natgillin/translations-raw huggingface dataset:
5.1 Pharmacodynamic properties Pharmacotherapeutic group: Immunosuppressants, Other immunosuppressants, ATC code: L04AX06
Farmakoterapevtska skupina: zdravila za zaviranje imunske odzivnosti, druga zdravila za zaviranje imunske odzivnosti, oznaka ATC: L04AX06
In peripheral tissues, pomalidomide was preferentially taken up by tumors with apparent peripheral distribution clearance (Q/F) and apparent peripheral volume of distribution (V3/F) 3.7-fold and 8-fold higher, respectively, than that of healthy subjects.
V perifernih tkivih so pomalidomid najraje privzemali tumorji z navideznim perifernim porazdelitvenim očistkom (Q/F) in navideznim perifernim volumnom porazdelitve (V3/F), ki sta bila 3,7krat oziroma 8-krat večja kot pri zdravih osebah.
• The need to avoid foetal exposure due to teratogenicity of pomalidomide in animals and the expected teratogenic effect of pomalidomide in humans
• potrebo po izogibanju fetalni izpostavljenosti zaradi teratogenosti pomalidomida pri živalih in pričakovanega teratogenega učinka pomalidomida na človeka;
Patients should be instructed never to give this medicinal product to another person and to return any unused capsules to their pharmacist at the end of treatment.
Bolnikom je treba naročiti, da nikoli ne dajo svojega zdravila drugim in da po koncu zdravljenja vrnejo neporabljene kapsule farmacevtu.
Your doctor may need to reduce the dose of Imnovid, bortezomib or dexamethasone or stop one or more of these medicines based on the results of your blood tests, your general condition, other medicines you may be taking (e.g. ciprofloxacin, enoxacin and fluvoxamine) and if you experience side effects (especially rash or swelling) from treatment.
Zdravnik lahko zmanjša vaš odmerek zdravila Imnovid, bortezomiba ali deksametazona ali ukine eno ali več teh zdravil na podlagi rezultatov vaših krvnih preiskav, splošnega stanja, drugih zdravil, ki jih mogoče jemljete (npr. ciprofloksacin, enoksacin in fluvoksamin), in če imate zaradi zdravljenja neželene učinke (posebno izpuščaj ali otekanje).
E3 ubiquitin ligases are responsible for the poly-ubiquitination of a variety of substrate proteins, and may partially explain the pleiotropic cellular effects observed with pomalidomide treatment.
Ubikvitin ligaze E3 so odgovorne za poli-ubikvitinacijo različnih substratnih beljakovin in lahko deloma razložijo pleiotropne celične učinke, ki jih ugotavljamo pri zdravljenju s pomalidomidom.
In addition, findings consistent with acute myelogenous leukemia led to euthanasia of 1 monkey; clinical observations and clinical pathology and/or bone marrow alterations observed in this animal were consistent with immunosuppression.
Poleg tega so izsledki, ki so kazali na akutno mielogeno levkemijo, povzročili evtanazijo 1 opice; klinična opazovanja in klinična patologija in/ali spremembe kostnega mozga, ki so jih pri tej živali opazili, so kazali na imunosupresijo.
For women of childbearing potential, pomalidomide is contraindicated unless all of the following are met:
Za ženske v rodni dobi je pomalidomid kontraindiciran, razen če so izpolnjeni vsi navedeni pogoji:
• Women of childbearing potential, unless all the conditions of the pregnancy prevention programme are met (see sections 4.4 and 4.6).
• ženske v rodni dobi, če ne izpolnjujejo vseh pogojev programa za preprečevanje nosečnosti (glejte poglavji 4.4 in 4.6),
The capsules are packaged in Polyvinyl chloride (PVC)/ polychlorotrifluoroethylene (PCTFE) blisters with push through aluminium foil.
Kapsule so pakirane v pretisne omote iz polivinilklorida (PVC)/poliklorotrifluoroetilena (PCTFE)/aluminijeve folije.
Interrupt dose until symptoms are controlled.
Prekinite odmerek, dokler simptomi niso pod nadzorom.
Administration of pomalidomide in smokers, with smoking tobacco known to induce the CYP1A2 isoform, had no clinically relevant effect on exposure to pomalidomide compared to that exposure to pomalidomide observed in non-smokers.
