natgillin/translations-raw huggingface dataset:
Starttidspunktet for bivirkninger med myelosuppression klasse 3 eller højere lå generelt senere i behandlingen (efter 2 måneder eller mere).
The time of onset for adverse reactions of myelosuppression Grade 3 or higher was generally later in treatment (after 2 or more months).
I toksicitetsforsøg med gentagen dosis af op til 3 måneders varighed hos rotter og hunde var målorganerne de gastrointestinale, hæmatopoietiske, og lymfopoietiske systemer.
In repeat-dose toxicity studies of up to 3 months duration in rats and dogs, the target organs were the gastrointestinal, haematopoietic, and lymphopoietic systems.
De primære effektmål var investigator-vurderet progressionsfri overlevelse (invPFS) i henhold til RECIST (Response Evaluation Criteria in Solid Tumors), version 1.1.
The primary efficacy outcome was investigator-assessed progression-free survival (invPFS) evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 (v1.1).
Hyppighed af CTCAE klasse 3 og derover
Frequency of all CTCAE grades Frequency of CTCAE grade 3 and above
Du kan nemmere blive solskoldet under behandling med Rubraca.
You may get sunburn more easily during treatment with Rubraca.
Det vides ikke, om rucaparib/eller dets metabolitter udskilles i human mælk.
It is unknown whether rucaparib/or its metabolites are excreted in human milk.
Rubraca er et lægemiddel mod kræft, også kendt som en ‘PARP (poly adenosin diphosphat-ribose polymerase) hæmmer'.
Rubraca is an anti-cancer medicine, also known as a ‘PARP (poly adenosine diphosphate-ribose polymerase) inhibitor'.
Navn og adresse på fremstilleren (fremstillerne) ansvarlig(e) for batchfrigivelse Almac Pharma Services Ltd
Name and address of the manufacturer(s) responsible for batch release Almac Pharma Services Ltd
Efter gentagen dosering to gange dagligt varierede ophobning baseret på AUC fra 3,5 til 6,2 gange.
Following repeated twice daily dosing, the accumulation based on AUC ranged from 3.5 to 6.2 fold.
Rucaparibs samlede sikkerhedsprofil er baseret på data fra 937 patienter i kliniske forsøg med ovariecancer, der blev behandlet med rucaparib monoterapi.
The overall safety profile of rucaparib is based on data from 937 patients in clinical trials in ovarian cancer treated with rucaparib monotherapy.
- Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
• Do not take a double dose to make up for a forgotten dose.
Hyppigheden af forekomst af bivirkninger er defineret som: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Frequencies of occurrence of adverse reactions are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare
Tag ikke lægemidlet efter den udløbsdato, der står på flasken og kartonen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
Do not use this medicine after the expiry date which is stated on the bottle and the carton after EXP.
Rubraca kan påvirke din evne til at føre motorkøretøj eller betjene værktøj eller maskiner.
Rubraca may affect your ability to drive or use tools or machines.
Antiemetika, som f.eks. 5-HT3-antagonister, dexamethason, aprepitant og fosaprepitant, kan bruges som behandling for kvalme/opkastning og kan også overvejes som profylaktisk (dvs. forebyggende) brug inden påbegyndelse af Rubraca.
Antiemetics, such as 5-HT3 antagonists, dexamethasone, aprepitant and fosaprepitant, can be used as treatment for nausea/vomiting and may also be considered for prophylactic (i.e., preventative) use prior to starting Rubraca.
Fortsæt med rucaparib såfremt bilirubin er < ULN og alkalisk phosphatase (ALP) er < 3 x ULN
Continue rucaparib provided bilirubin is < ULN and alkaline phosphatase is < 3 x ULN
Risikoen for en klinisk signifikant stigning af QTcF (dvs. > 20 msek) fra baseline er derfor lav.
Thus, the risk for clinically significant QTcF increase from baseline (i.e. > 20 msec) is low.
Kvinder i den fødedygtige alder bør rådes til at undgå at blive gravide, mens de får rucaparib.
Women of childbearing potential should be advised to avoid becoming pregnant while receiving rucaparib.
Alle patienter havde opnået respons (komplet eller delvis) på deres seneste platinbaserede kemoterapi, og deres cancerantigen 125 (CA-125) lå under den øvre grænse for normal (ULN).
