natgillin/translations-raw huggingface dataset:
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med talazoparib i alle undergrupper af den pædiatriske population for brystkræft (se pkt.
The European Medicines Agency has waived the obligation to submit the results of studies with talazoparib in all subsets of the paediatric population in breast cancer (see section 4.2 for information on paediatric use).
Den tumorhæmmende aktivitet ved talazoprib blev også observeret i en patientafledt xenograft (PDX) BRCA-muterende brystkræftsmodel, hvor patienten tidligere havde været behandlet med et platinbaseret regime.
Talazoparib anti-tumour activity was also observed in a patient-derived xenograft (PDX) BRCA mutant breast cancer model where the patient was previously treated with a platinum-based regimen.
Karakteristika for demografi, baseline og sygdom - EMBRACA-studiet Talazoparib
Demographic, baseline, and disease characteristics - EMBRACA study Talazoparib
Forkortelser: aBC=fremskreden brystkræft; CI=konfidensinterval; CNS=centralnervesystemet; HR+=hormonreceptor-positiv; ITT=intent-to-treat; PCT=behandling valgt af lægen (kemoterapi); PFS=progressionsfri overlevelse; TNBC=triple-negativ brystkræft.
Abbreviations: aBC=advanced breast cancer; CI=confidence interval; CNS=central nervous system; HR+=hormone receptor-positive; ITT=intent-to-treat; PCT=physician's choice treatment (chemotherapy); PFS=progression-free survival; TNBC=triple-negative breast cancer.
Virkning af fødeindtagelse
The effect of food
Talazoparib er et substrat for transportørerne P-gp og Breast Cancer Resistance Protein (BCRP), og det udskilles primært uforandret gennem nyrerne.
Talazoparib is a substrate for drug transporters P-gp and Breast Cancer Resistance Protein (BCRP) and it is mainly eliminated by renal clearance as unchanged compound.
Kapslerne skal synkes hele og må ikke åbnes eller opløses i noget.
To avoid contact with the capsule content, the capsules should be swallowed whole, and must not be opened or dissolved.
Samtidig brug af kraftige P-gp-hæmmere (herunder blandt andet amiodaron, carvedilol, clarithromycin, cobicistat, darunavir, dronedaron, erythromycin, indinavir, itraconazol, ketoconazol, lapatinib, lopinavir, propafenon, quinidin, ranolazin, ritonavir, saquinavir, telaprevir, tipranavir og verapamil) skal undgås.
Concomitant use of strong P-gp inhibitors (including but not limited to amiodarone, carvedilol, clarithromycin, cobicistat, darunavir, dronedarone, erythromycin, indinavir, itraconazole, ketoconazole, lapatinib, lopinavir, propafenone, quinidine, ranolazine, ritonavir, saquinavir, telaprevir, tipranavir, and verapamil) should be avoided.
Overvej genoptagelse af Talzenna ved næste reducerede dosis eller seponer
Consider resuming Talzenna at next lower dose or discontinue
Opsummering af virkningsresultater - EMBRACA-studiet Talazoparib
Summary of efficacy results - EMBRACA study Talazoparib
Bivirkninger relateret til myelosuppression i forbindelse med dosisændringer blev indberettet for op til ca. 30% af patienterne populationen, der fik talazoparib 1 mg/dag, og de bivirkninger, der var forbundet med permanent seponering af studiemedicinen udgjorde mindre end 1% af patienterne.
Myelosuppression-related adverse events associated with dose modifications were reported for up to approximately 30% of patients in the talazoparib 1 mg/day population and those associated with permanent study drug discontinuation were reported for less than 1% of patients.
Fertile kvinder må ikke blive gravide, mens de får Talzenna, og må ikke være gravide ved behandlingsstart.
Women of childbearing potential should not become pregnant while receiving Talzenna and should not be pregnant at the beginning of treatment.
PARP-hæmmere (PARPi) udøver cytotoksiske virkninger på kræftceller i form af 2 mekanismer: Hæmning af PARP's katalytiske aktivitet og ved indfangning af PARP, hvorved PARP-protein, der er bundet til en PARPi, ikke umiddelbart dissocieres fra en DNA-læsion, hvilket hindrer DNA-reparation, replikation og transkription, hvilket medfører apoptose og/eller celledød.
