natgillin/translations-raw huggingface dataset:
Sunitinib er identificeret som en hæmmer af receptorerne for trombocytafledte vækstfaktorer (PDGFR og PDGF), vaskulære endotel- vækstfaktorer (VEGFR1, VEGFR2 og VEGF3), stamcellefaktor (KIT), Fms-lignende tyrosinkinase-3 (FLT3), kolonistimulerende faktor (CSF-1R) og gliacelleafledt neurotrof faktor (RET).
Sunitinib was identified as an inhibitor of platelet-derived growth factor receptors (PDGFRα and PDGFRβ), VEGF receptors (VEGFR1, VEGFR2, and VEGFR3), stem cell factor receptor (KIT), Fms-like tyrosine kinase-3 (FLT3), colony stimulating factor receptor (CSF-1R), and the glial cell-line derived neurotrophic factor receptor (RET).
Hvis du har taget for mange kapsler, skal du omgående kontakte lægen eller skadestuen.
If you have accidentally taken too many capsules, talk to your doctor straight away.
• Forhøjet indhold af urinsyre i blodet.
• High level of uric acid in the blood.
Der er rapporteret tilfælde af myopati og/eller Rabdomyolyse, nogle med akut nyresvigt.
Cases of myopathy and/or rhabdomyolysis, some with acute renal failure, have been reported.
8 af disse patienter havde DVT; 1 var grad 1, 2 var grad 2, 4 var grad 3 og 1 var grad 4.
Eight of these patients had DVT; 1 with Grade 1, 2 with Grade 2, 4 with Grade 3, and 1 with Grade 4.
Administration af sunitinib sammen med potente CYP3A4-hæmmere (f.eks. ritonavir, itraconazol, erythromycin, clarithromycin, grapefrugtjuice) kan øge sunitinibkoncentrationen.
Administration of sunitinib with potent CYP3A4 inhibitors (e.g., ritonavir, itraconazole, erythromycin, clarithromycin, grapefruit juice) may increase sunitinib concentrations.
Der er set tilfælde af leversvigt, nogle med letalt udfald, hos <1% af de patienter med solide tumorer, der blev behandlet med sunitinib.
Cases of hepatic failure, some with a fatal outcome, were observed in < 1% of solid tumour patients treated with sunitinib.
Ring straks til lægen, ved symptomer som smerter eller trykken i brystet, smerter i armene, ryggen, nakken eller kæben, åndenød, følelsesløshed eller svaghed i den ene side af kroppen, problemer med at gå, hovedpine eller svimmelhed, mens du bliver behandlet med Sutent.
Call your doctor immediately if you get symptoms such as chest pain or pressure, pain in your arms, back, neck or jaw, shortness of breath, numbness or weakness on 1 side of your body, trouble talking, headache, or dizziness while on treatment with Sutent.
Diarré, kvalme/opkastning, mavesmerter, dyspepsi og stomatitis/orale smerter er de hyppigst rapporterede gastrointestinale bivirkninger; der er også set tilfælde af øsofagitis (se pkt.
Diarrhoea, nausea/vomiting, abdominal pain, dyspepsia, and stomatitis/oral pain were the most commonly reported gastrointestinal adverse reactions; oesophagitis events have been also reported (see section 4.8).
Akut koronarsyndrom, angina pectoris, ustabil angina pectoris, koronararterieokklusion og myokardieiskæmi
k Acute coronary syndrome, angina pectoris, angina unstable, coronary artery occlusion, and myocardial ischaemia.
Til pNET er den anbefalede dosis af Sutent 37,5 mg 1 gang dagligt indtaget oralt uden planlagte behandlingspauser.
For pNET, the recommended dose of Sutent is 37.5 mg taken orally once daily without a scheduled rest period.
Der sås ingen udviklingstoksisitet ved 1 mg/kg/dag (eksponering ca. >0,9 gange AUC hos patienter behandlet med ADD).
No development toxicity was observed at 1 mg/kg/day (approximate exposure ≥ 0.9 times the AUC in patients administered the RDD).
I den anden del af studiet, hvor patienter med tidligere behandling mod cancer, men uden risikofaktorer for hjertetoksicitet, blev inkluderet, blev sunitinib generelt tolereret, og det kunne håndteres klinisk ved en dosis på 15 mg/m2 dagligt (maksimal tolereret dosis) i doseringsskema 4/2.