All patients had achieved a response (complete or partial) to their most recent platinum-based chemotherapy and their cancer antigen 125 (CA-125) was below the upper limit of normal (ULN).
Baseret på dets virkningsmekanisme og prækliniske data kan rucaparib forårsage fosterskader, når det gives til en gravid kvinde.
Based on its mechanism of action and preclinical data, rucaparib may cause fetal harm when administered to a pregnant woman.
ARIEL3 viste en statistisk signifikant forbedring i PFS for patienter randomiseret til rucaparib sammenlignet med placebo hos ITT-populationen og i HRD- og tBRCA-undergrupper.
ARIEL3 demonstrated a statistically significant improvement in PFS for patients randomised to rucaparib as compared with placebo in the ITT population and in the HRD and tBRCA subgroups.
En lav blodcelletælling kan være et tegn på et alvorligt knoglemarvsproblem - som f.eks. ‘myelodysplastisk syndrom' (MDS) eller ‘akut myeloid leukæmi' (AML).
• a low blood-cell count may be a sign of a serious bone marrow problem - such as ‘myelodysplastic syndrome' (MDS) or ‘acute myeloid leukaemia' (AML).
Andre moderate til svære ikke-hæmatologiske bivirkninger som f.eks. kvalme og opkastning kan håndteres ved dosisafbrydelse og/eller -reduktioner, hvis de ikke kontrolleres tilstrækkeligt af passende symptomatisk behandling.
Other moderate to severe non-haematological adverse reactions such as nausea and vomiting, can be managed through dose interruption and/or reductions, if not adequately controlled by appropriate symptomatic management.
Nedsat appetit, øget blodkreatininb
Decreased appetite, Increased blood creatinineb
Rucaparibs gennemsnitlige halveringstid (t1/2) var 25,9 timer.
The mean half-life (t1/2) of rucaparib was 25.9 hours.
Forhøjede lever-transaminaser (aspartat aminotransferase (ASAT)) og/eller alanin aminotransferase (ALAT) forekommer tidligt i behandlingen og er som regel forbigående.
Liver transaminase elevations (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)) occur early in treatment and are generally transient.
In vitro var M324 mindst 30 gange mindre potent end rucaparib mod PARP-1, PARP-2 og PARP-3.
In vitro, M324 was at least 30 fold less potent than rucaparib against PARP-1, PARP-2, and PARP-3.
Populations PK-analyse antydede, at det er usandsynligt, at samtidig brug af PPI'er, har en klinisk meningsfuld effekt på rucaparib PK. Der kan ikke drages nogen konkret konklusion vedrørende effekten af samtidig administration af rucaparib og PPI'er, da dosisniveau og administrationstidspunkt ikke er blevet dokumenteret detaljeret for PPI'erne.
Population PK analysis suggested that concomitant use of PPIs is unlikely to have clinically meaningful impact on rucaparib PK. A firm conclusion cannot be made regarding the effect of co-administration of rucaparib and PPIs because dose level and time of administration have not been documented in detail for the PPIs.
Andre lægemidler kan også påvirke den måde, Rubraca fungerer på.
Also some other medicines can affect the way Rubraca works.
Myelodysplastisk syndrom/akut myeloid leukæmi (MDS/AML), herunder tilfælde med letalt udfald, er rapporteret hos patienter, der fik rucaparib.
Myelodysplastic syndrome/acute myeloid leukaemia (MDS/AML), including cases with fatal outcome, have been reported in patients who received rucaparib.
- For kvinder, som kan blive gravide, anbefales en graviditetstest før behandling med Rubraca påbegyndes.
• For women who are able to become pregnant, a pregnancy test is recommended before starting treatment with Rubraca
Ingen signifikant P-gp hæmning blev observeret in vivo (pkt.
No significant P-gp inhibition was observed in vivo (section 4.5).
Trombocytopeni og anæmi førte til ophør hos 1,8 % og 2,1 % af patienterne.
Thrombocytopenia and anaemia led to discontinuation in 1.8% and 2.1% of patients.
Større følsomhed overfor bivirkninger hos ældre patienter (≥ 65 år) kan ikke udelukkes.