PARP inhibitors (PARPi) exert cytotoxic effects on cancer cells by 2 mechanisms, inhibition of PARP catalytic activity and by PARP trapping, whereby PARP protein bound to a PARPi does not readily dissociate from a DNA lesion, thus preventing DNA repair, replication, and transcription, thereby resulting in apoptosis and/or cell death.
Hvis samtidig administration med en kraftig P-gp-hæmmer ikke kan undgås, skal dosis af Talzenna reduceres til 0,75 mg 1 gang dagligt.
If co-administration with a strong P-gp inhibitor is unavoidable, the Talzenna dose should be reduced to 0.75 mg once daily.
Der blev gennemført en farmakokinetisk analyse af populationen med data fra 490 patienter med cancer for at vurdere betydning af alder (18-88 år), køn (53 mænd og 437 kvinder) samt kropsvægt (35,7-162 kg) på for talazoparibs farmakokinetik.
A population PK analysis was conducted using data from 490 patients with cancer to evaluate the impact of age (ranging from 18 to 88 years), sex (53 males and 437 females), and body weight (ranging from 35.7 kg to 162 kg) on the PK of talazoparib.
Disse toksikologiske fund stemmer overens med farmakologien for talazoparib og det vævsfordelingsmønster.
These toxicity findings are consistent with the pharmacology of talazoparib and its tissue distribution pattern.
Response Evaluation Criteria in Solid Tumors (RECIST) Version 1,1, som vurderet af blindet uafhængig central gennemgang (BICR).
The primary efficacy endpoint was progression-free survival (PFS) evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as assessed by blinded independent central review (BICR).
Hvor meget skal man tage Den anbefalede dosis er 1 kapsel af 1 mg dagligt.
How much to take The recommended dose is one 1-mg capsule taken by mouth once daily.
Tabel 3 giver et overblik over bivirkningerne efter systemorganklasse og hyppighed.
Table 3 summarises adverse reactions based on pooled dataset listed by system organ class, and frequency category.
Efter en enkelt oral dosis talazoparib samtidig med fedtholdig, kalorieholdig føde (ca. 827 kalorier, 57 % fedt) faldt den gennemsnitlige Cmax for talazoparib med ca. 46 %, median Tmax blev forsinket fra 1 til 4 timer, hvorimod AUCinf ikke blev påvirket.
Following a single oral dose of talazoparib with high-fat, high-calorie food (approximately 827 calories, 57% fat), the mean Cmax of talazoparib was decreased by approximately 46%, the median Tmax was delayed from 1 to 4 hours, while the AUCinf was not affected.
I et studie omfattende undersøgelse af embryo-føtal udvikling hos rotter førte talazoparib til embryoføtal død, fostermisdannelse (indsunkne øjne, små øjne, delt sternebra, sammenvokset arcus vertebrae cervicalis) og strukturelle variationer i knoglerne ved systemisk AUC24 eksponering af moderen med ca. 0,09 gange den relevante humane eksponering ved den anbefalede dosis.
In an embryo-foetal development study in rats, talazoparib resulted in embryo-foetal death, foetal malformation (depressed eye bulge, small eye, split sternebrae, fused cervical vertebral arch) and structural variations in bones at a maternal systemic AUC24 exposure approximately 0.09-fold the relevant human exposure at the recommended dose.
Det kan være, at lægen vil undersøge din knoglemarv for at se, om det kunne være tilfældet for dig.
Your doctor may want to test your bone marrow to check for these problems.
Talazoparibs mediane tilsyneladende fordelingsvolumen (Vss/F) var 420 l. In vitro er ca. 74 % af talazoparib bundet til plasmaproteiner uden koncentrationsafhængighed over koncentrationsintervallet 0,01 mikroM til 1 mikroM.
The population mean apparent volume of distribution (Vss/F) of talazoparib was 420 L. In vitro, talazoparib is approximately 74% bound to plasma proteins with no concentration dependence over the concentration range of 0.01 µM to 1 µM.
De mest almindelige (≥ 25%) bivirkninger hos patienter, der fik talazoparib i disse kliniske studier, var træthed (57,1%), anæmi (49,6%), kvalme (44,3%), neutropeni (30,2%), thrombocytopeni (29,6%) og hovedpine (26,5%).
