natgillin/translations-raw huggingface dataset:
Remove the treosulfan powder carefully from the inner surface of the vial by shaking.
S stresanjem previdno odstranite prašek treosulfana z notranje površine viale.
No dose adjustment is necessary for mild or moderate impairment, but treosulfan is contraindicated in patients with severe impairment (see section 4.3).
Pri blagi ali zmerni okvari prilagajanje odmerka ni potrebno, je pa treosulfan kontraindiciran pri bolnikih s težko okvaro (glejte poglavje 4.3).
Do not use Trecondi:  if you are allergic to treosulfan,  if you suffer from an active uncontrolled infection,  if you suffer from severe heart, lung, liver or kidney diseases,  if you suffer from hereditary DNA repair disorder, a condition that reduces the ability to repair
 če ste alergični na treosulfan,  če imate aktivno neobvladano okužbo,  če imate težko bolezen srca, pljuč, jeter ali ledvic,  če imate dedno bolezen popravljanja DNK, to je bolezen, ki zmanjša sposobnost za popravljanje
The recommended dose is 10-14 g/m² body surface area.
Priporočeni odmerek je 10-14 g/m² telesne površine.
The epoxides formed alkylate nucleophilic centres of deoxyribonucleic acid (DNA) and are able to induce DNA cross-links which are considered responsible for the stem cell depleting and antineoplastic effects.
Nastali epoksidi alkilirajo nukleofilne centre deoksiribonukleinske kisline (DNK) in so sposobni inducirati navzkrižne povezave DNK, ki veljajo za odgovorne za zmanjšanje števila matičnih celic in antineoplastične učinke.
• heart not pumping enough blood for the body's needs (heart failure), heart attack, fluid in the sac around the heart (pericardial effusion)
• srce, ki ne črpa dovolj krvi za potrebe telesa (popuščanje srca), srčni infarkt, tekočina v vreči okrog srca (perikardialni izliv),
• sudden decrease of kidney function, blood in the urine
• nenadno opešanje delovanja ledvic, kri v urinu,
It is unknown whether treosulfan is excreted in human milk.
Ni znano, ali se treosulfan izloča v materino mleko.
Detailed in vitro studies did not completely exclude potential interactions between high plasma concentrations of treosulfan and CYP3A4, CYP2C19, or P-gp substrates.
Natančne študije in vitro niso popolnoma izključile možnih interakcij med visokimi koncentracijami treosulfana v plazmi in substrati CYP3A4, CYP2C19 ali P-gp.
The most frequent adverse reactions reported were nausea (39.5%), stomatitis (36%), vomiting (22.5%), diarrhoea (15.6%), and abdominal pain (10.4%).
Najpogostejši neželeni učinki, o katerih so poročali, so bili navzea (39,5 %), stomatitis (36 %), bruhanje (22,5 %), driska (15,6 %) in bolečina v trebuhu (10,4 %).
No specific antidote of treosulfan overdose is known.
Specifičnega antidota za prevelik odmerek treosulfana ne poznamo.
If you are a man treated with this medicine, you should not father a child during and up to 6 months after treatment.
Če ste moški, ki ga zdravijo s tem zdravilom, med zdravljenjem in do 6 mesecev po koncu zdravljenja ne smete zaploditi otroka.
Therefore, men treated with treosulfan are advised not to father a child during and up to 6 months after treatment and to seek advice on cryo-conservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with treosulfan.
Zato je treba moškim, ki se zdravijo s treosulfanom, svetovati, naj med zdravljenjem in do 6 mesecev po zdravljenju ne zaplodijo otroka in naj se posvetujejo o možnosti zamrznitve sperme pred začetkom zdravljenja, ker obstaja možnost nepovratne neplodnosti zaradi zdravljenja s treosulfanom.
Reconstituted solution for infusion
Rekonstituirana raztopina za infundiranje
A report from an investigator-initiated trial performed in children with primary immunodeficiencies lists four cases of seizures occurring after other treosulfan-based conditioning regimens (see section 4.4).