Greater sensitivity of some elderly patients (≥ 65 years of age) to adverse events cannot be ruled out.
Rucaparib er en hæmmer af poly (ADP-ribose) polymerase (PARP) enzymer, herunder PARP-1, PARP-2, og PARP-3, som spiller en rolle i reparationen af DNA.
Rucaparib is an inhibitor of poly(ADP-ribose) polymerase (PARP) enzymes, including PARP-1, PARP-2, and PARP-3, which play a role in DNA repair.
Stigninger i serumkreatinin, overvejende milde til moderate (CTCAE klasse 1 eller 2), blev observeret hos 20 % af patienterne inden for de første få ugers behandling med rucaparib.
Increases in serum creatinine, predominantly mild to moderate (CTCAE Grade 1 or 2), were observed in 20% of patients within the first few weeks of treatment with rucaparib.
Den gennemsnitlige orale biotilgængelighed efter en enkelt oral dosis på 12 til 120 mg rucaparib var 36 %.
The mean absolute oral bioavailability following a single oral dose of 12 to 120 mg rucaparib was 36%.
Kardiologisk elektrofysiologi
Cardiac electrophysiology
Dette lægemiddel er godkendt under “betingede omstændigheder”.
This medicine has been given ‘conditional approval'.
Alle 106 patienter modtog rucaparib 600 mg to gange dagligt.
All 106 patients received rucaparib 600 mg twice daily.
PFS-hændelser, n (%) PFS, median i måneder (95 % CI)
PFS events, n (%) PFS, median in months (95% CI)
Der skal udvises forsigtighed og overvejes yderligere international normaliset ratio (INR) overvågning ved samtidig administration af warfarin og overvågning af det terapeutiske lægemiddelniveau af phenytoin, hvis anvendt samtidigt med rucaparib.
Caution should be exercised and additional International Normalised Ratio (INR) monitoring with co-administration of warfarin and therapeutic drug level monitoring of phenytoin should be considered, if used concomitantly with rucaparib.
Virkninger af rucaparib på andre lægemidler
Effects of rucaparib on other medicinal products
Rubraca påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
Rubraca has minor influence on the ability to drive and use machines.
Der er ingen data om virkningen af rucaparib på human fertilitet.
There are no data on the effect of rucaparib on human fertility.
Da hæmning af disse transportere kan øge ekskretion af metformin i nyrerne og reducere leveroptagelse af metformin, tilrådes forsigtighed, når metformin gives samtidig med rucaparib.
As inhibition of these transporters could increase metformin renal elimination and decrease liver uptake of metformin, caution is advised when metformin is co-administered with rucaparib.
Systemorganklasser i henhold til MedDRA
MedDRA system organ class
Enzymer, der er ansvarlige for rucaparib-metabolisme, er ikke blevet identificeret.
Enzymes responsible for rucaparib metabolism have not been identified.
Rucaparib har vist sig at formindske tumorvækst i muse-xenograftmodeller af human cancer med eller uden defekter i BRCA.
Rucaparib has been shown to decrease tumour growth in mouse xenograft models of human cancer with or without deficiencies in BRCA.
In vitro var IC50 af rucaparib mod det humane ether-à-go-go relaterede gen (hERG) 22,6 µM, hvilket er cirka 13 gange højere end Cmax hos patienter ved den anbefalede dosis.
In vitro, the IC50 of rucaparib against the human ether-à-go-go related gene (hERG) was 22.6 µM, which is approximately 13-fold higher than the Cmax in patients at the recommended dose.
Patienter med moderat eller svært nedsat nyrefunktion bør følges nøje for nyrefunktion og bivirkninger.
Patients with moderate or severe renal impairment should be carefully monitored for renal function and adverse reactions.
Klasse 1-3 forhøjelser i ASAT/ALAT kan håndteres uden ændring af rucaparib-dosis, eller ved behandlingsændring (afbrydelse og/eller dosisnedsættelse).
Grade 1-3 elevations in AST/ALT can be managed without change to the rucaparib dose, or with treatment modification (interruption and/or dose reduction).
Rucaparib var ikke mutagent i en bakteriel revers mutation (Ames) analyse.
Rucaparib was not mutagenic in a bacterial reverse mutation (Ames) assay.
