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.
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HOS-148105 · Präparat HOS-099834
Summary of the safety profile
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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HOS-148106 · Präparat HOS-099834
Ph+ CML (ASCEMBL, X2101, ASC4FIRST studies)
The most common adverse reactions of any grade (incidence ≥20%) in patients receiving asciminib
were musculoskeletal pain (34.4%), thrombocytopenia (28.1%), fatigue (25.4%), upper respiratory
tract infections (24.8%), headache (22.8%), neutropenia (21.8%), arthralgia (20.7%) and diarrhoea
(20.7%).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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HOS-148107 · Präparat HOS-099834
The most common adverse reactions of ≥ grade 3 (incidence ≥5%) in patients receiving asciminib
were thrombocytopenia (16.5%), neutropenia (13.8%), increased pancreatic enzymes (9.4%) and
hypertension (9.2%).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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HOS-148108 · Präparat HOS-099834
Serious adverse reactions occurred in 9.9% of patients receiving asciminib. The most frequent serious
adverse reactions (incidence ≥1%) were pleural effusion (1.6%), lower respiratory tract infections
(1.6%), thrombocytopenia (1.3%), pancreatitis (1.1%) and pyrexia (1.1%).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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HOS-148109 · Präparat HOS-099834
Ph+ CML-CP with the T315I mutation in patients resistant to, intolerant to or ineligible for ponatinib
(X2101 study)
The safety dataset for the 200 mg twice-daily dose is limited to 48 patients, of whom 34 had a
treatment intensity of >90%.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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HOS-148110 · Präparat HOS-099834
The most common adverse reactions of any grade (incidence ≥20%) in patients receiving asciminib
were musculoskeletal pain (41.7%), fatigue (35.4%), increased pancreatic enzymes (31.3%), diarrhoea
(27.1%), nausea (27.1%), increased hepatic enzymes (25.0%), arthralgia (25.0%), cough (22.9%),
thrombocytopenia (20.8%), vomiting (20.8%) and headache (20.8%).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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HOS-148111 · Präparat HOS-099834
The most common adverse reactions of ≥grade 3 (incidence ≥5%) in patients receiving asciminib were
increased pancreatic enzymes (22.9%), thrombocytopenia (16.7%), neutropenia (12.5%), increased
hepatic enzymes (10.4%), hypertension (8.3%), anaemia (6.3%), vomiting (6.3%) and abdominal pain
(6.3%).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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HOS-148112 · Präparat HOS-099834
Serious adverse reactions occurred in 12.5% of patients receiving asciminib. The most frequent
serious adverse reactions (incidence ≥1%) were abdominal pain (4.2%), vomiting (4.2%), lower
respiratory tract infections (4.2%), constipation (2.1%), headache (2.1%), non-cardiac chest pain
(2.1%) and pleural effusion (2.1%).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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HOS-148113 · Präparat HOS-099834
Tabulated list of adverse reactions
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HOS-148114 · Präparat HOS-099834
The overall safety profile of asciminib has been evaluated in 556 patients with Ph+ CML in chronic
(CP) and accelerated (AP) phases in the pivotal phase III study A2301 (ASCEMBL) and the phase I
study X2101, and with newly diagnosed Ph+ CML-CP in the pivotal phase III study J12301
(ASC4FIRST). In ASCEMBL (N=156), patients received asciminib as monotherapy at a dose of
40 mg twice daily. In X2101 (N=200), patients received asciminib as monotherapy at doses ranging
from 10 to 200 mg twice daily and 80 to 200 mg once daily. Of these patients, 48 with the T315I
mutation received asciminib 200 mg twice daily. In ASC4FIRST (N=200), patients received asciminib
as monotherapy at a dose of 80 mg once daily. In the pooled dataset, the median duration of exposure
