Ein Paarvergleich findet Originalpassagen, die den anderen Wirkstoff wörtlich nennen. Aussagen gelten für das jeweilige Präparat und seine Formulierung. Klassenbegriffe und abweichende Synonyme können fehlen. Kein Treffer bedeutet nicht, dass keine Wechselwirkung besteht.
RxNorm 05-Oct-2026 · geprüft 2026-10-25 · 1009 Präparate · 54812 Quellenpassagen · 148 strukturierte Aussagen. Automatisch aktualisiert, ohne menschliche Freigabe.
Nebenwirkungen · Sprycel
SPRYCEL 20 mg film-coated tablets SPRYCEL 50 mg film-coated tablets SPRYCEL 70 mg film-coated tablets SPRYCEL 80 mg film-coated tablets SPRYCEL 100 mg film-coated tablets SPRYCEL 140 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13
HOS-116695 · Präparat HOS-094467
The overall safety profile of SPRYCEL in the paediatric Ph+ CML-CP population was similar to that
of the adult population, regardless of formulation. Of the 130 SPRYCEL-treated paediatric subjects
with CML-CP, 2 (1.5%) experienced adverse reactions leading to treatment discontinuation.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Sprycel
SPRYCEL 20 mg film-coated tablets SPRYCEL 50 mg film-coated tablets SPRYCEL 70 mg film-coated tablets SPRYCEL 80 mg film-coated tablets SPRYCEL 100 mg film-coated tablets SPRYCEL 140 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13
HOS-116696 · Präparat HOS-094467
Tabulated list of adverse reactions
The following adverse reactions, excluding laboratory abnormalities, were reported in patients treated
with SPRYCEL used as single-agent therapy in clinical studies and post-marketing experience
(Table 5). These reactions are presented by system organ class and by frequency. Frequencies are
defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100);
rare (≥ 1/10,000 to < 1/1,000); not known (cannot be estimated from available post-marketing data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Sprycel
SPRYCEL 20 mg film-coated tablets SPRYCEL 50 mg film-coated tablets SPRYCEL 70 mg film-coated tablets SPRYCEL 80 mg film-coated tablets SPRYCEL 100 mg film-coated tablets SPRYCEL 140 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13
HOS-116697 · Präparat HOS-094467
Table 5: Tabulated summary of adverse reactions
Infections and infestations
Very common infection (including bacterial, viral, fungal, non-specified)
Common pneumonia (including bacterial, viral, and fungal), upper respiratory tract
infection/inflammation, herpes virus infection (including cytomegalovirus - CMV),
enterocolitis infection, sepsis (including uncommon cases with fatal outcomes)
Not known hepatitis B reactivation
Blood and lymphatic system disorders
Very Common myelosuppression (including anaemia, neutropaenia, thrombocytopaenia)
Common febrile neutropaenia
Uncommon lymphadenopathy, lymphopaenia
Rare aplasia pure red cell
Immune system disorders
Uncommon hypersensitivity (including erythema nodosum)
Rare anaphylactic shock
Endocrine disorders
Uncommon hypothyroidism
Rare hyperthyroidism, thyroiditis
Metabolism and nutrition disorders
Common appetite disturbancesa, hyperuricaemia
Uncommon tumour lysis syndrome, dehydration, hypoalbuminemia, hypercholesterolemia
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2026-10-02T12:05:00Z · SHA-256 c065657005bf3f51d58db1cb5b29a1453d36e1fc897c0adb5e47ed684f07722e · Passage a9f8336cd990ff5870b80f0dbc402fd99754f86f0d927dcc0d03059ea12ea308 · Zeichen 2320–3497 im Abschnitt
Nebenwirkungen · Sprycel
SPRYCEL 20 mg film-coated tablets SPRYCEL 50 mg film-coated tablets SPRYCEL 70 mg film-coated tablets SPRYCEL 80 mg film-coated tablets SPRYCEL 100 mg film-coated tablets SPRYCEL 140 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13–14
HOS-116698 · Präparat HOS-094467
13
Rare diabetes mellitus
Psychiatric disorders
Common depression, insomnia
Uncommon anxiety, confusional state, affect lability, libido decreased
Nervous system disorders
Very common headache
Common neuropathy (including peripheral neuropathy), dizziness, dysgeusia, somnolence
Uncommon CNS bleeding*b, syncope, tremor, amnesia, balance disorder
