natgillin/translations-raw huggingface dataset:
Hæmningen af knogleomsætningsmarkørerne kunne påvises efter 3 måneder og blev fastholdt gennem en observationsperiode på 36 måneder i et substudie under PEARL-studiet.
The suppression of bone turnover markers was evident by 3 months and persisted throughout the 36-month observation period in a sub-study of the PEARL study.
Lasofoxifen har en halveringstid på ca. 6 dage.
Lasofoxifene has a half-life of approximately 6 days.
• Smerter ved vandladning, blod i urinen
• Painful urination, blood in urine
I begge studier nedsatte behandlingen sværhedsgraden af patienternes mest generende baseline VVA-symptom, nedsatte vaginalt pH, nedsatte procentdelen af vaginale parabasale celler fra maturation index (MI) og øgede procentdelen af vaginale overfladeceller fra MI.
In both studies, it decreased the severity of the subject's most bothersome baseline VVA symptom, decreased vaginal pH, decreased the percentage of vaginal parabasal cells from the maturation index (MI) and increased the percentage of vaginal superficial cells from the MI.
Det anbefalede daglige indtag af vitamin D er 400-800 IU.
The recommended intake of vitamin D is 400-800 IU daily.
Signifikante stigninger i BMD blev set så tidligt som efter 3 måneder for lænderygsøjle og total hofte.
Significant increases in BMD were observed as early as 3 months for lumbar spine and total hip.
Skeletale virkninger:
Skeletal effects:
Derfor bør Fablyn kun bruges til behandling af osteoporose, efter at behandlingen for mammacancer, herunder adjuverende behandling, er afsluttet.
Therefore, FABLYN should be used for the treatment of osteoporosis only after the treatment of breast cancer, including adjuvant therapy, has been completed.
• Trykken i den nedre del af maven
• Pressure in the lower abdomen
Knoglevæv, der nydannes gennem to år under behandling med lasofoxifen, er af normal kvalitet.
Bone formed during two years' administration of lasofoxifene is of normal quality.
Disse observationer støtter konklusionen, at lasofoxifen ikke har nogen egen østrogenagonistisk aktivitet i brystvæv.
These observations support the conclusion that lasofoxifene has no intrinsic estrogen agonist activity in breast tissue.
Fablyns virkning på lipidprofilen blev undersøgt i et 3-års substudie under PEARL-studiet; substudiet involverede 1014 postmenopausale kvinder.
The effect of FABLYN on the lipid profile was evaluated in a 3-year substudy of the PEARL study; the substudy enrolled 1,014 postmenopausal women.
De fleste bivirkninger, som er set, var milde.
Most of the side effects that occurred during studies were mild.
** Endometriehyperplasi-hændelser baseret på indrapporteringer fra investigatorer uden histopatologi og uden histologisk verifikation.
** Endometrial hyperplasia events based on investigator reporting rather than histopathology findings and did not require histological confirmation.
ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
Forekomsten af cystiske endometrieforandringer og endometrietykkelse blev undersøgt hos en undergruppe af studiepopulationen (298 patienter) ved en årlig transvaginal ultralydsundersøgelse (TVU) gennem 3 år.
The incidence of endometrial cystic change and endometrial thickness was analyzed in a subset of the study population (298 patients) with an annual transvaginal ultrasound (TVU) through 3 years.
• FABLYN medfører morfologiske forandringer, især cystisk atrofi i endometriet.
• FABLYN causes morphologic changes, particularly the cystic atrophy of endometrium.
Følgende information om Fablyns virkning på endometriet gennem 5 års eksponering kommer fra PEARL-studiet.
The following results of the effects of FABLYN on the endometrium through 5 years of exposure are reported from the PEARL study.
I en populationsfarmakokinetisk analyse ses der ingen klinisk relevante forskelle i lasofoxifens farmakokinetik mellem postmenopausale kvinder med estimeret creatininclearance så lav som 32 ml/min og kvinder med normal creatininclearance.
In a population pharmacokinetic analysis, there were no clinically meaningful differences in lasofoxifene pharmacokinetics between postmenopausal women with estimated creatinine clearance as low as 32 ml/min and those with normal creatinine clearance.
