natgillin/translations-raw huggingface dataset:
Trastuzumabemtansin er ikke undersøgt hos patienter med serum-aminotransferaser >2,5 ´ øvre normalgrænse eller total-bilirubin >1,5 ´ øvre normalgrænse inden behandlingsstart. 
Trastuzumab emtansine has not been studied in patients with serum transaminases > 2.5 ´ ULN or total bilirubin > 1.5 ´ ULN prior to initiation of treatment.
Det rekonstituerede koncentrat må ikke indeholde synlige partikler og skal være klart til let opaliserende. 
The reconstituted solution should be free of visible particulates, clear to slightly opalescent.
Meget almindelige bivirkninger (kan påvirke mere end 1 ud 10 patienter): · Kadcyla kan forårsage inflammation (betændelseslignende reaktion) i leveren eller beskadige leverceller og dermed øge mængden af leverenzymer i blodet. 
Very common (may affect more than 1 in 10 people): · Kadcyla may cause inflammation or damage to cells in the liver, resulting in elevated liver enzymes in blood tests.
Patienter med forhøjede aminotransferaser oplevede i størstedelen af tilfældene forbedring til grad 1 eller normalværdi inden for 30 dage efter sidste dosis trastuzumabemtansin (se pkt. 
Patients with elevated transaminases improved to Grade 1 or normal within 30 days of the last dose of trastuzumab emtansine in the majority of the cases (see section 4.8).
Den farmakokinetiske populationsanalyse viste ingen forskelle i trastuzumabemtansin-optagelse afhængigt af sygdomsstatus (adjuverende vs. metastatisk regi). 
The population pharmacokinetic analysis suggested no difference in trastuzumab emtansine exposure based on disease status (adjuvant vs. metastatic setting).
Almindelige bivirkninger: · kulderystelser eller influenzalignende symptomer · nedsat kaliumindhold i blodet (påvises ved blodprøve) · hududslæt · nedsat antal hvide blodlegemer (påvises ved blodprøve) · tørre øjne, rindende øjne eller sløret syn · røde øjne eller øjeninfektion · fordøjelsesproblemer · hævede ben og arme · blødende tandkød/gummer · forhøjet blodtryk · svimmelhed · smagsforstyrrelser · kløe · hukommelsesbesvær · hårtab · hudreaktion på hænder og fødder (palmoplantar erytrodysæstesi) · negleproblemer 
Common: · chills or flu like symptoms · decrease in your potassium levels (shown in a blood test) · skin rashes · decreased white blood cells (shown in a blood test) · dry eyes, watery eyes or blurred vision · eye redness or infection · indigestion · swelling of legs and/or arms · bleeding from the gums · increase in blood pressure · feeling dizzy · taste disturbances · itching · difficulty in remembering · hair loss · hand-and-foot skin reaction (Palmar-plantar erythrodysaesthesia syndrome) · nail disorder
Justering af startdosis er ikke nødvendig hos patienter med let eller moderat nedsat nyrefunktion (se pkt. 
No adjustment to the starting dose is needed in patients with mild or moderate renal impairment (see section 5.2).
Derudover er maytasin i ikke-kliniske studier vist at være udviklingstoksisk, hvilket taler for, at DM1, den mikrotubulærhæmmende cytotoksiske maytansin-komponent i trastuzumabemtansin, tilsvarende vil være teratogent og potentielt embryotoksisk. 
In addition, developmental toxicity of maytansine has been identified in non-clinical studies which suggests that DM1, the microtubule-inhibiting cytotoxic maytansinoid component of trastuzumab emtansine, will be similarly teratogenic and potentially embryotoxic.
DM1 var aneugent eller klastogent i en in vivo enkeltdosis rottemarvs-mikronukleus-analyse ved eksponeringer, der var sammenlignelige med den gennemsnitlig maksimale koncentration af DM1 hos mennesker, der har fået trastuzumabemtansin. 
DM1 was aneugenic or clastogenic in an in vivo single-dose rat bone marrow micronucleus assay at exposures that were comparable to mean maximum concentrations of DM1 measured in humans administered trastuzumab emtansine.
Farven på det rekonstituerede koncentrat skal være farveløs til lysebrun. 
The colour of the reconstituted solution should be colourless to pale brown.
INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 160 mg 
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 160 mg
Perifer neuropati, hovedpine 
Nervous system disorders Neuropathy peripheral, Headache
I kliniske studier var forekomsten og sværhedsgraden af trombocytopeni højere hos asiatiske patienter (se pkt. 
In clinical studies, the incidence and severity of thrombocytopenia were higher in Asian patients (see section 4.8).
Transaminaseforhøjelser svarende til grad 3 og 4 var indberettet hos 1,5% af patienterne med eBC. 
Grade 3 and 4 increased transaminases were reported in 1.5% of patients with EBC.
Tørre øjne, konjunktivitis, sløret syn, tåreflåd 
Dry eye, Conjunctivitis, Vision blurred, Lacrimation increased
Medianvarigheden af respons blev ikke nået med trastuzumabemtansin, og var 9,5 måneder i kontrolarmen. 
The median duration of response was not reached with trastuzumab emtansine vs. 9.5 months in the control arm.
På grund af utilstrækkelige data er det ikke klarlagt, om dosisjustering er nødvendig hos patienter med svært nedsat nyrefunktion, og patienter med svært nedsat nyrefunktion bør derfor monitoreres omhyggeligt. 
The potential need for dose adjustment in patients with severe renal impairment cannot be determined due to insufficient data and therefore patients with severe renal impairment should be monitored carefully.
Farmakokinetikken for trastuzumabemtansin og DM1-holdige katabolitter blev undersøgt efter administration af 3,6 mg/kg trastuzumabemtansin til patienter med HER2-positiv metastatisk brystkræft og normal (n=10), let nedsat (Child-Pugh A; n=10) og moderat nedsat (Child-Pugh B; n=8) leverfunktion. 
The pharmacokinetics of trastuzumab emtansine and DM1-containing catabolites were evaluated after the administration of 3.6 mg/kg of trastuzumab emtansine to metastatic HER2+ breast cancer patients with normal hepatic function (n=10), mild (Child-Pugh A; n=10) and moderate (Child-Pugh B; n=8) hepatic impairment.
En anden sjælden tilstand, der kan forekomme i leveren, er en tilstand, der kaldes nodulær regenerativ hyperplasi. 
Another rare abnormality that can occur in the liver is a condition known as nodular regenerative hyperplasia (NRH).
Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket. 
· If you get any side effects, talk to your doctor, pharmacist or nurse.
Efter binding til HER2 gennemgår trastuzumabemtansin en receptor-medieret internalisering og efterfølgende lysosomnedbrydning, hvorved DM1-holdige cytotoksiske katabolitter (primært lysin-MCC-DM1) frigives. 
Upon binding to HER2, trastuzumab emtansine undergoes receptor-mediated internalization and subsequent lysosomal degradation, resulting in release of DM1-containing cytotoxic catabolites (primarily lysine-MCC-DM1).
Hos patienter med serum-aminotransferaser >3 ´ øvre normalgrænse og samtidigt total-bilirubin >2 ´ øvre normalgrænse skal behandlingen seponeres permanent. 
Treatment in patients with serum transaminases > 3 ´ ULN and concomitant total bilirubin > 2 ´ ULN should be permanently discontinued.
Hvis LVEF <45% bekræftes, skal trastuzumabemtansin seponeres 
If LVEF < 45% is confirmed, discontinue trastuzumab emtansine.
Figur 2 Kaplan-Meier-kurver for progressionsfri overlevelse vurderet af uafhængig komité 
Figure 2 Kaplan-meier curve of IRC-assessed progression-free survival
Diagnosen nodulær regenerativ hyperplasi kan kun bekræftes histologisk. 
Diagnosis of NRH can be confirmed only by histopathology.
Når hjertemusklen er svækket, kan man udvikle symptomer som åndenød i hvile eller under søvn, brystsmerter, hævede ben eller arme samt en følelse af hurtige eller uregelmæssige hjerteslag. 
When the heart muscle is weak, patients may develop symptoms such as shortness of breath at rest or when sleeping, chest pain, swollen legs or arms, and a sensation of rapid or irregular heartbeats.
Den systemiske trastuzumabemtansin-eksponering (AUC) ved første behandlingscyklus var henholdsvis ca. 38% og 67% lavere hos patienter med let og moderat nedsat leverfunktion end hos patienter med normal leverfunktion. 