Resultaterne i ikke-kliniske toksikologiforsøg udført med oral rucaparib var generelt konsistente med de bivirkninger, der blev observeret i kliniske forsøg.
The findings in non-clinical toxicology studies performed with oral rucaparib were generally consistent with the adverse events observed in clinical studies.
Der skal udvises forsigtighed, når rucaparib administreres samtidig med UGT1A1-substrater (ex irinotecan) til patienter med UGT1A1*28 (dårlig metabolisator) på grund af en mulig øgning af eksponeringen af SN-38 (den aktive metabolit af irinotecan)og tilknyttede toksiciteter.
Caution should be used when rucaparib is co-administered with UGT1A1 substrates (i.e. irinotecan) to patients with UGT1A1*28 (poor metabolizer) due to a possible increase in the exposure of SN-38 (the active metabolite of irinotecan) and associated toxicities.
Rubraca indeholder det aktive stof rucaparib.
Rubraca contains the active substance rucaparib.
- Kvinder i den fødedygtige alder skal bruge effektiv prævention:
• Women who are able to become pregnant must use effective birth control (contraception):
Virkning af andre lægemidler på rucaparib
Effect of other medicinal products on rucaparib
Patienter bør ikke starte Rubraca-behandling, før hæmatologisk toksicitet forårsaget af tidligere kemoterapi er restitueret (≤ CTCAE klasse 1).
Patients should not start Rubraca treatment until they have recovered from haematological toxicities caused by previous chemotherapy (≤ CTCAE Grade 1).
Patienter med kimcelle (g)BRCA (n=88, 83,0 %) eller somatiske (s)BRCA (n=18, 17,0 %) mutationer blev inkluderet.
Patients with germline (g)BRCA (n=88, 83.0%) or somatic (s)BRCA (n=18, 17.0%) mutations were included.
Derudover er rucaparib en hæmmer af BCRP med IC50 værdi, hvilket antyder potentiel BCRP-hæmning og øgede eksponeringer af lægemidler, som er BCRP-substrater (f.eks. rosuvastatin).
In addition, rucaparib is an inhibitor of the BCRP with IC50 value suggesting potential BCRP inhibition and increased exposures of medicinal products that are BCRP substrates (e.g., rosuvastatin).
Effekten af Rubraca hos patienter, der tidligere har fået behandling med en PARP-hæmmer i vedligeholdelsesforløbet, er således ikke undersøgt og kan ikke ekstrapoleres ud fra de tilgængelige data.
As such, efficacy of Rubraca in patients who have received prior treatment with a PARP inhibitor in the maintenance setting, has not been investigated and cannot be extrapolated from the available data.
Rucaparib har vist sig at have in vitro og in vivo anti-svulst-aktivitet i BRCA mutationscellelinjer gennem en mekanisme, der er kendt som ”synthetic lethality”, hvor tab af to DNA-reparationsveje er påkrævet for celledød.
Rucaparib has been shown to have in vitro and in vivo anti-tumour activity in BRCA mutant cell lines through a mechanism known as synthetic lethality, whereby the loss of two DNA repair pathways is required for cell death.
Ingen bivirkninger indfriede kriterierne for Hy's lov for lægemiddelinduceret leverskade.
No events met Hy's Law criteria for drug-induced liver injury.
Gennemsnitsalderen var 61 år (interval: 36 til 85); de fleste af patienterne var hvide (80 %), og alle havde en Eastern Cooperative Oncology Group (ECOG)-præstationsstatus på 0 eller 1.
The mean age was 61 years (range: 36 to 85); most of the patients were white (80%); and all had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Den mest fremherskende metabolit var M324, et oxidativt deamineringsprodukt af rucaparib, der tegnede sig for 18,6 % af radioaktiviteten i plasma.
The most abundant metabolite was M324, an oxidative deamination product of rucaparib, accounting for 18.6% of the radioactivity in plasma.
Gastrointestinale toksiciteter
Gastrointestinal toxicities
Den kliniske relevans af UGT1A1-hæmning af rucaparib er ikke klarlagt.
The clinical relevance of UGT1A1 inhibition by rucaparib is not clear.
Det progressionsfrie interval til næstsidste platinbehandling var 6-12 måneder hos 39 % af patienterne og > 12 måneder hos 61 %.