Poročilo o preskušanju na pobudo raziskovalca, opravljeno pri otrocih s primarnimi imunskimi pomanjkljivostmi, navaja štiri primere epileptičnih napadov, ki so se pojavili po drugih shemah kondicioniranja na podlagi treosulfana (glejte poglavje 4.4).
Not known Alkalosis
Neznana Alkaloza
The efficacy and safety of treosulfan-based conditioning was evaluated in 70 patients with acute lymphoblastic leukaemia (ALL), AML, MDS, or juvenile myelomonocytic leukaemia (JMML) who received a conditioning regimen with treosulfan and fludarabine with (n = 65) or without (n = 5) thiotepa (see section 4.2).
Učinkovitost in varnost kondicioniranja na podlagi treosulfana so ocenili pri 70 bolnikih z akutno limfoblastno levkemijo (ALL), AML, MDS ali juvenilno mielomonocitno levkemijo (JMML), ki so prejemali shemo kondicioniranja s treosulfanom in fludarabinom s tiotepo (n = 65) ali brez nje (n = 5) (glejte poglavje 4.2).
• high blood sugar level
• zvišana raven sladkorja v krvi,
Rare Confusional state
Redki Stanje zmedenosti
Treosulfan is used to prepare patients for bone marrow transplant (haematopoietic stem cell transplantation).
Treosulfan se uporablja za pripravo bolnikov na presaditev kostnega mozga (transplantacija krvotvornih matičnih celic).
Rare Epistaxis, pneumonitis
Redki Epistaksa, pnevmonitis
• leakage of fluid from the capillaries (small blood vessels), high blood pressure, low blood pressure
• uhajanje tekočine iz kapilar (majhnih krvnih žil), zvišan krvni tlak, znižan krvni tlak,
The immunosuppressive effects of treosulfan are attributed to its toxicity against primitive and committed progenitor cells, T and NK cells, reduction of cellularity of primary and secondary lymphatic organs and a preclusive effect on the ‘cytokine storm' that precedes the development of Graft-versus-Host-Disease (GvHD) and is involved in the pathogenesis of veno-occlusive disease.
Imunosupresivne učinke treosulfana pripisujejo njegovi toksičnosti za primitivne in usmerjene progenitorne celice, celice T in NK, zmanjšanju celularnosti primarnih in sekundarnih limfatičnih organov in preprečevalnemu vplivu na 'citokinsko nevihto', ki ji sledi razvoj bolezni presadka zoper gostitelja (Graft-versus-Host-Disease - GvHD) in ki je vpletena v patogenezo venookluzivne bolezni.
As with all cytotoxic substances, appropriate precautions should be taken when handling treosulfan.
Tako kot pri vseh citotoksičnih snoveh so pri ravnanju s treosulfanom potrebni ustrezni varnostni ukrepi.
Prophylactic or empiric anti-infective treatment (bacterial, viral, fungal) should therefore be considered.
Zato pride v poštev profilaktično ali empirično zdravljenje proti okužbam (bakterijskim, virusnim, glivičnim).
Published literature data report on gonadotoxicity of treosulfan in pre-pubertal and pubertal male and female mice.
Podatki, objavljeni v literaturi, poročajo o gonadotoksičnosti treosulfana pri predpubertetnih in pubertetnih mišjih samcih in samicah.
Blood alkaline phosphatase increased, C-reactive protein increased
Zvišana alkalna fosfataza v krvi, zvišan C-reaktivni protein
Maximum plasma levels (mean ± SD) in adult patients after a 2-hour intravenous infusion of 10, 12, or 14 g/m² treosulfan were 306 ± 94 µg/mL, 461 ± 102 µg/mL, and 494 ± 126 µg/mL, respectively.
Najvišje plazemske koncentracije (povprečje ± SD) pri odraslih bolnikih po 2-urni intravenski infuziji 10, 12 ali 14 g/m² treosulfana so bile 306 ± 94 µg/ml, 461 ± 102 µg/ml oziroma 494 ± 126 µg/ml.