Uporaba pomalidomida pri kadilcih, pri čemer je znano, da kajenje tobaka inducira izoobliko CYP1A2, ni klinično pomembno vplivalo na izpostavljenost pomalidomidu v primerjavi s to izpostavljenostjo pri nekadilcih.
• Bleeding within the skull.
• krvavitve znotraj lobanje,
Based on population PK analysis using a two-compartment model, healthy subjects and MM patients had comparable apparent clearance (CL/F) and apparent central volume of distribution (V2/F).
Na podlagi analize populacijske farmakokinetike, z uporabo dvoprostornega modela, so imele zdrave osebe in bolniki z DP primerljiv navidezni očistek (CL/F) in navidezni centralni volumen porazdelitve (V2/F).
Pomalidomide is eliminated with a median plasma half-life of approximately 9.5 hours in healthy subjects and approximately 7.5 hours in patients with multiple myeloma.
Pomalidomid se izloča z mediano razpolovnega časa v plazmi približno 9,5 ur pri zdravih osebah in približno 7,5 ur pri bolnikih z diseminiranim plazmocitomom.
• Even if a woman of childbearing potential has amenorrhoea she must follow all the advice on effective contraception
• tudi če ima ženska v rodni dobi amenorejo, mora upoštevati vsa navodila za zanesljivo kontracepcijo,
Population Pharmacokinetics (PK)
Populacijska farmakokinetika (FK)
• Prior to prescribing (where appropriate, and in agreement with the National Competent Authority, dispensing) all healthcare professionals who intend to prescribe (and dispense) pomalidomide are provided with a physician information pack containing the following:
• pred predpisovanjem (kjer je ustrezno in v dogovoru s pristojnim nacionalnim organom, pred izdajanjem) morajo vsi zdravstveni delavci, ki nameravajo predpisovati (in izdajati) pomalidomid, prejeti paket izobraževalnih gradiv za zdravnike, ki vsebuje naslednje: o paket izobraževalnih gradiv za zdravstvene delavce,
Overall survival is summarised in Table 12 for the ITT population.
Celokupno preživetje je povzeto v preglednici 12 za populacijo ITT.
Frequencies are defined in accordance with current guidance, as: very common (≥ 1/10), common (≥ 1/100 to < 1/10); and uncommon (≥ 1/1,000 to < 1/100).
Njihova pogostnost je določena v skladu s trenutnimi smernicami kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10) in občasni (≥ 1/1.000 do < 1/100).
Pomalidomide is contraindicated during pregnancy and in women of childbearing potential, except when all the conditions for pregnancy prevention have been met, see section 4.3 and section 4.4.
Pomalidomid je med nosečnostjo in pri ženskah v rodni dobi kontraindiciran, razen če so izpolnjeni vsi pogoji za preprečevanje nosečnosti, glejte poglavje 4.3 in poglavje 4.4.
The 3 predominant metabolites in urine (formed via hydrolysis or hydroxylation with subsequent glucuronidation) account for approximately 23%, 17%, and 12%, respectively, of the dose in the urine.
Trije prevladujoči presnovki v urinu (nastanejo s hidrolizo ali hidroksilacijo, ki ji sledi glukuronidacija) predstavljajo 23 % oz. 17 % oz. 12 % odmerka v urinu.
• Decreased number of lymphocytes (one type of white blood cells) often caused by infection (lymphopenia).
• zmanjšano število limfocitov (vrsta belih krvničk), ki ga pogosto povzroči okužba (limfopenija),
• by stimulating the immune system to attack the cancer cells
• spodbuja imunski sistem, da napada rakave celice,
Infections led to pomalidomide discontinuation in 2.0-2.9% of patients.
Okužbe so povzročile ukinitev pomalidomida pri 2,0-2,9 % bolnikov.
The potential for such drug-drug interactions, including the potential impact of pomalidomide on the pharmacokinetics of combined oral contraceptives, has not been evaluated clinically (see section 4.4 Teratogenicity).
Potencial takega medsebojnega delovanja med zdravili, vključno z možnim vplivom pomalidomida na farmakokinetiko kombiniranih peroralnih kontraceptivov, ni bil klinično ocenjen (glejte poglavje 4.4., Teratogenost).
