Effekten af rucaparib blev undersøgt hos 106 patienter i 2 multicenter, enkelt-arms, ikke-blindede kliniske forsøg, forsøg 10 og ARIEL2, hos patienter med fremskreden BRCA-muteret epitelial kræft i æggestokkene, æggelederne eller primær peritoneal kræft, som var progredieret efter 2 eller flere tidligere kemoterapier (primær effektpopulation).
Treatment of BRCA-mutated ovarian cancer after 2 or more chemotherapies The efficacy of rucaparib was investigated in 106 patients in 2 multicentre, single-arm, open-label clinical studies, Study 10 and ARIEL2, in patients with advanced BRCA-mutant epithelial ovarian, fallopian tube or primary peritoneal cancer who had progressed after 2 or more prior chemotherapies (the primary efficacy population).
I en eksplorativ analyse blev der noteret respons hos 38 % (95 % CI 23 % - 54 %) af patienterne (n=15) på rucaparib sammenlignet med 9 % (95 % CI 1 % - 28 %) af patienterne (n=2) på placebo (to-sidet p-vædi = 0,0055), herunder 7 (18 %) patienter i rucaparibgruppen, som opnåede en komplet remission.
In an exploratory analysis, a response was noted in 38% (95% CI 23% - 54%) of patients (n=15) on rucaparib compared to 9% (95% CI 1%28%) of patients (n=2) on placebo (2-sided p-value = 0.0055), including 7 (18%) patients in the rucaparib group who achieved a complete remission.
Tredje dosisreduktion
Third dose reduction
Begrænsede data er tilgængelige for patienter med moderat eller svært nedsat leverfunktion (se pkt.
Limited data are available for patients with moderate or severe hepatic impairment (see section 4.2).
Rucaparib nedregulerer CYP2B6 i humane hepatocytter ved klinisk relevant eksponering.
Rucaparib down regulated CYP2B6 in human hepatocytes at clinically relevant exposures.
In vitro er rucaparib en hæmmer af BCRP og P-gpefflukstransportører.
In vitro, rucaparib is an inhibitor of the BCRP and P-gp efflux transporters.
Bivirkninger, som hyppigst førte til dosisnedsættelse eller -afbrydelse, var anæmi (20 %), træthed/asteni (18 %), kvalme (16 %), trombocytopeni (15 %) og forhøjet ASAT/ALAT (10 %).
Adverse reactions that most commonly led to dose reduction or interruption were anaemia (20%), fatigue/asthenia (18%), nausea (16%), thrombocytopenia (15%), and AST/ALT elevations (10%).
Baseret på in vitro data var CYP2D6, og i mindre grad CYP1A2 og CYP3A4, i stand til at metabolisere rucaparib.
Based on in vitro data, CYP2D6, and to a lesser extent CYP1A2 and CYP3A4, were able to metabolize rucaparib.
Vedligeholdelsesbehandling af recidiverende ovariecancer Effekten af rucaparib blev undersøgt i ARIEL3, et dobbeltblindet klinisk multicenterforsøg, hvor 564 patienter med recidiverende epitelial ovariecancer, tubacancer eller primær peritonealcancer, som responderede på platinbaseret kemoterapi, blev randomiserede (2:1) til Rubracatabletter 600 mg oralt to gange dagligt (n=375) eller placebo (n=189).
The efficacy of rucaparib was investigated in ARIEL3, a double-blind, multicentre clinical trial in which 564 patients with recurrent EOC, FTC or PPC who were in response to platinum-based chemotherapy were randomized (2:1) to receive Rubraca tablets 600 mg orally twice daily (n=375) or placebo (n=189).
Hos patienter med moderat nedsat nyrefunktion (CLCR 30-59 ml/min) steg hyppigheden af nogle bivirkninger: Klasse 3 eller 4 anæmi (31 %), grad 3 eller 4 trombocytopeni (12 %) og grad 3 træthed/asteni (15 %) var højere end hos patienter med let nedsat nyrefunktion (CLCR >59-80 ml/min) eller normal nyrefunktion (CLCR >80 ml/min) (21 %, 5 % og 8 %).
