FrancophonIA/ELRC3.0 huggingface dataset:
English: International Normalised Ratio increased Leukopenia
Danish: Forhøjet INR (International Normalised Ratio) Leukopeni
English: Rolapitant is slowly eliminated with a mean terminal half-life of approximately 7 days.
Danish: Rolapitant elimineres langsomt med en gennemsnitlig halveringstid på ca. 7 dage.
English: Wallet card, each containing 2 film-coated tablets - WITH BLUE BOX
Danish: Brevkort med 2 filmovertrukne tabletter - MED BLUE BOX
English: Pharmacotherapeutic group: Antiemetics and antinauseants, other antiemetics, ATC code: A04AD14
Danish: Farmakoterapeutisk klassifikation: Antiemetica og midler mod kvalme, andre antiemetica, ATC-kode: A04AD14
English: Increased plasma concentration of CYP2D6 substrates may result in potential adverse reactions.
Danish: Forhøjet plasmakoncentration af CYP2D6-substrater kan potentielt medføre bivirkninger.
English: There are no data on the presence of rolapitant in human milk.
Danish: Der foreligger ingen data vedrørende udskillelse af rolapitant i human mælk.
English: There is no medicinal product interaction between rolapitant and dexamethasone, so no dosage adjustment for dexamethasone is required.
Danish: Der er ingen lægemiddelinteraktion mellem rolapitant og dexamethason, og derfor er dosisjustering af dexamethason ikke nødvendig.
English: There are no available data on rolapitant use in pregnant women.
Danish: Der foreligger ingen data fra anvendelse af rolapitant til gravide kvinder.
English: It is not known whether Varuby is present in milk; therefore, breast-feeding is not recommended during treatment with this medicine.
Danish: Det vides ikke, om Varuby udskilles i mælk, og derfor anbefales det ikke at amme under behandling med dette lægemiddel.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity, teratogenic potential, and carcinogenic potential.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, genotoksicitet, teratogenicitet samt karcinogenicitet.
English: The usual dose is two tablets.
Danish: Den sædvanlige dosis er to tabletter.
English: Each dose (two tablets) contains 230 mg of lactose.
Danish: Hver dosis (to tabletter) indeholder 230 mg lactose.
English: Effects on offspring at this dose included decreased postnatal survival, and decreased body weights and body weight gain, and may be related to the maternal toxicity observed.
Danish: Effekter på afkom ved denne dosis var nedsat postnatal overlevelse og nedsat legemsvægt og vægtøgning, og disse kan relateres til den observerede maternelle toksicitet.
English: In pooled samples collected over 2 weeks, 8.3% of the dose was recovered in the urine primarily as metabolites and 37.8% of the dose was recovered in the feces primarily as unchanged rolapitant.
Danish: I puljede prøver indsamlet over 2 uger blev 8,3 % af dosis genfundet i urinen primært som metabolitter, og 37,8 % af dosis blev genfundet i fæces primært som uomdannet rolapitant.
English: The impact of nausea and vomiting on patients' daily lives was assessed using the Functional Living Index-Emesis (FLIE).
Danish: I hvilken udstrækning kvalme og opkastning påvirker patienternes dagligdag blev vurderet med Functional Living Index-Emesis (FLIE).
English: Rolapitant is a selective antagonist of human substance P/neurokinin 1 (NK1) receptors.
Danish: Rolapitant er en selektiv antagonist af human substans P/neurokinin 1 (NK1)-receptorer.
English: A summary of the results from the non-AC and AC subsets are provided in Table 3.
Danish: Et sammendrag af resultaterne af undergrupperne ikke-AC og AC er vist i tabel 3.
English: - Take the tablets within 2 hours before you start your chemotherapy cycle.
Danish: • Tag tabletterne højst 2 timer, før du starter på din cyklus med kemoterapi.
English: The exposure ratio of M19 to rolapitant was approximately 50% in plasma.
Danish: Eksponeringsforholdet mellem M19 og rolapitant var ca. 50 % i plasma.
English: Varuby has minor influence on the ability to drive and use machines.
Danish: Varuby påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: Concomitant administration of rifampicin, a strong enzyme inducer significantly decreased the systemic exposure to rolapitant and to its active metabolite.