- Systemic exposures (AUC) of trastuzumab emtansine at Cycle 1 in patients with mild and moderate hepatic impairment were approximately 38% and 67% lower than that of patients with normal hepatic function, respectively.
Hvis trombocyttallet er faldet svarende til trombocytopeni grad 3 eller derover (<50.000/mm3), må trastuzumabemtansin ikke administreres, før trombocyttallet er forbedret til grad 1 (≥75.000/mm3) (se pkt. 
In the event of decreased platelet count to Grade 3 or greater (< 50,000/mm3), do not administer trastuzumab emtansine until platelet counts recover to Grade 1 (≥ 75,000/mm3) (see section 4.2).
Reaktioner sekundært til ekstravasation er observeret i kliniske studier med trastuzumabemtansin. 
Reactions secondary to extravasation have been observed in clinical studies with trastuzumab emtansine.
Hvad er Kadcyla? 
What Kadcyla is
Smerter i bevægeapparatet, artralgi, myalgi 
Musculoskeletal pain, Arthralgia, Myalgia
Hvis fortyndet under aseptiske forhold, kan infusionsvæsken opbevares i op til 24 timer ved 2°C - 8°C. 
If diluted aseptically, it may be stored for up to 24 hours at 2°C to 8°C.
Ikke almindelige bivirkninger (kan påvirke op til 1 ud af 100 patienter): · Inflammation i lungerne kan forårsage vejrtrækningsproblemer som åndenød (i hvile eller ved aktivitet), hoste eller hosteanfald med tør hoste - dette kan være tegn på inflammation i lungerne. 
Uncommon (may affect up to 1 in 100 people): · Inflammation of your lungs can cause breathing problems such as shortness of breath (either at rest or while performing any type of activity), coughing or coughing spells with a dry coughthese are signs of inflammation of your lung tissue.
Dysfunktion af venstre ventrikel indberettedes hos 2,2% af patienterne i kliniske mBC-studier med trastuzumabemtansin. 
Left ventricular dysfunction was reported in 2.2% of patients in MBC clinical studies with trastuzumab emtansine.
In vitro metaboliseringsstudier i humane levermikrosomer antyder, at DM1, en lille molekylekomponent i trastuzumabemtansin, primært metaboliseres af CYP3A4 og i mindre grad af CYP3A5. 
In vitro metabolism studies in human liver microsomes suggest that DM1, a small molecule component of trastuzumab emtansine, is metabolised mainly by CYP3A4 and to a lesser extent by CYP3A5.
Hvis du er i tvivl, så spørg lægen eller sundhedspersonalet, inden du får Kadcyla. 
If you are not sure, talk to your doctor or nurse before you are given Kadcyla.
In vitro metaboliseringsstudier med humane levermikrosomer tyder på, at DM1, en komponent i trastuzumabemtansin, primært metaboliseres af CYP3A4 og i mindre omfang af CYP3A5. 
In vitro metabolism studies in human liver microsomes suggest that DM1, a component of trastuzumab emtansine, is metabolised mainly by CYP3A4 and, to a lesser extent, by CYP3A5.
I ikke-kliniske studier udskiltes trastuzumabemtansin-katabolitter, inklusive DM1, Lys-MCC-DM1 og MCC-DM1, primært i galden med minimal udskillelse i urinen. 
In nonclinical studies, trastuzumab emtansine catabolites including DM1, Lys-MCC-DM1, and MCC-DM1 are mainly excreted in the bile with minimal elimination in urine.
● Kontrolarm (lapatinib plus capecitabin): lapatinib 1250 mg/dag oralt 1 gang dagligt i en 21-dages cyklus plus capecitabin 1000 mg/m2 oralt 2 gange dagligt på Dag 1-14 i en 21-dages cyklus 
· Trastuzumab emtansine arm: trastuzumab emtansine 3.6 mg/kg intravenously over 30-90 minutes on Day 1 of a 21-day cycle · Control arm (lapatinib plus capecitabine): lapatinib 1250 mg/day orally once per day of a 21-day cycle plus capecitabine 1000 mg/m2 orally twice daily on Days 1-14 of a 21-day cycle
Der blev taget biopsier fra brysttumoren med henblik på at påvise HER2-overekspression, defineret som et 3+ IHC- eller ISH-amplifikationsratio ≥2,0, bestemt ved centralt laboratorium. 