• Infections of the nose, sinuses and throat, caused by bacteria or viruses.
• okužbe nosu, obnosnih votlin (sinusov) in žrela, ki jih povzročijo bakterije ali virusi,
Log-Rank Test Two sided P-Value d
Test log-rank dvostranska vrednost p d
According to local practice, medically supervised pregnancy tests with a minimum sensitivity of 25 mIU/mL must be performed for women of childbearing potential as outlined below.
V skladu z lokalno prakso je treba pri ženskah v rodni dobi opraviti test nosečnosti pod zdravniškim nadzorom, z občutljivostjo vsaj 25 m i.e./ml, kot je opisano spodaj.
• Medroxyprogesterone acetate depot
• depo medroksiprogesteronacetat,
The prescriber must inform the patient about the expected teratogenic risk and the strict pregnancy prevention measures as specified in the Pregnancy Prevention Programme and provide patients with appropriate patient educational brochure, patient card and/or equivalent tool in accordance with the national implemented patient card system.
Zdravniki, ki zdravilo predpisujejo, morajo bolnikom dati vse informacije o pričakovanem teratogenem tveganju in strogih ukrepih za preprečevanje nosečnosti, ki so določeni v programu za preprečevanje nosečnosti, in bolnikom izročiti ustrezno izobraževalno brošuro za bolnika, kartico bolnika in/ali enakovredno sredstvo v skladu z nacionalno uvedenim sistemom kartic za bolnika.
The recommended starting dose of bortezomib is 1.3 mg/m2 intravenous or subcutaneous once daily, on the days shown in Table 1.
Priporočeni začetni odmerek bortezomiba je 1,3 mg/m2 intravensko ali subkutano enkrat na dan, na dneve ki so prikazani v preglednici 1.
• Swelling of the body, including swelling of the arms or legs.
• oteklost telesa, vključno z otekanjem rok in nog.
The use of erythropoietic agents carries a risk of thrombotic events including thromboembolism.
Z uporabo eritropoetskih zdravil je povezano tveganje trombotičnih dogodkov, vključno z trombembolijo.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B.
A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B.
If the patient forgets to take a dose of pomalidomide on one day, then the patient should take the normal prescribed dose as scheduled on the next day.
Če bolnik en dan pozabi vzeti odmerek pomalidomida, mora naslednji dan vzeti običajni predpisani odmerek.
These immunosuppressive effects resulted in early euthanasia of 4 monkeys due to poor health condition (watery stool, inappetence, reduced food intake, and weight loss); histopathologic evaluation of these animals showed chronic inflammation of the large intestine and villous atrophy of the small intestine.
Ti imunosupresivni učinki so povzročili zgodnjo evtanazijo 4 opic zaradi slabega zdravja (vodeno blato, neješčost, manjše uživanje hrane in izguba telesne mase); histopatološka ocena teh živali je pokazala kronično vnetje debelega črevesa in atrofijo črevesnih resic tankega črevesa.
• Certain types of skin cancer (squamous cell carcinoma and basal cell carcinoma), which can cause changes in the appearance of your skin or growths on your skin.
• Nekatere vrste kožnega raka (ploščatocelični karcinom in bazalnocelični karcinom), ki lahko povzročijo spremembe videza kože ali rašče na koži.
The mean changes in exposure to pomalidomide in each of these renal impairment groups are not of a magnitude that requires dosage adjustments.
Srednje spremembe izpostavljenosti pomalidomidu v nobeni od teh skupin z okvaro ledvic niso tako velike, da bi bile potrebne prilagoditve odmerjanja.
This could lead to a condition where the tumours break down and cause unusual levels of chemicals in the blood which can lead to kidney failure.
To lahko povzroči razkroj tumorjev in posledično neobičajno visoke ravni kemikalij v krvi, ki lahko povzročijo ledvično odpoved.
Pomalidomide is distributed in semen of healthy subjects at a concentration of approximately 67% of plasma level at 4 hours post-dose (approximately Tmax) after 4 days of once daily dosing at 2 mg.
Pomalidomid se porazdeli v spermi zdravih oseb v koncentraciji približno 67 % ravni plazme 4 ure po odmerku (približno tmax) po 4 dneh odmerjanja 2 mg enkrat na dan.
