natgillin/translations-raw huggingface dataset:
Dette var evident for præ-/perimenopausale kvinder (HR 0,46 [95 % CI: 0,28-0,75]) og postmenopausale kvinder (HR 0,52 [95 % CI: 0,40-0,66]) og patienter med visceral metastatisk sygdom (HR 0,50 [95 % CI: 0,38-0,65]) og patienter med ikke-visceral metastatisk sygdom (HR 0,48 [95 % CI: 0,33-0,71]).
This was evident for pre/perimenopausal women (HR of 0.46 [95% CI: 0.28, 0.75]) and postmenopausal women (HR of 0.52 [95% CI: 0.40, 0.66]) and patients with visceral site of metastatic disease (HR of 0.50 [95% CI: 0.38, 0.65]) and non-visceral site of metastatic disease (HR of 0.48 [95% CI: 0.33, 0.71]).
Virkningen af palbociclib i kombination med letrozol versus letrozol plus placebo blev evalueret i et internationalt, randomiseret, dobbeltblind, placebokontrolleret, multicenterstudie med parallelle grupper hos kvinder med ER-positiv, HER2-negativ lokalt fremskreden brystkræft, hvor kurativ resektion eller strålebehandling ikke var mulig, eller metastatisk brystkræft, som ikke forudgående havde fået systemisk behandling for deres fremskredne sygdom.
The efficacy of palbociclib in combination with letrozole versus letrozole plus placebo was evaluated in an international, randomised, double-blind, placebo-controlled, parallel-group, multicentre study conducted in women with ER-positive, HER2-negative locally advanced breast cancer not amenable to resection or radiation therapy with curative intent or metastatic breast cancer who had not received prior systemic treatment for their advanced disease.
21 hårde kapsler
63 hard capsules
Amning Du må ikke amme, mens du tager IBRANCE.
You should not breast-feed while taking IBRANCE.
Interaktion mellem palbociclib og orale kontraceptiva
Drug-drug interaction between palbociclib and oral contraceptives
Dosisjustering er ikke nødvendig ved svage og moderate CYP3A-hæmmere.
No dose adjustments are needed for mild and moderate CYP3A inhibitors.
Skema 9 - Effektdata ved visceral og ikke-visceral sygdom fra PALOMA-3 studiet (intent-totreat population) Visceral sygdom
Efficacy results in visceral and non-visceral disease from PALOMA-3 study
- Hvis du er allergisk over for palbociclib eller et af de øvrige indholdsstoffer i IBRANCE
- if you are allergic to palbociclib or any of the other ingredients of this medicine (listed in section 6).
Samtidig behandling med CYP3A4-hæmmere eller -induktorer
Concomitant treatment with inhibitors or inducers of CYP3A4
* Sekundære endepunktsresultater er baseret på bekræftet og ubekræftet respons iht.
* Secondary endpoints results are based on confirmed and unconfirmed responses according to RECIST 1.1.
Patienter med fremskreden/metastatisk symptomatisk visceral spredning, der på kort sigt havde risiko for livstruende komplikationer (herunder patienter med massive ukontrollerede effusioner (pleural, perikardial, peritoneal), pulmonal lymfangitis og mere end 50 % leverinvolvering) var ikke egnede til inklusion i studiet.
Patients with advanced/metastatic, symptomatic, visceral spread, that were at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and over 50% liver involvement), were not eligible for enrolment into the study.
Virkninger af andre lægemidler på palbociclibs farmakokinetik
Effects of other medicinal products on the pharmacokinetics of palbociclib
Kaplan-Meier-kurver over samlet overlevelse (intent-to-treat-population)PALOMA-3 studiet (13. april 2018 som skæringsdato)
Kaplan-Meier plot of overall survival (intent-to-treat population) - PALOMA-3 study (13 April 2018 cutoff)
Der blev observeret reduceret fostervægt ved en toksisk dosis på 300 mg/kg/dag hos hunrotter (3 gange den kliniske eksponering baseret på AUC), og en øget forekomst af skeletvariationer, herunder de små falanges i forbenene, ved en toksisk dosis på 20 mg/kg/dag hos hunkaniner (4 gange den kliniske eksponering baseret på AUC).
Reduced foetal body weights were observed at a maternally toxic dose of 300 mg/kg/day in rats (3 times human clinical exposure based on AUC), and an increased incidence of skeletal variations, including small phalanges in the forelimb was observed at a maternally toxic dose of 20 mg/kg/day in rabbits (4 times human clinical exposure based on AUC).