In the second part of the study, including patients with prior anticancer therapy but without risk factors for cardiac toxicity, sunitinib was generally tolerable and clinically manageable at the dose of 15 mg/m daily (MTD) on Schedule 4/2.
Det første åbne, dosis-eskaleringsstudie blev udført hos patienter med GIST efter behandlingssvigt med imatinib (median maksimal daglig dosis på 800 mg) på grund af resistens eller intolerans.
An initial open-label, dose-escalation study was conducted in patients with GIST after failure of imatinib (median maximum daily dose 800 mg) due to resistance or intolerance.
Derudover havde 24% af sunitinib-patienterne fået somatostatin-analoger sammenlignet med 22% af placebo-patienterne.
In addition, 24% of sunitinib patients had received somatostatin analogues compared with 22% of placebo patients.
Sammenfatning af overall-overlevelse
Summary of progression-free survival
2 af disse patienter i placebogruppen havde DVT, 1 var grad 2 og 1 var grad 3.
Two of these patients on placebo had DVT, 1 with Grade 2 and 1 with Grade 3.
Selvom sunitinib og den primære metabolit ikke elimineres ved hæmodialyse, var den systemiske eksponering for sunitinib 47% lavere og for den primære metabolit 31% lavere hos patienter med nyresygdom i slutstadiet sammenlignet med personer med normal nyrefunktion.
Although sunitinib and its primary metabolite were not eliminated through haemodialysis in subjects with ESRD, the total systemic exposures were lower by 47% for sunitinib and 31% for its primary metabolite compared to subjects with normal renal function.
I dette studie var median TTP 34,0 uger (95% CI = 22,0-46,0).
In this study, the median TTP was 34.0 weeks (95% CI: 22.0, 46.0).
Nedsat absolut neutrofiltal og nedsat antal blodplader er rapporteret i forbindelse med sunitinibn (se pkt.
Decreased absolute neutrophil counts and decreased platelet counts were reported in association with sunitinib (see section 4.8).
I kliniske studier forekom tumorblødning hos ca. 2% af patienterne med GIST.
In clinical trials, tumour haemorrhage was reported in approximately 2% of patients with GIST.
Der sås reduceret neonatal vægt under og efter afvænningsperioden ved 3 mg/kg/dag.
Reduced offspring body weights were observed during the preweaning and postweaning periods at 3 mg/kg/day.
106 patienter fik mindst en 50 mg dosis af sunitinib efter doseringsskema 4/2.
One hundred and 6 patients received at least one 50 mg dose of sunitinib on Schedule 4/2.
Lægen rådes til at opveje den kardiovaskulære bivirkningsrisiko mod den potentielle fordel ved sunitinib.
Physicians are advised to weigh this risk against the potential benefits of sunitinib.
Gangrænøs pyoderma Toksisk epidermal nekrolyse
Pyoderma gangrenosum Toxic epidermal necrolysis*
Den investigatorvurderede mediane PFS var 13,2 måneder både i den samlede population (95% CI: 10,9-16,7) og i den behandlingsnaïve population (95% CI: 7,4-16,8).
The investigator-assessed median PFS was 13.2 months, both in the overall population (95% CI: 10.9, 16.7) and in the treatment-naïve cohort (95% CI: 7.4, 16.8).
Langvarig behandling med sunitinib så ikke ud til at være forbundet med nye typer eller øget sværhedsgrad af behandlingsrelaterede bivirkninger.
Prolonged treatment with sunitinib did not appear to be associated with new types of TRAEs.
Hæmatologiske forstyrrelser (f.eks. neutropeni, trombocytopeni og anæmi) er blandt de mest almindelige bivirkninger.
Haematological disorders (e.g., neutropenia, thrombocytopenia, and anaemia) are amongst the most common adverse drug reactions.
På baggrund af ikke-kliniske data kan mænds og kvinders fertilitet påvirkes af behandling med sunitinib (se pkt.
Based on nonclinical findings, male and female fertility may be compromised by treatment with sunitinib (see section 5.3).
Risikofaktorer for TLS inkluderer høj tumorbyrde, præeksisterende kronisk nyreinsufficiens, oliguri, dehydrering, hypotension og sur urin.
Risk factors for TLS include high tumour burden, pre-existing chronic renal insufficiency, oliguria, dehydration, hypotension, and acidic urine.
