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-137595 · Präparat HOS-098067
Gastrointestinal Diarrhoea Dyspepsia f
disorders Vomiting
Nausea
Stomatitis f
Skin and subcutaneous Alopecia g Nail disorder f Erythema
tissue disorders Pruritus g Dry skin e multiforme
Rash g
Musculoskeletal and Muscular
connective tissue weakness e
disorders
General disorders and Pyrexia e
administration site Fatigue
conditions
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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HOS-137596 · Präparat HOS-098067
10
Investigations Alanine
aminotransferase
increased g
Aspartate
aminotransferase
increased g
a
Abemaciclib in combination with anastrozole, letrozole, exemestane, tamoxifen, or fulvestrant.
b
Infections include all reported preferred terms that are part of the system organ class infections and
infestations.
c
Venous thromboembolic events include deep vein thrombosis (DVT), pulmonary embolism, cerebral
venous sinus thrombosis, subclavian, axillary vein thrombosis, DVT inferior vena cava and pelvic
venous thrombosis.
d
ILD/pneumonitis for early breast cancer (EBC) include all reported preferred terms that are part of
the MedDRA SMQ interstitial lung disease. For metastatic breast cancer (mBC) preferred terms
include interstitial lung disease, pneumonitis, organising pneumonia, pulmonary fibrosis and
bronchiolitis obliterans.
e
Considered ADRs in the mBC setting only (MONARCH 2 and MONARCH 3).
f
Considered ADRs in the EBC setting only (monarchE).
g
Common frequency in the EBC setting (monarchE), very common in the mBC setting
(MONARCH 2 and MONARCH 3).
h
Common frequency in mBC setting (MONARCH 2 and MONARCH 3), very common in the EBC
setting (monarchE).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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HOS-137597 · Präparat HOS-098067
Description of selected adverse reactions
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HOS-137598 · Präparat HOS-098067
Neutropenia
Neutropenia was reported frequently across studies. In the monarchE study, neutropenia was reported
in 45.8 % of patients. Grade 3 or 4 decrease in neutrophil counts (based on laboratory findings) was
reported in 19.1 % of patients receiving abemaciclib in combination with endocrine therapy with a
median time to onset of 30 days, and median time to resolution of 16 days. Febrile neutropenia was
reported in 0.3 % patients. In MONARCH 2 and MONARCH 3 studies, neutropenia was reported in
45.1 % of patients. Grade 3 or 4 decrease in neutrophil counts (based on laboratory findings) was
reported in 28.2 % of patients receiving abemaciclib in combination with aromatase inhibitors or
fulvestrant. The median time to onset of Grade 3 or 4 neutropenia was 29 to 33 days, and median time
to resolution was 11 to 15 days. Febrile neutropenia was reported in 0.9 % patients. Dose modification
is recommended for patients who develop Grade 3 or 4 neutropenia (see section 4.2).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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HOS-137599 · Präparat HOS-098067
Diarrhoea
Diarrhoea was the most commonly reported adverse reaction (see Table 8). Incidence was greatest
during the first month of abemaciclib treatment and was lower subsequently. In the monarchE study,
the median time to onset of the first diarrhoea event of any grade was 8 days. The median duration of
diarrhoea was 7 days for Grade 2 and 5 days for Grade 3. In MONARCH 2 and MONARCH 3 studies,
the median time to onset of the first diarrhoea event of any grade was approximately 6 to 8 days. The
median duration of diarrhoea was 9 to 12 days for Grade 2 and 6 to 8 days for Grade 3. Diarrhoea
returned to baseline or lesser grade with supportive treatment such as loperamide and/or dose
adjustment (see section 4.2).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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HOS-137600 · Präparat HOS-098067
Increased aminotransferases
In the monarchE study, ALT and AST elevations were reported frequently (12.3 % and 11.8 %,
respectively) in patients receiving abemaciclib in combination with endocrine therapy. Grade 3 or 4
ALT or AST elevations (based on laboratory findings) were reported in 2.6 % and 1.6 % patients. The
median time to onset of Grade 3 or 4 ALT elevation was 118 days, and median time to resolution was
14.5 days. The median time to onset of Grade 3 or 4 AST elevation was 90.5 days, and median time to
resolution was 11 days. In MONARCH 2 and MONARCH 3 studies, ALT and AST elevations were
reported frequently (15.1 % and 14.2 %, respectively) in patients receiving abemaciclib in
combination with aromatase inhibitors or fulvestrant. Grade 3 or 4 ALT or AST elevations (based on
laboratory findings) were reported in 6.1 % and 4.2 % patients. The median time to onset of Grade 3
11
or 4 ALT elevation was 57 to 61 days, and median time to resolution was 14 days. The median time to
onset of Grade 3 or 4 AST elevation was 71 to 185 days, and median time to resolution was 13 to
15 days. Dose modification is recommended for patients who develop Grade 3 or 4 ALT or AST
increase (see section 4.2).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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HOS-137601 · Präparat HOS-098067
Creatinine
Although not an adverse reaction, abemaciclib has been shown to increase serum creatinine. In the
monarchE study, 99.3 % of patients had serum creatinine elevations (based on laboratory findings),
and of these, 0.5 % of patients had Grade 3 or 4 elevations. In patients receiving endocrine therapy
alone, 91.0 % reported an increase in serum creatinine (all laboratory grades). In MONARCH 2 and
MONARCH 3 studies, 98.3 % of patients had serum creatinine elevations (based on laboratory
findings), and of these, 1.9 % of patients had Grade 3 or 4 elevations. In patients receiving an
aromatase inhibitor or fulvestrant alone, 78.4 % reported an increase in serum creatinine (all
laboratory grades). Abemaciclib has been shown to increase serum creatinine due to inhibition of renal
tubular secretion transporters without affecting glomerular function (as measured by iohexol
clearance) (see section 4.5). In clinical studies, increases in serum creatinine occurred within the first
month of abemaciclib dosing, remained elevated but stable through the treatment period, were
reversible upon treatment discontinuation, and were not accompanied by changes in markers of renal
function, such as blood urea nitrogen (BUN), cystatin C, or calculated glomerular filtration rate based
on cystatin C.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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HOS-137602 · Präparat HOS-098067
Reporting of suspected adverse reactions
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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HOS-137603 · Präparat HOS-098067
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.