natgillin/translations-raw huggingface dataset:
Via hæmning af CXCR4 og CXCR5 kemokinreceptorernes signalering, der induceres af hhv. kemokinerne CXCL12 og CXCL13, hæmmer idelalisib cellemigration til oprindelsesstedet og retention af maligne B-celler i tumor-mikromiljøet, herunder lymfatisk væv og i knoglemarven.
Through inhibition of chemokine receptors CXCR4 and CXCR5 signalling induced by the chemokines CXCL12 and CXCL13, respectively, idelalisib inhibits homing and retention of malignant B-cells in the tumour microenvironment including lymphoid tissues and the bone marrow.
Efter en enkelt 150 mg dosis var idelalisib AUC (totalt, dvs. bundet plus ubundet) ~60 % højere ved moderat og svært nedsat funktion, sammenlignet med matchede kontroller.
Following a single 150 mg dose, idelalisib AUC (total, i.e., bound plus unbound) was ~60% higher in moderate and severe impairment compared to matched controls.
For patienter med evidens for CMV-viræmi og kliniske tegn på CMV-infektion skal midlertidig afbrydelse af idelalisib, indtil infektionen er ophørt, overvejes.
For patients with evidence of CMV viraemia and clinical signs of CMV infection, consideration should be given to interrupting idelalisib until the infection has resolved.
Patienterne blev randomiseret i forholdet 2:1 til at få idelalisib 150 mg to gange dagligt og 12 infusioner af ofatumumab i løbet af 24 uger, eller kun 12 infusioner med ofatumumab i løbet af 24 uger.
Subjects were randomised 2:1 to receive idelalisib 150 mg twice daily and 12 infusions of ofatumumab over 24 weeks, or 12 infusions of ofatumumab only over 24 weeks.
Responskategori*†
Response category*†
Fase 1- og fase 2-studierne vurderede sikkerheden af idelalisib hos i alt 536 patienter med hæmatologisk malignitet, herunder 400 patienter, som fik idelalisib (en hvilken som helst dosis) som enkeltstof, og 136 patienter, som fik idelalisib i kombination med et anti-CD20 monoklonalt antistof (rituximab eller ofatumumab).
The Phase 1 and 2 studies assessed the safety of idelalisib in a total of 536 subjects with haematologic malignancies, including 400 subjects who received idelalisib (any dose) as a single agent and 136 subjects who received idelalisib in combination with an anti-CD20 monoclonal antibody (rituximab or ofatumumab).
I et fertilitetsstudie hos hanrotter blev der observeret reduktioner i vægten af epididymis og testikler, men uden bivirkninger på parrings- eller fertilitetsparametre, og ingen degeneration eller tab i spermatogenese blev observeret.
In a rat male fertility study, decreases in epididymides and testes weight were observed but no adverse effects on mating or fertility parameters, and no degeneration or loss in spermatogenesis were observed.
Den anbefalede dosis er 150 mg idelalisib to gange dagligt.
The recommended dose is 150 mg idelalisib twice daily.
Behandling med Zydelig skal seponeres permanent i tilfælde af moderat eller svær symptomatisk pneumonitis eller organiserende pneumoni (se pkt.
Treatment with Zydelig must be permanently discontinued in the event of moderate or severe symptomatic pneumonitis or organising pneumonia (see sections 4.4 and 4.8).
Tabel 5: Virkningsresultater fra studie 312-0119 Idelalisib + O N = 174
Table 5: Efficacy results from study 312-0119 Idelalisib + O N = 174
Efter en enkelt 150 mg dosis blev der ikke observeret nogen klinisk relevante ændringer i eksponering over for idelalisib eller GS-563117 hos patienter med svært nedsat nyrefunktion, sammenlignet med raske personer.
Following a single 150 mg dose, no clinically relevant changes in exposures to idelalisib or GS-563117 were observed in subjects with severe renal impairment compared to healthy subjects.
Infektioner (se pkt.
Infections (see section 4.4)
Idelalisib inducerer apoptose og hæmmer celledelingen i cellelinjer, der stammer fra maligne B-celler, og i primære tumorceller.
Idelalisib induces apoptosis and inhibits proliferation in cell lines derived from malignant B-cells and in primary tumour cells.