Rare cerebrovascular accident, transient ischaemic attack, convulsion, optic neuritis, VIIth
nerve paralysis, dementia, ataxia
Eye disorders
Common visual disorder (including visual disturbance, vision blurred, and visual acuity
reduced), dry eye
Uncommon visual impairment, conjunctivitis, photophobia, lacrimation increased
Ear and labyrinth disorders
Common tinnitus
Uncommon hearing loss, vertigo
Cardiac disorders
Common congestive heart failure/cardiac dysfunction*c, pericardial effusion*, arrhythmia
(including tachycardia), palpitations
Uncommon myocardial infarction (including fatal outcome)*, electrocardiogram QT prolonged*,
pericarditis, ventricular arrhythmia (including ventricular tachycardia), angina
pectoris, cardiomegaly, electrocardiogram T wave abnormal, troponin increased
Rare cor pulmonale, myocarditis, acute coronary syndrome, cardiac arrest,
electrocardiogram PR prolongation, coronary artery disease, pleuropericarditis
Not known atrial fibrillation/atrial flutter
Vascular disorders
Very common haemorrhage*d
Common hypertension, flushing
Uncommon hypotension, thrombophlebitis, thrombosis
Rare deep vein thrombosis, embolism, livedo reticularis
Not known thrombotic microangiopathy
Respiratory, thoracic and mediastinal disorders
Very common pleural effusion*, dyspnoea
Common pulmonary oedema*, pulmonary hypertension*, lung infiltration, pneumonitis, cough
Uncommon pulmonary arterial hypertension, bronchospasm, asthma, chylothorax*
Rare pulmonary embolism, acute respiratory distress syndrome
Not known interstitial lung disease
Gastrointestinal disorders
Very common diarrhoea, vomiting, nausea, abdominal pain
Common gastrointestinal bleeding*, colitis (including neutropaenic colitis), gastritis, mucosal
inflammation (including mucositis/stomatitis), dyspepsia, abdominal distension,
constipation, oral soft tissue disorder
Uncommon pancreatitis (including acute pancreatitis), upper gastrointestinal ulcer, oesophagitis,
ascites*, anal fissure, dysphagia, gastroesophageal reflux disease
Rare protein-losing gastroenteropathy, ileus, anal fistula
Not known fatal gastrointestinal haemorrhage*
Hepatobiliary disorders
Uncommon hepatitis, cholecystitis, cholestasis
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Sprycel
SPRYCEL 20 mg film-coated tablets SPRYCEL 50 mg film-coated tablets SPRYCEL 70 mg film-coated tablets SPRYCEL 80 mg film-coated tablets SPRYCEL 100 mg film-coated tablets SPRYCEL 140 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 14–15
HOS-116699 · Präparat HOS-094467
14
Skin and subcutaneous tissue disorders
Very common skin rashe
Common alopecia, dermatitis (including eczema), pruritus, acne, dry skin, urticaria,
hyperhidrosis
Uncommon neutrophilic dermatosis, photosensitivity, pigmentation disorder, panniculitis, skin
ulcer, bullous conditions, nail disorder, palmar-plantar erythrodysesthesia syndrome,
hair disorder
Rare leukocytoclastic vasculitis, skin fibrosis
Not known Stevens-Johnson syndromef
Musculoskeletal and connective tissue disorders
Very common musculoskeletal paing
Common arthralgia, myalgia, muscular weakness, musculoskeletal stiffness, muscle spasm
Uncommon rhabdomyolysis, osteonecrosis, muscle inflammation, tendonitis, arthritis
Rare epiphyses delayed fusion,h growth retardationh
Renal and urinary disorders
Uncommon renal impairment (including renal failure), urinary frequency, proteinuria
Not known nephrotic syndrome
Pregnancy, puerperium and perinatal conditions
Rare abortion
Reproductive system and breast disorders
Uncommon gynecomastia, menstrual disorder
General disorders and administration site conditions
Very common peripheral oedemai, fatigue, pyrexia, face oedemaj
Common asthenia, pain, chest pain, generalised oedema*k, chills
Uncommon malaise, other superficial oedemal
Rare gait disturbance
Investigations
Common weight decreased, weight increased
Uncommon blood creatine phosphokinase increased, gamma-glutamyltransferase increased
Injury, poisoning, and procedural complications
Common contusion
a Includes decreased appetite, early satiety, increased appetite.