Der blev dog ikke observeret relation mellem Rb1-ekspression og tumorrespons i et follow-up studie med friske tumorprøver.
However, in a follow-up study with fresh tumour samples, no relation between RB1 expression and tumour response was observed.
Ved skæringsdatoen for data 31. maj 2017 sås reduktion i risiko i følgende undergrupper fortsat: (1) patienter med enten viscerale metastaser (HR 0,62 [95 % CI: 0,47; 0,81], median progressionsfri overlevelse [mPFS] 19,3 måneder versus 12,3 måneder) eller uden viscerale metastaser (HR 0,50 [95 % CI: 0,37; 0,67], mPFS 35,9 måneder versus 17,0 måneder) og (2) patienter med enten kun knoglesygdom (HR 0,41 [95 % CI: 0,26; 0,63], mPFS 36,2 måneder versus 11,2 måneder) eller uden kun-knoglesygdom (HR 0,62 [95 % CI: 0,50; 0,78], mPFS 24,2 måneder versus 14,5 måneder).
Based on the 31-May-2017 data cutoff date, this reduction in risk continued to be observed in the following subgroups: (1) patients with either visceral metastases (HR of 0.62 [95% CI: 0.47, 0.81], median progression-free survival [mPFS] 19.3 months versus 12.3 months) or without visceral metastases (HR of 0.50 [95% CI: 0.37, 0.67], mPFS 35.9 months versus 17.0 months) and (2) patients with either bone only disease (HR of 0.41 [95% CI: 0.26, 0.63], mPFS 36.2 months versus 11.2 months) or without bone-only disease (HR of 0.62 [95% CI: 0.50, 0.78], mPFS 24.2 months versus 14.5 months).
Seponer IBRANCE permanent hos patienter med alvorlig interstitiel lungesygdom (ILS)/pneumonitis (se pkt.
Permanently discontinue IBRANCE in patients with severe interstitial lung disease (ILD)/pneumonitis (see section 4.4).
Der var ingen indvirkning på brunstcyklus (hunrotter) eller parring og fertilitet hos rotter (han- og hunrotter) i ikke-kliniske reproduktionsstudier, men der er ikke tilgængelige fertilitetsdata for mennesker.
There were no effects on oestrous cycle (female rats) or mating and fertility in rats (male or female) in nonclinical reproductive studies.
Progressionsfri overlevelse baseret på uafhængig vurdering Antal hændelser (%) Median PFS (måneder (95 % CI))
Progression-Free Survival by Independent Assessment Number of events (%) Median PFS [months (95% CI)]
Det er navnlig følgende lægemidler, som kan øge risikoen for bivirkninger med IBRANCE:
In particular, the following may increase the risk of side effects with IBRANCE:
Der er ikke udført interaktionsstudier med palbociclib og orale kontraceptiva (se pkt.
DDI studies of palbociclib with oral contraceptives have not been conducted (see section 4.6).
Kapselindhold: mikrokrystallinsk cellulose, lactosemonohydrat, natriumstivelsesglykolat type A, vandfri kolloid silica, magnesiumstearat.
- The other ingredients are: Capsule content: microcrystalline cellulose, lactose monohydrate, sodium starch glycolate type A, colloidal anhydrous silica, magnesium stearate.
Data fra lægemiddelinteraktionsdelen af et klinisk studie med patienter med brystkræft viste, at der ikke var nogen klinisk relevant interaktion mellem palbociclib og fulvestrant, når disse to lægemidler blev administreret samtidigt.
Data from a clinical study in patients with breast cancer showed that there was no clinically relevant drug interaction between palbociclib and fulvestrant when the two medicinal products were coadministered.
Hæmatologiske forstyrrelser
Haematological disorders
Virkningen af palbociclib i kombination med fulvestrant versus fulvestrant plus placebo blev evalueret i et internationalt, randomiseret, dobbeltblind multicenterstudie med parallelle grupper hos kvinder med HR-positiv, HER2-negativ lokalt fremskreden brystkræft, hvor kurativ resektion eller strålebehandling ikke var muligt, eller metastatisk brystkræft, uanset deres menopausale status, hvor sygdommen havde progredieret efter forudgående endokrin terapi i det (neo)-adjuverende eller metastatiske scenario.
