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 · 96 Präparate · 6744 Quellenpassagen. Automatisch aktualisiert, ohne menschliche Freigabe.
Nebenwirkungen · MabThera
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HOS-087544 · Präparat HOS-083527
Vascular hypertension, vasculitis
disorders orthostatic (predominately
hypotension, cutaneous),
hypotension leukocytoclastic
vasculitis
Respiratory, bronchospasm5, asthma, interstitial lung respiratory lung infiltration
thoracic and respiratory bronchiolitis disease8 failure5
mediastinal disease, obliterans,
disorders chest pain, lung disorder,
dyspnoea, hypoxia
increased cough,
rhinitis
Gastrointestinal nausea vomiting, abdominal gastro-intestinal
disorders diarrhoea, enlargement perforation8
abdominal pain,
dysphagia,
stomatitis,
constipation,
dyspepsia,
anorexia,
throat irritation
Skin and pruritus, urticaria, severe bullous
subcutaneous rash, sweating, skin reactions,
tissue disorders +alopecia night sweats, Stevens-Johnson
+skin disorder syndrome,
toxic epidermal
necrolysis
(Lyell’s
syndrome)8
Musculoskeletal hypertonia,
and connective myalgia,
tissue disorders arthralgia,
back pain,
neck pain,
pain
Renal and renal failure5
urinary
disorders
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Nebenwirkungen · MabThera
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HOS-087545 · Präparat HOS-083527
General disorders fever, tumour pain, infusion site pain
and chills, flushing,
administration asthenia, malaise,
site conditions headache cold syndrome,
+fatigue,
+shivering,
+multi-organ
failure5
Investigations decreased IgG
levels
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Nebenwirkungen · MabThera
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HOS-087546 · Präparat HOS-083527
17
MedDRA
Very Common
Common Uncommon Rare Very Rare Not known
System Organ
Class
For each term, the frequency count was based on reactions of all grades (from mild to severe), except for terms marked with "+"
where the frequency count was based only on severe (≥ grade 3 NCI common toxicity criteria) reactions. Only the highest
frequency observed in the trials is reported
1 includes reactivation and primary infections; frequency based on R-FC regimen in relapsed/refractory CLL
2 see also section infection below
3 observed during post-marketing surveillance
4 see also section haematologic adverse reactions below
5 see also section infusion-related reactions below. Rarely fatal cases reported
6 signs and symptoms of cranial neuropathy. Occurred at various times up to several months after completion of MabThera
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Nebenwirkungen · MabThera
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HOS-087547 · Präparat HOS-083527
therapy
7 observed mainly in patients with prior cardiac condition and/or cardiotoxic chemotherapy and were mostly associated with
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Nebenwirkungen · MabThera
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HOS-087548 · Präparat HOS-083527
infusion-related reactions
8 includes fatal cases
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Nebenwirkungen · MabThera
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HOS-087549 · Präparat HOS-083527
The following terms have been reported as adverse reactions during clinical trials, however, were
reported at a similar or lower incidence in the MabThera arms compared to control arms:
haematotoxicity, neutropenic infection, urinary tract infection, sensory disturbance, pyrexia.
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Nebenwirkungen · MabThera
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HOS-087550 · Präparat HOS-083527
Signs and symptoms suggestive of an infusion-related reaction were reported in more than 50% of
patients in clinical trials, and were predominantly seen during the first infusion, usually in the first one
to two hours. These symptoms mainly comprised fever, chills and rigors. Other symptoms included
flushing, angioedema, bronchospasm, vomiting, nausea, urticaria/rash, fatigue, headache, throat
irritation, rhinitis, pruritus, pain, tachycardia, hypertension, hypotension, dyspnoea, dyspepsia, asthenia
and features of tumour lysis syndrome. Severe infusion-related reactions (such as bronchospasm,
hypotension) occurred in up to 12% of the cases. Additional reactions reported in some cases were
myocardial infarction, atrial fibrillation, pulmonary oedema and acute reversible thrombocytopenia.
Exacerbations of pre-existing cardiac conditions such as angina pectoris or congestive heart failure or
severe cardiac disorders (heart failure, myocardial infarction, atrial fibrillation), pulmonary oedema,
multi-organ failure, tumour lysis syndrome, cytokinerelease syndrome, renal failure, and respiratory
failure were reported at lower or unknown frequencies.The incidence of infusion-related symptoms
decreased substantially with subsequent infusions and is < 1% of patients by the eighth cycle of
MabThera (containing) treatment.
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Nebenwirkungen · MabThera
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HOS-087551 · Präparat HOS-083527
Description of selected adverse reactions
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Nebenwirkungen · MabThera
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HOS-087552 · Präparat HOS-083527
Infections
MabThera induces B-cell depletion in about 70-80% of patients, but was associated with decreased
serum immunoglobulins only in a minority of patients.