Breast tumor samples were required to show HER2 overexpression defined as 3+ IHC or ISH amplification ratio ≥ 2.0 determined at a central laboratory.
Der sås infusionsrelaterede reaktioner hos 1,6% af patienterne med eBC; ingen af hændelserne var af grad 3 eller 4. 
Infusion-related reactions were reported in 1.6% of patients with EBC, with no Grade 3 or 4 events reported.
I den deskriptive opfølgningsanalyse af samlet overlevelse var hazard ratio 0,75 (95% konfidensinterval 0,64; 0,88). 
In the descriptive follow-up overall survival analysis, the hazard ratio was 0.75 (95% CI 0.64, 0.88).
I en følsomhedsanalyse hvor patienterne blev censureret på tidspunktet for overkrydsning, var hazard ratio 0,69 (95% konfidensinterval 0,59; 0,82). 
In a sensitivity analysis censoring patients at the time of cross-over, the hazard ratio was 0.69 (95% CI 0.59, 0.82).
Patienter som fik seponeret trastuzumabemtansin kunne gennemføre den planlagte forsøgsbehandling med op til 14 serier af HER2-rettet behandling med trastuzumab, hvis investigator vurderede, at det var hensigtsmæssigt i forhold til toksicitet. 
Patients who discontinued trastuzumab emtansine could complete the duration of their intended study treatment up to 14 cycles of HER2-directed therapy with trastuzumab if appropriate based on toxicity considerations and investigator discretion.
Inflammerede eller beskadigede leverceller kan sende bestemte stoffer (leverenzymer) ud i blodet i større mængde end normalt. 
Inflamed or injured liver cells may leak higher than normal amounts of certain substances (liver enzymes) into the bloodstream, resulting in elevated liver enzymes in blood tests.
Fertile kvinder skal anvende sikker prævention under behandlingsforløbet med trastuzumabemtansin og i 7 måneder efter sidste dosis. 
Women of childbearing potential should use effective contraception while receiving trastuzumab emtansine and for 7 months following the last dose of trastuzumab emtansine.
Inden inklusion skulle HER2-positiv status for brysttumorbiopsier bekræftes centralt, defineret som en score på 3+ ved IHC eller genamplifikation ved ISH. 
Prior to enrolment, breast tumour samples were required to be centrally confirmed for HER2-positive status defined as a score of 3 + by IHC or gene amplification by ISH.
Når DM1 konjugeres til trastuzumab, opnås selektivitet for den cytotoksiske agent for tumorceller med HER2-overekspression, hvilket øger den intracellulære afgivelse af DM1 direkte til de maligne celler. 
Conjugation of DM1 to trastuzumab confers selectivity of the cytotoxic agent for HER2-overexpressing tumour cells, thereby increasing intracellular delivery of DM1 directly to malignant cells.
Trastuzumabemtansin udviste lineær farmakokinetik på tværs af doser spændende fra 2,4 til 4,8 mg/kg ved intravenøs administration hver 3. uge; hos patienter, der fik doser svarende til 1,2 mg/kg eller derunder, var clearance hurtigere. 
Trastuzumab emtansine when administered intravenously every 3 weeks exhibited linear PK across doses ranging from 2.4 to 4.8 mg/kg; patients who received doses less than or equal to 1.2 mg/kg had faster clearance.
Udslæt, pruritus, alopeci, negleproblemer, palmoplantar erytrodysæstesi, urticaria 
Rash, Pruritus, Alopecia, Nail disorder, Palmarplantar erythrodysaesthesia syndrome, Urticaria
Hvis LVEF <40% bekræftes, seponeres trastuzumabemtansin 
If LVEF <40% is confirmed, discontinue trastuzumab emtansine
Da de fleste af patienterne i de kliniske studier med trastuzumabemtansin var kvinder, er det ikke formelt evalueret, om køn spiller en rolle for farmakokinetikken af trastuzumabemtansin. 
Because most of the patients in trastuzumab emtansine clinical studies were females, the effect of gender on the PK of trastuzumab emtansine was not formally evaluated.
● de hyppigste alvorlige bivirkninger (>0,5% af patienterne) var blødning, feber, trombocytopeni, dyspnø, abdominalsmerter, muskuloskeletale smerter og opkastning. 