b Includes central nervous system haemorrhage, cerebral haematoma, cerebral haemorrhage, extradural haematoma,
haemorrhage intracranial, haemorrhagic stroke, subarachnoid haemorrhage, subdural haematoma, and subdural
haemorrhage.
c Includes brain natriuretic peptide increased, ventricular dysfunction, left ventricular dysfunction, right ventricular
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Sprycel
SPRYCEL 20 mg film-coated tablets SPRYCEL 50 mg film-coated tablets SPRYCEL 70 mg film-coated tablets SPRYCEL 80 mg film-coated tablets SPRYCEL 100 mg film-coated tablets SPRYCEL 140 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 15
HOS-116700 · Präparat HOS-094467
dysfunction, cardiac failure, cardiac failure acute, cardiac failure chronic, cardiac failure congestive, cardiomyopathy,
congestive cardiomyopathy, diastolic dysfunction, ejection fraction decreased and ventricular failure, left ventricular
failure, right ventricular failure, and ventricular hypokinesia.
d Excludes gastrointestinal bleeding and CNS bleeding; these adverse reactions are reported under the gastrointestinal
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Sprycel
SPRYCEL 20 mg film-coated tablets SPRYCEL 50 mg film-coated tablets SPRYCEL 70 mg film-coated tablets SPRYCEL 80 mg film-coated tablets SPRYCEL 100 mg film-coated tablets SPRYCEL 140 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 15
HOS-116701 · Präparat HOS-094467
disorders system organ class and the nervous system disorders system organ class, respectively.
e Includes drug eruption, erythema, erythema multiforme, erythrosis, exfoliative rash, generalised erythema, genital rash,
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Sprycel
SPRYCEL 20 mg film-coated tablets SPRYCEL 50 mg film-coated tablets SPRYCEL 70 mg film-coated tablets SPRYCEL 80 mg film-coated tablets SPRYCEL 100 mg film-coated tablets SPRYCEL 140 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 15
HOS-116702 · Präparat HOS-094467
heat rash, milia, miliaria, pustular psoriaisis, rash, rash erythematous, rash follicular, rash generalised, rash macular, rash
maculo-papular, rash papular, rash pruritic, rash pustular, rash vesicular, skin exfoliation, skin irritation, toxic skin
eruption, urticaria vesiculosa, and vasculitic rash.
f In the post-marketing setting, individual cases of Stevens-Johnson syndrome have been reported. It could not be
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Sprycel
SPRYCEL 20 mg film-coated tablets SPRYCEL 50 mg film-coated tablets SPRYCEL 70 mg film-coated tablets SPRYCEL 80 mg film-coated tablets SPRYCEL 100 mg film-coated tablets SPRYCEL 140 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 15
HOS-116703 · Präparat HOS-094467
determined whether these mucocutaneous adverse reactions were directly related to SPRYCEL or to concomitant
medicinal product.
g Musculoskeletal pain reported during or after discontinuing treatment.
h Frequency reported as common in paediatric studies.
i Gravitational oedema, localised oedema, oedema peripheral.
j Conjunctival oedema, eye oedema, eye swelling, eyelid oedema, face oedema, lip oedema, macular oedema, oedema
mouth, orbital oedema, periorbital oedema, swelling face.
k Fluid overload, fluid retention, gastrointestinal oedema, generalised oedema, peripheral swelling, oedema, oedema due to
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Sprycel
SPRYCEL 20 mg film-coated tablets SPRYCEL 50 mg film-coated tablets SPRYCEL 70 mg film-coated tablets SPRYCEL 80 mg film-coated tablets SPRYCEL 100 mg film-coated tablets SPRYCEL 140 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 15
HOS-116704 · Präparat HOS-094467
cardiac disease, perinephric effusion, post procedural oedema, visceral oedema.
l Genital swelling, incision site oedema, oedema genital, penile oedema, penile swelling, scrotal oedema, skin swelling,
testicular swelling, vulvovaginal swelling.
