natgillin/translations-raw huggingface dataset:
Do not use this medicine after the expiry date which is stated on the carton and the vial after “EXP”.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in viali poleg oznake »EXP«.
- if you go on to have a stem cell transplant, it is possible that you could then develop complications (graft versus host disease) that are difficult to manage.
- če imate presaditev matičnih celic, se lahko razvijejo zapleti (bolezen presadka proti gostitelju), ki jih je težko obvladati.
Table 3: Overall and Compartmental Response Rate in Early Disease Stages
Preglednica 3: splošna stopnja odziva in stopnja odziva po telesnih predelih v zgodnjih stadijih bolezni
If a dose is missed by more than 2 days, the next dose should be administered as soon as possible, after which the dosing schedule should be resumed with doses given based on the new scheduled days.
Če se z odmerkom zamudi za več kot 2 dni, je treba naslednji odmerek uporabiti čim prej, nato pa je treba časovni načrt odmerjanja nadaljevati na novo določene dneve.
Afterwards POTELIGEO could be used during breast-feeding if clinically needed.
Pozneje se zdravilo POTELIGEO lahko uporablja med dojenjem, če je to klinično potrebno.
CI=confidence interval; CR=complete response; PR=partial response
IZ = interval zaupanja; PO = popoln odziv; DO = delni odziv.
No specific studies have been conducted to evaluate potential effects on fertility.
Specifičnih študij za oceno morebitnih učinkov na plodnost niso izvedli.
Due to the mechanism of action of the medicine, it may harm your baby if it is administered when you are pregnant or breast- feeding.
Zaradi mehanizma delovanja lahko to zdravilo škoduje otroku, če ga uporabljate, ko ste noseči ali dojite.
Patients should be closely monitored for symptoms or signs that suggest SJS or TEN.
Bolnike je treba pozorno spremljati zaradi simptomov ali znakov, ki kažejo na SJS ali TEN.
The subjects had a medical history including various risk factors.
Anamneza preskušancev je vključevala različne dejavnike tveganja.
The median duration of exposure with mogamulizumab was 5.6 months (range: <1 to 45.3 months).
Mediano trajanje izpostavljenosti mogamulizumabu je bilo 5,6 meseca (razpon: od < 1 do 45,3 meseca).
In case of overdose, the patient, including their vital signs, should be closely monitored (for at least 1 hour) and supportive treatment should be administered if required.
Če pride do prevelikega odmerjanja, je treba bolnika pozorno spremljati, vključno z vitalnimi znaki (najmanj 1 uro), in po potrebi uvesti podporno zdravljenje.
At study baseline, 38% had stage IB-II disease, 10% stage III, 52% stage IV.
Ob izhodišču študije je 38 % bolnikov imelo stadij bolezni IB-II, 10 % stadij III in 52 % stadij IV.
Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature (at 25°C) under ambient room light.
Dokazano je, da je raztopina kemijsko in fizikalno stabilna 24 ur, če se hrani pri sobni temperaturi (25 °C) in na sobni svetlobi.
Table 4: Progression Free Survival (PFS) by Treatment Group and Disease Stage (Randomised Treatment Period)
Preglednica 4: Preživetje brez napredovanja bolezni (PFS) glede na zdravljeno skupino in stadij bolezni (randomizirano obdobje zdravljenja)
This study included patients regardless of their baseline level of CCR4 expression in skin biopsy.
Ta študija je vključevala bolnike ne glede na izhodiščno raven izraženosti CCR4 pri kožni biopsiji.
These time limits include storage of the infusion solution in the infusion bag through the duration of infusion.
Ta časovna omejitev vključuje shranjevanje raztopine za infundiranje v infuzijski vrečki med infundiranjem.
• The diluted solution is compatible with polyvinyl chloride (PVC) or polyolefin (PO) infusion bags.
• Razredčena raztopina je združljiva z infuzijskimi vrečkami iz polivinilklorida (PVC) ali poliolefina (PO).
The population PK analysis included 444 patients receiving mogamulizumab in six clinical trials.
Analiza populacijske FK je vključevala 444 bolnikov, ki so prejemali mogamulizumab v 6 kliničnih preskušanjih.