Danish: Samtidig administration af rifampicin, en potent enzyminduktor, reducerede den systemiske eksponering for rolapitant og dets aktive metabolit signifikant.
English: Dizziness and fatigue may occur following administration of rolapitant (see section 4.8).
Danish: Svimmelhed og træthed kan forekomme efter administration af rolapitant (se pkt.
English: Cisplatin-Based Highly Emetogenic Chemotherapy (HEC)
Danish: Cisplatinbaseret højemetogen kemoterapi (HEC)
English: A total of 1332 patients were included in the evaluation of efficacy, 80% were women and 20% were men.
Danish: I alt 1.332 patienter blev inkluderet i evalueringen af effekt, hvoraf 80 % var kvinder, og 20 % var mænd.
English: UGT1A1 and UGT2B7 substrates (e.g. irinotecan and morphine, respectively) Rolapitant modestly inhibited UGT1A1 and UGT2B7 in vitro.
Danish: UGT1A1- og UGT2B7-substrater (f.eks. hhv. irinotecan og morfin) Rolapitant hæmmede i moderat grad UGT1A1 og UGT2B7 in vitro.
English: Indigo carmine (E132) Polysorbate 80
Danish: Indigokarmin (E 132) Polysorbat 80
English: A human Positron Emission Tomography (PET) study with rolapitant demonstrated that rolapitant crosses the blood brain barrier and occupies brain NK1 receptors.
Danish: Et humant positron-emissionstomografi (PET)-studie med rolapitant viste, at rolapitant krydser blodhjerne-barrieren og okkuperer NK1-receptorer i hjernen.
English: Breast-feeding is not recommended during treatment with Varuby.
Danish: Amning anbefales ikke under behandling med Varuby.
English: Swallow the tablets whole, with some water.
Danish: Tabletterne skal sluges hele med lidt vand.
English: A total of 1087 patients were randomised to either the rolapitant regimen (N=544) or control therapy (N=543) across Study 1 and Study 2; 1070 patients were included in the evaluation of efficacy; 37% were women and 63% were men.
Danish: I alt 1.087 patienter blev randomiseret til enten rolapitantregimet (N = 544) eller kontrolbehandling (N = 543) i studie 1 og studie 2; 1.070 patienter blev inkluderet i effektvurderingen; 37 % var kvinder, og 63 % var mænd.
English: Standard dose of 5-HT3 receptor antagonist.
Danish: Standarddosis af 5-HT3-antagonist.
English: Multiple-Cycle Extension: In each study, patients had the option of continuing into a multiple-cycle extension for up to 5 additional cycles of chemotherapy receiving the same treatment as assigned in cycle 1.
Danish: Forlængelsesstudie med flere cyklusser: I hvert studie havde patienterne mulighed for at fortsætte i en forlængelse med op til yderligere 5 kemoterapicyklusser og få den samme behandling som i cyklus 1.
English: - problems walking
Danish: • problemer med at gå
English: 180 mg (two tablets) should be administered within 2 hours prior to initiation of each chemotherapy cycle but at no less than 2-week intervals.
Danish: 180 mg (to tabletter) administreres højst 2 timer før initiering af hver kemoterapicyklus, men med mindst 2 ugers interval.
English: 2 film-coated tablets
Danish: 2 filmovertrukne tabletter
English: Abdominal distension Abdominal pain Stomatitis
Danish: Abdominal distension Abdominalsmerter Stomatitis
English: Dexamethasone 20 mg orally; 30 min prior to chemotherapy
Danish: Dexamethason 20 mg oralt 30 min. inden kemoterapi
English: In rodents, rolapitant was tested in repeated dose oral toxicity studies up to 26 weeks in duration, and the liver, thyroid, kidneys, epididymis and uterus were identified as target organs.
Danish: Hos gnavere blev rolapitant testet i toksicitetsstudier af en varighed på op til 26 uger med gentagne orale doser, og lever, thyreoidea, nyrer, epididymis og uterus blev identificeret som målorganer.
English: Varuby is given as part of combination therapy (see section 4.2).
