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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Dyspnoea * Common (6%) - Common (3%) Common (1%)
Gastrointestinal disorders
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Vomiting ^ Very common Common (7%) Very common -
(62%) (20%)
Diarrhoea ^ Very common Very common Very common -
(56%) (10%) (30%)
Nausea ^ Very common Common (2%) Very common -
(52%) (17%)
Stomatitis ^* Very common Common (1%) Very common Common (1%)
(40%) (14%)
Constipation - - Very common -
(10%)
Dry mouth Common (4%) - Common (6%) -
Skin and subcutaneous tissue disorders
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Rashes (acneiform) ^* Very common Common (2%) Very common Common (2%)
(60%) (55%)
Paronychia ^ Very common Very common Very common Common (3%)
(50%) (10%) (17%)
Dry skin Very common Common (1%) Very common -
(44%) (13%)
Rashes (non-acneiform) ^* Very common Common (2%) Very common Common (1%)
(39%) (27%)
Hair changes ^* Very common - Very common -
(29%) (18%)
General disorders
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Pyrexia Very common Common (5%) Common (5%) Common (1%)
(44%)
Asthenic events * Very common - Very common -
(37%) (15%)
Peripheral oedema * Very common - Very common -
(18%) (16%)
Facial oedema * Common (8%) - Common (4%) -
Investigations f
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10
MedDRA SOC and Paediatric Pool a KOMET Study b
MedDRA term (N = 126) (N = 137)
Overall Frequency of Overall Frequency of
Frequency CTCAE Grade 3 Frequency CTCAE
(All CTCAE and above d (All CTCAE Grade 3 and
Grades) c Grades) c above e
^
Blood CPK increased Very common Common (6%) Very common Common (7%)
(54%) (37%)
AST increased Very common Common (2%) Very common Common (1%)
(37%) (12%)
*
Haemoglobin decreased Very common Common (2%) Very common Common (2%)
(35%) (11%)
Blood albumin decreased * Very common - Common (2%) -
(35%)
ALT increased Very common Common (2%) Very common Common (1%)
(29%) (11%)
Ejection fraction decreased ^ Very common Common (1%) Common (7%) Common (1%)
(21%)
Blood creatinine increased Very common Common (1%) Common (2%) -
(19%)
Increased blood pressure * Very common - Common (4%) Common (2%)
(11%)
a
NF1-PN Paediatric Pool data (N = 126) is pooled from SPRINT Phase I (N = 24), SPRINT Phase II, Stratum
1 (N = 50), China Phase I study; paediatric cohort (N=16), Japan Phase I Study (N=12), and Phase I Food
effect (N=24) studies. Frequency percentage numbers are rounded to the nearest full number.
b
NF1-PN adult patients data is from KOMET study (N = 137). Frequency percentage numbers are rounded to
the nearest full number.
c
Per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), all studies used
CTCAE v5.0, except for SPRINT paediatric study which used CTCAE v4.03.
d
All events were CTCAE grade 3, except for two CTCAE grade 4 event of blood CPK increased and one
CTCAE grade 4 event of blood creatinine increased. There were no deaths.
e
All events were CTCAE grade 3, except for one CTCAE grade 4 event of pyrexia and four CTCAE grade 4
events of blood CPK increased. There were no deaths.
f
In the SPRINT study, all lab abnormalities were reported as AEs. In other studies included in the NF1-PN
paediatric and adult patients, lab abnormalities were only reported as AEs when they met SAE criteria,
resulted in discontinuation, or were clinically relevant as judged by the investigator.
CPK = creatine phosphokinase; AST = aspartate aminotransferase; ALT = alanine aminotransferase
^
See Description of selected adverse reactions
††
Identified ADRs from other clinical trial experience in adult patients (N = 347), with multiple tumour types,
receiving treatment with selumetinib (75 mg twice daily). These ADRs have not been reported in paediatric or
adult population with NF1 who have inoperable PN.