The efficacy of palbociclib in combination with fulvestrant versus fulvestrant plus placebo was evaluated in an international, randomised, double-blind, parallel-group, multicentre study conducted in women with HR-positive, HER2-negative locally advanced breast cancer not amenable to resection or radiation therapy with curative intent or metastatic breast cancer, regardless of their menopausal status, whose disease progressed after prior endocrine therapy in the (neo)adjuvant or metastatic setting.
Der blev observeret en reduktion i risikoen for sygdomsprogression eller død i palbociclib plus fulvestrant-armen i alle patientundergrupper defineret iht.
A reduction in the risk of disease progression or death in the palbociclib plus fulvestrant arm was observed in all individual patient subgroups defined by stratification factors and baseline characteristics.
IBRANCE 100 mg hårde kapsler EU/1/16/1147/003
IBRANCE 100 mg hard capsules EU/1/16/1147/003
Palbociclib metaboliseres primært af CYP3A og sulfotransferase (SULT) enzymet SULT2A1.
4.5 Interaction with other medicinal products and other forms of interaction Palbociclib is primarily metabolised by CYP3A and sulphotransferase (SULT) enzyme SULT2A1.
< 1.000/mm 3, grad 4: ANC < 500/mm
Grade 3: ANC 500 - <1000/mm3; Grade 4: ANC <500/mm3.
IBRANCE 125 mg hårde kapsler EU/1/16/1147/005
IBRANCE 125 mg hard capsules EU/1/16/1147/005
Forringelse af fertilitet
Impairment of fertility
Interaktion mellem palbociclib og fulvestrant
Drug-drug interaction between palbociclib and fulvestrant
Tag ikke IBRANCE
Do not take IBRANCE:
Samtidig brug af potente CYP3A-induktorer, herunder, men ikke begrænset til carbamazepin, enzalutamid, phenytoin, rifampicin og perikon bør undgås (se pkt.
The concomitant use of strong CYP3A inducers including, but not limited to: carbamazepine, enzalutamide, phenytoin, rifampin, and St. John's Wort should be avoided (see sections 4.3 and 4.4).
Ved metastatisk sygdom blev der også observeret en fordel, uanset om antallet af forudgående behandlingslinjer var 0 (HR 0,59 [95 % CI: 0,37-0,93]), 1 (HR 0,46 [95 % CI: 0,320,64]), 2 (HR 0,48 [95 % CI: 0,30-0,76]), eller ≥ 3 (HR 0,59 [95 % CI: 0,28-1,22]).
Benefit was also observed regardless of lines of prior therapy in the metastatic setting, whether 0 (HR of 0.59 [95% CI: 0.37, 0.93]), 1 (HR of 0.46 [95% CI: 0.32, 0.64]), 2 (HR of 0.48 [95% CI: 0.30, 0.76]), or ≥3 lines (HR of 0.59 [95% CI: 0.28, 1.22]).
Data fra lægemiddelinteraktionsdelen af et klinisk studie med patienter med brystkræft viste, at der ikke var nogen interaktion mellem palbociclib og letrozol, når disse to lægemidler blev administreret samtidigt.
Data from the drug-drug interaction (DDI) evaluation portion of a clinical study in patients with breast cancer showed that there was no drug interaction between palbociclib and letrozole when the 2 medicinal products were coadministered.
d. Leukopeni omfatter følgende foretrukne termer: Leukopeni, nedsat antal leukocytter.
d Leukopenia includes the following PTs: Leukopenia, White blood cell count decreased.
e. Anæmi omfatter følgende foretrukne termer: Anæmi, nedsat hæmoglobin, nedsat hæmatokrit.
e Anaemia includes the following PTs: Anaemia, Haemoglobin decreased, Haematocrit decreased.
3, grad 2: ANC 1.000 - < 1.500/mm
b ANC: Grade 1: ANC < LLN - 1500/mm3; Grade 2: ANC 1000 - <1500/mm3;
Maksimalværdi for palbociclib ubundet eksponering (ubundet Cmax) blev forøget med henholdsvis 7 %, 38 % og 72 % for let, moderat og svært nedsat leverfunktion i forhold til personer med normal leverfunktion.
Peak palbociclib unbound exposure (unbound Cmax) was increased by 7%, 38% and 72% for mild, moderate and severe hepatic impairment, respectively, relative to subjects with normal hepatic function.