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Nebenwirkungen · MabThera
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HOS-087553 · Präparat HOS-083527
Localised candida infections as well as Herpes zoster were reported at a higher incidence in the
MabThera-containing arm of randomised studies. Severe infections were reported in about 4% of
patients treated with MabThera monotherapy. Higher frequencies of infections overall, including
grade 3 or 4 infections, were observed during MabThera maintenance treatment up to 2 years when
compared to observation. There was no cumulative toxicity in terms of infections reported over a
2-year treatment period. In addition, other serious viral infections either new, reactivated or
exacerbated, some of which were fatal, have been reported with MabThera treatment. The majority of
patients had received MabThera in combination with chemotherapy or as part of a haematopoetic
stemcell transplant. Examples of these serious viral infections are infections caused by the herpes
viruses (Cytomegalovirus, Varicella Zoster Virus and Herpes Simplex Virus), JC virus (progressive
multifocal leukoencephalopathy (PML)), enterovirus (meningoencephalitis) and hepatitis C virus (see
section 4.4.). Cases of fatal PML that occurred after disease progression and retreatment have also
been reported in clinical trials. Cases of hepatitis B reactivation, have been reported, the majority of
which were in patients receiving MabThera in combination with cytotoxic chemotherapy. In patients
with relapsed/refractory CLL, the incidence of grade 3/4 hepatitis B infection (reactivation and
primary infection) was 2% in R-FC vs 0% FC. Progression of Kaposi’s sarcoma has been observed in
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Nebenwirkungen · MabThera
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HOS-087554 · Präparat HOS-083527
18
MabThera-exposed patients with pre-existing Kaposi’s sarcoma. These cases occurred in
non-approved indications and the majority of patients were HIV positive.
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Nebenwirkungen · MabThera
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HOS-087555 · Präparat HOS-083527
Haematologic adverse reactions
In clinical trials with MabThera monotherapy given for 4 weeks, haematological abnormalities occurred
in a minority of patients and were usually mild and reversible. Severe (grade 3/4) neutropenia was
reported in 4.2%, anaemia in 1.1% and thrombocytopenia in 1.7% of the patients. During MabThera
maintenance treatment for up to 2 years, leucopenia (5% vs. 2%, grade 3/4) and neutropenia (10% vs.
4%, grade 3/4) were reported at a higher incidence when compared to observation. The incidence of
thrombocytopenia was low (<1%, grade 3/4) and was not different between treatment arms. During the
treatment course in studies with MabThera in combination with chemotherapy, grade 3/4 leucopenia
(R-CHOP 88% vs. CHOP 79%, R-FC 23% vs. FC 12%), neutropenia (R-CVP 24% vs. CVP 14%;
R-CHOP 97% vs. CHOP 88%, R-FC 30% vs. FC 19% in previously untreated CLL), pancytopenia
(R-FC 3% vs. FC 1% in previously untreated CLL) were usually reported with higher frequencies when
compared to chemotherapy alone. However, the higher incidence of neutropenia in patients treated with
MabThera and chemotherapy was not associated with a higher incidence of infections and infestations
compared to patients treated with chemotherapy alone. Studies in previously untreated and
relapsed/refractory CLL have established that in up to 25% of patients treated with R-FC neutropenia
was prolonged (defined as neutrophil count remaining below 1x109/L between Day 24 and 42 after the
last dose) or occurred with a late onset (defined as neutrophil count below 1x109/L later than 42 days
after last dose in patients with no previous prolonged neutropenia or who recovered prior to Day 42)
following treatment with MabThera plus FC.There were no differences reported for the incidence of
anaemia. Some cases of late neutropenia occurring more than four weeks after the last infusion of
MabThera were reported. In the CLL first-line study, Binet stage C patients experienced more adverse
events in the R-FC arm compared to the FC arm (R-FC 83% vs. FC 71%). In the relapsed/refractory CLL
study grade 3/4 thrombocytopenia was reported in 11% of patients in the R-FC group compared to 9% of
patients in the FC group.
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Nebenwirkungen · MabThera
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HOS-087556 · Präparat HOS-083527
In studies of MabThera in patients with Waldenstrom’s macroglobulinaemia, transient increases in
serum IgM levels have been observed following treatment initiation, which may be associated with
hyperviscosity and related symptoms. The transient IgM increase usually returned to at least baseline
level within 4 months.
