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 · Zaltrap
ZALTRAP 25 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 12–13
HOS-215781 · Präparat HOS-155534
12
Fistula formation
Fistula formation involving GI and non-GI sites has occurred in patients treated with ZALTRAP. In
the pivotal study of MCRC patients, fistulas (anal, enterovesical, enterocutaneous, colovaginal,
intestinal sites) were reported in 9 of 611 patients (1.5 %) treated with the ZALTRAP/FOLFIRI
regimen and 3 of 605 patients (0.5 %) treated with the placebo/FOLFIRI regimen.
Grade 3 GI fistula formation occurred in 2 patients treated with ZALTRAP (0.3 %) and in 1
placebo-treated patient (0.2 %). Across the three Phase III placebo-controlled clinical studies
(colorectal, pancreatic, and lung cancer populations), the incidence of fistula (all grades) was 1.1 % for
patients treated with ZALTRAP and 0.2 % for patients treated with placebo. Grade 3-4 fistula
occurred in 0.2 % of patients treated with ZALTRAP and 0.1 % of patients treated with placebo (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
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Nebenwirkungen · Zaltrap
ZALTRAP 25 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 13
HOS-215782 · Präparat HOS-155534
Hypertension
In the pivotal study of MCRC patients, hypertension (all grades) has been reported in 41.2 % of
patients treated with ZALTRAP/FOLFIRI and 10.7 % of patients treated with placebo/FOLFIRI. An
increased risk of grade 3-4 hypertension (including hypertension and one case of essential
hypertension) has been observed in patients receiving the ZALTRAP/FOLFIRI regimen.
Grade 3 hypertension (requiring adjustment in existing anti-hypertensive therapy or treatment with
more than one medicinal product) was reported in 1.5 % of patients treated with the placebo/FOLFIRI
regimen and 19.1 % of patients treated with the ZALTRAP/FOLFIRI regimen. Grade 4 hypertension
(hypertensive crisis) was reported in 1 patient (0.2 %) treated with the ZALTRAP/FOLFIRI regimen.
Among those patients treated with the ZALTRAP/FOLFIRI regimen developing
grade 3-4 hypertension, 54 % had onset during the first two cycles of treatment (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 2024-08-29T14:23:00Z · SHA-256 5b4c1b4848635140cdb6155c414b72c6acf77bc314124cac5763c972a8858b1a · Passage 29c27c6cc837c04b9c1962c0a7263dad108cc4ba9d36261d1806bd4a4fe6e4bb · Zeichen 12260–13199 im Abschnitt
Nebenwirkungen · Zaltrap
ZALTRAP 25 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 13
HOS-215783 · Präparat HOS-155534
Thrombotic and embolic events
Arterial thromboembolic events
In the pivotal study of MCRC patients, ATE (including transient ischaemic attack, cerebrovascular
accident, angina pectoris, intracardiac thrombus, myocardial infarction, arterial embolism, and
ischaemic colitis) were reported in 2.6 % of patients treated with the ZALTRAP/FOLFIRI regimen
and 1.5 % of patients treated with the placebo/FOLFIRI regimen. Grade 3-4 events occurred in
11 patients (1.8 %) treated with the ZALTRAP/FOLFIRI regimen and 3 patients (0.5 %) treated with
the placebo/FOLFIRI regimen. Across the three Phase III placebo-controlled clinical studies
(colorectal, pancreatic, and lung cancer populations), the incidence of ATE (all grades) was 2.3 % for
patients treated with ZALTRAP and 1.7 % for patients treated with placebo. Grade 3-4 ATE occurred
in 1.7 % of patients treated with ZALTRAP and 1.0 % of patients treated with placebo (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 2024-08-29T14:23:00Z · SHA-256 5b4c1b4848635140cdb6155c414b72c6acf77bc314124cac5763c972a8858b1a · Passage 3ff1d7c23c5958a0c67922622e3550dd05370f39fda1720ab09e9651553a142a · Zeichen 13201–14137 im Abschnitt
Nebenwirkungen · Zaltrap
ZALTRAP 25 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 13
HOS-215784 · Präparat HOS-155534
Venous thromboembolic events
VTE include deep venous thrombosis and pulmonary embolism. In the pivotal study of MCRC
patients, all grades VTE occurred in 9.3 % of patients treated with the ZALTRAP/FOLFIRI regimen
and 7.3 % of patients treated with the placebo/FOLFIRI regimen. Grade 3-4 VTE occurred in 7.9 % of
patients treated with the ZALTRAP/FOLFIRI regimen and in 6.3 % of patients treated with the
placebo/FOLFIRI regimen. Pulmonary embolism occurred in 4.6 % of patients treated with the
ZALTRAP/FOLFIRI regimen and 3.5 % of patients treated with the placebo/FOLFIRI regimen.