Så enhver blødning fra skeden, mens De tager FABLYN, er derfor unormal.
So any vaginal bleeding while you take FABLYN is unexpected.
Hos nogle kvinder vil disse ændringer i sidste instans føre til nedsat knoglemasse, osteoporose og øget risiko for frakturer, særligt af rygsøjle, hofte og håndled.
In some women, these changes will eventually lead to decreased bone mass, osteoporosis, and increased risk for fractures, particularly of the spine, hip, and wrist.
Fablyns virkning i behandlingen af VVA blev undersøgt i to 12-ugers fase 3-studier med postmenopausale kvinder med moderate eller alvorlige tegn og symptomer på VVA, uafhængigt af osteoporose-status (889 patienter).
The efficacy of FABLYN in the treatment of VVA was investigated in two 12-week Phase 3 studies in postmenopausal women with moderate or severe signs and symptoms of VVA, regardless of osteoporosis status (involving 889 patients).
Sikkerheden af Fablyn ved osteoporosebehandling blev vurderet i et stort (8556 patienter) dobbeltblindt, randomiseret, placebokontrolleret multinationalt fase 3-fraktur-studie (PEARL-studiet).
The safety of FABLYN in the treatment of osteoporosis was assessed in a large (8,556 patients) double-blind, randomized, placebo-controlled multinational Phase 3 fracture trial (the PEARL study).
Den øgede omsætning medfører accelereret knogletab, da den kompensatoriske øgning i knogledannelsen ikke er tilstrækkelig til at opveje den øgede knogleresorption.
The increased turnover causes accelerated bone loss because the compensatory increase in bone formation is not sufficient to offset increased bone resorption.
Dyreforsøg har vist udskillelse af lasofoxifen i mælk.
Animal studies have shown excretion of lasofoxifene in milk.
• Aktivt stof: lasofoxifen.
• The active substance is lasofoxifene.
Da immobilisering i sig selv øger risikoen for venøse tromboemboliske hændelser, bør Fablyn seponeres mindst 3 uger før og under langvarig immobilisering (f.eks. post-operativ hvile, forlænget sengeleje), og behandlingen bør først genoptages, når patienten er fuldt oppegående.
Because immobilization increases the risk for venous thromboembolic events independent of therapy, FABLYN should be discontinued at least 3 weeks prior to and during prolonged immobilization (e.g., post-surgical recovery, prolonged bed rest), and therapy should be resumed only after the patient is fully ambulatory.
Fablyn indeholder lactose.
FABLYN contains lactose.
Indehaver af markedsføringstilladelsen er: Dr. Friedrich Eberth Arzneimittel GmbH, Am Bahnhof 2, 92289 Ursensollen, Tyskland.
Marketing Authorisation Holder and Manufacturer The Marketing Authorisation Holder is Dr. Friedrich Eberth Arzneimittel GmbH, Am Bahnhof 2, 92289 Ursensollen, Germany.
Studiepopulationen bestod af 497 kvinder med osteoporose, defineret ved lav rygsøjle-BMD (Tscore ≤ 2,5).
The study population consisted of 497 women with osteoporosis as defined by low vertebral BMD (T-score ≤ 2.5).
Fablyn er indiceret til behandling af osteoporose hos postmenopausale kvinder med øget risiko for frakturer.
FABLYN is indicated for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.
Fablyn er ikke indiceret til børn og unge under 18 år, da lægemidlet kun anvendes til postmenopausale kvinder.
There is no indication for FABLYN in children and adolescents below 18 years of age since the medicinal product is for use in postmenopausal women only.
Reduktionen i forekomsten af non-vertebrale frakturer blev også set hos postmenopausale kvinder med svær osteoporose (defineret som baseline lænderygsøjle-BMD T-score ≤2,5 + prævalent fraktur eller BMD T-score ≤ -3) (p = 0,0183).
The reduction in the incidence of non-vertebral fractures was also observed in postmenopausal women with severe osteoporosis (defined as a baseline lumbar spine BMD T-score ≤ -2.5 + prevalent fracture or BMD T-score ≤ -3) (p = 0.0183).
Fablyn har ingen kendt virkning på evnen til at føre motorkøretøj eller betjene maskiner.
FABLYN has no known influence on the ability to drive and use machines.