Danish: Varuby gives som led i kombinationsbehandling (se pkt.
English: The formation of M19 was significantly delayed with the median Tmax of 120 hours (range: 24-168 hours) and the mean half-life of M19 was 158 hours.
Danish: Dannelsen af M19 var signifikant forsinket med median-tmax på 120 timer (24-168 timer), og den gennemsnitlige halveringstid for M19 var 158 timer.
English: Single dose = 2 tablets
Danish: Enkeltdosis = 2 tabletter
English: A total of 1369 patients were randomised to either the rolapitant regimen (N=684) or control therapy (N=685).
Danish: I alt 1.369 patienter blev randomiseret til enten rolapitantregime (N = 684) eller kontrolbehandling (N = 685).
English: Polyvinyl alcohol Titanium dioxide (E171) Macrogol
Danish: Tabletovertræk Polyvinylalkohol Titandioxid (E 171) Macrogol
English: Of these 1332 patients, 28% were greater than 65 years of age and 6% were greater than 75 years of age.
Danish: Af disse 1.332 patienter var 28 % over 65 år, og 6 % var over 75 år.
English: In a population pharmacokinetic analysis of rolapitant, the Vd/F was 387 L in cancer patients.
Danish: I en farmakokinetisk populationsanalyse af rolapitant var Vd/F 387 l hos cancerpatienter.
English: Of the 1070 patients, 26% were greater than 65 years of age and 3% were greater than 75 years of age.
Danish: Af de 1.070 patienter var 26 % over 65 år, og 3 % var over 75 år.
English: HEC Study 1
Danish: HEC studie 1
English: Study medicinal products were administered prior to chemotherapy on Day 1 at the following intervals: rolapitant (1 to 2 hours prior); granisetron and dexamethasone (30 minutes prior).
Danish: Studielægemidlerne blev administreret før kemoterapi på dag 1 med følgende intervaller: rolapitant (1 til 2 timer før), granisetron og dexamethason (30 minutter før).
English: Study 1 and Study 2 (HEC)
Danish: Studie 1 og studie 2 (HEC)
English: - if you take an herbal medicine called St John's wort (Hypericum performatum), used to treat depression and difficulty sleeping (see section 2 under ‘Other medicines and Varuby').
Danish: • hvis du tager naturlægemidlet perikon (Hypericum perforatum), der bruges til at behandle depression og søvnbesvær (se punkt 2 under ”Brug af anden medicin sammen med Varuby”).
English: Rolapitant is a moderate CYP2D6 inhibitor.
Danish: Rolapitant er en moderat CYP2D6-hæmmer.
English: Rolapitant displays linear PK with exposures increased in a dose-proportional manner.
Danish: Rolapitant udviser lineær farmakokinetik med eksponeringer, som stiger proportionalt med dosis.
English: The estimated time to first emesis in the combined analysis is depicted by the Kaplan-Meier plot in
Danish: Den estimerede tid til første emese i den kombinerede analyse er vist med Kaplan-Meier-plottene i figur 1.
English: The apparent volume of distribution (Vd/F) was 460 L in healthy subjects, indicating an extensive tissue distribution of rolapitant.
Danish: Fordelingsvolumen (Vd/F) var 460 l hos raske frivillige forsøgsdeltagere, hvilket tyder på en omfattende vævsfordeling af rolapitant.
English: The safety profile in the multiple-cycle extensions of highly and moderately emetogenic chemotherapy studies for up to 6 cycles of chemotherapy is similar to the profile observed in Cycle 1.
Danish: Sikkerhedsprofilen i forlængelsesstudier med flere cyklusser med stærkt og moderat emetogen kemoterapi (op til 6 kemoterapicyklusser) svarer til den profil, der blev observeret i cyklus 1.
English: If you stop taking Varuby
Danish: Hvis du holder op med at tage Varuby
English: Increased plasma concentrations of BCRP substrates (e.g. methotrexate, irinotecan, topotecan, mitoxantrone, rosuvastatin, sulfasalazine, doxorubicin, bendamustine) may result in potential adverse reactions.