Across the three Phase III placebo-controlled clinical studies (colorectal, pancreatic, and lung cancer
populations), the incidence of VTE (all grades) was 7.1 % for patients treated with ZALTRAP and
7.1 % for patients treated with placebo.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2024-08-29T14:23:00Z · SHA-256 5b4c1b4848635140cdb6155c414b72c6acf77bc314124cac5763c972a8858b1a · Passage 67f86269530aa1473fcb52bacd282cef6a7e6cc054b64a060f6be45f43c2e0df · Zeichen 14139–14962 im Abschnitt
Nebenwirkungen · Zaltrap
ZALTRAP 25 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 13–14
HOS-215785 · Präparat HOS-155534
Proteinuria
In the pivotal study of MCRC patients, proteinuria (compiled from clinical and laboratory data) was
reported in 62.2 % patients treated with the ZALTRAP/FOLFIRI regimen compared to 40.7 %
patients treated with the placebo/FOLFIRI regimen. Grade 3-4 proteinuria occurred in 7.9 % of
patients treated with the ZALTRAP/FOLFIRI regimen compared to 1.2 % of patients treated with the
placebo/FOLFIRI regimen. Nephrotic syndrome occurred in 2 patients (0.5 %) treated with the
ZALTRAP/FOLFIRI regimen compared to none of the patients treated with the placebo/FOLFIRI
regimen. One patient treated with the ZALTRAP/FOLFIRI regimen presenting with proteinuria and
13
hypertension was diagnosed with thrombotic microangiopathy (TMA). Across the three Phase III
placebo-controlled clinical studies (colorectal, pancreatic, and lung cancer populations), the incidence
of nephrotic syndrome was 0.5 % of patients treated with ZALTRAP and 0.1 % of patients treated
with placebo (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 · Zaltrap
ZALTRAP 25 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 14
HOS-215786 · Präparat HOS-155534
Neutropenia and neutropenic complications
In the pivotal study of MCRC patients, neutropenia (all grades) has been reported in 67.8 % of patients
treated with ZALTRAP/FOLFIRI and 56.3 % of patients treated with placebo/FOLFIRI.
Grade 3-4 neutropenia was observed in 36.7 % of patients treated with the ZALTRAP/FOLFIRI
regimen compared to 29.5 % patients treated with the placebo/FOLFIRI regimen. The most common
grade 3-4 neutropenic complication was the occurrence of febrile neutropenia in 4.3 % of patients
treated with the ZALTRAP/FOLFIRI regimen compared to 1.7 % of patients treated with the
placebo/FOLFIRI regimen. Grade 3-4 neutropenic infection/sepsis occurred in 1.5 % of patients
treated with the ZALTRAP/FOLFIRI regimen and 1.2 % of patients treated with the placebo/FOLFIRI
regimen (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 2024-08-29T14:23:00Z · SHA-256 5b4c1b4848635140cdb6155c414b72c6acf77bc314124cac5763c972a8858b1a · Passage 73a84296836273a39e1cdec1b254389e848fa0dfdbc2db7ede34563b422b1ebe · Zeichen 16010–16824 im Abschnitt
Nebenwirkungen · Zaltrap
ZALTRAP 25 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 14
HOS-215787 · Präparat HOS-155534
Infections
Infections occurred at a higher frequency in patients receiving the ZALTRAP/FOLFIRI regimen
(46.2 %, all grades; 12.3 %, grade 3-4) than in patients receiving the placebo/FOLFIRI regimen
(32.7%, all grades; 6.9 %, grade 3-4), including urinary tract infection, nasopharyngitis, upper
respiratory tract infection, pneumonia, catheter site infection, and tooth infection.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2024-08-29T14:23:00Z · SHA-256 5b4c1b4848635140cdb6155c414b72c6acf77bc314124cac5763c972a8858b1a · Passage 093c8471a68ac212f427adcda9c421f98034cae7f39e7161090b926a35778b19 · Zeichen 16826–17206 im Abschnitt
Nebenwirkungen · Zaltrap
ZALTRAP 25 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 14
HOS-215788 · Präparat HOS-155534
Diarrhoea and dehydration
In the pivotal study of MCRC patients, diarrhoea (all grades) has been observed in 69.2 % of patients
treated with ZALTRAP/FOLFIRI and 56.5 % of patients treated with placebo/FOLFIRI. Dehydration
(all grades) has been observed in 9.0 % of patients treated with ZALTRAP/FOLFIRI and 3.0 % of
patients treated with placebo/FOLFIRI. Grade 3-4 diarrhoea was reported in 19.3 % of patients treated
with the ZALTRAP/FOLFIRI regimen compared to 7.8 % of patients treated with the
placebo/FOLFIRI regimen. Grade 3-4 dehydration was reported in 4.3 % of patients treated with the
ZALTRAP/FOLFIRI regimen compared to 1.3 % of patients treated with the placebo/FOLFIRI
regimen (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 · Zaltrap
ZALTRAP 25 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 14
HOS-215789 · Präparat HOS-155534