* For additional details, see section "Description of selected adverse reactions"
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Sprycel
SPRYCEL 20 mg film-coated tablets SPRYCEL 50 mg film-coated tablets SPRYCEL 70 mg film-coated tablets SPRYCEL 80 mg film-coated tablets SPRYCEL 100 mg film-coated tablets SPRYCEL 140 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 15–16
HOS-116705 · Präparat HOS-094467
15
Description of selected adverse reactions
Myelosuppression
Treatment with SPRYCEL is associated with anaemia, neutropaenia and thrombocytopaenia. Their
occurrence is earlier and more frequent in patients with advanced phase CML or Ph+ ALL than in
chronic phase CML (see section 4.4).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Sprycel
SPRYCEL 20 mg film-coated tablets SPRYCEL 50 mg film-coated tablets SPRYCEL 70 mg film-coated tablets SPRYCEL 80 mg film-coated tablets SPRYCEL 100 mg film-coated tablets SPRYCEL 140 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 16
HOS-116706 · Präparat HOS-094467
Bleeding
Bleeding drug-related adverse reactions, ranging from petechiae and epistaxis to
grade 3 or 4 gastrointestinal haemorrhage and CNS bleeding, were reported in patients taking
SPRYCEL (see section 4.4).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Sprycel
SPRYCEL 20 mg film-coated tablets SPRYCEL 50 mg film-coated tablets SPRYCEL 70 mg film-coated tablets SPRYCEL 80 mg film-coated tablets SPRYCEL 100 mg film-coated tablets SPRYCEL 140 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 16
HOS-116707 · Präparat HOS-094467
Fluid retention
Miscellaneous adverse reactions such as pleural effusion, ascites, pulmonary oedema and pericardial
effusion with or without superficial oedema may be collectively described as “fluid retention”. In the
newly diagnosed chronic phase CML study after a minimum of 60 months follow-up, dasatinib-related
fluid retention adverse reactions included pleural effusion (28%), superficial oedema (14%),
pulmonary hypertension (5%), generalised oedema (4%), and pericardial effusion (4%). Congestive
heart failure/cardiac dysfunction and pulmonary oedema were reported in < 2% of patients.
The cumulative rate of dasatinib-related pleural effusion (all grades) over time was 10% at 12 months,
14% at 24 months, 19% at 36 months, 24% at 48 months and 28% at 60 months. A total of
46 dasatinib-treated patients had recurrent pleural effusions. Seventeen patients had 2 separate adverse
reactions, 6 had 3 adverse reactions, 18 had 4 to 8 adverse reactions and 5 had > 8 episodes of pleural
effusions.
The median time to first dasatinib-related grade 1 or 2 pleural effusion was 114 weeks (range: 4 to
299 weeks). Less than 10% of patients with pleural effusion had severe (grade 3 or 4) dasatinib-related
pleural effusions. The median time to first occurrence of grade ≥ 3 dasatinib-related pleural effusion
was 175 weeks (range: 114 to 274 weeks). The median duration of dasatinib-related pleural effusion
(all grades) was 283 days (~40 weeks).
Pleural effusion was usually reversible and managed by interrupting SPRYCEL treatment and using
diuretics or other appropriate supportive care measures (see sections 4.2 and 4.4). Among
dasatinib-treated patients with drug-related pleural effusion (n=73), 45 (62%) had dose interruptions
and 30 (41%) had dose reductions. Additionally, 34 (47%) received diuretics, 23 (32%) received
corticosteroids, and 20 (27%) received both corticosteroids and diuretics. Nine (12%) patients
underwent therapeutic thoracentesis.
Six percent of dasatinib-treated patients discontinued treatment due to drug-related pleural effusion.