· the most common serious ADRs (> 0.5% of patients) were haemorrhage, pyrexia, thrombocytopenia, dyspnoea, abdominal pain, musculoskeletal pain, and vomiting.
Lægen vil kontrollere din hjertefunktion, inden du starter behandling og jævnligt under behandlingen. 
Your doctor will check your heart function before and regularly during treatment.
Dyrestudier med maytansin, et stof, som er tæt beslægtet med DM1 og af samme maytansinoidklasse, tyder på, at DM1, den mikrotubulærhæmmende cytotoksiske komponent i trastuzumabemtansin, kan forventes at være såvel teratogen som embryotoksisk (se pkt. 
Animal studies of maytansine, a closely related chemical entity of the same maytansinoid class as DM1, suggest that DM1, the microtubule inhibiting cytotoxic component of trastuzumab emtansine, is expected to be teratogenic and potentially embryotoxic (see section 5.3).
Kadcyla er, som enkeltstof, indiceret til adjuverende behandling af voksne patienter med HER2positiv tidlig brystkræft med invasiv residualsygdom i bryst og/eller lymfekirtler efter neoadjuverende taxan-baseret og HER2-targeteret behandling. 
Kadcyla, as a single agent, is indicated for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy.
Behandling med trastuzumabemtansin er ikke undersøgt hos patienter, der har fået seponeret trastuzumab permanent på grund af infusionsrelaterede reaktioner; behandling af disse patienter frarådes. 
Trastuzumab emtansine treatment has not been studied in patients who had trastuzumab permanently discontinued due to infusion-related reactions (IRR); treatment is not recommended for these patients.
Derudover hæmmer trastuzumabemtansin, ligesom trastuzumab, afstødning af HER2-ECD, hæmmer signaler gennem fosfatidylinositol-3-kinase- (PI3-K) signalvejen og medierer antistof-afhængig, cellemedieret cytotoksicitet (ADCC) i humane brystkræftceller med overekspression af HER2. 
In addition, trastuzumab emtansine, like trastuzumab, inhibits shedding of the HER2 ECD, inhibits signalling through the phosphatidylinositol 3-kinase (PI3-K) pathway, and mediates antibody-dependent cell-mediated cytotoxicity (ADCC) in human breast cancer cells that overexpress HER2.
Tabel 5 Laboratorieafvigelser observeret hos patienter behandlet med trastuzumabemtansin i studie BO27938/KATHERINE 
Table 5 Laboratory abnormalities observed in patients treated with trastuzumab emtansine in study BO27938/KATHERINE
Der er gennemført et randomiseret, internationalt multicenter, åbent, klinisk fase III-studie med patienter med HER2-positiv, inoperabel, lokalt fremskreden brystkræft eller metastatisk brystkræft, som tidligere var behandlet med et taxan og trastuzumab, inklusive patienter tidligere behandlet med trastuzumab og et taxan som adjuverende behandling, og som oplevede recidiv under den adjuverende behandling, eller inden for seks måneder efter den adjuverende behandling var afsluttet. 
A Phase III, randomised, multicentre, international, open-label clinical study was conducted in patients with HER2-positive unresectable locally advanced breast cancer (LABC) or MBC who had received prior taxane and trastuzumab-based therapy, including patients who received prior therapy with trastuzumab and a taxane in the adjuvant setting and who relapsed during or within six months of completing adjuvant therapy.
Levertoksicitet, primært i form af asymptomatiske stigninger i aminotransferaser (grad 1-4 transaminitis), er observeret i kliniske studier med trastuzumabemtansin behandling (se pkt. 
Hepatotoxicity, predominantly in the form of asymptomatic increases in the concentrations of serum transaminases (Grade 1-4 transaminitis), has been observed during treatment with trastuzumab emtansine in clinical studies (see section 4.8).
Hvidt/hvidligt, frysetørret pulver. 
White to off-white lyophilised powder.
Tabel 4 og 5 viser laboratorieafvigelser observeret hos patienter behandlet med trastuzumabemtansin i de kliniske studier TDM4370g/BO21977/EMILIA og studie BO27938/KATHERINE. 