Trombotisk mikroangiopati h, *
Thrombotic microangiopathyh,*
Desuden bør patienter, der er i sunitinibbehandling, observeres tæt for symptomer på thyroideadysfunktion, og de patienter, som udvikler tegn og/eller symptomer herpå, bør have foretaget laboratorieundersøgelse af thyroideafunktionen.
In addition, patients should be observed closely for signs and symptoms of thyroid dysfunction during treatment, and patients who develop any signs and/or symptoms suggestive of thyroid dysfunction should have laboratory testing of thyroid function performed as clinically indicated.
• Unormal, rørformet passage mellem to normale hulrum i kroppen eller huden.
• Abnormal tube like passage from one normal body cavity to another body cavity or the skin.
Disse hændelser er ikke kumulative, men er typisk reversible og fører sædvanligvis ikke til seponering af behandlingen.
The above events were not cumulative, were typically reversible, and generally did not result in treatment discontinuation.
Resultaterne af dette studie viste, at sunitinib havde en effekt på QTc-intervallet (defineret som middel placebo-justeret ændring på >10 msek med en 90% CI øvre grænse >15 msek) ved terapeutisk koncentration (dag 3) ved brug af ”within-day” baseline-korrektionsmetoden og ved højere end terapeutisk koncentration (dag 9) ved begge baseline-korrektionsmetoder.
The results of this study demonstrated that sunitinib had an effect on QTc interval (defined as a mean placebo-adjusted change of > 10 msec with a 90% confidence interval [CI] upper limit > 15 msec) at therapeutic concentration (Day 3) using the within-day baseline correction method,
Herudover er de følgende grad 3 bivirkninger blevet rapporteret hos 5 patienter i publikationer: træthed (2) og gastrointestinale bivirkninger (herunder diarré)(2), hæmatologiske bivirkninger (herunder anæmi) (2), cholecystitis (1), hypertyroidisme (1) og mucositis
In addition, the publications reported the following Grade 3 adverse drug reactions experienced by 5 patients: fatigue (2), gastrointestinal adverse drug reactions (including diarrhoea) (2), haematologic adverse drug reactions (including anaemia) (2), cholecystitis (1), hyperthyroidism (1), and mucositis (1).
Sunitinib er ikke mutagent i bakterier ved metabolisk aktivering af lever hos rotter.
Sunitinib was not mutagenic in bacteria using metabolic activation provided by rat liver.
Bivirkninger set efter markedsføring, men også indrapporteret fra kliniske studier, er inkluderet.
Post-marketing adverse reactions identified in clinical studies are also included.
Symptomerne kan aftage under behandlingen.Hypotyreose kan udvikles under behandlingen.
Hypothyroidism may develop during treatment.
Erythema multiforme Stevens-Johnsons syndrom
Stevens-Johnson syndrome*
Der er ikke foretaget systematisk sikkerhedsvurdering ved fortsat behandling med sunitinib hos patienter med moderat til alvorlig proteinuri.
The safety of continued sunitinib treatment in patients with moderate to severe proteinuria has not been systematically evaluated.
På grund af manglende sygdomskontrol blev studiet lukket ned ved tidspunktet for den planlagte interimanalyse.
The study was closed at the time of planned interim analysis due to the lack of disease control.
I studie A6181038 havde samtidig administration af BCRP-hæmmeren gefitinib ingen klinisk relevant virkning på Cmax og AUC-værdien for sunitinib eller sunitinib + metabolit (se pkt.
In study A6181038 the co-administration of gefitinib, a BCRP inhibitor, did not result in a clinically relevant effect on the Cmax and AUC for sunitinib or total drug (sunitinib + metabolite) (see section 4.5).
Sunitib inducerer ikke strukturelle kromosomafvigelser i humane perifere blod-lymfocytter in vitro.
Sunitinib did not induce structural chromosome aberrations in human peripheral blood lymphocyte cells in vitro.
Ved gentagen daglig dosis akkumuleres sunitinib 3-4 gange, og dets aktive hovedmetabolit akkumuleres 7-10 gange.
With repeated daily administration, sunitinib accumulates 3- to 4-fold and its primary active metabolite accumulates 7- to 10-fold.
Patienter bør informeres om, at de kan opleve svimmelhed under behandling med sunitinib.