Der var signifikant færre af disse henvisninger i Fablyn-gruppen (0,9 %) end i placebogruppen (3,3 %).
These referrals were significantly less frequent in the FABLYN group (0.9%) than in the placebo group (3.3%).
Tabletten kan tages på alle tidspunkter af dagen og uden hensyntagen til indtagelse af mad og drikke.
The tablet may be taken any time of day without regard to food and beverage intake.
Som for andre selektive østrogenreceptormodulatorer (SERM) er der set et let fald (ca. 4 %) i trombocyttal hos lasofoxifenbehandlede patienter i PEARL-studiet.
As observed with other Selective Estrogen Receptor Modulators (SERMs), slightly decreased (approximately 4%) platelet counts were observed in lasofoxifene-treated patients in PEARL.
Da mindre end 2 % af lasofoxifen genfindes i urinen som uomdannet substans, er der ikke foretaget undersøgelser på personer med nyreinsufficiens.
Since less than 2% of lasofoxifene is recovered in urine as unchanged active substance, a study in subjects with renal insufficiency was not conducted.
I nogle tilfælde sås spontan remission af disse fund under behandlingen.
In some cases, these findings were observed to resolve spontaneously on treatment.
FREMSTILLERENS BATCHNUMMER Lot:
BATCH NUMBER Lot:
En mindre alvorlig hændelse, overfladisk tromboflebit, er også set hyppigere med Fablyn sammenlignet med placebo.
A less serious event, superficial thrombophlebitis, also has been reported more frequently with FABLYN compared to placebo.
Vaginalt udflåd sås hos 1 ud af 26 patienter.
Vaginal discharge occurred in about one in 26 patients.
• Unormale drømme, humørsvingninger
• Abnormal dreams, mood swings
Lasofoxifen er en SERM, hvis biologiske virkninger overvejende medieres gennem binding til østrogenreceptorer.
Lasofoxifene is a SERM whose biological actions are largely mediated through binding to estrogen receptors.
Fablyns sikkerhed ved osteoporosebehandling blev også vurderet i et fase-2 placebokontrolleret studie med japanske, koreanske og taiwanesiske kvinder.
The safety of FABLYN in the treatment of osteoporosis was also assessed in a Phase 2 placebocontrolled trial in Japanese, Korean and Taiwanese women.
Tag ikke FABLYN
Do not take FABLYN
Lasofoxifen var ikke teratogen hos rotter op til en dosis på 10 mg/kg (ca. 53 gange AUC hos mennesker) eller kaniner op til en dosis på 3 mg/kg (under niveauet for systemisk eksponering hos mennesker).
Lasofoxifene was not teratogenic in rats up to a dose of 10mg/kg (approximately 53 times the AUC in humans) or rabbits up to a dose of 3 mg/kg (below the level of systemic exposure in humans).
Der blev foretaget en analyse af de patienter, der blev henvist til egen læge med henblik på eventuelt præparatskifte efter observation af et af følgende fund: a) ≥7 % BMD-tab i lænderygsøjle eller ≥10 % BMD-tab i lårbenshals efter 12 måneder; b) ≥11 % BMD-tab i lænderygsøjle eller ≥14 % BMD-tab i lårbenshals efter 24 måneder; c) ≥2 on-study radiografisk verificerede rygsøjlefrakturer efter 24 måneder.
An analysis was conducted of the subjects who were referred to their physician for consideration of treatment with an alternative osteoporosis medicinal product if one of the following was observed: a) ≥7% BMD loss at LS or ≥10% BMD loss at femoral neck at Month 12; b) ≥11% BMD loss at lumbar spine (LS) or ≥14% BMD loss at femoral neck at Month 24; c) ≥2 on-study radiographic vertebral fractures by Month 24.
Fablyn øger muligvis hyppigheden af hedeture og kan ikke mindske forekomsten af hedeture forbundet med østrogenmangel.
FABLYN may increase the incidence of hot flushes and is not effective in reducing hot flushes associated with estrogen deficiency.