to asciminib was 123.29 weeks (range: 0.1 to 439 weeks).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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HOS-148115 · Präparat HOS-099834
9
Adverse reactions from clinical studies (Table 2) are listed by MedDRA system organ class. Within
each system organ class, the adverse reactions are ranked by frequency, with the most frequent
reactions first. Within each frequency grouping, adverse reactions are presented in order of decreasing
seriousness. In addition, the corresponding frequency category for each adverse reaction is based on
the following convention: 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); very rare (<1/10 000).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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HOS-148116 · Präparat HOS-099834
10
Table 2 Adverse reactions observed with asciminib in clinical studies
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HOS-148117 · Präparat HOS-099834
Frequency
System organ class Adverse reaction
category
Very common Upper respiratory tract infection1
Infections and infestations
Common Lower respiratory tract infection2, influenza
Blood and lymphatic system Very common Thrombocytopenia3, neutropenia4, anaemia5
disorders Uncommon Febrile neutropenia, pancytopenia
Immune system disorders Uncommon Hypersensitivity
Endocrine disorders Common Hypothyroidism6
Metabolism and nutrition Very common Dyslipidaemia7
disorders Common Decreased appetite, hyperglycaemia
Nervous system disorders Very common Headache, dizziness
Eye disorders Common Dry eye, vision blurred
Cardiac disorders Common Palpitations
Vascular disorders Very common Hypertension8
Respiratory, thoracic and Very common Cough
mediastinal disorders Common Pleural effusion, dyspnoea, non-cardiac chest pain
Pancreatic enzymes increased9, vomiting, diarrhoea,
Very common
Gastrointestinal disorders nausea, abdominal pain10, constipation
Common Pancreatitis11
Very common Hepatic enzyme increased12
Hepatobiliary disorders
Common Blood bilirubin increased13
Skin and subcutaneous tissue Very common Rash14, pruritus
disorders Common Urticaria
Musculoskeletal and
Very common Musculoskeletal pain15, arthralgia
connective tissue disorders
General disorders and Very common Fatigue16
administration site conditions Common Oedema17, pyrexia18
Common Blood creatine phosphokinase increased
Investigations
Uncommon Electrocardiogram QT prolonged
1
Upper respiratory tract infection includes: upper respiratory tract infection, nasopharyngitis, pharyngitis and
rhinitis.
2
Lower respiratory tract infections include: pneumonia, bronchitis and tracheobronchitis.
3
Thrombocytopenia includes: thrombocytopenia and platelet count decreased.
4
Neutropenia includes: neutropenia and neutrophil count decreased.
5
Anaemia includes: anaemia, haemoglobin decreased and normocytic anaemia.
6
Hypothyroidism includes hypothyroidism, autoimmune thyroiditis, blood thyroid stimulating hormone
increased, autoimmune hypothyroidism and primary hypothyroidism.
7
Dyslipidaemia includes: hypertriglyceridaemia, blood cholesterol increased, hypercholesterolaemia, blood
triglycerides increased, hyperlipidaemia and dyslipidaemia.
8
Hypertension includes: hypertension and blood pressure increased.
9
Pancreatic enzymes increased includes: lipase increased, amylase increased and hyperlipasaemia.
10
Abdominal pain includes: abdominal pain and abdominal pain upper.
11
Pancreatitis includes: pancreatitis and pancreatitis acute.
12
Hepatic enzymes increased includes: alanine aminotransferase increased, aspartate aminotransferase increased,
gamma-glutamyltransferase increased, transaminases increased and hypertransaminasaemia.
13
Blood bilirubin increased includes: blood bilirubin increased, bilirubin conjugated increased and
hyperbilirubinaemia.
14
Rash includes: rash, rash maculopapular and rash pruritic.
15
Musculoskeletal pain includes: pain in extremity, back pain, myalgia, bone pain, musculoskeletal pain, neck
pain, musculoskeletal chest pain and musculoskeletal discomfort.
16
Fatigue includes: fatigue and asthenia.
17
Oedema includes: oedema and oedema peripheral.