The progression-free interval to penultimate platinum therapy was 6-12 months in 39% of patients and > 12 months in 61%.
Øget alaninaminotransferase/øget aspartataminotransferase
Increased alanine aminotransferase, Increased aspartate aminotransferase
Hypercholesterolæmib, dehydrering
Hypercholesterolaemiab, Dehydration
Tumorvævsprøver for alle patienterne (N = 564) blev testet centralt for at bestemme positiv status for HRD (defineret som tilstedeværelse af en skadelig tumor BRCA [tBRCA]-mutation eller højt genomisk tab af heterozygositet).
Tumour tissue samples for all of the patients (N=564) were tested centrally to determine HRD positive status (as defined by the presence of a deleterious tumour BRCA [tBRCA] mutation or high genomic loss of heterozygosity).
Opkastning og/eller kvalme blev rapporteret hos hhv. 42 % og 77 % af patienterne og var generelt af lav grad (CTCAE klasse 1 til 3).
Vomiting and nausea were reported in 42% and 77% of patients, respectively and were generally low grade (CTCAE Grade 1 to 3).
Den kliniske relevans af MRP2- og MRP3-interaktion i tarmsystemet er ikke kendt.
The clinical relevance MRP2 and MRP3 interaction in the gut is not known.
Ingen af patienterne havde fået forudgående behandling med en PARP-hæmmer.
None of the patients had received prior treatment with a PARP inhibitor.
a. Den gennemsnitlige virknings varighed bestemmes ud fra patienterne med objektivt tumorrespons ifølge RECIST-retningslinjerne efter behandling med rucaparib.
a The median duration of response is determined from the patients who had an objective tumour response according to RECIST guidelines, following treatment with rucaparib.
Bivirkninger kan reguleres ved dosisafbrydelser og/eller dosisreduktioner for moderate til svære reaktioner (dvs. CTCAE klasse 3 eller 4) såsom neutropeni, anæmi og trombocytopeni.
Adverse reactions may be managed through dose interruptions and/or dose reductions for moderate to severe reactions (i.e. CTCAE Grade 3 or 4) such as neutropenia, anaemia and thrombocytopenia.
Intravenøs administration af rucaparib hos rotter og hunde medførte hjertepåvirkninger ved en høj Cmax (5,4 til 7,3 gange højere end for patienter), men ikke ved en lavere Cmax (1,3 til 3,8 gange højere end for patienter).
Intravenous administration of rucaparib in the rat and dog induced cardiac effects at a high Cmax (5.4 to 7.3-fold higher than patients), but not at a lower Cmax (1.3 to 3.8-fold higher than patients).
Under behandling med rucaparib kan der ses hændelser med myelosuppression (anæmi, neutropeni, trombocytopeni), og de ses typisk først efter 8-10 ugers behandling med rucaparib.
During treatment with rucaparib, events of myelosuppression (anaemia, neutropenia, thrombocytopenia) may be observed and are typically first observed after 8-10 weeks of treatment with rucaparib.
Bivirkningsfrekvenserne er medtaget på MedDRA systemorganklasse på det foretrukne termniveau.
The adverse reaction frequency is listed by MedDRA System Organ Class (SOC) at the preferred term level.
Risikoen for en klinisk relevant effekt ved samtidig administration af protonpumpehæmmere (PPI'er) er sandsynligvis lille (se pkt.
The risk for a clinically relevant effect of concomitant administration of proton pump inhibitors (PPIs) is likely small (see section 5.2).
In vitro-studier har vist, at rucaparibinduceret cytotoksicitet indebærer hæmning af PARP-enzymatisk aktivitet, og ”binding” af PARPDNA komplekser, der resulterer i øgede DNA-skader, apoptose og celledød.
In vitro studies have shown that rucaparibinduced cytotoxicity involves inhibition of PARP enzymatic activity and the trapping of PARP-DNA complexes resulting in increased DNA damage, apoptosis, and cell death.
For den platinresistente population (N = 20) var ORR ved investigators gennemgang 35,0 % (95 % CI [15,4; 59,2] med en komplet responsrate på 5,0 % og en delvis responsrate på 30,0 %.