Adults with malignant disease
Odrasli z maligno boleznijo
All patients engrafted, with a median time to neutrophil engraftment of 21 (range, 12-46) days.
Pri vseh bolnikih so se presajene celice prijele, z medianim časom do prijetja nevtrofilcev 21 (razpon 12-46) dni.
Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
Ni dovolj študij na živalih o vplivu zdravila na sposobnost razmoževanja (glejte poglavje 5.3).
How to use Trecondi
Kako uporabljati zdravilo Trecondi
The adverse reactions reported in the table below are derived from two clinical trials (including a total of 88 patients; median age 8 years [range 0-17 years]) where treosulfan combined with fludarabine (and mostly with additional thiotepa) was administered as conditioning treatment prior to alloHSCT in paediatric patients with malignant or non-malignant diseases.
Neželeni učinki, navedeni v preglednici v nadaljevanju, izvirajo iz dveh kliničnih preskušanj (v kateri je bilo vključenih skupaj 88 bolnikov; mediana starost 8 let [razpon 0-17 let]), v katerih so dajali treosulfan v kombinaciji s fludarabinom (in večinoma z dodatno tiotepo) kot zdravljenje s kondicioniranjem pred alloHSCT pri pediatričnih bolnikih z malignimi ali nemalignimi boleznimi.
• blocking of a vein into the liver (adults: uncommon; children and adolescents: not known)
• zapora vene v jetrih (odrasli: občasni; otroci in mladostniki: neznana),
• If you have any further questions, ask your doctor, pharmacist or nurse.
 Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Transplant-related mortality at 12 months is 2.9% (90% CI 0.9 - 8.9%).
Smrtnost, povezana s presadkom, pri 12 mesecih je bila 2,9 % (90 % IZ 0,9 - 8,9 %).
How much treosulfan contributes to their occurrence is unknown.
Ni znano, koliko k njihovemu pojavljanju prispeva treosulfan.
Pharmacotherapeutic group: Antineoplastic agents, alkylating agents, ATC code: L01AB02
Farmakoterapevtska skupina: Zdravila z delovanjem na novotvorbe (citostatiki), alkilirajoči citostatiki, oznaka ATC: L01AB02
Trecondi contains the active substance treosulfan, which belongs to a group of medicines called alkylating agents.
Zdravilo Trecondi vsebuje učinkovino treosulfan, ki pripada skupini zdravil, ki se imenujejo alkilirajoča sredstva.
• Treosulfan should be administered before fludarabine;
• Treosulfan je treba dati pred fludarabinom.
• decrease in the oxygen supply to parts of the body (hypoxia)
• zmanjšana preskrba nekaterih delov telesa s kisikom (hipoksija),
Profound myelosuppression/pancytopenia is the desired therapeutic effect of conditioning therapy and occurs in all patients.
Močna mielosupresija/pancitopenija je želeni terapevtski učinek pripravljalnega zdravljenja in nastopi pri vseh bolnikih.
You must not get pregnant during treatment with this medicine and up to 6 months after treatment.
Med zdravljenjem s tem zdravilom in do 6 mesecev po koncu zdravljenja ne smete zanositi.
• increased blood level of creatinine (a substance normally removed by the kidneys into the urine), increased blood level of lactate dehydrogenase (a substance that indicates tissue or cellular damage)
• zvišana raven kreatinina v krvi (snov, ki jo navadno odstranjujejo ledvice z urinom), zvišana raven laktat dehidrogenaze v krvi (snov, ki kaže na tkivno ali celično okvaro).
The median (25%/75% percentiles) duration of neutropenia was 21 (16, 26) days in paediatric patients with malignant diseases and 24 (17, 26) days in patients with non-malignant disorders.
Mediano (25 %/75 % percentila) trajanje nevtropenije je bilo 21 (16, 26) dni pri pediatričnih bolnikih z malignimi boleznimi in 24 (17, 26) dni pri bolnikih z nemalignimi boleznimi.