Discard any unused portion left in the vial in accordance with local requirements.
Morebitno neporabljeno vsebino viale je treba zavreči skladno z lokalnimi predpisi.
The effects of POTELIGEO in pregnancy and breast-feeding are not known.
Učinki zdravila POTELIGEO med nosečnostjo in dojenjem niso znani.
Once opened, the medicinal product should be diluted and infused immediately (see section 6.6).
Po odprtju je treba zdravilo takoj razredčiti in infundirati (glejte poglavje 6.6).
The most frequently reported serious adverse reactions were pneumonia, pyrexia, infusion related reaction and cellulitis.
Resni neželeni učinki, o katerih so najpogosteje poročali, so bili pljučnica, pireksija, z infuzijo povezana reakcija in celulitis.
- allergic to mogamulizumab or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na mogamulizumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Safety post last dose
Varnost po zadnjem odmerku
The destruction of cancer cells and the body's reaction to it can very occasionally lead to a problem called tumour lysis syndrome.
Uničenje rakavih celic in reakcija telesa na to lahko v redkejših primerih povzroči težavo, ki se imenuje sindrom tumorske lize;
To start with, the infusions will be given once a week for the first 5 doses, then once every 2 weeks.
Na začetku boste prvih 5 odmerkov dobili enkrat na teden, pozneje pa boste dobivali infuzije enkrat na 2 tedna.
Infusion-related reactions have been observed in 33% of patients treated with POTELIGEO.
Reakcije, povezane z infundiranjem, so opazili pri 33 % bolnikov, zdravljenih z zdravilom POTELIGEO.
The medicine is for use in patients who have received at least one medicine given by mouth or by injection.
Zdravilo je namenjeno uporabi pri bolnikih, ki so predhodno prejeli vsaj eno zdravilo peroralno (skozi usta) ali z injekcijo.
Patients with rapidly proliferating tumour and high tumour burden are at risk of TLS.
Pri bolnikih, ki imajo tumor s hitro proliferacijo in veliko tumorsko breme, obstaja tveganje za TLS.
The IRRs were mostly mild or moderate in severity, although there have been a few reports of severe reactions (Grade 3).
Te reakcije so bile večinoma blage ali zmerne, vendar so poročali tudi o nekaj hudih reakcijah (3. stopnja).
A higher risk of transplant complications has been reported if mogamulizumab is given within a short time frame (approximately 50 days) before HSCT.
Poročali so o večjem tveganju za zaplete pri presaditvi, če je mogamulizumab dan nedolgo (približno 50 dni) pred HSCT.
Mogamulizumab is dosed via intravenous route and therefore is immediately and completely bioavailable.
Mogamulizumab se daje po intravenski poti, zato je njegova biološka uporabnost takojšnja in popolna.
The final concentration of the diluted solution should be between 0.1 mg/mL to 3.0 mg/mL.
Končna koncentracija razredčene raztopine mora biti med 0,1 mg/ml in 3,0 mg/ml.
Overall response was reported as a composite score from measures in each compartment, and a response had to be demonstrated at two successive overall disease assessments (at least 8 weeks apart during the first year and 16 weeks apart thereafter) in order to be confirmed.
Skupni odziv je bil poročan kot sestavljen rezultat po merilih za vsak telesni predel in odziv je moral biti za potrditev dokazan pri dveh zaporednih splošnih ocenah bolezni (s presledkom najmanj 8 tednov v prvem letu in pozneje 16 tednov).
Large cell transformation (LCT) There are limited data available on patients with LCT.
Transformacija velikih celic (LCT) O bolnikih z LCT je na voljo malo podatkov.
• Administer infusion solution over at least 60 minutes through an intravenous line containing a sterile, low protein binding 0.22 micron (or equivalent) in-line filter.
• Raztopino za infundiranje je treba dajati najmanj 60 minut skozi intravensko linijo s sterilnim 0,22-mikronskim (ali enakovrednim) linijskim filtrom, ki malo veže proteine.
Treatment should be continued unless you get serious side effects or the cutaneous T-cell lymphoma starts to get worse.
Zdravljenje je treba nadaljevati, razen če se pojavijo resni neželeni učinki ali se kožni T-celični limfom poslabša.