The most common (≥ 25%) adverse reactions in patients receiving talazoparib in these clinical studies were fatigue (57.1%), anaemia (49.6%), nausea (44.3%), neutropenia (30.2%), thrombocytopenia (29.6%), and headache (26.5%).
Dosis kan nedsættes til 0,75 mg (tages som 3 kapsler af 0,25 mg 1 gang dagligt) eller til 0,5 mg (2 kapsler af 0,25 mg 1 gang dagligt) eller til 0,25 mg (1 kapsel af 0,25 mg 1 gang dagligt).
The dose may be lowered to 0.75 mg (taken as three 0.25-mg capsules) once daily, or 0.5 mg (two 0.25-mg capsules) once daily, or 0.25 mg (one 0.25-mg capsule) once daily.
I toksicitetsstudier med gentagne doser hos rotter og hunde har de primære fund ved subterapeutisk eksponering omfattet knoglemarvs-hypocellularitet med dosisafhængig reduktion af de hæmatopoietiske celler, svind af lymfevæv i flere organer samt atrofi og/eller degenerative ændringer af testikler, epedidymis og tubuli seminiferi.
In repeat-dose toxicity studies in rats and in dogs, the main findings at subtherapeutic exposures included bone marrow hypocellularity with dose-dependent decrease in haematopoietic cells, depletion of lymphoid tissue in multiple organs and atrophy and/or degenerative changes in testes, epididymis and seminiferous tubules.
Efter gentagen daglig dosering med talazoparib 1 mg til patienterne lå det geometriske gennemsnitsareal (% koefficient af variationen (CV%)) under plasmakoncentration-tidskurven (AUC) og den maksimalt observerede plasmakoncentration (Cmax) for talazoparib ved steady-state i intervallet henholdsvis 126 (107) ng x t/ml til 208 (37) ng x t/ml og 11 (90) ng/ml til 19 (27) ng/ml.
Following repeated daily dosing of 1 mg talazoparib to patients, the geometric mean (% coefficient of variation [CV%]) area under the plasma concentration-time curve (AUC) and maximum observed plasma concentration (Cmax) of talazoparib at steady-state was in the range of 126 (107) ng•hr/mL to 208 (37) ng•hr/mL and 11 (90) ng/mL to 19 (27) ng/mL, respectively.
Median PFS=8,6 måneder 95% CI (7,2; 9,3)
Median PFS=8.6 months 95% CI (7.2, 9.3)
Behandling af kræftcellelinjer med defekter i de DNA-reparerende gener med talazoparib-enkeltstof fører til øget indhold af γH2AX, en markør for dobbeltstrengede DNA-brud, og medfører nedsat celleproliferation og øget apoptose.
Treatment of cancer cell lines that are harbouring defects in DNA repair genes with talazoparib single agent leads to increased levels of γH2AX, a marker of double stranded DNA breaks, and results in decreased cell proliferation and increased apoptosis.
Stoffer, der kan påvirke plasmakoncentrationerne af talazoparib
Agents that may affect talazoparib plasma concentrations
Ud fra en farmakokinetisk analyse af populationen, der omfattede 490 patienter, hvoraf 41 patienter var asiater og 449 patienter var ikke-asiater (361 hvide, 16 sorte, 9 andre og 63 ikke angivet), var talazoparib CL/F højere hos asiatiske patienter sammenlignet patienter, der ikke var asiatiske, førende til 19,2 % lavere eksponering (AUC) for asiatiske patienter.
Based on a population PK analysis that included 490 patients, where 41 patients were Asian and 449 patients were Non-Asian (361 White, 16 Black, 9 Others, and 63 Not reported), talazoparib CL/F was higher in Asian patients compared to Non-Asian patients, leading to 19% lower exposure (AUC) in Asian patients.
Forkortelser: n=antal patienter.
Abbreviations: n=number of patients; N/A=not applicable.
Talazoparib udskilles overvejende uændret via urinen med 55 % af den administrerede dosis, hvorimod uændret talazoparib fundet i fæces udgjorde 14 %.
Excretion of unchanged talazoparib in urine was the major route of elimination accounting for 55% of the administered dose, while unchanged talazoparib recovered in the faeces accounted for 14%.
Bivirkninger relateret til myelosuppression grad 3 og grad 4 blev indberettet for anæmi med 34,8% og 0,4%, for neutropeni med 15,6% og 1,8% og for thrombocytopeni med 12,8% og 4,0%.
