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 · Abiraterone Mylan
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HOS-146791 · Präparat HOS-099564
A higher incidence of hypertension and hypokalaemia was observed in the hormone sensitive
population (study 3011). Hypertension was reported in 36.7% of patients in the hormone sensitive
population (study 3011) compared to 11.8% and 20.2% in studies 301 and 302, respectively.
Hypokalaemia was observed in 20.4% of patients in the hormone sensitive population (study 3011)
compared to 19.2% and 14.9% in 301 and 302, respectively).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Abiraterone Mylan
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HOS-146792 · Präparat HOS-099564
The incidence and severity of adverse events was higher in the subgroup of patients with baseline
ECOG2 performance status grade and also in elderly patients (≥75 years ).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Abiraterone Mylan
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HOS-146793 · Präparat HOS-099564
Description of selected adverse reactions
Cardiovascular reactions
The three Phase 3 studies excluded patients with uncontrolled hypertension, clinically significant heart
disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months,
severe or unstable angina, or NYHA Class III or IV heart failure (study 301) or Class II to IV heart
failure (studies 3011 and 302) or cardiac ejection fraction measurement of < 50%. All patients enrolled
(both active and placebo-treated patients) were concomitantly treated with androgen deprivation
therapy, predominantly with the use of LHRH analogues, which has been associated with diabetes,
myocardial infarction, cerebrovascular accident and sudden cardiac death. The incidence of
cardiovascular adverse reactions in the Phase 3 studies in patients taking abiraterone acetate versus
patients taking placebo were as follows: atrial fibrillation 2.6% vs. 2.0%, tachycardia 1.9% vs. 1.0%,
angina pectoris 1.7% vs. 0.8%, cardiac failure 0.7% vs. 0.2%, and arrhythmia 0.7% vs. 0.5%.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Abiraterone Mylan
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HOS-146794 · Präparat HOS-099564
Hepatotoxicity
Hepatotoxicity with elevated ALT, AST and total bilirubin has been reported in patients treated with
abiraterone acetate. Across Phase 3 clinical studies, hepatotoxicity grades 3 and 4 (e.g., ALT or AST
increases of > 5 x ULN or bilirubin increases > 1.5 x ULN) were reported in approximately 6% of
patients who received abiraterone acetate, typically during the first 3 months after starting treatment. In
Study 3011, grade 3 or 4 hepatotoxicity was observed in 8.4% of patients treated with abiraterone. Ten
patients who received abiraterone were discontinued because of hepatotoxicity; two had Grade 2
hepatotoxicity, six had Grade 3 hepatotoxicity, and two had Grade 4 hepatotoxicity. No patient died of
hepatotoxicity in Study 3011. In the Phase 3 clinical studies, patients whose baseline ALT or AST
were elevated were more likely to experience liver function test elevations than those beginning with
normal values. When elevations of either ALT or AST > 5 x ULN, or elevations in bilirubin > 3 x
ULN were observed, abiraterone acetate was withheld or discontinued. In two instances marked
increases in liver function tests occurred (see section 4.4). These two patients with normal baseline
hepatic function, experienced ALT or AST elevations 15 to 40 x ULN and bilirubin elevations 2 to 6 x
ULN. Upon discontinuation of treatment, both patients had normalisation of their liver function tests
and one patient was re-treated without recurrence of the elevations. In study 302, Grade 3 or 4 ALT or
9
AST elevations were observed in 35 (6.5%) patients treated with abiraterone acetate.
Aminotransferase elevations resolved in all but 3 patients (2 with new multiple liver metastases and 1
with AST elevation approximately 3 weeks after the last dose of abiraterone acetate). In Phase 3
clinical studies, treatment discontinuations due to ALT and AST increases or abnormal hepatic
function were reported in 1.1% of patients treated with abiraterone acetate and 0.6% of patients treated
with placebo; no deaths were reported due to hepatotoxicity events.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Abiraterone Mylan
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HOS-146795 · Präparat HOS-099564
In clinical studies, the risk for hepatotoxicity was mitigated by exclusion of patients with baseline
hepatitis or significant abnormalities of liver function tests. In the 3011 study, patients with baseline
ALT and AST > 2.5 x ULN, bilirubin > 1.5 x ULN or those with active or symptomatic viral hepatitis
or chronic liver disease; ascites or bleeding disorders secondary to hepatic dysfunction were excluded.
In the 301 study, patients with baseline ALT and AST ≥ 2.5 x ULN in the absence of liver metastases
and > 5 x ULN in the presence of liver metastases were excluded. In the 302 study, patients with liver
metastases were not eligible and patients with baseline ALT and AST ≥ 2.5 x ULN were excluded.
Abnormal liver function tests developing in patients participating in clinical studies were vigorously
managed by requiring treatment interruption and permitting re-treatment only after return of liver
function tests to the patient’s baseline (see section 4.2). Patients with elevations of ALT or AST > 20 x
ULN were not re-treated. The safety of re-treatment in such patients is unknown. The mechanism for
hepatotoxicity is not understood.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Abiraterone Mylan
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HOS-146796 · Präparat HOS-099564
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.
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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.