Danish: Forhøjede plasmakoncentrationer af BCRPsubstrater (f.eks. methotrexat, irinotecan, topotecan, mitoxantron, rosuvastatin, sulfasalazin, doxorubicin, bendamustin) kan potentielt medføre bivirkninger.
English: Moderately emetogenic chemotherapy regimen Day 1
Danish: Moderat emetogent kemoterapiregime Dag 1
English: Non-AC
Danish: Ikke-AC
English: OCT1 substrates In vitro, rolapitant is not an inhibitor of OCT1 at the tested concentrations up to 20 µM.
Danish: OCT1-substrater In vitro er rolapitant ikke en hæmmer af OCT1 ved de testede koncentrationer på op til 20 µM.
English: Varuby should not be used during pregnancy unless clearly necessary.
Danish: Varuby bør kun anvendes under graviditet på tvingende indikation.
English: Therefore, caution should be taken when rolapitant is combined with a medicinal product metabolised by CYP2D6, notably those having a narrow therapeutic margin (e.g. propafenone, tamoxifen, metoprolol used in heart failure, thioridazine, pimozide).
Danish: Der skal derfor udvises forsigtighed, når rolapitant kombineres med et lægemiddel, der metaboliseres af CYP2D6, især lægemidler med en smal terapeutisk margin (f.eks. propafenon, tamoxifen, metoprolol anvendt ved hjerteinsufficiens, thioridazin, pimozid).
English: Decreases in the number of corpora lutea and implantation sites were observed in the female rat fertility and early embryonic development study (see section 5.3).
Danish: Der blev observeret et fald i antallet af corpora lutea og implantationssteder i et studie af hunrotters fertilitet og den tidlige fosterudvikling (se pkt.
English: Each tablet contains 90 mg of rolapitant (as hydrochloride monohydrate).
Danish: En tablet indeholder 90 mg rolapitant (som hydrochloridmonohydrat).
English: No Emesis
Danish: Ingen emese
English: Varuby contains lactose
Danish: Varuby indeholder lactose
English: Moderately Emetogenic Chemotherapy and Combinations of Anthracycline and Cyclophosphamide Chemotherapy
Danish: Moderat emetogen kemoterapi og kombinationer af anthracyclin- og cyclophosphamidkemoterapi
English: The pharmacokinetics of Varuby was not studied in patients with severe hepatic impairment (Child-Pugh Class C).
Danish: Varubys farmakokinetik er ikke blevet undersøgt hos patienter med svært nedsat leverfunktion (Child-Pugh-klasse C).
English: At the time the study was designed, AC containing chemotherapy regimens were considered to be moderately emetogenic.
Danish: Da studiet blev designet, blev ACholdige kemoterapiregimer betragtet som moderat emetogene.
English: A 3-fold increase in the exposure of dextromethorphan, a CYP2D6 substrate, was observed 7 days after a single oral dose of rolapitant and may last longer.
Danish: Der er observeret en tredobling af eksponeringen for dextromethorphan, et CYP2D6-substrat, 7 dage efter en enkelt oral dosis af rolapitant, og den kan vare længere.
English: Therefore, clinical monitoring of adverse reactions and, if possible, biological monitoring are recommended when rolapitant is combined with digoxin or with other P-gp substrates (e.g. dabigatran or colchicine), and in particular in patients with renal impairment.
Danish: Derfor anbefales klinisk overvågning for bivirkninger og, hvis det er muligt, biologisk monitorering, når rolapitant kombineres med digoxin eller andre P-gp-substrater (f.eks. dabigatran eller colchicin).
English: The median Tmax for M19 was delayed to 204 hours in patients with mild or moderate hepatic impairment compared to 168 hours in healthy subjects.
Danish: Den mediane tmax for M19 var 204 timer hos patienter med let eller moderat nedsat leverfunktion sammenlignet med 168 timer hos raske frivillige forsøgsdeltagere.
English: - Film-coat: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, indigo carmine (E132), and polysorbate 80.
Danish: • Tabletovertræk: polyvinylalkohol, titandioxid (E 171), macrogol, talcum, indigokarmin (E132) og polysorbat 80.
English: Information is insufficient for the effect of severe renal impairment.
Danish: Der foreligger ikke tilstrækkelige oplysninger om effekten ved svært nedsat nyrefunktion.