Grade 3 and Grade 4 myelosuppression-related events were reported for anaemia 34.8% and 0.4%, neutropenia 15.6% and 1.8%, and thrombocytopenia 12.8% and 4.0%.
Noget medicin kan påvirke måden, Talzenna virker på.
Also some medicines can affect the way Talzenna works.
Det er navnlig følgende, som kan øge risikoen for bivirkninger med Talzenna: - Amiodaron, carvedilol, dronedaron, propafenon, kinidin, ranolazin og verapamil, der almindeligvis bruges til behandling af problemer med hjertet.
In particular, the following may increase the risk of side effects with Talzenna: Amiodarone, carvedilol, dronedarone, propafenone, quinidine, ranolazine and verapamilgenerally used to treat heart problems.
Farmakokinetisk populationsanalyse har også vist, at samtidig brug af kraftige P-gp-hæmmere øgede eksponeringen for talazoparib med 45 % sammenlignet med talazoparib givet alene.
Population pharmacokinetic (PK) analysis has also shown that concomitant use of strong P-gp inhibitors increased talazoparib exposure by 45%, relative to talazoparib given alone.
Forkortelser: BICR=blindet udafhængig central gennemgang; CI=konfidensinterval; CMH=CochranMantel-Haenszel; CR=klomplet respons; IQR=interkvartilt interval; ITT=intent-to-treat; ORR=objektiv responsrate; OS=samlet overlevelse; PR=partielt respons; RECIST 1.1=Response Evaluation Criteria in Solid Tumors version 1.1.
Abbreviations: BICR=blinded independent central review; CI=confidence interval; CMH=CochranMantel-Haenszel; CR=complete response; IQR=interquartile range; ITT=intent-to-treat; ORR=objective response rate; OS=overall survival; PR=partial response; RECIST 1.1=Response Evaluation Criteria in Solid Tumors version 1.1. a. Hazard ratio was based on stratified Cox regression model with treatment as the only covariate
Middel alder (år (interval)) Alderskategori (år), n (%)
Median age (y [range]) Age category (y), n (%)
Der er indberettet tilfælde af myelodysplastisk syndrom/akut myeloid leukæmi (MDS/AML) hos patienter, der har fået PARP-hæmmere (poly-adenosindifosfat-ribose-polymerase), herunder talazoparib.
Myelodysplastic syndrome/Acute Myeloid Leukaemia (MDS/AML) have been reported in patients who received poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitors, including talazoparib.
Der skal foretages en graviditetstest af alle fertile kvinder forud for behandling.
A pregnancy test should be performed on all women of childbearing potential prior to treatment.
Talzenna må kun bruges til patienter med moderat til kraftigt nedsat leverfunktion, hvis fordelene opvejer de mulige risici, og patienten skal nøje monitoreres med hensyn til leverfunktion og bivirkninger.
Talzenna may only be used in patients with moderate or severe hepatic impairment if the benefit outweighs the potential risk, and the patient should be carefully monitored for hepatic function and adverse events.
Talzenna bruges til behandling af voksne med en type brystkræft, der kaldes HER2-negativ brystkræft, som har et unormalt arveligt BRCA-gen.
Talzenna is used to treat adults with breast cancer of a type known as HER2-negative breast cancer who have an abnormal inherited BRCA gene.
- Cyklosporin bruges ved organtransplantation for at forhindre afstødning af det nye organ.
Ciclosporin - used in organ transplantation to prevent rejection.
KG Nürnberger Strasse 12 90537 Feucht Tyskland
Manufacturer Excella GmbH & Co. KG Nürnberger Strasse 12 90537 Feucht Germany
28 % af patienterne i det pivotale studie tog syreneutraliserende midler, hovedsageligt protonpumpehæmmere.
Twenty-eight percent (28%) of the patients in the pivotal study were taking acid-reducing agents, mainly proton pump inhibitors.
Samtidig brug af kraftige P-glykoprotein-hæmmere under behandling med talazoparib skal undgås.
Concomitant use of strong P-gp inhibitors during treatment with talazoparib should be avoided.
Fortæl altid lægen eller apotekspersonalet, 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.