Sekundære endepunktsresultater er baseret på bekræftet og ubekræftet respons iht.
Secondary endpoint results are based on confirmed and unconfirmed responses according to RECIST 1.1.
• Perikon, som er et naturlægemiddel, der anvendes til behandling af let depression og angst.
• St. John's Wort, an herbal product used to treat mild depression and anxiety.
Hud og subkutane væv Meget almindelig Udslæt
Skin and subcutaneous tissue disorders
Tør hud
Dry eye
Dosisjustering er ikkenødvendig ved samtidig administration af palbociclib og moderate CYP3A-induktorer (se pkt.
No dose adjustments are required for coadministration of palbociclib with moderate CYP3A inducers (see section 4.5).
f. Trombocytopeni omfatter følgende foretrukne termer: Trombocytopeni, nedsat trombocyttal.
f Thrombocytopenia includes the following PTs: Thrombocytopenia, Platelet count decreased.
IBRANCE 100 mg hårde kapsler
IBRANCE 100 mg hard capsules
Sådan skal du tage IBRANCE
How to take IBRANCE
stomatitis.
Stomatitisg
Foretrukken term n (%)
All Grades n (%)
I ikke-fastende tilstand (efter indtagelse af et måltid med moderat fedtindhold) medførte samtidig administration af flere doser af protonpumpehæmmeren (PPI) rabeprazol og en enkelt dosis IBRANCE 125 mg nedsættelse af palbociclib Cmax med 41 %, men havde begrænset indvirkning på AUCinf (13 % nedsættelse) sammenlignet med en enkelt dosis palbociclib 125 mg givet alene.
Under fed conditions (intake of a moderate-fat meal), coadministration of multiple doses of the proton pump inhibitor (PPI) rabeprazole with a single dose of 125 mg IBRANCE decreased palbociclib Cmax by 41%, but had limited impact on AUCinf (13% decrease) compared with a single dose of 125 mg IBRANCE administered alone.
Risk/benefit skal overvejes nøje inden samtidig administration.
Coadministration should only be considered after careful evaluation of the potential benefits and risks.
Resultaterne krydsede den præspecificerede Haybittle-Peto-effektgrænse (α = 0,00135) og viste en statistisk signifikant forlængelse af PFS og en klinisk relevant virkning af behandlingen.
The study met its primary endpoint of prolonging investigator-assessed PFS at the interim analysis conducted on 82% of the planned PFS events; the results crossed the prespecified Haybittle-Peto efficacy boundary (α=0.00135), demonstrating a statistically significant prolongation in PFS and a clinically meaningful treatment effect.
Anbefalet dosisjustering og håndtering af IBRANCE- Hæmatologiske bivirkninger CTCAE-grad
IBRANCE dose modification and management - Haematological toxicities CTCAE Grade
Interaktion mellem palbociclib og letrozol
Drug-drug interaction between palbociclib and letrozole
På grund af aromatase-hæmmerens virkningsmekanisme er ablation eller suppression af ovarierne med en LHRH-agonist et krav, når præ-/perimenopausale kvinder gives palbociclib i kombination med en aromatasehæmmer.
Ovarian ablation or suppression with an LHRH agonist is mandatory when pre/perimenopausal women are administered IBRANCE in combination with an aromatase inhibitor, due to the mechanism of action of aromatase inhibitors.
IBRANCE 75 mg hårde kapsler IBRANCE 100 mg hårde kapsler IBRANCE 125 mg hårde kapsler
IBRANCE 75 mg hard capsules IBRANCE 100 mg hard capsules IBRANCE 125 mg hard capsules
Fald i leukocytter Fald i neutrofile Anæmi
WBC decreased Neutrophils decreased Anaemia
Hjælpestoffer, som behandleren skal være opmærksom på Hver hård kapsel indeholder 93 mg lactose (som monohydrat).
Each hard capsule contains 93 mg of lactose (as monohydrate).
Endokrinterapi skal kombineres med en luteiniserende hormon-frigivende hormon (LHRH)-agonist hos præ- og perimenopausale kvinder.
In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist.
Palbociclib cirkulerede primært som uomdannet lægemiddel i plasma.
Palbociclib was the major circulating drug-derived entity in plasma.
Maksimal (Cmax) eksponering for palbociclib blev forøget med henholdsvis 17 %, 12 % og 15 % for let, moderat og svært nedsat nyrefunktion.