The study demonstrated statistically significant improvements in ORR and response by compartment in the blood, skin, and lymph nodes as compared to vorinostat.
Študija je pokazala statistično pomembne izboljšave v SSO in odzivu po telesnih predelih za kri, kožo in bezgavke v primerjavi z vorinostatom.
The safety and efficacy of POTELIGEO in children and adolescents aged below 18 years has not been established.
Pediatrična populacija Varnost in učinkovitost zdravila POTELIGEO pri otrocih in mladostnikih, mlajših od 18 let, nista dokazani.
Exposure-Response analysis indicated that efficacy was not correlated with mogamulizumab exposure in the pivotal study.
Analiza izpostavljenost-odziv je pokazala, da učinkovitost ni bila v korelaciji z izpostavljenostjo mogamulizumabu v ključni študiji.
The primary efficacy endpoint was progression-free survival (PFS) based on investigator assessment using a global composite response criteria that took into account all potentially affected disease compartments (skin, blood, lymph nodes and viscera).
Primarni opazovani dogodek učinkovitosti je bilo preživetje brez napredovanja bolezni (PFS) na podlagi ocene raziskovalca z uporabo globalnih sestavljenih meril odziva, v katerih so upoštevani vsi telesni predeli, ki jih bolezen lahko prizadene (koža, kri, bezgavke in drobovje).
- Lack of energy (fatigue) - Constipation - Swollen legs or ankles - Headache
- pomanjkanje energije (utrujenost) - zaprtost - otečene noge ali gležnji - glavobol
Efficacy, as measured by improvement in PFS based on investigator assessment, was not associated with increasing mogamulizumab exposure.
Učinkovitost, merjena z izboljšanjem preživetja brez napredovanja bolezni na podlagi ocene raziskovalca, ni bila povezana s povečano izpostavljenostjo mogamulizumabu.
Reasons for crossover to mogamulizumab were disease progression (109 patients) and treatment intolerance (27 patients).
Razloga za prehod na mogamulizumab sta bila napredovanje bolezni (109 bolnikov) in nezmožnost prenašanja zdravljenja (27 bolnikov).
• Calculate the required volume of POTELIGEO needed to prepare the infusion solution for the 1 mg/kg dosage based on patient weight (see section 4.2).
• Izračunajte količino zdravila POTELIGEO, ki je potrebna za pripravo raztopine za infundiranje za odmerek 1 mg/kg, glede na telesno maso bolnika (glejte poglavje 4.2).
56% of patients received mogamulizumab for at least 6 cycles, and 25% of patients received mogamulizumab for at least 12 cycles.
56 % bolnikov je prejelo najmanj 6 krogov zdravljenja z mogamulizumabom in 25 % bolnikov je prejelo najmanj 12 krogov zdravljenja z mogamulizumabom.
Contents of the pack and other information What POTELIGEO contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo POTELIGEO
The combination of mogamulizumab with systemic immune modulating medicinal products or with other licensed therapies for MF or SS has not been studied and is, therefore, not recommended, especially in consideration of the risk of severe infections in patients treated with mogamulizumab.
Kombinacij mogamulizumaba s sistemskimi imunomodulirajočimi zdravili ali drugimi odobrenimi zdravili za zdravljenje FM ali SS niso preučili in zato niso priporočljive, zlasti ob upoštevanju tveganja za pojav resnih okužb pri bolnikih, ki se zdravijo z mogamulizumabom.
Figure 1: Plot of Kaplan-Meier curve of progression-free survival by investigator's assessment (ITT) population
Slika 1: Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni po oceni raziskovalca - populacija ITT
- Inflammation of the liver (hepatitis)
- vnetje jeter (hepatitis)
Mogamulizumab is produced in Chinese hamster ovary cells by recombinant DNA technology.
Mogamulizumab je pridobljen iz ovarijskih celic kitajskega hrčka s tehnologijo rekombinantne DNK.
Patients were included in the analysis for a specific compartment if they had presence of disease in that compartment at baseline, or had any post-baseline response assessment for that compartment.
Bolniki so bili vključeni v analizo za določen telesni predel, če so ob izhodišču imeli bolezen na tem predelu ali če so imeli po izhodišču kakršno koli oceno odziva na tem predelu.