Disse er beskrevet i den Pharmacovigilance-plan, der er vedtaget i version 1.4 af Risk Management Planen (RMP), som er præsenteret i modul 1.8.2 af ansøgningen om markedsføringstilladelse og enhver følgende opdatering af RMP vedtaget af CHMP
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.4 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Der blev set statistisk signifikante stigninger i apolipoprotein A-1, som er associeret med HDL-kolesterol, og i serumtriglycerider (gennemsnitlig ændring vs. placebo henholdsvis 6,1 % og 4,9 %).
Statistically significant increases were seen for apolipoprotein A-1, which is associated with HDL cholesterol, and serum triglycerides (median changes vs. placebo 6.1% and 4.9%, respectively).
Antallet af patienter, der fik seponeret behandlingen på grund af vaginalblødning, var lavt [Fablyn: 4 (0,1 %), placebo: 0].
The number of subjects discontinuing treatment as a result of vaginal bleeding was low [FABLYN: 4 (0.1%), placebo: 0].
B. BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
B. CONDITIONS OF THE MARKETING AUTHORISATION
Lasofoxifens orale clearance (CL/F) hos postmenopausale kvinder er ca. 6,6 l/time.
The apparent oral clearance (CL/F) of lasofoxifene in postmenopausal women is approximately 6.6 l/hr.
Oral anvendelse
For oral use
Kliniske data indikerer, at Fablyn har en østrogenlignende virkning på knoglevæv såvel som antagonistiske virkninger på brystvæv.
Clinical data indicate that FABLYN has an estrogen-like agonist effect on bone as well as antagonistic effects on the breast.
Der er ikke foretaget undersøgelser af virkningen på evnen til at føre motorkøretøj eller betjene maskiner.
No studies on the effects on the ability to drive and use machines have been performed.
MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER BEHOLDER ETIKET
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE LABEL
Graviditet og amning: Fablyn må kun anvendes til postmenopausale kvinder.
Pregnancy and lactation: FABLYN is only for use in postmenopausal women.
For hele studiepopulationen (N=8556) var der efter 5 år signifikant lavere forekomst af alvorlige koronare hændelser, herunder koronardød, ikke-fatal myokardieinfarkt, ny iskæmisk hjertesygdom, hospitalisering på grund af ustabil angina pectoris og revaskulariseringsprocedurer.
At 5 years in the overall study population (N=8,556), the incidence of major coronary events, including coronary death, non-fatal myocardial infarction, new ischemic heart disease, hospitalization for unstable angina, and revascularisation procedures, was significantly lower.
Fablyns virkning på BMD hos postmenopausale japanske, koreanske og taiwanesiske kvinder med osteoporose blev også undersøgt i et 1-års randomiseret, placebokontrolleret, dobbelblindt osteoporosestudie.
The effects of FABLYN on BMD in postmenopausal Japanese, Korean and Taiwanese women with osteoporosis were also examined in a one-year, randomized, placebo-controlled, double-blind osteoporosis treatment trial.
Fablyn kan administreres på alle tidspunkter af dagen uden hensyntagen til indtagelse af mad og drikke.
FABLYN may be administered any time of day without regard to food or beverage intake.
Der er påvist en signifikant reduktion i forekomsten af vertebrale og non-vertebrale frakturer, men ikke hoftefrakturer (se pkt.
A significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated (see section 5.1).
Vaginalblødning blev set hos 74 (2,6 %) Fablyn-behandlede kvinder versus 37 (1,3 %) placebobehandlede kvinder.
Vaginal bleeding was reported in 74 (2.6%) FABLYN-treated women versus 37 (1.3%) placebo-treated women.
herunder kontraindikationen vedrørende patienter med aktiv eller tidligere tilfælde af VTE.
SmPC, including contraindication of FABLYN in patients with active or past history of VTE.
Dosisjustering af Fablyn er ikke nødvendig hos ældre patienter.
No dose adjustment for FABLYN is necessary in elderly patients.
Lasofoxifen absorberes langsomt fra mave-tarm-kanalen og maksimale plasmakoncentrationer opnås gennemsnitligt 6 timer efter dosering.
Lasofoxifene is slowly absorbed from the gastrointestinal tract with maximal plasma concentrations attained on average by approximately 6 hours after dosing.
Lasofoxifen undergår omfattende metabolisme i mennesker.
Lasofoxifene is extensively metabolized in humans.