NR: ikke nået * Respons bestemt af en uafhængig bedømmelseskomité (IRC), hvor ORR = fuldstændigt respons (CR) + delvist respons (PR) + mindre respons (MR) hos patienter med WM. † I den overordnede iNHL-kohorte havde 1 patient (0,6 %) med WM det bedste overordnede respons på MR
CI: confidence interval; n: number of responding subjects NR: not reached * Response as determined by an independent review committee (IRC) where ORR = complete response (CR) + partial response (PR) + minor response (MR) in subjects with WM. † In the overall iNHL cohort, 1 subject (0.6%) with WM had the best overall response of MR
Fuldt optrukken linje: idelalisib + O (N = 174), stiplet linje: ofatumumab (N = 87) O: ofatumumab; N: antal patienter i gruppen
Solid line: idelalisib + O (N = 174), dashed line: ofatumumab (N = 87) O: ofatumumab; N: number of subjects per group
Elektrokardiografisk
Electrocardiographic
Der skal udvises særlig forsigtighed, og dosisreduktion kan overvejes, når sildenafil eller tadalafil ordineres sammen med idelalisib med øget overvågning for bivirkninger.
Particular caution must be used and dose reduction may be considered when prescribing sildenafil or tadalafil with idelalisib with increased monitoring for adverse events.
Blodprøver kan også vise: • øgede niveauer af fedt i blodet
Blood tests may also show: • increased blood levels of fats
Figur 1: Kaplan-Meier-kurve for PFS fra studie 312-0116 (intent-to-treat-population)
Figure 1: Kaplan-Meier curve of PFS from study 312-0116 (intent-to-treat population)
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ETIKETTERING PÅ KARTON
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON LABEL
Zydelig er indiceret som monoterapi til behandling af voksne patienter med follikulært lymfom (FL), som er refraktært over for to tidligere behandlingsregimer (se pkt.
Zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment (see section 4.4).
Populationsfarmakokinetiske analyser indikerede, at alder ikke havde nogen klinisk relevant virkning på eksponeringerne over for idelalisib eller GS-563117, herunder ældre patienter (65 år og derover), sammenlignet med yngre patienter.
Population pharmacokinetic analyses indicated that age had no clinically relevant effect on the exposures to idelalisib or GS-563117, including elderly subjects (65 years of age and older), compared to younger subjects.
Idelalisib hæmmer phosphatidylinositol 3-kinase p110δ (PI3Kδ), som er hyperaktiv ved B-cellemaligniteter, og som er afgørende for en række signalerings-pathways, der stimulerer celledeling, overlevelse, cellemigration til oprindelsesstedet og retention af maligne celler i det lymfoide væv og knoglemarven.
Idelalisib inhibits phosphatidylinositol 3-kinase p110δ (PI3Kδ), which is hyperactive in B-cell malignancies and is central to multiple signalling pathways that drive proliferation, survival, homing, and retention of malignant cells in lymphoid tissues and bone marrow.
Eksponeringen for idelalisib kan reduceres ved administration sammen med CYP3A-inducere, såsom rifampicin, phenytoin, prikbladet perikon (Hypericum perforatum) eller carbamazepin.
Idelalisib exposure may be reduced when co-administered with CYP3A inducers such as rifampicin, phenytoin, St. John's wort (Hypericum perforatum), or carbamazepine.
Figur 2: Kaplan-Meier-kurve for PFS fra studie 312-0119 (intent-to-treat-population)
Figure 2: Kaplan-Meier curve of PFS from study 312-0119 (intent-to-treat population)
• hvis du har hævelse og vabler i slimhinden i munden, kønsdelene og/eller øjnene
• if you have swelling and blistering of the lining of the mouth, genitals, and/or eyes
Efter administration af 150 mg idelalisib to gange dagligt, var gennemsnittet (intervallet) Cmax og AUC ved steady-state hhv. 1.953 (272; 3.905) ng/ml og 10.439 (2.349; 29.315) ng•t/ml for idelalisib og 4.039 (669; 10.897) ng/ml og 39.744 (6.002; 119.770) ng•t/ml for GS-563117.
Following 150 mg twice daily administration of idelalisib, average (range) Cmax and AUC at steady-state were 1,953 (272; 3,905) ng/mL and 10,439 (2,349; 29,315) ng•h/mL for idelalisib and 4,039 (669; 10,897) ng/mL and 39,744 (6,002; 119,770) ng•h/mL for GS-563117, respectively.