Appropriate caution should be exercised when considering the treatment of such patients with pomalidomide, including periodic monitoring for signs or symptoms of cardiac events.
Ko se ocenjuje možnost zdravljenja teh bolnikov s pomalidomidom, je potrebna ustrezna previdnost, vključno z rednim spremljanjem glede znakov in simptomov, povezanih s srcem.
Within each SOC and frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Znotraj vsakega organskega sistema in skupine pogostnosti so neželeni učinki navedeni po padajoči resnosti.
Because of the potential for adverse reactions in breastfed infants from pomalidomide, a decision must be made whether to discontinue breast-feeding or to discontinue the medicinal product, taking into account the benefit of breast-feeding for the child and the benefit of the therapy for the woman.
Zaradi možnih neželenih učinkov pomalidomida pri dojenih otrocih se je treba odločiti med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja, pri čemer je treba upoštevati koristi dojenja za otroka in koristi zdravljenja za žensko.
Insertion of copper-releasing intrauterine devices is not recommended due to the potential risks of infection at the time of insertion and menstrual blood loss which may compromise patients with severe neutropenia or severe thrombocytopenia.
Vstavljanje intrauterinih vložkov, ki sproščajo baker, ni priporočljivo zaradi možnega tveganja za nastanek okužb ob času vstavitve in med menstrualno krvavitvijo, kar lahko ogrozi bolnice z resno nevtropenijo ali resno trombocitopenijo.
PFS (months) Mediana time (95% CI) b HR c (95% CI), p-valued ORR, n (%) sCR
PFS (meseci) Mediania čas (95 % IZ)b HR c (95 % IZ), vrednost pd ORR, n (%) sCR
• Prior to launch, all doctors who intend to prescribe pomalidomide and all pharmacists who may dispense pomalidomide receive a Direct Healthcare Professional Communication as described below.
• pred prihodom zdravila na trg morajo vsi zdravniki, ki nameravajo predpisovati pomalidomid, in vsi farmacevti, ki bodo izdajali pomalidomid, prejeti Neposredno obvestilo za zdravstvene delavce, kot je opisano spodaj;
The MAH should agree the final text of the Direct Healthcare Professional Communication and the physician information pack contents with the National Competent Authority in each Member State and ensure that the materials contain the key elements as described below.
Imetnik dovoljenja za promet z zdravilom se mora s pristojnim nacionalnim organom v vsaki državi članici dogovoriti o končnem besedilu Neposrednega obvestila za zdravstvene delavce in vsebini paketa izobraževalnih gradiv za zdravnike in zagotoviti, da gradiva vsebujejo ključne elemente, kot so opisani spodaj.
Clinically relevant drug-drug interactions are not anticipated when pomalidomide is coadministered with substrates of these pathways.
Klinično pomembnega medsebojnega delovanja med zdravili se ne pričakuje, ko se pomalidomid daje sočasno s substrati teh poti.
Patients > 75 years of age started treatment with 20 mg dexamethasone.
Bolniki stari > 75 let so zdravljenje začeli z 20 mg deksametazona.
Pomalidomide was detected in milk of lactating rats following administration to the mother.
Pomalidomid so zaznali v mleku podgan med laktacijo, ko so ga dali materam.
o Educational Health Care Professional's kit o Educational brochures for patients o Patient cards o Summary of Product Characteristics (SmPC) and Package Leaflet and Labelling.
o izobraževalne brošure za bolnike, o kartice za bolnike, o povzetek glavnih značilnosti zdravila (SmPC), navodilo za uporabo in označevanje.
Uterine examination on Gestation Day 13 showed a decrease in mean number of viable embryos and an increase in postimplantation loss at all dosage levels.
Pregled v maternici na 13. dan gestacije je pokazal zmanjšano število zarodkov, sposobnih preživetja, in višjo izgubo po ugnezditvi pri vseh ravneh odmerkov.
Complete blood counts should be monitored at baseline, weekly for the first 8 weeks and monthly thereafter.
Prvih 8 tednov je treba celotno krvno sliko spremljati na izhodišču, tedensko, nato pa vsak mesec.
Pomalidomide was not mutagenic in bacterial and mammalian mutation assays, and did not induce chromosomal aberrations in human peripheral blood lymphocytes or micronuclei formation in polychromatic erythrocytes in bone marrow of rats administered doses up to 2000 mg/kg/day.