Talazoparibs gennemsnitlige plasmahalveringstid (±standardafvigelse) var 90 timer (±58), og populationens gennemsnitlige (variationen mellem forsøgspersonerne), tilsyneladende orale clearance (CL/F) var 6,5 (31%) l/t for cancerpatienterne.
The mean (±standard deviation) terminal plasma half-life of talazoparib was 90 (±58) hours and the population mean (inter-subject variability) apparent oral clearance (CL/F) was 6.5 (31%) L/h in cancer patients.
Ud af de 431 patienter, der blev randomiseret i EMBRACA-studiet, blev det bekræftet centralt ved klinisk studieanalyse, at 408 (95%) havde risikogivende BRCA, heraf blev 354 (82%) bekræftet ved hjælp af BRACAnalysis CDx
Of the 431 patients randomised in the EMBRACA study, 408 (95%) were centrally confirmed to have a deleterious or suspected deleterious gBRCAm using a clinical trial assay; out of which 354 (82%) were confirmed using the BRACAnalysis CDx®.
Talzenna 1 mg hårde kapsler EU/1/19/1377/005
Talzenna 1 mg hard capsules EU/1/19/1377/005
Sådan skal du tage Talzenna 4.
How to store Talzenna 6.
Talazoparib Kemoterapi
Talazoparib Chemotherapy
Det er nødvendigt med yderst effektiv kontraception til kvindelige patienter, mens de behandles med Talzenna og i mindst 7 måneder efter behandlingen.
A highly effective method of contraception is required for female patients during treatment with Talzenna, and for at least 7 months after completing therapy.
Pakningsstørrelser: Karton med 30 × 1 kapsler eller 60 × 1 kapsler eller 90 × 1 kapsler i blister med enkeltdoser.
Pack sizes: cartons of 30 × 1 capsules, or 60 × 1 capsules, or 90 × 1 capsules in unit dose blisters.
Talzenna er indiceret som monoterapi til behandling af voksne patienter med germline BRCA1/2mutationer, som har lokalt fremskreden eller metastatisk HER2-negativ brystkræft.
Talzenna is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2-negative locally advanced or metastatic breast cancer.
Yderligere fund ved højere eksponeringer omfattede dosisafhængig forøgelse af apoptose/nekrose i mave-tarm-kanal, lever og ovarier.
Additional findings at higher exposures included dose-dependent increase in apoptosis/necrosis in the gastrointestinal (GI) tract, liver and ovary.
Gravide skal vejledes om den potentielle risiko for fosteret (se pkt.
Pregnant women should be advised of the potential risk to the foetus (see section 4.6).
EMBRACA var et open-label, randomiseret, parallelt, 2-armet multicenterstudie af Talzenna sammenlignet med kemoterapi (capecitabin, eribulin, gemcitabin, vinorelbin) hos patienter med germline BRCA-muteret, lokalt fremskreden eller metastatisk HER2-negativ brystkræft, som ikke havde fået mere end 3 forudgående cytotoksiske behandlinger med kemoterapi mod deres metastatiske eller lokalt fremskredne sygdom.
EMBRACA was an open-label, randomised, parallel, 2-arm multicentre study of Talzenna versus chemotherapy (capecitabine, eribulin, gemcitabine, vinorelbine) in patients with germline BRCA-mutated HER2-negative locally advanced or metastatic breast cancer who received no more than 3 prior cytotoxic chemotherapy regimens for their metastatic or locally advanced disease.
Der skal træffes foranstaltninger til rutinemæssig monitorering af hæmatologiske parametre og symptomer forbundet med anæmi, leukopeni/neutropeni og/eller trombocytopeni hos patienter, der får talazoparib.
Precautions should be taken to routinely monitor haematology parameters and signs and symptoms associated with anaemia, leucopenia/neutropenia, and/or thrombocytopenia in patients receiving talazoparib.
1 mg kapselskal
1 mg capsule shell
Bivirkninger relateret til myelosuppression, anæmi, neutropeni og thrombocytopeni blev meget ofte indberettet for patienter, der blev behandlet med talazoparib 1 mg/dag.
Myelosuppression-related adverse reactions of anaemia, neutropenia, and thrombocytopenia were very commonly reported in patients treated with talazoparib 1 mg/day.
Meget almindelig (kan påvirke flere end 1 ud af 10 personer) - være forpustet, føle sig træt, bleg hud eller hurtigt hjerterytme - det kan være tegn på et lavt antal røde blodlegemer (anæmi).