Hypersensitivity reactions
In the pivotal study of MCRC patients, severe hypersensitivity reactions have been reported in 0.3 %
of patients treated with the ZALTRAP/FOLFIRI regimen and 0.5 % of patients treated with the
placebo/FOLFIRI regimen (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 2024-08-29T14:23:00Z · SHA-256 5b4c1b4848635140cdb6155c414b72c6acf77bc314124cac5763c972a8858b1a · Passage b72729e3c5e30930648f8b79726890fe7ec24ab4111a99d09f9cc2c93de41dbc · Zeichen 17919–18181 im Abschnitt
Nebenwirkungen · Zaltrap
ZALTRAP 25 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 14
HOS-215790 · Präparat HOS-155534
Compromised wound healing
Treatment with ZALTRAP is associated with potential for compromised wound healing
(wound dehiscence, anastomotic leakage). In the pivotal study for MCRC, compromised wound
healing was reported in 3 patients (0.5 %) treated with the ZALTRAP/FOLFIRI regimen and
5 patients (0.8 %) treated with the placebo/FOLFIRI regimen. Grade 3 compromised wound healing
was reported in 2 patients (0.3 %) treated with the ZALTRAP/FOLFIRI regimen and in none of the
patients treated with the placebo/FOLFIRI regimen. Across the three Phase III placebo-controlled
clinical studies (colorectal, pancreatic, and lung cancer populations), the incidence of compromised
wound healing (all grades) was 0.5 % for patients treated with ZALTRAP and 0.4 % for patients
treated with placebo. Grade 3-4 compromised wound healing occurred in 0.2 % of patients treated
with ZALTRAP and none of patients treated with placebo (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 · Zaltrap
ZALTRAP 25 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 14
HOS-215791 · Präparat HOS-155534
Posterior reversible encephalopathy syndrome (PRES)
PRES was not reported in the pivotal Phase III study of MCRC patients. In other studies, PRES was
reported in patients treated with monotherapy ZALTRAP (0.5 %) and in combination with other
chemotherapies (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 · Zaltrap
ZALTRAP 25 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 14–15
HOS-215792 · Präparat HOS-155534
14
Additional adverse reactions and laboratory abnormalities reported with a ≥5 % difference (all
grades) in patients treated with the ZALTRAP/FOLFIRI regimen versus the placebo/FOLFIRI
regimen
The following adverse reactions and laboratory abnormalities were reported with a ≥ 5 % difference
(all grades) in patients treated with the ZALTRAP/FOLFIRI regimen versus the placebo/FOLFIRI
regimen (in order of decreasing frequency): leucopenia (78.3 % versus 72.4 % all grades; 15.6 %
versus 12.2 % Grades 3-4), increased AST (57.5 % versus 50.2 % all grades; 3.1 % versus
1.7% Grades 3-4), stomatitis (50.1 % versus 32.9 % all grades; 12.8 % versus 4.6 % Grades 3-4),
fatigue (47.8 % versus 39.0 % all grades; 12.6 % versus 7.8 % Grade 3-4), thrombocytopenia (47.4 %
versus 33.8 % all grades; 3.3 % versus 1.7 % Grades 3-4), increased ALT (47.3 % versus 37.1 % all
grades; 2.7 % versus 2.2 % Grades 3-4), decreased appetite (31.9 % versus 23.8 % all grades; 3.4 %
versus 1.8 % Grade 3-4), weight loss (31.9 % versus 14.4 % all grades; 2.6 % versus 0.8 %
Grades 3-4), dysphonia (25.4 % versus 3.3 % all grades; 0.5 % versus 0 Grades 3-4), headache
(22.3 % versus 8.8 % all grades; 1.6 % versus 0.3 % Grades 3-4), asthenia (18.3 % versus 13.2 % all
grades; 5.1% versus 3.0 % Grades 3-4), Palmar- Plantar Erythrodysaesthesia syndrome (11.0 %
versus 4.3 % all grades; 2.8 % versus 0.5 % Grades 3-4), and skin hyperpigmentation (8.2 % versus
2.8 % all grades; 0 versus 0 Grades 3-4).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Zaltrap
ZALTRAP 25 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 15
HOS-215793 · Präparat HOS-155534
Paediatric population
The safety in paediatric patients has not been established.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Zaltrap
ZALTRAP 25 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 15
HOS-215794 · Präparat HOS-155534
Other special populations
Elderly
Of the 611 patients treated with the ZALTRAP/FOLFIRI regimen in the pivotal study of MCRC
patients, 172 (28.2 %) were aged ≥ 65 and < 75 and 33 (5.4 %) were age ≥ 75. Elderly (≥ 65 years
of age) may be more likely to experience adverse reactions. The incidence of diarrhoea, dizziness,
asthenia, weight decrease, and dehydration was increased by ≥5% in elderly compared to younger
patients. Elderly people should be closely monitored for the development of diarrhoea and potential
dehydration (see section 4.4).