If reaction recurs, discontinuing the infusion should be considered (see section 4.4).
Če se reakcija ponovi, je treba razmisliti o opustitvi infundiranja (glejte poglavje 4.4).
There are limited efficacy data in patients with low (<10%) CCR4 expression in the skin.
Podatki o učinkovitosti pri bolnikih z nizko (< 10 %) izraženostjo CCR4 v koži so omejeni.
CCR4 is expressed on the surface of some cancer cells including T cell malignancies, such as MF and SS in which CCR4 expression is inherent.
CCR4 je izražen na površini nekaterih rakavih celic, vključno z malignimi T-celičnimi novotvorbami, kot sta FM in SS, pri katerih je izraženost CCR4 inherentna.
The most common prior systemic therapies used by subjects in Europe were bexarotene (70%), interferon (59%), methotrexate (49%), extracorporeal photopheresis (ECP) (31%) and gemcitabine/gemcitabine regimens (28%).
Najpogostejše vrste predhodnega sistemskega zdravljenja, ki so jih uporabljali preskušanci v Evropi, so bile beksaroten (70 %), interferon (59 %), metotreksat (49 %), zunajtelesna fotofereza (ECP) (31 %) in gemcitabin/režimi zdravljenja z gemcitabinom (28 %).
Response in lymph nodes and viscera was evaluated at 4 weeks, then every 8 weeks in the first year, and then every 16 weeks thereafter.
Odziv bezgavk in drobovja so ovrednotili po 4 tednih, nato vsakih 8 tednov v prvem letu in pozneje vsakih 16 tednov.
Infusion interruptions occurred in approximately 6% of patients, most of which (approximately 90%) occurred within the first cycle of treatment with mogamulizumab.
Prekinitve infundiranja so bile potrebne pri približno 6 % bolnikov, pri čemer je bila večina prekinitev (približno 90 %) v prvem krogu zdravljenja z mogamulizumabom.
Tell your doctor or nurse or get medical help immediately if you have any of the following symptoms after starting POTELIGEO:
Nemudoma obvestite svojega zdravnika ali medicinsko sestro oziroma poiščite zdravniško pomoč, če se po začetku uporabe zdravila POTELIGEO pri vas pojavi kateri koli od naslednjih simptomov:
In the clinical trial (0761-010), there were 2 reports of respiratory failure with fatal outcome in patients with severe pneumonia occurring more than 9 months after starting treatment with mogamulizumab.
V kliničnem preskušanju (0761-010) so poročali o dveh primerih respiratorne odpovedi s smrtnim izidom pri bolnikih s hudo pljučnico, ki je nastopila več kot 9 mesecev po začetku zdravljenja z mogamulizumabom.
Treatment with mogamulizumab resulted in 8 confirmed complete responses (complete clearing of all affected compartments) compared with 0 patients on vorinostat: 4 of these 8 patients were initially randomized to mogamulizumab and 4 had crossed over to mogamulizumab during the study.
Zdravljenje z mogamulizumabom je doseglo 8 potrjenih popolnih odzivov (popolna ozdravitev vseh prizadetih predelov) v primerjavi z 0 bolniki v skupini z vorinostatom: 4 od teh 8 bolnikov so bili že na začetku razvrščeni v skupino z mogamulizumabom, 4 pa so med študijo prešli na mogamulizumab.
If they occur, POTELIGEO should be interrupted and treatment should not restart unless SJS or TEN is ruled out and cutaneous reaction has resolved to Grade 1 or less.
Če se pojavijo, je treba odmerjanje zdravila POTELIGEO prekiniti, zdravljenje pa se ne sme ponovno začeti, dokler SJS ali TEN nista izključena in se kožna reakcija izboljša do stopnje 1 ali nižje.
Patients were a median age of 64 years at the time of screening (range 25 to 101 years), 49.5% were 65 years or older, and 58.1% were male.
Ob presejanju je bila mediana starost bolnikov 64 let (razpon od 25 do 101 leta), 49,5 % bolnikov je bilo starih 65 let ali več in 58,1 % je bilo moških.
Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, monoclonal antibodies ATC code: L01XC25
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe in imunomodulatorji, monoklonska protitelesa; oznaka ATC: L01XC25
Mogamulizumab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.