In patients with moderate renal impairment (CLcr of 30-59 mL/min), frequencies of some adverse reactions increased: Grade 3 or 4 anaemia (31%), Grade 3 or 4 thrombocytopenia (12%), and Grade 3 fatigue/asthenia (15%) were higher than in patients with mild renal impairment (CLcr > 59-80 mL/min) or normal renal function (CLcr > 80 mL/min) (21%, 5%, and 8%).
Rucaparib genoptages derefter med en nedsat dosis, og LFT monitoreres ugentligt i 3 uger
Interrupt rucaparib until values return to Grade ≤ 2; then resume rucaparib with a dose reduction and monitor LFTs weekly for 3 weeks
For yderligere at bekræfte sikkerheden og effekten af rucaparib ved behandling af platinfølsom, recidiveret eller progressiv BRCA-muteret (kimcelle og/eller somatisk), high grade epitelial kræft i æggestokkene, æggelederne eller primær peritoneal kræft, skal indehaveren af markedsføringstilladelsen indsende resultaterne af forsøg CO-338-043 (ARIEL4), et fase 3, multicenter, ikke-blindet, randomiseret forsøg til evaluering af effektiviteten og sikkerheden af rucaparib versus kemoterapi til behandling af recidiveret kræft i æggestokkene.
In order to further confirm the safety and efficacy of rucaparib in the treatment of platinum sensitive, relapsed or progressive, BRCA mutated (germline and/ or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, the MAH should submit the results of study CO-338-043 (ARIEL4), a phase 3, multicentre, open-label, randomised study evaluating the efficacy and safety of rucaparib versus chemotherapy for treatment of relapsed ovarian cancer.
Hvis du har taget for mange tabletter, skal du fortælle det til lægen, apotekspersonalet eller sundhedspersonalet med det samme.
If you take more tablets than you should, tell your doctor, pharmacist or nurse straight away.
Rucaparib havde ingen virkning på Cmax af digoxin, mens det marginalt øgede AUC0-72h med 1,20 gange (90 % CI: 1,12 til 1,29).
Rucaparib showed no effect on Cmax of digoxin while marginally increasing AUC0-72h by 1.20 fold (90% CI: 1.12 to 1.29).
Rucaparib er en svag hæmmer af CYP2C8, CYP2D6 og UGT1A1.
Rucaparib is a weak inhibitor of CYP2C8, CYP2D6, and UGT1A1.
60 filmovertrukket tablet.
60 film-coated tablets.
Effekten af Rubraca som behandling for recidiverende eller progressiv epitelial ovariecancer, tubacancer eller primær peritonealcancer er ikke blevet undersøgt hos patienter, der tidligere er blevet behandlet med en PARP-hæmmer.
Efficacy of Rubraca as treatment for relapsed or progressive EOC, FTC, or PPC has not been investigated in patients who have received prior treatment with a PARP inhibitor.
Tabel over bivirkninger efter MedDRA systemorganklasse Bivirkninger
Tabulated list of adverse reactions by MedDRA system organ class Adverse reactions
Data antyder, at rucaparib er en moderat hæmmer af CYP1A2, og en mild hæmmer af CYP2C9, CYP2C19 og CYP3A.
Data suggest that rucaparib is a moderate inhibitor of CYP1A2, and a mild inhibitor of CYP2C9, CYP2C19, and CYP3A.
Brug af anden medicin sammen med Rubraca
Other medicines and Rubraca
Virkning af P-gp og BCRP-hæmmere på rucaparib PK kan ikke udelukkes.
Effect of P-gp and BCRP inhibitors on rucaparib PK cannot be ruled out.
In vitro hæmmede rucaparib reversibelt CYP1A2, CYP2C19, CYP2C9 og CYP3A, og i mindre grad CYP2C8, CYP2D6 og UGT1A1.
In vitro, rucaparib reversibly inhibited CYP1A2, CYP2C19, CYP2C9, and CYP3A, and to a lesser extent CYP2C8, CYP2D6, and UGT1A1.
De fleste patienter (95 %) havde tumorer med serøs histologi og 4 % af patienterne indberettede endometrioid histologi.
The primary tumour in most patients was ovarian (84%); most patients (95%) had serous histology and 4% of patients reported endometrioid histology.
HR (95 % CI) p-værdib nonBRCA LOH+ gruppe
HR (95% CI) p-valueb nonBRCA LOH+ Group
Spørg lægen, apotekspersonalet eller sygeplejersken, hvis der er noget, du er i tvivl om.