Peak palbociclib exposure (Cmax) was increased by 17%, 12%, and 15% for mild, moderate, and severe renal impairment, respectively, relative to subjects with normal renal function.
Dette lægemiddel indeholder lactose og bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af arvelig lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Passende monitorering er nødvendig (se pkt.
Appropriate monitoring should be performed (see sections 4.2 and 4.8).
Seponer IBRANCE permanent hos patienter med alvorlig ILS eller pneumonitis (se pkt.
Permanently discontinue IBRANCE in patients with severe ILD or pneumonitis (see section 4.2).
IBRANCE plus letrozol (N = 444)
IBRANCE plus Letrozole (N = 444)
IBRANCE 75 mg hårde kapsler
IBRANCE 75 mg hard capsules
Samtidig administration af multiple doser på 400 mg modafinil daglig, en moderat CYP3A-induktor, og en enkelt dosis IBRANCE 125 mg reducerede AUCinf og Cmax af palbociclib med henholdsvis 32 % og 11 % i forhold til en enkelt dosis IBRANCE 125 mg givet alene.
Coadministration of multiple 400 mg daily doses of modafinil, a moderate CYP3A inducer, with a single 125 mg IBRANCE dose decreased palbociclib AUCinf and Cmax by 32% and 11%, respectively, relative to a single 125 mg IBRANCE dose given alone.
IBRANCE 125 mg hårde kapsler
IBRANCE 125 mg hard capsules
IBRANCE skal anvendes med forsigtighed hos patienter med moderat eller svært nedsat leverfunktion, og der skal overvåges nøje for tegn på toksicitet (se pkt.
Administer IBRANCE with caution to patients with moderate or severe renal impairment, with close monitoring of signs of toxicity (see sections 4.2 and 5.2).
I fastende tilstand medførte samtidig administration af flere doser af protonpumpehæmmeren (PPI) rabeprazol og en enkelt dosis IBRANCE 125 mg nedsættelse af palbociclib AUCinf og Cmax med henholdsvis 62 % og 80 %.
Under fasting conditions, the coadministration of multiple doses of the proton pump inhibitor (PPI) rabeprazole with a single dose of 125 mg IBRANCE decreased palbociclib AUCinf and Cmax by 62% and 80%, respectively.
5,2 % af patienter, som fik IBRANCE i randomiserede kliniske studier, seponerede permanent på grund af en bivirkning uafhængigt af kombinationen.
Permanent discontinuation due to an adverse reaction occurred in 5.2% of patients receiving IBRANCE in randomised clinical studies regardless of the combination.
Der blev observeret en 6,9 måneders forskel i median OS i palbociclib plus fulvestrant-armen sammenlignet med placebo plus fulvestrant-armen.
A 6.9-month difference in median OS in the palbociclib plus fulvestrant arm compared with the placebo plus fulvestrant arm was observed; this result was not statistically significant at the prespecified significance level of 0.0235 (1-sided).
Det observerede NOEL for palbociclib-relateret karcinogenecitet var på henholdsvis 10 mg/kg/dag (ca. 2 gange den kliniske humane eksponering baseret på AUC) og 200 mg/kg/dag (ca. 4 gange den kliniske humane eksponering baseret på AUC) hos hanner og hunner.
The NOEL for palbociclib-related carcinogenicity effects was 10 mg/kg/day (approximately 2 times the human clinical exposure based on AUC) and
Udseende og pakningstørrelser - IBRANCE 75 mg leveres som uigennemsigtige, hårde kapsler med en lys orange underdel (mærket ”PBC 75” med hvid skrift) og en lys orange overdel (mærket ”Pfizer” med hvid skrift).
What IBRANCE looks like and contents of the pack - IBRANCE 75 mg is supplied as opaque, hard capsules, with a light orange body (printed “PBC 75” in white) and a light orange cap (printed “Pfizer” in white).
g. Stomatitis omfatter følgende foretrukne termer: Aftøs stomatitis, cheilitis, glossitis, glossalgi,
g Stomatitis includes the following PTs: Aphthous stomatitis, Cheilitis, Glossitis, Glossodynia, Mouth ulceration, Mucosal inflammation, Oral pain, Oropharyngeal discomfort, Oropharyngeal pain, Stomatitis.
Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
The primary endpoint of the study was progression-free survival (PFS) evaluated according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1, as assessed by investigator.