Pričakuje se, da bo mogamulizumab razpadel na manjše peptide in aminokisline po katabolnih poteh tako kot endogeni IgG.
Mogamulizumab targets cancer cells which are then destroyed by the immune system (the body's defence).
Mogamulizumab ciljno deluje na rakave celice, ki jih nato uniči imunski sistem (naravna obramba telesa).
Based on a population PK analysis, the steady-state concentrations of mogamulizumab were reached after 12 weeks of repeated dosing when administered using the recommended regimen, and systemic accumulation was 1.7-fold.
Na podlagi analize populacijske FK so bile koncentracije mogamulizumaba v stanju dinamičnega ravnovesja dosežene po 12 tednih ponavljajočega se odmerjanja, če se je uporabljal priporočeni režim odmerjanja, sistemsko kopičenje pa je bilo 1,7-kratno.
The pack contains a glass vial containing 5 mL concentrate for solution for infusion.
Pakiranje vsebuje stekleno vialo, ki vsebuje 5 ml koncentrata za raztopino za infundiranje.
This medicine is used to treat adults with mycosis fungoides and Sézary syndrome, which are types of cancers called cutaneous T-cell lymphomas.
To zdravilo se uporablja za zdravljenje odraslih s fungoidno mikozo in Sézaryjevim sindromom, ki sta tipa raka, imenovanega »kožni T-celični limfom«.
In the mogamulizumab arm, baseline CCR4 expression levels were available in 75% of patients (N=140).
V skupini z mogamulizumabom so bile izhodiščne ravni izraženosti CCR4 na voljo pri 75 % bolnikov (N = 140).
As a precautionary measure, it is preferable to avoid the use of mogamulizumab during pregnancy.
Iz previdnostnih razlogov se je med nosečnostjo uporabi mogamulizumaba bolje izogibati.
The most frequently reported adverse reactions were infusion-related reaction and rash (drug eruption); most of these reactions were non-serious and Grades 1 or 2.
Najpogosteje opažena neželena učinka sta bila z infuzijo povezana reakcija in medikamentozni izpuščaj (kožna reakcija na zdravilo); večina teh reakcij ni bila resna - stopnja 1 ali 2.
Of the 320 subjects exposed to mogamulizumab in Study 0761-010, 21 (6.6%), experienced at least one serious adverse drug reaction (SADR) that occurred within 90 days from the date of last study drug administration.
Od 320 preskušancev, ki so bili izpostavljeni mogamulizumabu v študiji 0761-010, jih je 21 (6,6 %) imelo vsaj eno resno neželeno reakcijo na zdravilo, ki se je pojavila v 90 dneh od datuma zadnjega odmerka preskušanega zdravila.
The safety of treatment with mogamulizumab after autologous or allogeneic HSCT has not been studied.
Varnost zdravljenja z mogamulizumabom po avtologni ali alogenski presaditvi HSCT ni raziskana.
CCR4 was detected on ≥1% of lymphocytes in 100% of patients, and 96% (134/140) had CCR4 detected on ≥10% of skin lymphocytes.
Pri 100 % so odkrili CCR4 v ≥ 1 % limfocitov in pri 96 % (134/140) bolnikov so odkrili CCR4 v ≥ 10 % limfocitov v koži.
In Study 0761-010 there were 10/290 evaluable patients with CCR4 expression <10%, of which 6 were randomised to mogamulizumab, and 4 were randomised to vorinostat and subsequently crossed over to mogamulizumab.
V študiji 0761-010 je bilo 10/290 ocenljivih bolnikov z izraženostjo CCR4 < 10 %, od katerih jih je bilo 6 že ob izhodišču razvrščenih v skupino z mogamulizumabom, 4 pa v skupino z vorinostatom in so nato prešli na mogamulizumab.
What you need to know before you use POTELIGEO Do not use POTELIGEO if you are:
Kaj morate vedeti, preden boste uporabili zdravilo POTELIGEO Ne uporabljajte zdravila POTELIGEO:
Mogamulizumab is a defucosylated, humanised IgG1 kappa immunoglobulin that selectively binds to CCR4, a G protein-coupled receptor for CC chemokines that is involved in the trafficking of lymphocytes to various organs including the skin, resulting in depletion of the target cells.