Tables 4 and 5 displays laboratory abnormalities observed in patients treated with trastuzumab emtansine in clinical study TDM4370g/BO21977/EMILIA and study BO27938/KATHERINE.
19,5% af patienterne havde fået andet HER2-rettet middel i tillæg til trastuzumab, som en del af et neoadjuverende behandlingsregime; 93,8% af disse patienter fik pertuzumab. 
The majority of the patients (76.9%) had received an anthracycline-containing neoadjuvant chemotherapy regimen.19.5% percent of patients received another HER2-targeted agent in addition to trastuzumab as a component of neoadjuvant therapy; 93.8% of these patients received pertuzumab.
· Efter tilberedning til infusionsvæske er Kadcyla holdbart i op til 24 timer ved 2°C - 8°C; 
· When prepared as a solution for infusion Kadcyla is stable for up to 24 hours at 2°C to 8°C, and must be discarded thereafter.
Forhøjet aspartattransaminase (ASAT) 
Increased Aspartate Transaminase (AST)
Stråle-pneumonitis 
Radiation pneumonitis
Trastuzumabemtansin må ikke substitueres eller kombineres med trastuzumab. 
Do not substitute or combine trastuzumab emtansine with or for trastuzumab 4.
22,5% af patienterne blev inkluderet i Nordamerika, 54,2% i Europa og 23,3% i resten af verden. 
All but 5 patients were women; 3 men were included in the trastuzumab arm and 2 in the trastuzumab emtansine arm. 22.5 percent of patients were enrolled in North America, 54.2% in Europe and 23.3% throughout the rest of the world.
Hos patienter med eBC var den samlede forekomst af perifer neuropati 32,3% og 
In patients with EBC, the overall incidence was 32.3% and 10.3% for
Der kendes endnu ingen specifik behandling af trastuzumabemtansinekstravasation. 
Specific treatment for trastuzumab emtansine extravasation is unknown at this time.
Trastuzumabemtansin skal rekonstitueres og fortyndes af sundhedspersonale og administreres som intravenøs infusion. 
Trastuzumab emtansine must be reconstituted and diluted by a healthcare professional and administered as an intravenous infusion.
Det primære endepunkt var progressionsfri overlevelse vurderet af investigator. 
The primary endpoint was investigator assessed Progression-Free Survival (PFS).
IDFS efter 3 år blev estimeret til 88,3% og 77,0% i henholdsvis trastuzumabemtansin- og trastuzumabarmen. 
Estimates of 3 years IDFS rates were 88.3% vs. 77.0% in trastuzumab emtansine vs. trastuzumab arms, respectively.
Der skal anvendes 0,20 eller 0,22 mikron integrereret polyethersulfonfilter til infusionen, når koncentratet til infusionsvæske fortyndes med natriumchlorid 9 mg/ml (0,9%) infusionsvæske. 
The use of 0.20 or 0.22 micron in-line polyethersulfone (PES) filter is required for the infusion when the concentrate for infusion is diluted with sodium chloride 9 mg/mL (0.9%) solution for infusion.
Der er identificeret tilfælde af nodulær regenerativ hyperplasi af leveren i leverbiopsier fra patienter behandlet med trastuzumabemtansin. 
Cases of nodular regenerative hyperplasia (NRH) of the liver have been identified from liver biopsies in patients treated with trastuzumab emtansine.
Ikke almindelige bivirkninger: · En anden unormal tilstand, der kan forekomme i forbindelse med behandling med Kadcyla, er en tilstand, der kaldes nodulær regenerativ hyperplasi. 
Uncommon: · Another abnormality that can be caused by Kadcyla is a condition known as nodular regenerative hyperplasia of the liver.
Dosisændringer hos patienter med mBC 
Dose Modifications for Patients with MBC Adverse reaction Severity
Trastuzumabemtansin påvirker kun i mindre grad evnen til at føre motorkøretøj og betjene maskiner. 
Trastuzumab emtansine has minor influence on the ability to drive and use machines.
Trastuzumabemtansin er ikke undersøgt hos patienter, hvor trastuzumab er seponeret permanent på grund af overfølsomhed; trastuzumabemtansin frarådes til disse patienter. 
Trastuzumab emtansine treatment has not been studied in patients who had trastuzumab permanently discontinued due to hypersensitivity; treatment with trastuzumab emtansine is not recommended for these patients.