CYP3A/P-gp-hæmmere
CYP3A/P-gp inhibitors
Et studie af idelalisibs farmakokinetik og sikkerhed blev udført hos raske personer samt patienter med svært nedsat nyrefunktion (estimeret CrCl på 15 til 29 ml/min).
A study of pharmacokinetics and safety of idelalisib was performed in healthy subjects and subjects with severe renal impairment (estimated CrCl 15 to 29 mL/min).
↑ serumkoncentrationer
↑ serum concentrations
Tabel 2: Bivirkninger rapporteret i kliniske studier hos patienter med hæmatologisk malignitet, som fik idelalisib
Table 2: Adverse drug reactions reported in clinical studies in subjects with haematologic malignancies receiving idelalisib
Tabel 3: Virkningsresultater fra studie 312-0116 Idelalisib + R N = 110
Table 3: Efficacy results from study 312-0116 Idelalisib + R N = 110
• budesonid, fluticason, lægemidler, der anvendes til at behandle høfeber og astma, og salmeterol, anvendes til at behandle astma
• budesonide, fluticasone, medicines used to treat hayfever and asthma, and salmeterol, used to treat asthma
GS-563117 er ikke en hæmmer af de metaboliserende enzymer CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 eller UGT1A1, eller af transporterne P-gp, BCRP, OATP1B1, OATP1B3, OAT1, OAT3 eller OCT2.
GS-563117 is not an inhibitor of the metabolising enzymes CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or UGT1A1, or of the transporters P-gp, BCRP, OATP1B1, OATP1B3, OAT1, OAT3, or OCT2.
• carbamazepin, S-mephenytoin, phenytoin, lægemidler, der anvendes til at forebygge krampeanfald
• carbamazepine, S-mephenytoin, phenytoin, medicines used to prevent seizures
In vitro-data indikerede, at idelalisib ikke er en hæmmer af de metaboliserende enzymer CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A eller UGT1A1, eller af transporterne OAT1, OAT3 eller OCT2.
In vitro data indicated that idelalisib is not an inhibitor of the metabolising enzymes CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A, or UGT1A1, or of the transporters OAT1, OAT3, or OCT2.
Follikulært lymfom (FL) er en kræftsygdom i en type hvide blodlegemer, som kaldes B-lymfocytter.
Follicular lymphoma (FL) is a cancer of a type of white blood cell called B-lymphocytes.
i studie 312-0116/0117 og 312-0119 forekom udslæt (rapporteret som generaliseret eksfoliativ dermatitis, lægemiddeludslæt, udslæt, erytematøst udslæt, generaliseret udslæt, makuløst udslæt, makulopapuløst udslæt, papuløst udslæt, pruritisk udslæt, pustuløst udslæt, vesikulært udslæt, papler og plaques) hos 31,1 % af de patienter, der fik idelalisib + et anti-CD20 monoklonalt antistof (rituximab eller ofatumumab), og hos 8,2 % af de patienter, der kun fik et anti-CD20 monoklonalt antistof (rituximab eller ofatumumab).
In studies 312-0116/0117 and 312-0119, rash (reported as dermatitis exfoliative generalised, drug eruption, rash, rash erythematous, rash generalised, rash macular, rash maculo-papular, rash papular, rash pruritic, rash pustular, rash vesicular, papule and skin plaque) occurred in 31.1% of subjects who received idelalisib + an anti-CD20 monoclonal antibody (rituximab or ofatumumab) and 8.2% who received an anti-CD20 monoclonal antibody only (rituximab or ofatumumab).
Der bør derfor udvises forsigtighed når Zydelig administreres til denne population, og det anbefales at intensivere overvågning for bivirkninger (se pkt.
Therefore, caution is recommended when administering Zydelig in this population and an intensified monitoring of adverse reactions is recommended (see sections 4.4 and 5.2).
Et klinisk lægemiddelinteraktionsstudie fandt at administration af idelalisib sammen med midazolam (et følsomt CYP3A-substrat) førte til en ~140 % forhøjelse i Cmax og en ~440 % forhøjelse i AUCinf for midazolam på grund af CYP3A-hæmning af GS-563117.