However, during chronic toxicity tests in rats spermatogenesis and ovarian function were significantly affected.
Vendar pa sta bili med testiranjem kronične toksičnosti na podganah pomembno prizadeti spermatogeneza in funkcija jajčnikov.
• life-threatening condition after bloodstream infection (septic shock)
• smrtno nevarno stanje po okužbi krvi v obtoku (septični šok),
All patients engrafted except one, who died on day +11; the median time to neutrophil and platelet recovery was 20 days.
ki je umrl dne +11; mediani čas do okrevanja nevtrofilcev in trombocitov je bil 20 dni.
Administration of treosulfan should be supervised by a physician experienced in conditioning treatment followed by alloHSCT.
Dajanje treosulfana mora nadzirati zdravnik, ki ima izkušnje s pripravljalnim zdravljenjem, ki mu sledi alloHSCT.
Blood creatinine increased, blood lactate dehydrogenase (LDH) increased
Zvišan kreatinin v krvi, zvišana laktat dehidrogenaza (LDH) v krvi
Acute GvHD, all Grades; % (95% CI) 52.1 (45.5, 58.7) 58.8 (52.5, 65.0) 0.1276 Acute GvHD, Grades III/IV; % (95%
Akutna GvHD, vse stopnje; % (95 % IZ) 52,1 (45,5; 58,7) 58,8 (52,5; 65,0) 0,1276 Akutna GvHD, stopnja III/IV; % (95 % IZ)
The overall survival at 12 months is 91.4% (90% CI 83.9-95.5%).
Skupno preživetje pri 12 mesecih je bilo 91,4 % (90 % IZ 83,9-95,5 %).
• bleeding in the eye, dry eye
• krvavitev v očesu, suho oko,
Muscular weakness
Mišična šibkost
Gastrointestinal disorders were observed in 357 patients (63.3%).
Bolezni prebavil so ugotovili pri 357 bolnikih (63,3 %).
Under physiological conditions (pH 7.4, temperature 37 °C), the pharmacologically inactive treosulfan is converted spontaneously (non-enzymatically) into the active monoepoxide intermediate (S,S-EBDM = (2S,3S)-1,2-epoxybutane-3,4-diol-4-methanesulfonate) and finally to L-diepoxibutane (S,S-DEB = (2S,3S)-1,2:3,4-diepoxybutane).
V fizioloških razmerah (pH 7,4, temperatura 37 °C) se farmakološko neaktivni treosulfan spontano (neencimsko) pretvori v aktivni monoepoksidni vmesni produkt (S,S-EBDM = (2S,3S)-1,2-epoksibutan-3,4-diol-4-metansulfonat) in na koncu v L-diepoksibutan (S,S-DEB = (2S,3S)-1,2:3,4-diepoksibutan).
• pain or inflammation at the injection site, feeling cold
• bolečina ali vnetje na mestu injiciranja, občutek mraza,
There have been isolated reports of seizures in infants (≤ 4 months of age) with primary immunodeficiencies after conditioning treatment with treosulfan in combination with fludarabine or cyclophosphamide.
Obstajajo posamezna poročila o epileptičnih napadih pri dojenčkih (starih ≤ 4 mesece) s primarnimi imunskimi pomanjkljivostmi po pripravljalnem zdravljenju s treosulfanom v kombinaciji s fludarabinom ali ciklofosfamidom.
Prophylactic use of mouthwashes (e.g. with barrier protectants, antimicrobials) or application of ice within the oral cavity (lessens blood flow to the oral mucosa and reduces the amount of treosulfan reaching the cell) is recommended.
Priporočamo uporabo ustnih vodic (npr. s sredstvi za zaščito pregrade, s protimikrobnimi sredstvi) ali vnašanje ledu v ustno votlino (ta zmanjša pretok krvi v ustno sluznico in zmanjša količino treosulfana, ki doseže celice).