Check with your doctor, pharmacist, or nurse if you are not sure.
Leverfunktionstest monitoreres ugentligt, indtil der ses resolution til klasse ≤2
Grade 3 without other signs of liver dysfunction Monitor LFTs weekly until resolution to Grade ≤ 2
Fortæl altid lægen, apotekspersonalet eller sundhedspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken, or might take any other medicines.
En populations-PK-analyse blev foretaget for at evaluere effekten af nedsat nyrefunktion på clearance for rucaparib hos patienter, der modtager rucaparib 600 mg to gange dagligt.
A population PK analysis was performed to evaluate the effect of renal impairment on the clearance of rucaparib in patients receiving rucaparib 600 mg twice daily.
Trombocytopenib, neutropenib, febril neutropeni, leukopenib
Thrombocytopeniab, Neutropeniab, Febrile neutropenia, Leukopeniab
Lægemidlet må kun udleveres efter ordination på en særlig recept (se Bilag I: Produktresumé, pkt.
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Det skyldes at Rubraca kan forårsage lave blodtællinger af: røde blodceller, hvide blodceller eller blodplader.
• red blood-cells, white blood-cells, or platelets.
Rucaparib inducerede CYP1A2 og nedregulerede CYP2B6 og CYP3A4 i humane hepatocytter ved klinisk relevante eksponeringer.
Rucaparib induced CYP1A2, and down regulated CYP2B6 and CYP3A4 in human hepatocytes at clinically relevant exposures.
CI: Konfidensinterval
CI: Confidence interval
CYP1A2-substrater
CYP1A2 substrates
Behandling afbrydes, hvis ASAT/ALATniveauer ikke falder til klasse ≤ 2 inden for 2 uger.
Interrupt treatment if AST/ALT levels do not decline within 2 weeks until Grade ≤ 2, then resume rucaparib at the same or at a reduced dose
Selvom der ikke blev set hjertepåvirkning efter oral dosering, kan hjertepåvirkning hos patienter ikke udelukkes ved oral administration af rucaparib baseret på fundene i de intravenøse forsøg og sikkerhedsmargener.
Although no cardiac effects were observed following oral dosing, based on the findings in the intravenous studies and safety margins, cardiac effects in patients cannot be excluded when rucaparib is given orally.
- i 6 måneder efter at have taget sidste dosis Rubraca.
during treatment with Rubraca and for 6 months after taking the last dose of Rubraca.
Baseret på virkningsmekanismen er det muligt, at rucaparib kan påvirke human fertilitet.
Moreover, according to its mechanism of action, rucaparib may impact human fertility.
Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Rubraca.
Talk to your doctor, pharmacist or nurse before or during taking Rubraca.
Under ophold udendørs bør patienterne bruge en hat og beskyttende beklædning samt bruge solcreme og læbepomade med solbeskyttelsesfaktor (SPF) 50 eller derover.
Patients should avoid spending time in direct sunlight because they may burn more easily during rucaparib treatment; when outdoors, patients should wear a hat and protective clothing, and use sunscreen and lip balm with sun protection factor (SPF) of 50 or greater.
Der er intet krav om BRCA-testning, før Rubraca anvendes som vedligeholdelsesbehandling af voksne patienter med recidiverende high-grade epitelial ovariecancer, tubacancer eller primær peritonealcancer, der udviser fuldstændig eller delvis respons på platinbaseret kemoterapi.
There is no requirement for BRCA testing prior to using Rubraca for the maintenance treatment of adult patients with relapsed high-grade epithelial ovarian cancer (EOC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) who are in a complete or partial response to platinum-based chemotherapy.
Et dyreforsøg vedrørende reproduktionstoksicitet, viste embryo-fatal toksicitet ved administrering af rucaparib til drægtige rotter i doser under niveau af den anbefalede dosis til mennesker på 600 mg to gange dagligt (se pkt.
In an animal reproduction study, administration of rucaparib to pregnant rats during the period of organogenesis resulted in embryo-fetal toxicity at exposures below those in patients receiving the recommended human dose of 600 mg twice daily (see section 5.3).
Der blev imidlertid observeret mild bifasisk aktivering og hæmning af MRP2, og koncentrationsafhængig hæmning af MRP3 blev observeret ved koncentrationer større end den observerede plasma Cmax rucaparib.