Patients should be advised that they may experience dizziness during treatment with sunitinib.
I dette studie var den objektive responsrate 36,5% (95% CI: 24,7%-49,6%) og medianTTP var 37,7 uger (95% CI: 24,0-46,4).
In this study the objective response rate was 36.5% (95% CI: 24.7%, 49.6%) and the median TTP was 37.7 weeks (95% CI: 24.0, 46.4).
Hæmorroider Glossodyni Oral smerte Mundtørhed Flatulens
Haemorrhoids Glossodynia Oral pain
• Problemer med sårheling efter operation.
• Problems with wound healing after surgery.
Behandlingsrelaterede, venøse tromboemboliske hændelser er rapporteret hos ca. 1,0% af patienterne med solide tumorer, som blev behandlet med sunitinib i kliniske studier, herunder GIST og RCC.
Treatment-related venous thromboembolic events were reported in approximately 1.0% of patients with solid tumours who received sunitinib on clinical trials, including GIST and RCC.
Sunitinib er ikke undersøgt hos patienter med svært nedsat leverfunktion (Child-Pugh klasse C) og kan derfor ikke anbefales til denne patientgruppe (se pkt.
Sunitinib has not been studied in subjects with severe (Child-Pugh class C) hepatic impairment and therefore its use in patients with severe hepatic impairment cannot be recommended (see section 5.2).
Dit stofskifte skal måles, inden du begynder at tage Sutent og regelmæssigt under behandlingen.
Your thyroid function should be checked before you take Sutent and regularly while you are taking it.
Den mediane progressionsfrie overlevelse var 2,3 måneder i gruppen med gliom af høj grad og 2,7 måneder i ependymom-gruppen.
Median PFS was 2.3 months in the HGG group and 2.7 months in the ependymoma group.
Hvis du udvikler disse hudsymptomer, skal du straks kontakte en læge.
If you develop a rash or these skin symptoms, seek immediate advice from a doctor.
- Bindevævssvulst i mave-tarmkanalen (GIST), hvor imatinib (anden medicin mod kræft) ikke virker, eller hvor imatinib ikke kan bruges.
- Gastrointestinal stromal tumour (GIST), a type of cancer of the stomach and bowel, where imatinib (another anticancer medicine) no longer works or you cannot take imatinib.
Der foreligger ikke data vedrørende anvendelsen af sunitinib hos gravide kvinder.
There are no studies in pregnant women using sunitinib.
Hos de 807 patienter, som fik langvarig behandling med sunitinib, forekom de fleste behandlingsrelaterede bivirkninger initialt i de første 6 måneder til 1 år og var derefter stabile eller faldt i hyppighed over tid.
In the 807 patients who received long-term sunitinib treatment, most treatment-related adverse events (TRAEs) occurred initially in the first 6 months-1 year and then were stable or decreased in frequency over time, with the exception of hypothyroidism, which gradually increased over time, with new cases occurring over the 6 year period.
Neuroendokrine tumorer i pancreas (pNET)
Pancreatic neuroendocrine tumours (pNET)
Udover den lægemiddelspecifikke virkning er der er ikke identificeret andre specifikke risikofaktorer for sunitinib-induceret kardiomyopati hos de behandlede patienter.
No specific additional risk factors for sunitinib-induced cardiomyopathy apart from the drug-specific effect have been identified in the treated patients.
Blodglucose skal kontrolleres jævnligt hos diabetespatienter, og om nødvendigt justeres dosis af antidiabetika for at minimere risikoen for hypoglykæmi (se pkt.
Blood glucose levels in diabetic patients should be checked regularly in order to assess if antidiabetic medicinal product's dosage needs to be adjusted to minimise the risk of hypoglycaemia (see section 4.8).
I alt 29 sunitinib-behandlede patienter og 24 placebo-behandlede patienter havde ikke fået forudgående systemisk behandling; blandt disse patienter var hazard ratio for PFS 0,365 (95% CI: 0,156 - 0,857), p = 0,0156.
A total of 29 patients in the sunitinib arm and 24 in the placebo arm had received no prior systemic treatment; among these patients, the hazard ratio for PFS was 0.365 (95% CI: 0.156, 0.857), p=0.0156.