English: Tell your doctor, pharmacist or nurse if you notice any of the following side effects:
Danish: Fortæl det til lægen, apotekspersonalet eller sundhedspersonalet, hvis du bemærker en eller flere af følgende bivirkninger:
English: Table 1: Proportion of patients receiving cisplatin chemotherapy responding by treatment group and phase (Studies 1 and 2 - HEC Individual Results)
Danish: Tabel 1: Andel af patienter, der får cisplatinkemoterapi, som responderer, efter behandlingsgruppe og fase (studie 1 og 2 (HEC) individuelle resultater)
English: On Day 2 to 4, patients received 8 mg twice daily of oral dexamethasone.
Danish: På dag 2 til 4 fik patienterne 8 mg oral dexamethason to gange dagligt.
English: to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known: frequency cannot be estimated from the available data.
Danish: Hyppighederne defineres 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).
English: It is important that you tell your doctor if you are breast-feeding or are planning to breast-feed before taking this medicine.
Danish: Det er vigtigt, at du fortæller lægen det, hvis du ammer eller har planer om at amme, før du tager dette lægemiddel.
English: In vitro studies suggest that rolapitant is not expected to inhibit OATP1B1 at clinically relevant concentrations and rolapitant is not an inhibitor of OATP1B3 at the tested concentrations up to 20 µM.
Danish: In vitro-studier tyder på, at rolapitant ikke hæmmer OATP1B1 ved klinisk relevante koncentrationer, og rolapitant er ikke en hæmmer af OATP1B3 ved de testede koncentrationer på op til 20 µM.
English: Unchanged rolapitant or M19 were not found in pooled urine sample.
Danish: Der blev ikke fundet uomdannet rolapitant eller M19 i puljede urinprøver.
English: When 600 mg rifampicin was administered once daily for 7 days before and 7 days after administration of a single dose of 180 mg rolapitant, the mean AUC was reduced by 87% and its active metabolite by 89% compared to administration of rolapitant alone.
Danish: Når 600 mg rifampicin blev administreret en gang dagligt i 7 dage før og 7 dage efter administration af en enkelt dosis på 180 mg rolapitant, blev det gennemsnitlige AUC reduceret med 87 % og dets aktive metabolit med 89 % sammenlignet med administration af rolapitant alene.
English: Adverse reactions per system organ class
Danish: Bivirkninger efter systemorganklasse
English: Table 3: Proportion of Patients Receiving AC or non-AC Chemotherapy Achieving Complete Response
Danish: Tabel 3: Andel af patienter, som fik AC- eller ikke-AC-kemoterapi, med fuldstændigt respons
English: The European Medicines Agency has deferred the obligation to submit the results of studies with rolapitant in all subsets of the paediatric population in prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cisplatin-based cancer therapy and moderately emetogenic cancer therapy (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med rolapitant i alle undergrupper af den pædiatriske population som profylakse mod akut og sen kvalme og opkastning associeret med initiale og gentagne cyklusser af højemetogen cisplatinbaseret cancerbehandling og moderat emetogen cancerbehandling (se pkt.
English: Rolapitant did not affect the fertility or general reproductive performance of male rats.
Danish: Rolapitant påvirkede ikke fertiliteten eller reproduktionsevnen generelt hos hanrotter.
English: Concurrent administration of 400 mg ketoconazole once daily for 21 days following a single 90 mg dose of rolapitant, did not significantly affect the Cmax of rolapitant while the AUC increased by 21%.
Danish: Administration af 400 mg ketoconazol en gang dagligt i 21 dage efter en enkelt 90 mg dosis af rolapitant havde ikke nogen signifikant indvirkning på rolapitants Cmax, mens AUC blev øget med 21 %.
English: Table 2: Proportion of Patients Receiving Moderately Emetogenic Chemotherapy Responding by Treatment Group and Phase
Danish: Tabel 2: Andel af patienter, der fik moderat emetogen kemoterapi, som responderede, efter behandlingsgruppe og fase
English: On Day 2 to 3, patients received 2 mg once daily of oral granisetron.