Pomalidomid v preskusih mutagenosti pri bakterijah in sesalcih ni bil mutagen in ni spodbudil kromosomske aberacije v limfocitih periferne krvi pri ljudeh ali nastajanja mikronukleusov v polikromatskih eritrocitih v kostnem mozgu podgan, ki so jim dajali odmerke do 2.000 mg/kg/dan.
Frequencies for Pom+Btz+Dex (any grade) are defined in accordance with current guidance, as: very common (≥1/10), common (≥1/100 to <1/10); and uncommon (≥1/1,000 to <1/100).
Pogostnosti za Pom+Btz+deks (vse stopnje) so opredeljene v skladu z veljavnimi smernicami kot zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10) in občasni (≥ 1/1.000 do < 1/100).
Stop taking Imnovid and see a doctor straight away if you notice any of the serious side effects listed above - you may need urgent medical treatment.
Takoj prenehajte jemati zdravilo Imnovid in pojdite k zdravniku, če opazite kakega od zgoraj navedenih resnih neželenih učinkov - mogoče bo potrebno nujno medicinsko zdravljenje.
• She understands the need to commence the treatment as soon as pomalidomide is dispensed following a negative pregnancy test
• mora razumeti potrebo, da prične z zdravljenjem, brž ko je izdan pomalidomid po negativnem testu nosečnosti,
Do not take Imnovid:
Ne jemljite zdravila Imnovid:
These patients should be closely monitored for signs and symptoms of active HBV infection throughout therapy.
Te bolnike morate ves čas zdravljenja skrbno spremljati glede znakov in simptomov aktivne infekcije s HBV.
Interrupt dose until muscle weakness ≤ Grade 1.
Prekinite odmerek, dokler ni oslabelost mišic ≤ 1. stopnje.
Stop dexamethasone dosing until the adverse event resolves to ≤ Grade 2.
Prenehajte dajati deksametazon, dokler se neželeni učinki ne zmanjšajo na ≤ 2. stopnjo.
Based on in vitro data, pomalidomide is not an inhibitor or inducer of cytochrome P-450 isoenzymes, and does not inhibit any drug transporters that were studied.
Na podlagi podatkov in vitro pomalidomid ni zaviralec ali spodbujevalec izoencimov citokroma P-450 in ne zavira nobenega od prenašalcev zdravil, ki so jih proučevali.
Pomalidomide is absorbed with a maximum plasma concentration (Cmax) occurring between 2 and 3 hours and is at least 73% absorbed following administration of single oral dose.
Ko se pomalidomid absorbira, so največje koncentracije v plazmi (Cmax) dosežene po 2 do 3 urah in vsaj 73 % se absorbira po uporabi enega peroralnega odmerka.
Patients with a prior history of serious allergic reactions associated with thalidomide or lenalidomide were excluded from clinical studies.
Bolniki s predhodnimi resnimi alergijskimi reakcijami med zdravljenjem s talidomidom ali lenalidomidom so bili izključeni iz kliničnih študij.
PFS is summarised in Table 11 for the ITT population.
PFS je povzeto v preglednici 11 za populacijo ITT.
Overall Survival (week)
Celokupno preživetje (tedni)
The patient card shall contain the following elements:
Kartica za bolnika mora vsebovati naslednje elemente:
Maintain dose and treat with histamine (H2) blockers or equivalent.
Ohranite odmerek in zdravite z antagonisti histaminskih receptorjev (H2) ali enakovrednim zdravilom.
Peripheral neuropathy led to discontinuation of bortezomib in approximately 12.9% of patients, pomalidomide in 1.8% and dexamethasone in 2.2 - 8.9% of patients, respectively.
Periferna nevropatija je povzročila ukinitev bortezomiba pri približno 12,9 % bolnikov, pomalidomida pri 1,8 % in deksametazona pri 2,2-8,9 % bolnikov.
• Urinary tract infection, which may cause a burning sensation when passing urine, or a need to pass urine more often.
• okužbe sečil, ki lahko povzročijo pekoč občutek pri odvajanju urina ali potrebo po pogostnejšem odvajanju urina,
This includes vasectomised males who should wear a condom if engaged in sexual activity with a pregnant woman or a woman of childbearing potential as seminal fluid may still contain pomalidomide in the absence of spermatozoa.