Baseret på denne analyse forventes en dosis på ca. 20 mg/m2 dagligt (BSA-interval: 1,10-1,87 m2) hos pædiatriske patienter at resultere i plasmaeksponeringer for sunitinib og dets aktive metabolit (mellem 75 og 125% af AUC), der er sammenlignelige med voksnes med GIST, der får sunitinib 50 mg dagligt i dosisskema 4/2 (AUC 1233 ng.time/ml).
Based on this analysis, a dose of approximately 20 mg/m daily in paediatric patients, with BSA values between 1.10 and 1.87 m2, is expected to provide plasma exposures to sunitinib and its active metabolite comparable (between 75 and 125% of the AUC) to those in adults with GIST administered sunitinib 50 mg daily on Schedule 4/2 (AUC 1233 ng.hr/mL).
Forkortelser: CI=konfidensinterval; N=antal patienter; NA=ikke relevant; pNET= neuroendokrine tumorer i pancreas; RECIST=respons evaluering af kriterier for solide tumorer.
Abbreviations: CI=confidence interval; N=number of patients; NA=not applicable; pNET=pancreatic neuroendocrine tumours; RECIST=response evaluation criteria in solid tumours.
I det pivotale fase 3 GIST-studie (n = 312) forekom behandlingsrelaterede letale hjertebivirkninger hos 1% af patienterne i hver behandlingsgruppe i studiet (dvs. sunitinib og placebogruppen).
In the pivotal Phase 3 GIST study (N = 312), treatment-related fatal cardiac reactions were reported in 1% of patients on each arm of the study (i.e. sunitinib and placebo arms).
Brug af anden medicin sammen med Sutent
Other medicines and Sutent
Som følge af den tidlige lukning af studiet blev koden for de resterende patienter brudt, og de blev tilbudt behandling med sunitinib i et åbent forlængelsesstudie.
As a result of the early study closure, remaining patients were unblinded and offered access to open-label sunitinib in an extension study.
Disse reaktioner er ikke kumulative, men er typisk reversible og fører sædvanligvis ikke til seponering.
The above reactions were not cumulative, were typically reversible, and generally did not result in treatment discontinuation.
Pankreatitis er set med hyppigheden ikke-almindelig (<1%) hos patienter, der fik sunitinib for GIST eller mRCC. Der er ikke rapporteret om behandlingsrelateret pankreatitis i fase 3 pNET-studiet (se pkt.
Pancreatitis has been observed uncommonly (< 1%) in patients receiving sunitinib for GIST or MRCC. No treatment-related pancreatitis was reported in the Phase 3 pNET study (see section 4.4).
Den mediane PFS var 11,4 måneder for sunitinib og 5,5 måneder for placebo [hazard ratio: 0,418 (95% CI: 0,263- 0,662), p = 0,0001]; lignende resultater blev set, når responsvurdering baseret på RECIST, sammenholdt med investigator-tumor-måling blev brugt til at bestemme sygdomsprogression, som vist i tabel 4.
The median PFS was 11.4 months for the sunitinib arm compared to 5.5 months for the placebo arm [hazard ratio: 0.418 (95% CI: 0.263, 0.662), p-value=0.0001]; similar results were observed when derived tumour response assessments based upon application of RECIST to investigator tumour measurements were used to determine disease progression, as shown in Table 4.
• Smerter i maven (mavepine) på grund af betændelse i bugspytkirtlen.
• Pain in the stomach (abdomen) caused by inflammation of the pancreas.
På baggrund af individuel sikkerhed og tolerabilitet kan dosisafbrydelse blive nødvendig.
Dose interruptions may be required based on individual safety and tolerability.
Sutent er indiceret til behandling af voksne med avanceret/metastaserende renalcellekarcinom (mRCC).
Metastatic renal cell carcinoma (MRCC) Sutent is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults.
• Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter ”EXP” Udløbsdatoen er den sidste dag i den nævnte måned.
- Do not use this medicine after the expiry date which is stated on carton, bottle and blister foil after “EXP”.
• Forhøjet indhold af muskelenzym (kreatinkinase) i blodet.
• Increased blood level of enzyme (creatine phosphokinase) from muscle.
Yderligere påvirkninger, som blev set i andre studier omfatter forlængelse af QTc-intervallet, LVEFnedsættelse og testikel tubulær atrofi, øget mesangialceller i nyren, blødning i gastrointestinalkanalen og oral mukosa, og hypertrofi af hypofyseforlapceller.