Very common (may affect more than 1 in 10 people) 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).
Farmakokinetisk populationsanalyse tyder på, at samtidig brug af syrenedsættende midler, herunder protonpumpehæmmere og H2-receptor antagonister eller andre syrenedsættende midler, ikke havde en signifikant indvirkning på absorptionen af talazoparib.
Population PK analysis indicates that co-administration of acid-reducing agents including proton pump inhibitors and histamine receptor 2 antagonists (H2RA), or other acid-reducing agents had no significant impact on the absorption of talazoparib.
Kaplan-Meier-kurver for PFS - EMBRACA-studiet tid (måneder)
Kaplan-Meier curves of PFS - EMBRACA study
Øvrige indholdsstoffer: - Kapselindhold: silikonificeret mikrokrystalinsk cellulose (sMCC) (mikrokrystalinsk cellulose og siliciumdioxid).
Capsule content: silicified microcrystalline cellulose (sMCC) (microcrystalline cellulose and silicone dioxide).
Hvis samtidig administration med en kraftig P-gp-hæmmer ikke kan undgås, skal dosis af Talzenna reduceres (se pkt.
If co-administration with a strong P-gp inhibitor is unavoidable, the Talzenna dose should be reduced (see section 4.2).
Trombocyttælling < 50.000/μl
Platelet count < 50,000/μL
Systemisk hormonal kontraception Der er ikke udført interaktionsstudier med talazoparib og orale kontraceptiva.
Drug-drug interaction studies between talazoparib and oral contraceptives have not been conducted.
1 mg (en 1 mg kapsel) 1 gang dagligt
1 mg (one 1 mg capsule) once daily
EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF IKKEANVENDT LÆGEMIDDEL ELLER AFFALD HERAF
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
Beholder i højdensitets polyethylen (HDPE) og lukning i polypropylen (PP) med varmeinduceret forsegling.
High-density polyethylene (HDPE) bottle and polypropylene (PP) closure with heat induction seal liner.
Status for BRCA-mutationer (gen 1 for forhøjet risiko for brystkræft (BRCA1) eller gen 2 for forhøjet risiko for brystkræft (BRCA2)) var ens i begge behandlingsarme.
BRCA mutation status (breast cancer susceptibility gene 1 [BRCA1] positive or breast cancer susceptibility gene 2 [BRCA2] positive) was similar across both treatment arms.
EU/1/19/1377/002 (30 hårde kapsler) EU/1/19/1377/003 (60 hårde kapsler) EU/1/19/1377/004 (90 hårde kapsler)
EU/1/19/1377/002 (30 hard capsules) EU/1/19/1377/003 (60 hard capsules) EU/1/19/1377/004 (90 hard capsules)
Hvis du har taget for meget Talzenna
If you take more Talzenna than you should
Udviklingsmæssig toksikologi
Developmental toxicology
Fertile kvinder og mænd med gravide eller fertile partnere skal bruge en sikker form for prævention.
Women who can become pregnant and men with partners who are or can become pregnant should use effective contraception.
Da prævention, der indeholder hormoner ikke kan anbefales, hvis du har brystkræft, skal du anvende to ikke-hormonholdige præventionsmåder.
Since the use of hormonal contraception is not recommended if you have breast cancer, you should use two non-hormonal contraception methods.
- cobicistat, darunavir, indinavir, lopinavir, ritonavir, saquinavir, telaprevir og tipranavir bruges til behandling af hiv-infektioner/aids.
Cobicistat, darunavir, indinavir, lopinavir, ritonavir, saquinavir, telaprevir and tipranavir - used to treat HIV infections/AIDS.
Talazoparib hæmmer ikke nogen af de større uridindiphosphat-glukuronosyltransferase (UGT) isoformer (1A1, 1A4, 1A6, 1A9, 2B7 og 2B15) in vitro ved klinisk relevante koncentrationer.
In vitro, talazoparib did not inhibit any of the major uridine-diphosphate glucuronosyltransferase (UGT) isoforms (1A1, 1A4, 1A6, 1A9, 2B7, and 2B15) at clinically relevant concentrations.
Genoptag Talzenna ved næste reducerede dosis
Resume Talzenna at next lower dose