No interaction with MRP2 or MRP3 was observed in vitro at the clinical exposure of rucaparib, however, mild bi-phasic activation and inhibition of MRP2 and concentration dependent inhibition of MRP3 were observed at concentrations higher than the observed plasma Cmax of rucaparib.
Øvrige indholdsstoffer: - Tabletindhold: Mikrokrystallin, cellulose, natriumstivelsesglycolat (type A), kolloid vandfri silica og magnesiumstearat
• Tablet content: Microcrystalline cellulose, sodium starch glycolate (Type A), colloidal anhydrous silica and magnesium stearate.
Myelodysplastisk syndrom/akut myeloid leukæmia
Myelodysplastic syndrome / Acute myeloid leukaemiaa
Virkningsundersøgelse efter tilladelse til markedsføring (PAES): For yderligere at undersøge effekten af vedligeholdelsesbehandling med rucaparib til patienter med recidiverende high grade epitelial ovariecancer, tubacancer eller primær peritonealcancer, der udviser respons (komplet eller delvis) på platinbaseret kemoterapi, skal indehaveren af markedsføringstilladelsen indsende den endelige analyse af OS og opdaterede analyser af PFS2, det kemoterapifrie interval og tid til første efterfølgende kræfthæmmende behandling fra det randomiserede, dobbeltblindede fase 3-studie CO-338-014.
PAES: In order to further investigate the efficacy of rucaparib maintenance treatment in patients with relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy, the MAH should submit the final analysis of OS and updated analyses of PFS2, chemotherapy-free interval and time to start of subsequent anti-cancer treatment of the phase 3, randomised, double-blind study CO-338-014
Inden patienten påbegynder behandling med Rubraca som behandling for recidiverende eller progressiv epitelial ovariecancer, tubacancer eller primær peritonealcancer, skal vedkommende have bekræftet mutation, enten skadelige kimcelle eller somatiske mutationer, i brystcancergen 1 (BRCA1) eller brystcancergen 2 (BRCA2) ved hjælp af en valideret test.
Before taking Rubraca as treatment for relapsed or progressive EOC, FTC, or PPC, patients must have confirmation of deleterious germline or somatic mutations in the breast cancer 1 (BRCA1) or breast cancer 2 (BRCA2) gene using a validated test.
Gennemsnitlig responsvarigheda - dage (95 % CI)
Median duration of responsea - days (95% CI)
In vitro metaboliseres rucaparib primært af CYP2D6 og i mindre grad af CYP1A2, og CYP3A4.
In vitro, rucaparib is metabolised primarily by CYP2D6, and to a lesser extent by CYP1A2, and CYP3A4.
Gennemsnitlig progressionsfri overlevelse dage (95 % CI)
Median progression-free survival - days (95% CI)
Der er ikke behov for dosisjustering hos patienter med mild eller moderat nedsat nyrefunktion (se pkt.
No starting dose adjustment is required in patients with mild or moderate renal impairment (see section 5.2).
Tag altid lægemidlet nøjagtigt efter lægens, apotekspersonalets eller sundhedspersonalets anvisning.
Always take this medicine exactly as your doctor, pharmacist or nurse has told you.
Rubraca er indiceret som monoterapibehandling af voksne patienter med platinfølsom, recidiverende eller progressiv BRCA-muteret (kimcelle og/eller somatisk), high grade epitelial ovariecancer,
Rubraca is indicated as monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube,
Baseret på virkningsmekanismen kan rucaparib endvidere muligvis svække fertilitet hos mennesker.
In addition, according to its mechanism of action rucaparib may have the potential to impair fertility in humans.
Forsøg 10 populationskarakteristika hos 42 patienter var: Gennemsnitsalder 57 år (fra 42 til 84), hvid (83 %), ECOG performance status 0 (62 %) eller 1 (38 %), kræft i æggestokkene - high grade (100 %), 3 eller flere tidligere behandlingsformer med kemoterapi (36 %), gennemsnitlig tid fra diagnosen kræft i æggestokkene 43 måneder [fra 6 til 178], gennemsnitligt progressionsfrit tidsinterval fra sidste platin-behandling 8,0 måneder [fra: 6,0 til 116,4].