Additional effects observed in other studies included: QTc interval prolongation, LVEF reduction and testicular tubular atrophy, increased mesangial cells in kidney, haemorrhage in gastrointestinal tract and oral mucosa, and hypertrophy of anterior pituitary cells.
I tilfælde af pulmonale tumorer kan der være tale om alvorlig og livstruende hæmoptyse eller pulmonal blødning.
Tumour haemorrhage may occur suddenly, and in the case of pulmonary tumours, may present as severe and life-threatening haemoptysis or pulmonary haemorrhage.
Dehydrering Hypoglykæmi
Dehydration Hypoglycaemia
Ved terapeutisk plasmakoncentration var den maksimale middelændring af QTcF-intervallet (Fridericias korrektion) fra baseline 9 msek (90% CI: 15,1 msek).
At therapeutic plasma concentrations, the maximum QTcF interval (Frederica's correction) mean change from baseline was 9 msec (90% CI: 15.1 msec).
Ved brug af omfattende gentagne EKG-målinger på tidspunkter svarende til enten terapeutisk eksponering eller højere end terapeutisk ekponering sås ikke udvikling af alvorlig forlængelse af QTcintervallet (dvs. lig med eller større end grad 3 ifølge CTCAE version 3,0) hos nogen af patienterne i den evaluerbare population eller i ITT-populationen.
Using comprehensive serial ECG assessments at times corresponding to either therapeutic or greater than therapeutic exposures, none of the patients in the evaluable or intent-to-treat (ITT) populations were observed to develop QTc interval prolongation considered as “severe” (i.e. equal to or greater than Grade 3 by Common Terminology Criteria for Adverse Events [CTCAE] version 3.0).
- Hvis du har eller har haft et aneurisme (udvidelse ogsvækkelse af en blodårevæg) eller en rift i en blodårevæg.
- If you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
Studier af cancerpatienter ekskluderede patienter med ALAT eller ASAT >2,5 x den øvre referenceværdi, eller hvis levermetastaser var årsag til tallene >5,0 x den øvre referenceværdi.
Studies in cancer patients have excluded patients with ALT or AST > 2.5 x ULN (upper limit of normal) or > 5.0 x ULN if due to liver metastasis.
Sådan skal du tage Sutent
How to take Sutent
I gentagne dosistoksicitetsstudier af op til 9 måneders varighed på rotter og aber var påvirkninger af det primære målorgan identificeret i den gastrointestinale kanal (emesis og diarré hos aber); binyre (kortikal kongestion og/eller blødning hos rotter og aber og nekrose efterfulgt af fibrose hos rotter); blod-og lymfesystem (knoglemarvshypocellularitet og lymfoid udtømning i thymus, milt og lymfeknuder); eksokrin pancreas (acinar celledegranulering med enkeltcelle nekrose); spytkirtler (acinar hypertrofi); led (fortykkelse af vækstplade); uterus (atrofi) og ovarier (nedsat follikeludvikling).
In rat and monkey repeated-dose toxicity studies up to 9-months duration, the primary target organ effects were identified in the gastrointestinal tract (emesis and diarrhoea in monkeys); adrenal gland (cortical congestion and/or haemorrhage in rats and monkeys, with necrosis followed by fibrosis in rats); haemolymphopoietic system (bone morrow hypocellularity and lymphoid depletion of thymus, spleen, and lymph node); exocrine pancreas (acinar cell degranulation with single cell necrosis); salivary gland (acinar hypertrophy); bone joint (growth plate thickening); uterus (atrophy); and ovaries (decreased follicular development).
Diagnosen TMA, herunder trombotisk trombocytopenisk purpura (TTP) og hæmolytisk uræmisk syndrom (HUS), som indimellem har medført nyresvigt eller dødsfald, skal overvejes ved forekomst af hæmolytisk anæmi, trombocytopeni, træthed, fluktuerende neurologiske manifestationer, nedsat nyrefunktion og feber.
The diagnosis of TMA, including thrombotic thrombocytopaenic purpura (TTP) and haemolytic uraemic syndrome (HUS), sometimes leading to renal failure or a fatal outcome, should be considered in the occurrence of haemolytic anaemia, thrombocytopenia, fatigue, fluctuating neurological manifestation, renal impairment, and fever.