Pleural effusion did not impair the ability of patients to obtain a response. Among the dasatinib-treated
patients with pleural effusion, 96% achieved a cCCyR, 82% achieved a MMR, and 50% achieved a
MR4.5 despite dose interruptions or dose adjustment.
See section 4.4 for further information on patients with chronic phase CML and advanced phase CML
or Ph+ ALL.
Cases of chylothorax have been reported in patients presenting with pleural effusion. Some cases of
chylothorax resolved upon dasatinib discontinuation, interruption, or dose reduction, but most cases
also required additional treatment.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Sprycel
SPRYCEL 20 mg film-coated tablets SPRYCEL 50 mg film-coated tablets SPRYCEL 70 mg film-coated tablets SPRYCEL 80 mg film-coated tablets SPRYCEL 100 mg film-coated tablets SPRYCEL 140 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 16
HOS-116708 · Präparat HOS-094467
Pulmonary arterial hypertension (PAH)
PAH (pre-capillary pulmonary arterial hypertension confirmed by right heart catheterization) has been
reported in association with dasatinib exposure. In these cases, PAH was reported after initiation of
dasatinib therapy, including after more than one year of treatment. Patients with PAH reported during
dasatinib treatment were often taking concomitant medicinal products or had co-morbidities in
addition to the underlying malignancy. Improvements in haemodynamic and clinical parameters have
been observed in patients with PAH following discontinuation of dasatinib.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Sprycel
SPRYCEL 20 mg film-coated tablets SPRYCEL 50 mg film-coated tablets SPRYCEL 70 mg film-coated tablets SPRYCEL 80 mg film-coated tablets SPRYCEL 100 mg film-coated tablets SPRYCEL 140 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 16
HOS-116709 · Präparat HOS-094467
QT Prolongation
In the Phase III study in patients with newly diagnosed chronic phase CML, one patient (< 1%) of the
SPRYCEL-treated patients had a QTcF > 500 msec after a minimum of 12 months follow-up (see
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Sprycel
SPRYCEL 20 mg film-coated tablets SPRYCEL 50 mg film-coated tablets SPRYCEL 70 mg film-coated tablets SPRYCEL 80 mg film-coated tablets SPRYCEL 100 mg film-coated tablets SPRYCEL 140 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 16–17
HOS-116710 · Präparat HOS-094467
16
section 4.4). No additional patients were reported to have QTcF > 500 msec after a minimum of
60 months follow-up.
In 5 Phase II clinical studies in patients with resistance or intolerance to prior imatinib therapy,
repeated baseline and on-treatment ECGs were obtained at pre-specified time points and read centrally
for 865 patients receiving SPRYCEL 70 mg twice daily. QT interval was corrected for heart rate by
Fridericia's method. At all post-dose time points on day 8, the mean changes from baseline in QTcF
interval were 4 - 6 msec, with associated upper 95% confidence intervals < 7 msec. Of the
2,182 patients with resistance or intolerance to prior imatinib therapy who received SPRYCEL in
clinical studies, 15 (1%) had QTc prolongation reported as an adverse reaction. Twenty-one patients
(1%) experienced a QTcF > 500 msec (see section 4.4).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2026-10-02T12:05:00Z · SHA-256 c065657005bf3f51d58db1cb5b29a1453d36e1fc897c0adb5e47ed684f07722e · Passage 17d9fa6d2f94bb553e725423a75406abd07d650377540f7e2f9c013c9e312a17 · Zeichen 15012–15870 im Abschnitt
Nebenwirkungen · Sprycel
SPRYCEL 20 mg film-coated tablets SPRYCEL 50 mg film-coated tablets SPRYCEL 70 mg film-coated tablets SPRYCEL 80 mg film-coated tablets SPRYCEL 100 mg film-coated tablets SPRYCEL 140 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 17
HOS-116711 · Präparat HOS-094467
Cardiac adverse reactions