Mogamulizumab je defukoziliran, humaniziran kapaimunoglobulin IgG1, ki se selektivno veže na CCR4, tj. na G-proteine vezan receptor za CC-kemokine, ki sodeluje pri prenašanju limfocitov v različne organe, vključno s kožo, kar povzroči izčrpavanje ciljnih celic.
Based on a population PK analysis, the geometric mean (% coefficient of variation [CV%]) clearance (CL) is 12.0 mL/h (83.7%) and geometric mean elimination half-life (t1/2) is 17 days (65.5%).
Na podlagi analize populacijske FK je geometrična sredina (% koeficient variacije [CV%]) očistka (CL) 12,0 ml/h (83,7 %), geometrična sredina razpolovnega časa izločanja (t1/2) pa 17 dni (65,5 %).
No confirmed responses were observed in these 10 subjects with low (<10%) CCR4 expression.
Pri teh 10 preiskovancih z nizko (< 10 %) izraženostjo CCR4 ni bilo potrjenih odzivov.
Store in a refrigerator (2ºC to 8ºC).
Shranjujte v hladilniku (2 °C - 8 °C).
Mogamulizumab should not be infused concomitantly in the same intravenous line with other medicinal products.
Mogamulizumab se ne sme infundirati sočasno z drugimi zdravili skozi isto intravensko linijo.
See section 2 “POTELIGEO contains sodium”.
Glejte poglavje 2 »Zdravilo POTELIGEO vsebuje natrij«.
Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
Mogamulizumab has not been studied in patients with severe hepatic impairment (TB greater than 3 times ULN and any AST).
Mogamulizumaba niso raziskali pri bolnikih s hudo okvaro jeter (vrednost TB, višja od 3-kratne ULN, in kakršna koli vrednost AST).
Treatment with mogamulizumab continued until disease progression or unacceptable toxicity.
Zdravljenje z mogamulizumabom je trajalo do napredovanja bolezni ali pojava nesprejemljivih toksičnih učinkov.
Overall, the median period of progression free survival for stage IB/II subjects treated with mogamulizumab was 4.7 months compared to 3.9 months for vorinostat-treated patients (Table 4).
Na splošno je bilo mediano obdobje preživetja brez napredovanja bolezni pri bolnikih v stadiju IB/II, zdravljenih z mogamulizumabom, 4,7 meseca v primerjavi s 3,9 meseca pri bolnikih, zdravljenih z vorinostatom (preglednica 4).
The majority of treatment-related dermatologic reactions were Grade 1 or 2, with Grade ≥3 drug rash occurring in 4.3% of patients.
Večina kožnih reakcij, povezanih z zdravljenjem, je bila 1. ali 2. stopnje, medtem ko se je izpuščaj stopnje ≥ 3 pojavil pri 4,3 % bolnikov.
The exposure to mogamulizumab increased proportionally with dose over the dose range of 0.1 to 1.0 mg/kg.
Izpostavljenost mogamulizumabu se je večala sorazmerno z odmerkom v razponu od 0,1 do 1,0 mg/kg.
The following factors had no clinically important effect on the CL of mogamulizumab: age (range: 22 to 101 years), sex, ethnicity (other than Japanese, limited data are available in other ethnic populations), renal impairment, mild or moderate hepatic impairment, disease subtype (mycosis fungoides (MF) or Sézary Syndrome (SS)), degree of CCR4 expression or ECOG status, although it should be noted that patients with ECOG PS ≥2 were excluded from the clinical trials.
Naslednji dejavniki niso imeli klinično pomembnega vpliva na CL mogamulizumaba: starost (razpon od 22 do 101 leta), spol, etnična pripadnost (razen Japoncev je za druge etnične skupine na voljo malo podatkov), okvara ledvic, blaga ali zmerna okvara jeter, podtip bolezni (fungoidna mikoza (FM) ali Sézaryjev sindrom (SS)), stopnja izraženosti CCR4 ali status ECOG, vendar je treba upoštevati, da so bili bolniki s telesno zmogljivostjo ECOG ≥ 2 izključeni iz kliničnih preskušanj.