A clinical drug interaction study found that co-administration of idelalisib with midazolam (a sensitive CYP3A substrate) resulted in a ~140% increase in Cmax and a ~440% increase in AUCinf of midazolam due to the CYP3A inhibition by GS-563117.
Mikrokrystallinsk cellulose Hydroxypropylcellulose (E463) Croscarmellosenatrium Carboxymethylstivelsesnatrium Magnesiumstearat
Microcrystalline cellulose Hydroxypropyl cellulose (E463) Croscarmellose sodium Sodium starch glycolate Magnesium stearate
• Zydelig i kombination med rituximab er indiceret til behandling af voksne patienter med kronisk lymfatisk leukæmi (CLL):
• Zydelig is indicated in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL):
Den primære og eneste cirkulerende metabolit, GS-563117, er inaktiv over for PI3Kδ.
The primary and only circulating metabolite, GS-563117, is inactive against PI3Kδ.
Monitorér ANC mindst én gang ugentligt, indtil ANC ≥ 500/mm3, hvorefter Zydeligdoseringen kan genoptages med 100 mg to gange dagligt.
Monitor ANC at least weekly until ANC ≥ 500/mm3, then may resume Zydelig dosing at 100 mg twice daily.
Kronisk lymfatisk leukæmi (CLL) er en kræftsygdom i en type hvide blodlegemer, som kaldes B-lymfocytter.
Chronic lymphocytic leukaemia (CLL) is a cancer of a type of white blood cell called B-lymphocytes.
Filmovertrukne tabletter 60 filmovertrukne tabletter
Film-coated tablets 60 film-coated tablets
Amning skal ophøre under behandling med Zydelig.
Breast-feeding should be discontinued during treatment with Zydelig.
↑ serumkoncentrationer Øget overvågning for rifabutinassocierede bivirkninger, herunder neutropeni og uveitis, anbefales.
↑ serum concentrations Increased monitoring for rifabutinassociated adverse reactions including neutropenia and uveitis is recommended.
• quetiapin, et lægemiddel, der anvendes til at behandle skizofreni, bipolær lidelse og svær depressiv lidelse
• quetiapine, a medicine used to treat schizophrenia, bipolar disorder and major depressive disorder
*** Omfatter de foretrukne termer generaliseret eksfoliativ dermatitis, lægemiddeludslæt, udslæt, erytematøst udslæt, generaliseret udslæt, makuløst udslæt, makulopapuløst udslæt, papuløst udslæt, pruritisk udslæt, pustuløst udslæt, vesikulært udslæt, papler, plaques og eksfoliativt udslæt.
*** Includes the preferred terms dermatitis exfoliative generalised, drug eruption, rash, rash erythematous, rash generalised, rash macular, rash maculo-papular, rash papular, rash pruritic, rash pustular, rash vesicular, papule, skin plaque, and exfoliative rash.
Den primære metabolit er GS-563117, som ikke er farmakologisk aktiv.
Its primary metabolite is GS-563117, which is not pharmacologically active.
Pædiatrisk population Idelalisibs farmakokinetik hos pædiatriske patienter er ikke klarlagt (se pkt.
Paediatric population The pharmacokinetics of idelalisib in paediatric subjects has not been established (see section 4.2).
• rødme og vabler på huden • hævelse og vabler i slimhinden i munden, kønsdelene og/eller øjnene
• redness and blistering of the skin • swelling and blistering of the lining of the mouth, genitals, and/or eyes
ANC bør monitoreres mindst én gang ugentligt, indtil ANC er ≥ 500 pr. mm3, hvorefter behandlingen kan genoptages med 100 mg to gange dagligt (se pkt.
ANC should be monitored at least weekly until ANC is ≥ 500 per mm3 when treatment can be resumed at 100 mg twice daily (see section 4.4).
• dihydroergotamin, ergotamin, lægemidler, der anvendes til at behandle migræne-hovedpine
• dihydroergotamine, ergotamine, medicines used to treat migraine headache
Efter restitution af pneumonitis og hvis forsættelse af behandlingen er hensigtsmæssigt, kan det overvejes at genstarte behandlingen med 100 mg to gange dagligt.
Once pneumonitis has resolved and if re-treatment is appropriate, resumption of treatment at 100 mg twice daily can be considered.
Kvinder i den fertile alder skal anvende meget sikker kontraception, mens de tager idelalisib og i 1 måned efter behandlingsophør (se pkt.