To vključuje tudi moške, ki so imeli vazektomijo, ki morajo uporabljati kondom, če spolno občujejo z nosečnico ali žensko v rodni dobi, ker lahko semenska tekočina v odsotnosti semenčic še vedno vsebuje pomalidomid;
The most frequently reported adverse reaction was peripheral sensory neuropathy (47.8%).
Neželeni učinek, o katerem so najpogosteje poročali, je bila periferna senzorična nevropatija (47,8 %).
95% confidence interval about the median progression free survival time.
95 % interval zaupanja pri mediani časa preživetja brez napredovanja.
• That the patient should tell their doctor about any adverse events
• opozorilo, da mora bolnik zdravniku poročati o kakršnihkoli neželenih učinkih.
CYP dependent metabolites account for approximately 43% of the total excreted radioactivity, while nonCYP dependent hydrolytic metabolites account for 25%, and excretion of unchanged pomalidomide accounted for 10% (2% in urine and 8% in faeces).
Od CYP odvisni presnovki predstavljajo približno 43 % skupne izločene radioaktivnosti, hidrolitični presnovki, ki niso odvisni od CYP, predstavljajo 25 %, nespremenjenega pomalidomida pa se izloči 10 % (2 % v urinu in 8 % v blatu).
• Swallow the capsules whole, preferably with water.
• Kapsule zaužijte cele, po možnosti z vodo.
• A fast and irregular heartbeat (atrial fibrillation).
• hiter in nereden srčni utrip (atrijska fibrilacija),
Pomalidomide enhances T cell- and natural killer (NK) cell-mediated immunity and inhibits production of pro-inflammatory cytokines (e.g., TNF-α and IL-6) by monocytes.
Pomalidomid okrepi celično imunost, ki jo posredujejo celice T in naravne ubijalke (NK - Natural Killer), ter zavira nastajanje proinflamatornih citokinov (npr. TNF-α in IL-6) z monociti.
Do not increase the number of capsules you take to make up for not taking Imnovid the previous day.
Ne povečajte števila kapsul, da bi nadomestili kapsulo zdravila Imnovid, ki ste jo prejšnji dan izpustili.
st relapse and approximately 73% of patients received bortezomib as prior treatment.
Približno 40 % bolnikov je imelo prvi recidiv, približno 73 % bolnikov pa je kot predhodno zdravljenje prejemalo bortezomib.
• Severe, persistent or bloody diarrhoea (possibly with stomach pain or fever) caused by bacteria called Clostridium difficile.
• močna, trdovratna ali krvava driska (lahko z bolečinami v želodcu ali zvišano telesno temperaturo), ki jo povzročajo bakterije, ki se imenujejo Clostridium difficile;
The median duration of treatment was 8.8 months (12 treatment cycles) in the Pom+Btz+LD-Dex arm and 4.9 months (7 treament cycles) in the Btz+LD-Dex arm.
Mediano trajanje zdravljenja je bilo 8,8 meseca (12 ciklov zdravljenja) v skupini Pom+Btz+NO-deks in 4,9 meseca (7 ciklov zdravljenja) v skupini Btz+NO-deks.
Resume at one dose level lower than previous dose at next cycle (adverse event must be resolved or improved to ≤ Grade 2 before restarting dosing).
V naslednjem ciklu nadaljujte zdravljenje z odmerkom, za eno raven manjšim od predhodnega odmerka (pred ponovnim začetkom odmerjanja mora neželeni učinek izzveneti ali se ublažiti na ≤ 2. stopnjo).
No peripheral neuropathy reactions were reported as serious, and peripheral neuropathy led to dose discontinuation in 0.3% of patients (see section 4.4).
O resnih reakcijah periferne nevropatije niso poročali, periferna nevropatija pa je povzročila ukinitev odmerjanja pri 0,3 % bolnikov (glejte poglavje 4.4).
However, patients with hepatic impairment should be carefully monitored for adverse reactions and dose reduction or interruption of pomalidomide should be used as needed.
Vendar je treba bolnike z okvaro jeter skrbno spremljati glede neželenih učinkov in po potrebi zmanjšati odmerek ali prekiniti uporabo pomalidomida.