For the platinum-resistant population (N=20), ORR by investigator review was 35.0% (95% CI [15.4, 59.2], with a complete response rate of 5.0%, and a partial response rate of 30.0%.
Forhøjelser af kreatinin ved rucaparibbehandling kan skyldes hæmning af nyretransportørerne MATE1 og MATE2-K (se pkt.
Elevations in creatinine with rucaparib treatment may be due to inhibition of the renal transporters MATE1 and MATE2-K (see section 4.5).
Rucaparib tegnede sig for 44,9 % og 94,9 % af radioaktiviteten i henholdsvis urin og fæces, mens M324 tegnede sig for 50,0 % og 5,1 % af radioaktiviteten i henholdsvis urin og fæces.
Rucaparib accounted for 44.9% and 94.9% of radioactivity in urine and faeces, respectively; while M324 accounted for 50.0% and 5.1% of radioactivity in urine and faeces, respectively.
ORR'en var ved uafhængig radiologisk gennemgang for den platinfølsomme population 42/79, 53,2 % (95 % CI [41,6-64,5]).
The ORR, by independent radiology review for the platinum-sensitive population, was 42/79, 53.2% (95% CI [41.6-64.5]).
Der blev ikke set nogen virkning på hanners og hunners fertilitet i 3 måneders generelle toksikologiske forsøg med rotter og hunde ved eksponeringer på 0,09 til 0,3 gange den humane AUC ved den anbefalede dosis.
No effects on male and female fertility were observed in 3-month general toxicology studies in rats and dogs at exposures of 0.09 to 0.3 times the human AUC at the recommended dose.
Alle patienter havde fået mindst to tidligere platinbaserede kemoterapier (interval: 2 til 6), og 28 % af patienterne havde fået mindst tre tidligere platinbaserede kemoterapier.
All patients had received at least two prior platinum-based chemotherapies (range: 2 to 6) and 28% of patients had received at least three prior platinum-based chemotherapies.
Hvis du tager Rubraca, fordi din kræft har udviklet sig, skal du have foretaget en klinisk test for at undersøge, om du har et unormalt BRCA-gen.
If you take Rubraca because your cancer has progressed you will need to have a clinical test to identify an abnormality in the BRCA gene.
Efter administration af en enkelt oral dosis [14C]-rucaparib til patienter med faste tumorer tegnede uændret rucaparib sig for 64,0 % af radioaktiviteten i plasma.
Following administration of a single oral dose of [14C]-rucaparib to patients with solid tumours, unchanged rucaparib accounted for 64.0% of the radioactivity in plasma.
Fortæl din læge, apotekspersonalet eller sundhedspersonalet, hvis du tager nogle af følgende lægemidler:
Tell your doctor, pharmacist or nurse if you are taking any of the following medicines:
Den gennemsnitlige responsvarighed var 196 dage (95 % CI [113 - NA]).
The median duration of response was 196 days (95% CI [113 - NA]).
Hæmatologiske bivirkninger af alle CTCAE-klasser af anæmi, trombocytopeni og neutropeni blev rapporteret hos henholdsvis 42 %, 26 % og 16 % af patienterne.
Haematological adverse reactions of all CTCAE Grades of anaemia, thrombocytopenia and neutropenia were reported in 42%, 26% and 16% of patients respectively.
Plasmaeksponeringer af rucaparib, som målt ved Cmax og AUC, var tilnærmelsesvis dosisproportional ved evaluerede doser (40 til 500 mg dagligt, 240 til 840 mg to gange dagligt).
Plasma exposures of rucaparib, as measured by Cmax and AUC, were approximately dose proportional at evaluated doses (40 to 500 mg daily, 240 to 840 mg twice a day).
Det skyldes, at det ikke vides, om rucaparib går over i modermælken.
This is because it is not known if rucaparib passes into breast milk.
Lysfølsomhed blev rapporteret hos 13 % af patienterne som hudreaktioner af lav grad (CTCAE klasse 1 eller 2) og hos 2 (0,2 %) af patienterne som ≥ CTCAE klasse 3-reaktion.
Photosensitivity was reported in 13% of patients as low grade skin reactions (CTCAE Grade 1 or 2), and by 2 (0.2%) patients as ≥ CTCAE Grade 3 reaction.