Kvinderne i dette studie var i gennemsnit 63 år (interval 44 til 79) og i gennemsnit var der gået 13 år siden menopausen.
Women in this study had a median age of 63 years (range 44 to 79) and a median time since menopause of 13 years.
Lasofoxifen er administreret til postmenopausale kvinder i enkeltdoser så høje som 100 mg (200 gange den anbefalede enkeltdosis) og i flere doser så høje som 10 mg dagligt (20 gange den anbefalede dosis) i op til et år uden alvorlige dosis-relaterede bivirkninger.
Lasofoxifene has been administered to postmenopausal women at single doses as high as 100 mg (200 times the recommended unit dose) and multiple doses as high as 10 mg/day (20 times the recommended dose) for up to one year without dose-related serious adverse reactions.
Lasofoxifens biotransformation og disposition i mennesker er bestemt ved oral administration af 14C
Biotransformation and disposition of lasofoxifene in humans have been determined following oral administration of 14C-labeled lasofoxifene.
Der er ikke rapporteret tilfælde af overdosering med Fablyn.
No case of FABLYN overdose has been reported.
I en prænatal og postnatal undersøgelse af lasofoxifen hos rotter, der fik ≥0.01 mg/kg/dag, sås forsinket og/eller afbrudt partus, forøget mortalitet hos ungerne ved fødslen, ændret tidspunkt for udviklingstrin og nedsat vækst.
In a prenatal and postnatal study in rats, at ≥0.01 mg/kg/day lasofoxifene delayed and/or disrupted parturition, increased pup mortality at birth, altered the achievement of developmental milestones, and reduced growth.
Alle uforklarede mammaforandringer, opstået under Fablyn-behandling, bør undersøges.
Any unexplained breast abnormality occurring during FABLYN therapy should be investigated.
Patologen skal informeres om patientens brug af lasofoxifen ved vurdering af endometriehistology for at sikre en præcis diagnose af benign cystisk atrofi.
Pathologists should be made aware of a history of lasofoxifene use when assessing endometrial histology, to ensure an accurate diagnosis of benign cystic atrophy when present.
I forhold til placebo nedsatte Fablyn signifikant totalkolesterol, LDL-kolesterol, LDL-associeret apolipoprotein B-100 og high-sensitivity C-reaktivt protein (gennemsnitlige ændringer henholdsvis -10,4 %, -15,8 %, -11,8 %, -12,5 %); Der blev ikke set signifikante ændringer af HDL-kolesterol eller VLDL-kolesterol.
Relative to placebo, FABLYN significantly decreased total cholesterol, LDL cholesterol, LDL-associated apolipoprotein B-100, and high sensitivity C-reactive protein (median changes -10.4%, -15.8%, -11.8%, -12.5%, respectively); no significant changes versus placebo were seen for HDL cholesterol or VLDL cholesterol.
Fald i østrogenniveau efter menopause eller ooforektomi fører til accelereret knogletab på grund af forøget knogleomsætning, hvor knogleresorption overstiger knogledannelse.
Decreases in estrogen levels after menopause or oophorectomy lead to accelerated bone loss due to increased bone turnover, where bone resorption exceeds bone formation.
Studiepopulationen bestod af 8556 postmenopausale kvinder med osteoporose, defineret ved lav BMD (rygsøjle- eller hofte-BMD mindst 2,5 SD under den gennemsnitlige værdi for raske unge kvinder).
The study population consisted of 8,556 postmenopausal women with osteoporosis as defined by low BMD (vertebral or hip BMD at least 2.5 standard deviations below the mean value for healthy young women).
Fablyn øgede også signifikant helkrops-knoglemineralindholdet (BMC) sammenlignet med placebo efter 3 år.
FABLYN also significantly increased whole body bone mineral content (BMC), compared to placebo, at 3 years.
Paroxetin - Den stærke CYP2D6-inhibitor paroxetin øger den systemiske eksponering for lasofoxifen med 35 %, hvilket ikke vurderes at være klinisk relevant.
Paroxetine - The strong CYP2D6 inhibitor paroxetine increased the systemic exposure of lasofoxifene by 35% which is not considered to be clinically meaningful.