*
ADRs based on grouping of individual Preferred Terms (PT):
Asthenic events: fatigue, asthenia
Blood albumin decreased: hypoalbuminaemia, blood albumin decreased
CSR/RPED: detachment of macular retinal pigment epithelium, chorioretinopathy, and retinopathy
Dyspnoea: dyspnoea exertional, dyspnoea, dyspnoea at rest
Facial oedema: periorbital oedema, face oedema, lip swelling, eyelid oedema, swelling face
Haemoglobin decreased: anaemia, haemoglobin decreased
Hair changes: alopecia, hair colour change
Increased blood pressure: blood pressure increased, hypertension
Peripheral oedema: oedema peripheral, oedema, localised oedema, peripheral swelling
Rashes (acneiform): dermatitis acneiform, acne, folliculitis
Rashes (non-acneiform): rash pruritic, rash maculo-papular, rash papular, rash, rash erythematous, rash
macular
RVO: retinal vascular disorder, retinal vein occlusion, retinal vein thrombosis
Stomatitis: stomatitis, mouth ulceration, aphthous ulcer, gingival swelling
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Description of selected adverse reactions
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Left ventricular ejection fraction (LVEF) reduction
In the NF1-PN Paediatric Pool (N=126), LVEF reduction (PT: ejection fraction decreased) was
reported in 26 (21%) patients; among them, in 25 (19.8%) patients, the reported ADRs were CTCAE
grade 2, and in 1 (0.8%) patient, the ADR reported was CTCAE grade 3. In 4 (3.2%) patients, LVEF
decrease led to dose reduction and in 2 (1.6%) patients, LVEF decrease led to dose interruption. At the
time of analysis, of the 26 patients, 20 patients were recovered. The median time to first onset of
maximum CTCAE grade LVEF reduction was 283 days (median duration 110.5 days).
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In the NF1-PN adult patients (N = 137), LVEF reduction (PT: ejection fraction decreased) was
reported in 10 (7%) patients; among them, in 1 (0.7%) patient, the reported ADR was CTCAE grade 3.
In 2 (1.5%) patients, LVEF decrease led to dose interruption. At the time of analysis, 7 of the
10 patients had recovered. The median time to first onset of maximum CTCAE grade LVEF reduction
was 169 days (approximately 6 months) [median duration 112.5 days (approximately 4 months)].
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Patients with LVEF lower than the institutional LLN at baseline were not included in the pivotal
studies. In addition, a small number of serious cases of LVEF reduction associated with selumetinib
have been reported in paediatric patients who participated in an expanded access program. For clinical
management of LVEF reduction (see sections 4.2 and 4.4).
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Ocular toxicity
In the NF1-PN Paediatric Pool (N=126), CTCAE grade 1 and 2 events of blurred vision were reported
in 11 (9%) patients. Two patients (1.6%) required dose interruption. At the time of analysis, of the
11 patients, 10 patients were recovered. CTCAE grade 1 events of asymptomatic transient subretinal
fluid were observed in 8 (6.3%) patients; none of the patients developed retinopathy or other ocular
adverse events. No patients required dose modification and all events but one resolved. Another
paediatric patient (0.8%) experienced a CTCAE grade 1 event of retinopathy, and the event resolved
without dose modification.
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In the NF1-PN adult patients (N = 137), CTCAE grade 1 event of blurred vision was reported in
5 (4%) patients. One patient (0.7%) required dose interruption. All events were managed without dose
reduction and at the time of analysis, all 5 patients had recovered.
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In postmarketing experience, cases of RPED/CSR including detachment of retinal pigment epithelium,
central serous chorioretinopathy, serous retinal detachment, serous retinopathy, and retinal detachment
have been reported. Since these reactions are reported voluntarily from a population of uncertain size,
it is not always possible to reliably estimate their frequency or establish a causal relationship to drug
exposure.
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For clinical management of new visual disturbances (see sections 4.2 and 4.4).
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In addition, a single event of RPED was reported in a paediatric patient receiving selumetinib
monotherapy (25 mg/m2 twice daily) for pilocytic astrocytoma involving the optic pathway in an
externally sponsored paediatric study (see sections 4.2 and 4.4).