Use an effective method of contraception when either you or your partner is receiving this medicine.
Medtem ko vi ali vaš partner prejema to zdravilo, uporabljajta zanesljivo kontracepcijsko metodo.
• decreased counts of white blood cells with fever (febrile neutropenia)
• zmanjšano število belih krvničk z zvišano telesno temperaturo (febrilna nevtropenija),
Analyses of EFS at 2 years for various pre-defined subgroups (donor type, risk group, disease, age group, HCT-CI score, remission status at study entry, and various combinations of these parameters) were always in favour of the treosulfan regimen (hazard ratio [HR] of FT10 vs. FB2 < 1), with only one exception (risk group I of MDS patients; HR 1.14 [95% CI 0.48, 2.63]).
Analize EFS pri 2 letih za različne vnaprej definirane podskupine (vrsta donatorja, skupina tveganja, bolezen, starostna skupina, rezultat HCT-CI, status remisije ob vstopu v študijo in različne kombinacije teh parametrov) so bile vedno v korist sheme s treosulfanom (razmerje tveganja [HR] FT10 proti FB2 < 1), z eno samo izjemo (skupina tveganja I bolnikov z MDS; HR 1,14 [95 % IZ 0,48;
Cumulative incidence of relapse/progression; % (95% CI)
Kumulativna pogostnost recidiva/napredovanja bolezni; % (95 % IZ)
The total fludarabine dose is 150 mg/m²;
Skupni odmerek fludarabina je 150 mg/m²;
Treosulfan is for intravenous use as a two-hour infusion.
Treosulfan je namenjen za intravensko uporabo v obliki dveurne infuzije.
The reconstituted solution contains 50 mg treosulfan per mL and appears as a clear colourless solution.
Rekonstituirana raztopina vsebuje 50 mg treosulfana na ml in je na pogled bistra, brezbarvna raztopina.
Treosulfan is a prodrug that is spontaneously converted under physiological conditions (pH 7.4; 37 °C) into a monoepoxide intermediate and L-diepoxybutane with a half-life of 2.2 hours.
Treosulfan je prekurzor zdravila, ki se v fizioloških razmerah (pH 7,4; 37 °C) spontano pretvori v monoepoksidni vmesni produkt in L-diepoksibutan z razpolovnim časom 2,2 uri.
Very common Bilirubin increased
Zelo pogosti Zvišan bilirubin
Dermatitis diaper may occur in small children because of excretion of treosulfan in the urine.
Plenični izpuščaj Plenični izpuščaj se lahko pojavi pri majhnih otrocih zaradi izločanja treosulfana v urin.
Neoplasms benign, malignant and unspecified (including cysts and polyps)*
Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi)*
There is limited information available on treosulfan-based conditioning (FT14 regimen ± thiotepa; see section 4.2) in adult patients with non-malignant disorders (NMD).
Podatkov o kondicioniranju na podlagi treosulfana (shema FT14 ± tiotepa; glejte poglavje 4.2) pri odraslih bolnikih z nemalignimi boleznimi (non-malignant disorders - NMD) je malo.
The incidence of complete donor-type chimerism was 94.2% (90% CI 87.2-98.0%) at day +28 visit, 91.3% (90% CI 83.6-96.1%) at day +100 visit and 91.2% (90% CI 82.4-96.5%) at month 12 visit.
Pogostnost popolnega himerizma donatorske vrste je bila 94,2 % (90 % IZ 87,2-98,0 %) pri pregledu dne +28, 91,3 % (90 % IZ 83,6-96,1 %) pri pregledu dne +100 in 91,2 % (90 % IZ 82,4-96,5 %) pri pregledu v 12. mesecu.
This medicine is used in combination with fludarabine and in most cases also with thiotepa.
Uporaba pri otrocih in mladostnikih To zdravilo se uporablja v kombinaciji s fludarabinom in večinoma tudi s tiotepo.
There are no data from the use of treosulfan in pregnant women.
O uporabi treosulfana v nosečnosti ni podatkov.