Patients with risk factors or a history of cardiac disease should be monitored carefully for signs or
symptoms consistent with cardiac dysfunction and should be evaluated and treated appropriately (see
section 4.4).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-10-02T12:05:00Z · SHA-256 c065657005bf3f51d58db1cb5b29a1453d36e1fc897c0adb5e47ed684f07722e · Passage a082a82146cc6fd106d38502b5e3f3df30952891b99f5076b6ec28e995f4aec4 · Zeichen 15872–16113 im Abschnitt
Nebenwirkungen · Sprycel
SPRYCEL 20 mg film-coated tablets SPRYCEL 50 mg film-coated tablets SPRYCEL 70 mg film-coated tablets SPRYCEL 80 mg film-coated tablets SPRYCEL 100 mg film-coated tablets SPRYCEL 140 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 17
HOS-116712 · Präparat HOS-094467
Hepatitis B reactivation
Hepatitis B reactivation has been reported in association with BCR-ABL TKIs. Some cases resulted in
acute hepatic failure or fulminant hepatitis leading to liver transplantation or a fatal outcome (see
section 4.4).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-10-02T12:05:00Z · SHA-256 c065657005bf3f51d58db1cb5b29a1453d36e1fc897c0adb5e47ed684f07722e · Passage 9d4ba8f350486fc1e3f7a79431c0401477715afc19f4d1e97f06e2f022c27ca5 · Zeichen 16115–16355 im Abschnitt
Nebenwirkungen · Sprycel
SPRYCEL 20 mg film-coated tablets SPRYCEL 50 mg film-coated tablets SPRYCEL 70 mg film-coated tablets SPRYCEL 80 mg film-coated tablets SPRYCEL 100 mg film-coated tablets SPRYCEL 140 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 17
HOS-116713 · Präparat HOS-094467
In the Phase III dose-optimisation study in patients with chronic phase CML with resistance or
intolerance to prior imatinib therapy (median duration of treatment of 30 months), the incidence of
pleural effusion and congestive heart failure/cardiac dysfunction was lower in patients treated with
SPRYCEL 100 mg once daily than in those treated with SPRYCEL 70 mg twice daily.
Myelosuppression was also reported less frequently in the 100 mg once daily treatment group (see
Laboratory test abnormalities below). The median duration of therapy in the 100 mg once daily group
was 37 months (range 1-91 months). Cumulative rates of selected adverse reactions that were reported
in the 100 mg once daily recommended starting dose are shown in Table 6a.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2026-10-02T12:05:00Z · SHA-256 c065657005bf3f51d58db1cb5b29a1453d36e1fc897c0adb5e47ed684f07722e · Passage d6419ef6a2cabff5f4ba701f470fb626180ac99fd1ca38630033b9aaa0c60727 · Zeichen 16357–17104 im Abschnitt
Nebenwirkungen · Sprycel
SPRYCEL 20 mg film-coated tablets SPRYCEL 50 mg film-coated tablets SPRYCEL 70 mg film-coated tablets SPRYCEL 80 mg film-coated tablets SPRYCEL 100 mg film-coated tablets SPRYCEL 140 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 17
HOS-116714 · Präparat HOS-094467
Table 6a: Selected adverse reactions reported in a phase 3 dose optimisation study (imatinib
intolerant or resistant chronic phase CML)a
Minimum of 2 years Minimum of 5 years Minimum of 7 years
follow up follow up follow up
All Grade All Grade All Grade
grades 3/4 grades 3/4 grades 3/4
Preferred term Percent (%) of patients
Diarrhoea 27 2 28 2 28 2
Fluid retention 34 4 42 6 48 7
Superficial oedema 18 0 21 0 22 0
Pleural effusion 18 2 24 4 28 5
Generalised oedema 3 0 4 0 4 0
Pericardial effusion 2 1 2 1 3 1
Pulmonary
0 0 0 0 2 1
hypertension
Haemorrhage 11 1 11 1 12 1
Gastrointestinal
2 1 2 1 2 1
bleeding
a Phase 3 dose optimisation study results reported in recommended starting dose of 100 mg once daily (n=165) population
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2026-10-02T12:05:00Z · SHA-256 c065657005bf3f51d58db1cb5b29a1453d36e1fc897c0adb5e47ed684f07722e · Passage b5448f40741907db0b13f242dff8ca284b915d40133a9978ab6dea860b29a640 · Zeichen 17110–18829 im Abschnitt
This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.