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Paronychia
In the NF1-PN Paediatric Pool (N=126), paronychia was reported in 63 (50%) patients. The median
time to first onset of maximum CTCAE grade paronychia adverse event was 375 days (approximately
12 months) and the median duration of events was 55 days (approximately 2 months). The majority
(51 patients, 40.5% the NF1-PN Paediatric Pool) had a maximum CTCAE grade of 1 or 2. Grade ≥ 3
events occurred in 12 (10%) patients. Eighteen patients (14.3%) required dose interruption for adverse
event of paronychia, and 9 patients (7.1%) had an AE of paronychia that led to dose reduction. In one
patient (0.8%) the event led to treatment discontinuation.
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12
In the NF1-PN adult patients (N = 137), paronychia was reported in 23 (17%) patients. The median
time to first onset of maximum CTCAE grade paronychia was 206 days (approximately 7 months) and
the median duration of the maximum grade event was 63 days (approximately 2 months). Nineteen
(13.9%) patients had a maximum CTCAE grade of 1 or 2. Grade 3 events occurred in 4 (3%) patients.
One patient (0.7%) required dose interruption for adverse event of paronychia, and 3 patients (2.2%)
had an event of paronychia that led to dose reduction. Paronychia did not lead to dose discontinuation
in any of the patients. At the time of analysis, 11 of the 23 patients had recovered.
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Blood creatine phosphokinase (CPK) increase
ADRs of blood CPK elevation occurred in 68 (54%) patients in the NF1-PN Paediatric Pool (N=126).
The median time to first onset of the maximum CTCAE grade CPK increase was 112 days
(approximately 4 months) and the median duration of the maximum CTCAE grade event was
126 days (approximately 4 months). The majority (61 cases, 48.4% of the NF1-PN Paediatric Pool)
had maximum CTCAE grade event that was grade 1 or 2. A maximum CTCAE grade 3 events
occurred in 5 (4%) patients, and CTCAE grade 4 event occurred in 2 (1.6%) patients. Five patients had
an AE of blood CPK increase that led to treatment interruptions and required dose reduction.
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In the NF1-PN adult patients (N = 137), ADRs of blood CPK increase occurred in 51 (37%) patients.
The median time to first onset of the maximum CTCAE grade blood CPK increase was 103 days
(approximately 3 months), and the median duration of maximum grade event was 122 days
(approximately 4 months). Forty-two patients (30.7%) had maximum CTCAE grade of 1 or 2. A
maximum CTCAE grade 3 events occurred in 5 (3.6%) patients, and CTCAE grade 4 events occurred
in 4 (2.9%) patients. Six patients had an event of blood CPK increase that led to dose interruptions and
dose reduction was required in 3 patients. At the time of analysis, 21 of the 51 patients had recovered.
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Gastrointestinal toxicities
In the NF1-PN Paediatric Pool (N=126), vomiting (78 patients, 62%), diarrhoea (71 patients, 56%),
nausea (66 patients, 52%), and stomatitis (50 patients, 40%) were the most commonly reported
gastrointestinal (GI) events. The majority of these cases were CTCAE grade 1 or 2. CTCAE grade ≥ 3
events were reported for diarrhoea (10%), vomiting (7%), nausea (2%) and stomatitis (1%). Dose
modification was required in 25 (19.8%) patients with vomiting, 14 (11.1%) with nausea, 11 (8.7%)
with diarrhoea, and 6 (4.8%) with stomatitis. One patient each reported an event of diarrhoea, nausea
and stomatitis led to treatment discontinuation. Dose reduction had occurred in 1 patient with ADR of
diarrhoea and in 2 patients with ADR of stomatitis. No CTCAE grade ≥ 4 events were reported.
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HOS-145474 · Präparat HOS-099352
In the NF1-PN adult patients (N = 137), diarrhoea (41 patients, 30%), vomiting (27 patients, 20%),
nausea (23 patients, 17%), stomatitis (19 patients, 14%), and constipation (13 patients, 10%) were the
most reported gastrointestinal (GI) events. Most of these events were CTCAE grade 1 or 2. In
1 patient (0.7%), CTCAE grade 3 event was reported for stomatitis. Dose interruption was required in
2 patients (1.5%) each with nausea and vomiting, and in 1 patient (0.7%) each with diarrhoea and
stomatitis. Dose reduction occurred in 1 patient (0.7%) each with an ADR of nausea and stomatitis.
One patient reported an event of nausea that led to treatment discontinuation.
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