Danish: På dag 2 til 3 fik patienterne 2 mg oral granisetron én gang dagligt.
English: Angioedema Dermatitis acneiform Dry skin
Danish: Angioødem Akneiform dermatitis Tør hud
English: If you think you may have taken more than you should, tell your doctor straight away.
Danish: Hvis du mener, at du har taget for meget, skal du fortælle det til lægen med det samme.
English: HEC Study 2
Danish: HEC studie 2
English: Drug metabolising enzymes (and drug transporters) other than CYP3A4 involved in rolapitant hepatobiliary elimination remain to be elucidated.
Danish: Andre lægemiddelmetaboliserende enzymer (og lægemiddeltransportører) end CYP3A4, der er involveret i udskillelse af rolapitant via lever-/galdevejene, skal klarlægges.
English: If you forget to take Varuby
Danish: Hvis du har glemt at tage Varuby
English: Effects of other medicinal products on the pharmacokinetics of Varuby
Danish: Andre lægemidlers indvirkning på Varubys farmakokinetik
English: There are limited data in patients aged 75 years and older.
Danish: Der er begrænsede data for patienter ≥ 75 år.
English: 5-HT3 receptor antagonist
Danish: 5-HT3-antagonist
English: A total of 2,798 subjects received oral rolapitant at any dose, including 1,567 subjects in the CINV (chemotherapy-induced nausea and vomiting) studies.
Danish: I alt 2.798 deltagere fik oral rolapitant i forskellige doser, inklusive 1.567 deltagere i CINVstudierne (kemoterapiinduceret kvalme og opkastning).
English: Following administration of a single oral 180-mg dose of [14C]-rolapitant, on average 14.2% (range 9% to 20%) and 73% (range 52% to 89%) of the dose was recovered in the urine and feces, respectively over 6 weeks.
Danish: Efter administration af en enkelt oral dosis på 180 mg [14C]-rolapitant blev gennemsnitligt 14,2 % (9 % til 20 %) og 73 % (52 % til 89 %) af dosis genfundet i henholdsvis urin og fæces i løbet af 6 uger.
English: Because of the antiemetic activity of rolapitant, emesis induced by a medicinal product may not be effective.
Danish: På grund af rolapitants antiemetiske aktivitet vil det ikke altid være muligt at fremkalde emese medicinsk.
English: At the 180 mg dose of rolapitant, the mean NK1 receptor occupancy in the cortical regions was greater than 90% for at least 120 hours.
Danish: Ved en dosis på 180 mg rolapitant var den gennemsnitlige okkupation af NK1-receptorer i de kortikale områder mere end 90 % i mindst 120 timer.
English: The following regimens are recommended for the prevention of nausea and vomiting associated with emetogenic cancer therapy:
Danish: Følgende regimer anbefales til profylakse af kvalme og opkastning i forbindelse med emetogen cancerbehandling:
English: In a population pharmacokinetic analysis the apparent total clearance (CL/F) of rolapitant was 0.96 L/hour in cancer patients.
Danish: I en farmakokinetisk populationsanalyse var den totale clearance (CL/F) for rolapitant 0,96 l/time hos cancerpatienter.
English: Contents of the pack and other information What Varuby contains
Danish: Pakningsstørrelser og yderligere oplysninger Varuby indeholder:
English: Package leaflet: Information for the patient Varuby 90 mg film-coated tablets
Danish: Indlægsseddel: Information til patienten Varuby 90 mg filmovertrukne tabletter
English: No clinically significant effect was seen on the pharmacokinetics of rolapitant when ketoconazole, a strong CYP3A4 inhibitor was administered with rolapitant.
Danish: Der sås ingen klinisk signifikant indvirkning på rolapitants farmakokinetik, når ketoconazol, potent CYP3A4-hæmmer, blev administreret sammen med rolapitant.
English: A 70% increase in Cmax and 30% increase in AUC of digoxin, a P-gp substrate, were observed when administered with a single dose of 180 mg rolapitant.
Danish: Der blev observeret en stigning på 70 % i Cmax og på 30 % i AUC for digoxin, som er et P-gp-substrat, når det blev administreret samtidig med en enkelt dosis på 180 mg rolapitant.