Not known Renal failure, cystitisc, dysuria
Neznana Odpoved ledvic, cistitisc, dizurija
For preparation of sodium chloride 4.5 mg/mL (0.45%) solution equivalent volumes of sodium chloride 9 mg/mL (0.9%) solution and water for injections can be mixed.
Raztopino natrijevega klorida 4,5 mg/ml (0,45 %) lahko pripravite tako, da zmešate enaka volumna raztopine natrijevega klorida 9 mg/ml (0,9 %) in vode za injekcije.
Men should seek advice about the possibility of sperm preservation before starting therapy.
Moški naj se posvetujejo o možnosti zamrznitve sperme pred začetkom zdravljenja.
The main indications for an alloHSCT with treosulfan conditioning in adult NMD patients are haemoglobinopathies (e.g. sickle cell disease, thalassaemia major [TM]), primary immune deficiency, hemophagocytic disorder, immune dysregulatory disorder and bone marrow failure).
Glavne indikacije za alloHSCT s kondicioniranjem s treosulfanom pri odraslih bolnikih z NMD so hemoglobinopatije (npr. bolezen srpastih celic, velika talasemija - thalassaemia major [TM]), primarna imunska pomanjkljivost, hemofagocitna bolezen, bolezen z motenim uravnavanjem imunskega odziva in odpoved kostnega mozga.
c For testing superiority of treosulfan compared to busulfan.
cZa preskus superiornosti treosulfana v primerjavi z busulfanom.
Treosulfan is considered an irritant.
Treosulfan velja za iritant.
Fits (seizures) may occur very rarely in infants of less than 4 months of age.
Pri dojenčkih, mlajših od 4 mesecev, se lahko zelo redko pojavijo napadi krčev (epileptični napadi).
Acidosisb, glucose tolerance impaired, electrolyte imbalance
Acidozab, zmanjšana toleranca za glukozo, neravnovesje elektrolitov
Treosulfan is given in combination with fludarabine.
Treosulfan dajemo v kombinaciji s fludarabinom.
Treosulfan is given in combination with fludarabine with or without thiotepa.
Treosulfan dajemo v kombinaciji s fludarabinom s tiotepo ali brez nje.
• problems in the nerves of the arms or legs with symptoms such as numbness, reduced or increased sensitivity, tingling, burning pain (peripheral sensory neuropathy)
• težave z živci zgornjih ali spodnjih udov s simptomi, kakršni so odrevenelost, zmanjšana ali zvečana občutljivost, mravljinčenje, pekoča bolečina (periferna senzorična nevropatija),
• Keep this leaflet.
* Glejte podrobna poglavja v nadaljevanju.
Pregnant personnel should be excluded from handling cytotoxics.
Nosečnice ne smejo rokovati s citotoksičnimi zdravili.
Growth factors (G-CSF, GM-CSF), platelet and/or red blood cell support should be given as indicated.
Podporo v obliki rastnih faktorjev (G-CSF, GM-CSF), trombocitov in/ali rdečih krvničk dajemo, kadar je indicirana.
4.4 Special warnings and precautions for use
4.4 Posebna opozorila in previdnostni ukrepi Mielosupresija
Pathogens included bacteria (e.g. Staphylococcus, Enterococcus, Corynebacterium), viruses (e.g. cytomegalovirus [CMV], Epstein-Barr virus [EBV], herpes) as well as fungi (e.g. candida).
Corynebacterium), viruse (npr. citomegalovirus [CMV], Epstein-Barrov virus [EBV], herpes) in tudi glivice (npr. candida).
Use Luer-lock fittings on all syringes and sets.
Na vseh brizgah in infuzijskih sistemih uporabljajte nastavke Luer lock.
• inflammation of the lung (pneumonitis) (adults: uncommon)
• vnetje pljuč (pnevmonitis) (odrasli: občasni).