Women of childbearing potential must use highly effective contraception while taking idelalisib and for 1 month after stopping treatment (see section 4.6).
• diarré/betændelse i tyktarmen
• diarrhoea/inflammation of the large intestine
Udslættet gik typisk væk ved behandling (f.eks. topikale og/eller orale steroider, diphenhydramin) og ved dosisafbrydelse i svære tilfælde (se pkt.
Rash typically resolved with treatment (e.g., topical and/or oral steroids, diphenhydramine) and dose interruption for severe cases (see section 5.3, phototoxicity).
Virkning af andre lægemidler på idelalisibs farmakokinetik
Effect of other medicinal products on idelalisib pharmacokinetics
Et klinisk lægemiddelinteraktionsstudie fandt at administration af en enkeltdosis 150 mg idelalisib sammen med rifampicin (en kraftig CYP3A-inducer) førte til en ~75 % reduktion i idelalisib AUCinf.
A clinical drug interaction study found that co-administration of a single dose of 150 mg idelalisib with rifampicin (a strong CYP3A inducer) resulted in a ~75% reduction in idelalisib AUCinf.
Luftveje, thorax og mediastinum Pneumonitis
Respiratory, thoracic and mediastinal disorders Pneumonitis
De bivirkninger, der blev rapporteret med idelalisib alene eller i kombination med anti-CD20 et monoklonalt antistof (rituximab eller ofatumumab) er opstillet i tabel 2.
The adverse drug reactions reported with idelalisib alone or in combination with anti-CD20 monoclonal antibodies (rituximab or ofatumumab) are provided in Table 2.
Du må ikke holde op med at tage dette lægemiddel, medmindre lægen fortæller dig det. Spørg lægen, hvis der er noget, du er i tvivl om.
Do not stop taking this medicine unless your doctor tells you to.
Hvis du har sprunget en dosis over, og det er mere end 6 timer siden, du skulle have taget dosen, skal du vente og tage den næste dosis til den sædvanlige tid.
If you miss a dose by more than 6 hours, wait and take the next dose at your usual time.
Generelt henvises til produktresuméet for det andet præparat for anbefalinger vedrørende administration sammen med CYP3A4-hæmmere (se pkt.
In general, the SmPC for the other product must be consulted for the recommendations regarding co-administration with CYP3A4 inhibitors (see section 4.4).
Idelalisib metaboliseres primært via aldehydoxidase, og i mindre grad via CYP3A og glukuronidation (UGT1A4).
Idelalisib is metabolised primarily via aldehyde oxidase, and to a lesser extent via CYP3A and glucuronidation (UGT1A4).
Studie 312-0119 var et fase 3, randomiseret, åbent multicenterstudie med parallelle grupper med 261 patienter med tidligere behandlet CLL, som havde målbar lymfadenopati, var behandlingskrævende og oplevede CLL-progression < 24 måneder siden, den sidste tidligere behandling var gennemført.
Study 312-0119 was a Phase 3, randomised, open-label, multicentre, parallel-group study in 261 subjects with previously treated CLL who had measurable lymphadenopathy, required treatment, and experienced CLL progression < 24 months since the completion of the last prior therapy.
Organiserende pneumoni
Organising pneumonia
• amlodipin, diltiazem, felodipin, nicardipin, nifedipin, lægemidler, der anvendes til at behandle højt blodtryk og hjerteproblemer
• amlodipine, diltiazem, felodipine, nicardipine, nifedipine, medicines used to treat high blood pressure and heart problems
Idelalisib bør ikke administreres sammen med lovastatin eller simvastatin.
Idelalisib should not be co-administered with lovastatin or simvastatin.
Zydelig i kombination med rituximab er indiceret til behandling af voksne patienter med kronisk lymfatisk leukæmi (CLL):
Zydelig is indicated in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL):
BCRP-, OATP1B1-, OATP1B3- og P-gp-substrater Administration sammen med flere doser idelalisib 150 mg to gange dagligt hos raske personer førte til sammenlignelige eksponeringer over for rosuvastatin (AUC 90 % CI: 87; 121) og digoxin (AUC 90 % CI: 98; 111), hvilket ikke tyder på en klinisk relevant hæmning af BCRP, OATP1B1/1B3 eller systemisk P-gp af idelalisib.