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Nebenwirkungen · Zaltrap
ZALTRAP 25 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 15
HOS-215795 · Präparat HOS-155534
Renal impairment
In patients receiving ZALTRAP, the adverse reactions in patients with mild renal impairment at
baseline in three Phase III placebo-controlled clinical studies (N = 352) were comparable with those of
patients without renal impairment (N = 642). A limited number of patients having moderate/severe
renal impairment at baseline (N = 49) were treated with ZALTRAP. In these patients, non-renal events
were generally comparable between patients with renal impairment and those without renal
impairment, except a > 10 % higher incidence in dehydration (all grades) was noted (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 · Zaltrap
ZALTRAP 25 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 15
HOS-215796 · Präparat HOS-155534
Immunogenicity
As with all therapeutic proteins, there is a potential for immunogenicity with ZALTRAP.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Zaltrap
ZALTRAP 25 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 15
HOS-215797 · Präparat HOS-155534
Overall across all clinical oncology studies, similar incidence of low titre anti-drug antibody (ADA)
responses (post baseline) in the ADA assay were observed in both patients treated with placebo and
ZALTRAP (3.3 % and 3.8 %, respectively). High-titre antibody responses to aflibercept were not
detected in any patients. Seventeen (17) patients treated with ZALTRAP (1.6 %) and two (2)
placebo-treated patients (0.2 %) were also positive in the neutralising antibody assay. In the pivotal
study of MCRC patients, positive responses in the ADA assay were observed at higher levels in
patients treated with the placebo/FOLFIRI regimen [18/526 (3.4 %)] than with the
ZALTRAP/FOLFIRI regimen [8/521 (1.5 %)]. Positive results in the neutralising antibody assay in
the MCRC pivotal study were also higher in patients treated with the placebo/FOLFIRI regimen
[2/526 (0.38 % )] than with the ZALTRAP/FOLFIRI regimen [1/521 (0.19 %)]. There was no
observed impact on the pharmacokinetic profile of aflibercept in patients who were positive in the
immunogenicity assays.
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Nebenwirkungen · Zaltrap
ZALTRAP 25 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 15
HOS-215798 · Präparat HOS-155534
Given the similar ADA assay results in patients treated with placebo or ZALTRAP, the actual
incidence of immunogenicity with ZALTRAP based on these assays is likely to be overestimated.
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Version 2024-08-29T14:23:00Z · SHA-256 5b4c1b4848635140cdb6155c414b72c6acf77bc314124cac5763c972a8858b1a · Passage 15b95b0f45e12ff3c8754e8214e33809d36075e75459feac0d38e1d46772050d · Zeichen 23334–23519 im Abschnitt
Nebenwirkungen · Zaltrap
ZALTRAP 25 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 15–16
HOS-215799 · Präparat HOS-155534
15
Immunogenicity data are highly dependent on the sensitivity and specificity of the assay. Additionally,
the observed incidence of antibody positivity in an assay may be influenced by several factors,
including sample handling, timing of sample collection, concomitant medicinal products, and
underlying disease. For these reasons, comparison of the incidence of antibodies to ZALTRAP with
the incidence of antibodies to other products may be misleading.
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 2024-08-29T14:23:00Z · SHA-256 5b4c1b4848635140cdb6155c414b72c6acf77bc314124cac5763c972a8858b1a · Passage a29472922d7ee97029405e7ae11f958c0700e41c1c250108466889ab03f7bd48 · Zeichen 23570–24027 im Abschnitt
Nebenwirkungen · Zaltrap
ZALTRAP 25 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 16
HOS-215800 · Präparat HOS-155534
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare
professionals are asked to report any suspected adverse reactions via the national reporting system
listed in Appendix V.
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 2024-08-29T14:23:00Z · SHA-256 5b4c1b4848635140cdb6155c414b72c6acf77bc314124cac5763c972a8858b1a · Passage 42f7144177697b690f59b1bda795c3fd216297691cf296a2e1269a137feab3cd · Zeichen 24029–24384 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.