Alkalosis, electrolyte imbalance, hypomagnesaemia
Alkaloza, neravnovesje elektrolitov, hipomagneziemija
Myelosuppression, pancytopenia, febrile neutropenia
Mielosupresija, pancitopenija, febrilna nevtropenija
Blood and lymphatic system disorders*
Bolezni krvi in limfatičnega sistema*
OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Citotoksično sredstvo.
The infection rate was lowest in patients treated with the dose regimen of 10 g/m² of treosulfan per day, from day -4 to -2 (7.7%).
Pogostnost infekcij je bila najmanjša pri bolnikih, zdravljenih s shemo odmerjanja 10 g/m² treosulfana na dan od dneva -4 do -2 (7,7 %).
The median (25%/75% percentiles) duration of neutropenia was 14 (12, 20) days with the 10 g/m² treosulfan dose and 17.5 (14, 21) days with the 14 g/m² treosulfan dose.
Mediano (25 %/75 % percentila) trajanje nevtropenije je bilo 14 (12, 20) dni pri odmerku treosulfana 10 g/m² in 17,5 (14, 21) dni pri odmerku treosulfana 14 g/m².
Transaminases (ALT/AST) increased, bilirubin increased
Zvišani transaminazi (ALT/AST), zvišan bilirubin
As known for other alkylating conditioning agents treosulfan can cause ovarian suppression and amenorrhoea with menopausal symptoms in pre-menopausal women.
Kot je znano za druga alkilirajoča sredstva za kondicioniranje, lahko tudi treosulfan pri ženskah pred menopavzo povzroči supresijo jajčnikov in amenorejo s simptomi menopavze.
Tel.:
Nemčija Tel.:
The most commonly observed adverse reactions (adults/paediatric patients) after treosulfan-based conditioning followed by alloHSCT include infections (13.1% /11.4%), gastrointestinal disorders (nausea [39.5%/30.7%], stomatitis [36.0%/69.3%], vomiting [22.5%/43.2%], diarrhoea [15.6%/33.0%], abdominal pain [10.4%/17%]), fatigue (15.1%/2.3%), febrile neutropenia (11.3%/1.1%), oedema (7.8%/0%), rash (7.2%/12.5%), and increases of alanine transaminase (ALT [5.1%/9.1%]), aspartate transaminase (AST [4.4%/8.0%]), gamma-glutamyl transferase (γGT [3.7%/2.3%]), and bilirubin (18.8%/5.7%).
[39,5 %/30,7 %], stomatitis [36,0 %/69,3 %], bruhanje [22,5 %/43,2 %], driska [15,6 %/33,0 %], bolečina v trebuhu [10,4 %/17 %]), utrujenost (15,1 %/2,3 %), febrilna nevtropenija (11,3 %/1,1 %), edemi (7,8 %/0 %), izpuščaj (7,2 %/12,5 %) in zvišanje alanin-transaminaze (ALT [5,1 %/9,1 %]), aspartat-transaminaze (AST [4,4 %/8,0 %]), gama glutamil transferaze (γGT [3,7 %/2,3 %]) in bilirubina (18,8 %/5,7 %).
A retrospective comparison of treosulfan-based (n = 16) versus busulfan-based (n = 81) conditioning in adult patients revealed quite comparable survival rates (70.3 ± 15.1% vs. 69.3 ± 5.5%), while risk for acute GvHD was lower in the treosulfan group (odds ratio 0.28; 95% CI 0.12-0.67; P = 0.004) (Caocci G et al.; American Journal of Hematology 2017; 92(12):1303-1310).
Retrospektivna primerjava kondicioniranja na podlagi treosulfana (n = 16) s kondicioniranjem na podlagi busulfana (n = 81) pri odraslih bolnikih je razkrila povsem primerljive pogostnosti preživetja (70,3 ± 15,1 % proti 69,3 ± 5,5 %), medtem ko je bilo tveganje za akutno GvHD manjše v treosulfanski skupini (razmerje tveganja 0,28; 95 % IZ 0,12-0,67; P = 0,004) (Caocci G et al.;