• Tør hoste
• chest pain
IBRANCE 75 mg hårde kapsler IBRANCE 100 mg hårde kapsler IBRANCE 125 mg hårde kapsler palbociclib
IBRANCE 75 mg hard capsules IBRANCE 100 mg hard capsules IBRANCE 125 mg hard capsules palbociclib
Grad 3 og grad 4 infektioner forekom hos henholdsvis 4,5 % og 0,7 % af patienterne behandlet med IBRANCE i alle kombinationer (se pkt.
Infections have been reported at a higher rate in patients treated with IBRANCE in randomised clinical studies compared to patients treated in the respective comparator arm. Grade 3 and Grade 4 infections occurred respectively in 4.5% and 0.7% of patients treated with IBRANCE in any combination (see section 4.8).
Forhøjet ASAT
AST increased
N = antal patienter; CI = konfidensinterval; OR = objektiv respons baseret på bekræftet og ubekræftet respons iht.
N=number of patients; CI=confidence interval; OR=objective response based on confirmed and unconfirmed responses according to RECIST 1.1; TTR=time to first tumour response.
Placebo plus letrozoll (N = 222)
Placebo plus Letrozole (N = 222)
- IBRANCE 125 mg leveres som uigennemsigtige, hårde kapsler, med en karamelfarvet underdel (mærket ”PBC 125” med hvid skrift) og en karamelfarvet overdel (mærket ”Pfizer” med hvid skrift).
- IBRANCE 125 mg is supplied as opaque, hard capsules, with a caramel body (printed “PBC 125” in white) and a caramel cap (printed “Pfizer” in white).
• Sulfasalazin, som anvendes til behandling af leddegigt.
• Sulfasalazine used to treat rheumatoid arthritis.
Smagsforstyrrelser (dysgeusi)
Dysgeusia Eye disorders
Unormale leverblodprøver
Infectionsb Blood and lymphatic system disorders
Tillæg af palbociclib til fulvestrant resulterede i en symptomfordel ved væsentligt at forsinke tiden til forværring af smertesymptomer sammenlignet med placebo plus fulvestrant (median 8,0 måneder versus 2,8 måneder.
Addition of palbociclib to fulvestrant resulted in a symptom benefit by significantly delaying time-to-deterioration in pain symptom compared with placebo plus fulvestrant (median 8.0 months versus 2.8 months; HR of 0.64 [95% CI: 0.49, 0.85]; p<0.001).
Anbefalede dosisjusteringer af IBRANCE ved bivirkninger
IBRANCE recommended dose modifications for adverse reactions Dose level
Der blev observeret en reduktion i risikoen for sygdomsprogression eller død til fordel for palbociclib plus letrozol-armen i alle patientundergrupper, defineret iht.
A reduction in the risk of disease progression or death in favour of the palbociclib plus letrozole arm was observed in all individual patient subgroups defined by stratification factors and baseline characteristics in the primary and in the updated analysis.
Samtidig administration af flere doser itraconazol 200 mg og en enkelt dosis palbociclib 125 mg øgede den samlede eksponering (AUCinf) og peak-koncentration (Cmax) af palbociclib med henholdsvis ca. 87 % og 34 % i forhold til en enkelt dosis palbociclib 125 mg givet alene.
Coadministration of multiple 200 mg doses of itraconazole with a single 125 mg palbociclib dose increased palbociclib total exposure (AUCinf) and the peak concentration (Cmax) by approximately 87% and 34%, respectively, relative to a single 125 mg palbociclib dose given alone.
Titandioxid (E171) Ammoniumhydroxid (28% opløsning) Propylenglykol
Ammonium hydroxide (28% solution)
Nedsat leverfunktion
Platelets decreased
Patienterne var ligeligt fordelt mellem palbociclib plus letrozol-armen og placebo plus letrozol-armen mht. demografiske data ved baseline og prognostiske karakteristika.
Patients were well matched for baseline demographics and prognostic characteristics between the palbociclib plus letrozole arm and the placebo plus letrozole arm.
Indehaver af markedsføringstilladelsen Pfizer Europe MA EEIG Boulevard de la Plaine 17
NAME OF THE MARKETING AUTHORISATION HOLDER Pfizer Europe MA EEIG
Hjælpestoffer, som behandleren skal være opmærksom på Hver hård kapsel indeholder 74 mg lactose (som monohydrat).
Each hard capsule contains 74 mg of lactose (as monohydrate).