18
Pyrexia includes: pyrexia and body temperature increased.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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HOS-148118 · Präparat HOS-099834
11
Description of selected adverse reactions
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HOS-148119 · Präparat HOS-099834
Myelosuppression
Thrombocytopenia occurred in 28.1% of patients receiving asciminib, with grade 3 and 4 reactions
reported in 7% and 9.5% of patients, respectively. Among the patients with thrombocytopenia
≥ grade 3, the median time to first occurrence of reactions was 6 weeks (range: 0.14 to 64.14 weeks),
with median duration of any occurring reaction of 1.57 weeks (95% CI, range: 1.14 to 2 weeks). 2% of
patients receiving asciminib permanently discontinued due to thrombocytopenia, while asciminib was
temporarily withheld in 12.6% of patients due to the adverse reaction.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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HOS-148120 · Präparat HOS-099834
Thrombocytopenia occurred in 20.8% of patients with the T315I mutation receiving asciminib, with
grade 3 and 4 reactions reported in 16.7% of patients. Among the patients with thrombocytopenia
≥ grade 3, the median time to first occurrence of reactions was 8.36 weeks (range: 1.43 to
38.43 weeks), with median duration of any occurring reaction of 4.29 weeks (95% CI, range: 1.71 to
5.71 weeks). 2.1% of patients with the T315I mutation receiving asciminib permanently discontinued
due to thrombocytopenia, while asciminib was temporarily withheld in 6.3% of patients due to the
adverse reaction.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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HOS-148121 · Präparat HOS-099834
Neutropenia occurred in 21.8% of patients receiving asciminib, with grade 3 and 4 reactions reported
in 7.6% and 6.3% of patients, respectively. Among the patients with neutropenia ≥ grade 3, the median
time to first occurrence of reactions was 7.14 weeks (range: 0.14 to 180.14 weeks), with median
duration of any occurring reaction of 1.86 weeks (95% CI, range: 1.29 to 2 weeks). 1.3% of patients
receiving asciminib permanently discontinued due to neutropenia, while asciminib was temporarily
withheld in 9.4% of patients due to the adverse reaction.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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HOS-148122 · Präparat HOS-099834
Neutropenia occurred in 16.7% of patients with the T315I mutation receiving asciminib, with grade 3
and 4 reactions reported in 12.5% of patients. Among the patients with neutropenia ≥ grade 3, the
median time to first occurrence of reactions was 4.14 weeks (range: 0.14 to 16.57 weeks), with median
duration of any occurring reaction of 2.86 weeks (95% CI, range: 1.57 to 4.57 weeks). 2.1% of
patients with the T315I mutation receiving asciminib permanently discontinued due to neutropenia,
while asciminib was temporarily withheld in 2.1% of patients due to the adverse reaction.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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HOS-148123 · Präparat HOS-099834
Anaemia occurred in 12.9% of patients receiving asciminib, with grade 3 reactions occurring in 4.1%
of patients. Among the patients with anaemia ≥ grade 3, the median time to first occurrence of
reactions was 24.14 weeks (range: 0.14 to 207 weeks), with median duration of any occurring reaction
of 0.86 weeks (95% CI, range: 0.29 to 1.71 weeks). Asciminib was temporarily withheld in 0.5% of
patients due to the adverse reaction.
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HOS-148124 · Präparat HOS-099834
Anaemia occurred in 10.4% of patients with the T315I mutation receiving asciminib, with grade 3 and
4 reactions reported in 6.3% of patients. Among the patients with anaemia ≥ grade 3, the median time
to first occurrence of reactions was 38.43 weeks (range: 24.14 to 131 weeks), with median duration of
any occurring reaction of 0.86 weeks (95% CI, range: 0.14 to NE [not estimable] weeks).
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 2026-08-07T15:31:00Z · SHA-256 a2fd46262678a8eeb46669611ee0714c6effd5303baddb16f404cbe6b0d0ab23 · Passage 27e93e52135f8bdd640f4dc767ed22aa2c015692f5f0d1b03132980bc501d075 · Zeichen 11098–11488 im Abschnitt
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