Alle kvinder i studiet fik calcium (600-1200 mg dagligt) og vitamin D (400800 IU dagligt).
All women in the study received calcium (600-1200 mg/day) and Vitamin D (400-800 IU/day).
Hos patienter med dette i anamnesen bør niveauet af triglycerider i serum monitoreres under behandlingen med lasofoxifen.
Patients with this medical history should have serum triglycerides monitored when taking lasofoxifene.
Tal med lægen, inden De begynder at tage FABLYN, hvis:
You should talk to your doctor before starting to take FABLYN:
Lasofoxifens halveringstid hos postmenopausale kvinder er ca. 6 dage ved steady state, hvilket giver små koncentrationsudsving over doseringsintervallet på 24 timer.
At steady state, the half-life of lasofoxifene in postmenopausal women is approximately 6 days, resulting in small fluctuations in concentrations over the 24-hour dosing interval.
Blisterpakninger med 7, 28 eller 30 tabletter og beholdere med 90 tabletter.
Blister packs of 7, 28 or 30 tablets and bottles of 90 tablets.
Fablyn må kun anvendes til postmenopausale kvinder.
FABLYN is only for use in postmenopausal women.
Brug af FABLYN sammen med mad og drikke FABLYN kan tages med eller uden mad og drikke.
FABLYN can be taken with or without food and drink.
Lasofoxifen har vævs- og cellespecifikke virkninger i østrogen-responsivt væv.
Lasofoxifene produces tissue and cell-specific effects in estrogen-responsive tissues.
Alle kvinder i studiet fik calcium (1000 mg dagligt) og vitamin D (400-800 IU dagligt).
All women in the study received calcium (1,000 mg/day) and Vitamin D (400-800 IU/day).
Placebobehandlede kvinder havde en forekomst af cystiske forandringer på 1,9 % over 3 år, mens Fablyn-behandlede kvinder havde en forekomst på 20,4 %.
Placebo-treated women had a 1.9% incidence in cystic change over 3 years, whereas the FABLYNtreated women had a 20.4% incidence.
Det er ikke normalt, at FABLYN giver blødning fra skeden.
It is unlikely that FABLYN will cause vaginal bleeding.
Der var ingen tegn på osteomalaci, knoglemarvsfibrose, cellulær toksicitet, woven bone eller andre abnormiteter, som kunne påvirke knoglekvaliteten efter lasofoxifen-behandling.
There was no evidence of osteomalacia, marrow fibrosis, cellular toxicity, woven bone or other abnormalities affecting the quality of the bone following lasofoxifene treatment.
Hvis De har glemt at tage FABLYN
If you forget to take FABLYN
Behandlingen kan genoptages, så snart De kan bevæge Dem normalt igen og efter aftale med lægen.
Treatment with FABLYN can be restarted as soon as you regain your mobility and in consultation with your doctor.
• Kraftig sveden
• Excessive sweating
Lasofoxifen er i høj grad proteinbundet, elimineres hovedsageligt ved metabolisme og indgår sandsynligvis i den enterohepatiske cirkulation (se pkt.
Lasofoxifene is highly protein bound, predominantly cleared by metabolism and is likely to undergo enterohepatic circulation (see section 5.2).
Se indlægssedlen for yderligere information.
Contains lactose See the package leaflet for further information.
I kliniske studier ændrede lasofoxifen ikke metaboliseringen af dextromethorphan (CYP2D6-substrat) og chlorzoxazon (CYP2E1-substrat) eller farmakokinetikken af warfarin (CYP2C9-substrat), methylprednisolon (CYP3A4-substrat) eller digoxin (MDR1 P-glycoproteinsubstrat).
In clinical studies, lasofoxifene did not alter the metabolism of dextromethorphan (CYP2D6 substrate) and chlorzoxazone (CYP2E1 substrate) or the pharmacokinetics of warfarin (CYP2C9 substrate), methylprednisolone (CYP3A4 substrate) or digoxin (MDR1 P-glycoprotein substrate).
Lasofoxifens steady state-farmakokinetik stemmer overens med, hvad der kunne forventes ud fra enkeltdosis-farmakokinetikken.
Steady-state pharmacokinetics of lasofoxifene are consistent with expectations from its single-dose pharmacokinetics.