Study 10 population characteristics in 42 patients were: median age 57 years (range 42 to 84), white (83%), ECOG performance status 0 (62%) or 1 (38%), high grade ovarian cancer (100%), 3 or more prior lines of chemotherapy (36%), median time since ovarian cancer diagnosis 43 months [range: 6178], median progression-free interval from the last platinum treatment 8.0 months [range: 6.0
ARIEL2 populationskarakteristika hos 64 patienter var: Gennemsnitsalder 60 år (fra 33 til 80), hvid (75 %), ECOG performance status 0 (61 %) eller 1 (39%), kræft i æggestokkene - high grade (100 %), 3 eller flere tidligere behandlingsformer med kemoterapi (78 %), gennemsnitlig tid fra diagnosen kræft i æggestokkene 53 måneder [fra 22 til 197], gennemsnitlig progressionsfrit tidsinterval fra de sidste platin-behandling 7,6 måneder [fra 0 ,7 26,5].
ARIEL2 population characteristics in 64 patients were: median age 60 years (range 33 to 80), white(75%), ECOG performance status 0 (61%) or 1 (39%), high grade ovarian cancer (100%), 3 or more prior lines of chemotherapy (78%), median time since ovarian cancer diagnosis 53 months [range: 22-197], median progression-free interval from the last platinum treatment 7.6 months [range:
Rucaparibs vigtigste metaboliske veje var oxidering, N-demetylering, N-metylering, glucuronidering og N-formylering.
Oxidation, N-demethylation, N-methylation, glucuronidation, and N-formylation were the major metabolic pathways for rucaparib.
Sådan skal du tage Rubraca
How to take Rubraca
Rubraca er indiceret som monoterapi til vedligeholdelsesbehandling af voksne patienter med platinsensitiv, recidiverende high-grade epitelial ovariecancer, tubacancer eller primær peritonealcancer, der udviser respons (komplet eller delvis) på platinbaseret kemoterapi.
Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with platinumsensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
HR (95 % CI) p-værdib nonBRCA LOH- gruppe
HR (95% CI) p-valueb nonBRCA LOH- Group
Lymfopenib
Lymphopeniab
- Aktivt stof: rucaparib
• The active substance is rucaparib.
Baseret på disse resultater havde 70 % (130/186) af tBRCA-patienterne en gBRCA-mutation, og 30 % (56/186) havde en somatisk BRCA-mutation.
Blood samples for 94% (186/196) of the tBRCA patients were evaluated using a central blood germline BRCA (gBRCA) test. Based on these results, 70% (130/186) of the tBRCA patients had a gBRCA mutation and 30% (56/186) had a somatic BRCA mutation.
Ingen formelle undersøgelser for rucaparib hos patienter med nedsat nyrefunktion er blevet udført.
No formal studies of rucaparib in patients with renal impairment have been conducted.
Rucaparib er en potent hæmmer af MATE1 og MATE2-K, en moderat hæmmer af OCT1 og en svag hæmmer af OCT2.
Rucaparib is a potent inhibitor of MATE1 and MATE2-K, a moderate inhibitor of OCT1, and a weak inhibitor of OCT2.
Kvalme, opkastning, diarré, dyspepsi, mavesmerter
Nausea, Vomiting, Diarrhoea, Dyspepsia, Abdominal pain
In vitro er rucaparib en potent hæmmer af MATE1 og MATE2-K, en moderat hæmmer af OCT1 og en svag hæmmer af OCT2.
In vitro, rucaparib is a potent inhibitor of MATE1 and MATE2-K, a moderate inhibitor of OCT1, and a weak inhibitor of OCT2.
Rucaparib inducerede strukturelle kromosomafvigelser i in vitro lymfocyt-proliferationsanalysen.
Rucaparib induced structural chromosomal aberrations in the in vitro human lymphocyte chromosomal aberration assay.
Generelt af lav grad (CTCAE klasse 1 eller 2) og kan styres ved dosisreduktion (se tabel 1) eller afbrydelse.
Gastrointestinal toxicities (nausea and vomiting) are frequently reported with rucaparib, are generally low grade (CTCAE Grade 1 or 2), and may be managed with dose reduction (refer to Table 1) or interruption.
HR (95 % CI) p-værdib tBRCA grupped
HR (95% CI) p-valueb tBRCA Groupd
Lægemiddelinteraktion mellem rucaparib og p-piller er ikke blevet undersøgt.
Interactions between rucaparib and oral contraceptives have not been studied.