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Nebenwirkungen · MabThera
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HOS-087557 · Präparat HOS-083527
Cardiovascular adverse reactions
Cardiovascular reactions during clinical trials with MabThera monotherapy were reported in 18.8% of
patients with the most frequently reported events being hypotension and hypertension. Cases of grade 3
or 4 arrhythmia (including ventricular and supraventricular tachycardia) and angina pectoris during
infusion were reported. During maintenance treatment, the incidence of grade 3/4 cardiac disorders was
comparable between patients treated with MabThera and observation. Cardiac events were reported as
serious adverse reactions (including atrial fibrillation, myocardial infarction, left ventricular failure,
myocardial ischaemia) in 3% of patients treated with MabThera compared to < 1% on observation. In
studies evaluating MabThera in combination with chemotherapy, the incidence of grade 3 and 4 cardiac
arrhythmias, predominantly supraventricular arrhythmias such as tachycardia and atrial
flutter/fibrillation, was higher in the R-CHOP group (14 patients, 6.9%) as compared to the CHOP group
(3 patients, 1.5%). All of these arrhythmias either occurred in the context of a MabThera infusion or
were associated with predisposing conditions such as fever, infection, acute myocardial infarction or
pre-existing respiratory and cardiovascular disease. No difference between the R-CHOP and CHOP
group was observed in the incidence of other grade 3 and 4 cardiac events including heart failure,
myocardial disease and manifestations of coronary artery disease. In CLL, the overall incidence of grade
3 or 4 cardiac disorders was low both in the first-line study (4% R-FC, 3% FC) and in the
relapsed/refractory study (4% R-FC, 4% FC).
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Nebenwirkungen · MabThera
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HOS-087558 · Präparat HOS-083527
Respiratory system
Cases of interstitial lung disease, some with fatal outcome have been reported.
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Nebenwirkungen · MabThera
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HOS-087559 · Präparat HOS-083527
19
Neurologic disorders
During the treatment period (induction treatment phase comprising of R-CHOP for at most eight cycles),
four patients (2%) treated with R-CHOP, all with cardiovascular risk factors, experienced
thromboembolic cerebrovascular accidents during the first treatment cycle. There was no difference
between the treatment groups in the incidence of other thromboembolic events. In contrast, three patients
(1.5%) had cerebrovascular events in the CHOP group, all of which occurred during the follow-up
period. In CLL, the overall incidence of grade 3 or 4 nervous system disorders was low both in the
first-line study (4% R-FC, 4% FC) and in the relapsed/refractory study (3% R-FC, 3% FC).
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Nebenwirkungen · MabThera
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HOS-087560 · Präparat HOS-083527
Cases of posterior reversible encephalopathy syndrome (PRES) / reversible posterior
leukoencephalopathy syndrome (RPLS) have been reported. Signs and symptoms included visual
disturbance, headache, seizures and altered mental status, with or without associated hypertension. A
diagnosis of PRES/RPLS requires confirmation by brain imaging. The reported cases had recognised
risk factors for PRES/RPLS, including the patients’ underlying disease, hypertension,
immunosuppressive therapy and/or chemotherapy.
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Nebenwirkungen · MabThera
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HOS-087561 · Präparat HOS-083527
Gastrointestinal disorders
Gastrointestinal perforation in some cases leading to death has been observed in patients receiving
MabThera for treatment of non-Hodgkin’s lymphoma. In the majority of these cases, MabThera was
administered with chemotherapy.
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Nebenwirkungen · MabThera
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HOS-087562 · Präparat HOS-083527
IgG levels
In the clinical trial evaluating MabThera maintenance treatment in relapsed/refractory follicular
lymphoma, median IgG levels were below the lower limit of normal (LLN) (< 7 g/L) after induction
treatment in both the observation and the MabThera groups. In the observation group, the median IgG
level subsequently increased to above the LLN, but remained constant in the MabThera group. The
proportion of patients with IgG levels below the LLN was about 60% in the MabThera group throughout
the 2-year treatment period, while it decreased in the observation group (36% after 2 years).
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Nebenwirkungen · MabThera
MabThera 100 mg concentrate for solution for infusion MabThera 500 mg concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 20
HOS-087563 · Präparat HOS-083527
A small number of spontaneous and literature cases of hypogammaglobulinaemia have been observed in
paediatric patients treated with MabThera, in some cases severe and requiring long-term
immunoglobulin substitution therapy. The consequences of long term B-cell depletion in paediatric
patients are unknown.
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 2026-08-06T15:15:00Z · SHA-256 595c4e1a263e9a34be8b62842a5fc67f95f6a1b1f2a250341444a2960c6c3962 · Passage 4c2dfe39e426bc02338c56bde2eb8a336faf911d6a3b4766b0147173c19413e9 · Zeichen 21951–22257 im Abschnitt
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