Co-administration of multiple doses of idelalisib 150 mg twice daily to healthy subjects resulted in comparable exposures for rosuvastatin (AUC 90% CI: 87, 121) and digoxin (AUC 90% CI: 98, 111), suggesting no clinically relevant inhibition of BCRP, OATP1B1/1B3 or systemic P-gp by idelalisib.
Derfor skal kvinder i den fertile alder anvende meget sikker kontraception, mens de tager Zydelig og i 1 måned efter behandlingsophør.
Therefore, women of childbearing potential must use highly effective contraception while taking Zydelig and for 1 month after stopping treatment.
Du må ikke amme, når du tager Zydelig.
You should not breast-feed while taking Zydelig.
• amiodaron, bepridil, disopyramid, lidocain, quinidin, lægemidler, der anvendes til at behandle hjerteproblemer
• amiodarone, bepridil, disopyramide, lidocaine, quinidine, medicines used to treat heart problems
Administration af Zydelig sammen med moderate eller stærke CYP3A-inducere, såsom rifampicin, phenytoin, prikbladet perikon eller carbamazepin bør undgås, da det kan føre til nedsat virkning (se pkt.
Co-administration of Zydelig with moderate or strong CYP3A inducers such as rifampicin, phenytoin, St. John's wort, or carbamazepine should be avoided as this may result in decreased efficacy (see section 4.4).
Blodprøver kan også vise: • forhøjet niveau af leverenzymer i blodet
Blood tests may also show: • increased blood levels of liver enzymes
Ergotamin, dihydroergotamin ↑ serumkoncentrationer Idelalisib bør ikke administreres sammen med ergotamin eller dihydroergotamin.
Ergotamine, dihydroergotamine ↑ serum concentrations Idelalisib should not be co-administered with ergotamine or dihydroergotamine.
Når værdierne er vendt tilbage til grad 1 eller derunder (ALAT/ASAT ≤ 3 x ULN), kan behandlingen genoptages med 100 mg to gange dagligt.
Once values have returned to Grade 1 or below (ALT/AST ≤ 3 x ULN), treatment can be resumed at 100 mg twice daily.
Der skal udvises forsigtighed, og dosisreduktion kan overvejes, når tadalafil administreres sammen med idelalisib.
Caution should be exercised, including consideration of dose reduction, when co-administering tadalafil with idelalisib.
Idelalisib metaboliseres primært via aldehydoxidase, og i mindre grad via CYP3A og UGT1A4.
Idelalisib is metabolised primarily via aldehyde oxidase, and to a lesser extent via CYP3A and UGT1A4.
Idelalisib inducerede lymfoid depletion i milten, tymus, lymfeknuderne og tarmassocieret lymfoidt væv.
Idelalisib induced lymphoid depletion in spleen, thymus, lymph nodes and gut-associated lymphoid tissue.
Dosisjustering er ikke nødvendig for patienter med let-, moderat- eller svært nedsat nyrefunktion (se pkt.
No dose adjustment is required for patients with mild, moderate, or severe renal impairment (see section 5.2).
Et klinisk lægemiddelinteraktionsstudie fandt at administration af en enkeltdosis 400 mg idelalisib sammen med 400 mg ketoconazol én gang daligt (en kraftig CYP3A-, P-gp- og BCRP-hæmmer) førte til en 26 % forhøjelse i Cmax og en 79 % forhøjelse i AUCinf for idelalisib.
A clinical drug interaction study found that co-administration of a single dose of 400 mg idelalisib with 400 mg once daily ketoconazole (a strong CYP3A, P-gp and BCRP inhibitor) resulted in a 26% increase in Cmax and a 79% increase in AUCinf of idelalisib.
Studie 312-0116 var et fase 3 randomiseret, dobbeltblindet, placebokontrolleret studie med 220 patienter med tidligere behandlet CLL, som havde behov for behandling, men som ikke blev anset for at være egnede til cytotoksisk kemoterapi.
Study 312-0116 was a Phase 3, randomised, double-blind, placebo-controlled study in 220 subjects with previously treated CLL who required treatment but were not considered suitable for cytotoxic chemotherapy.
HMG-CO-A-REDUKTASEHÆMMERE
HMG CO-A REDUCTASE INHIBITORS
ANTIHYPERTENSIVA
ANTI-HYPERTENSIVES
Follikulært lymfom
Follicular lymphoma