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.
Gegenanzeigen · Plegridy
Plegridy 63 micrograms solution for injection in pre-filled syringe Plegridy 94 micrograms solution for injection in pre-filled syringe Plegridy 125 micrograms solution for injection in pre-filled syringe Plegridy 63 micrograms solution for injection in pre-filled pen Plegridy 94 micrograms solution for injection in pre-filled pen Plegridy 125 micrograms solution for injection in pre-filled pen · Abschnitt 4.3 · PDF-Seite 5
HOS-130104 · Präparat HOS-096849
- Hypersensitivity to natural or recombinant interferon beta or peginterferon or to any of the
excipients listed in section 6.1.
- Patients with current severe depression and/or suicidal ideation (see sections 4.4 and 4.8).
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 2026-10-16T14:15:00Z · SHA-256 9f3fdb5fd5d2821738d9e7759bf4a27d392135ec4288d0d0373a3c4d911e0836 · Passage 44f313d0192194305682287cd66b44f0d7f7889d678e4f222d4925bfe2b1abe6 · Zeichen 0–237 im Abschnitt
Wechselwirkungen · Plegridy
Plegridy 63 micrograms solution for injection in pre-filled syringe Plegridy 94 micrograms solution for injection in pre-filled syringe Plegridy 125 micrograms solution for injection in pre-filled syringe Plegridy 63 micrograms solution for injection in pre-filled pen Plegridy 94 micrograms solution for injection in pre-filled pen Plegridy 125 micrograms solution for injection in pre-filled pen · Abschnitt 4.5 · PDF-Seite 7
HOS-130105 · Präparat HOS-096849
No interaction studies have been performed. The clinical studies indicate that multiple sclerosis
patients can receive peginterferon beta-1a and corticosteroids during relapses. Interferons have been
reported to reduce the activity of hepatic cytochrome P450-dependent enzymes in humans and
animals. Caution should be exercised when peginterferon beta-1a is administered in combination with
medicinal products that have a narrow therapeutic index and are largely dependent on the hepatic
cytochrome P450 system for clearance, e.g. some classes of antiepileptics and antidepressants.
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 2026-10-16T14:15:00Z · SHA-256 9f3fdb5fd5d2821738d9e7759bf4a27d392135ec4288d0d0373a3c4d911e0836 · Passage 8e103745c902dd0278e956667bc6aca5214f3370e79836f0d44d7dbe05bad362 · Zeichen 0–582 im Abschnitt
Nebenwirkungen · Plegridy
Plegridy 63 micrograms solution for injection in pre-filled syringe Plegridy 94 micrograms solution for injection in pre-filled syringe Plegridy 125 micrograms solution for injection in pre-filled syringe Plegridy 63 micrograms solution for injection in pre-filled pen Plegridy 94 micrograms solution for injection in pre-filled pen Plegridy 125 micrograms solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 8
HOS-130106 · Präparat HOS-096849
Summary of safety profile
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 2026-10-16T14:15:00Z · SHA-256 9f3fdb5fd5d2821738d9e7759bf4a27d392135ec4288d0d0373a3c4d911e0836 · Passage 99a55ca4af57e3f8084f04de9b90ae1f535de122eb6718e41a163ac8419c036a · Zeichen 0–25 im Abschnitt
Nebenwirkungen · Plegridy
Plegridy 63 micrograms solution for injection in pre-filled syringe Plegridy 94 micrograms solution for injection in pre-filled syringe Plegridy 125 micrograms solution for injection in pre-filled syringe Plegridy 63 micrograms solution for injection in pre-filled pen Plegridy 94 micrograms solution for injection in pre-filled pen Plegridy 125 micrograms solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 8
HOS-130107 · Präparat HOS-096849
The most common adverse drug reactions (ADR) (at a higher incidence than placebo) for
Peginterferon beta-1a 125 micrograms subcutaneously every 2 weeks were injection site erythema,
influenza like illness, pyrexia, headache, myalgia, chills, injection site pain, asthenia, injection site
pruritus, and arthralgia.
The most commonly reported adverse reaction leading to discontinuation in patients treated with
peginterferon beta-1a 125 micrograms subcutaneously every 2 weeks was influenza-like illness (<1%).
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 2026-10-16T14:15:00Z · SHA-256 9f3fdb5fd5d2821738d9e7759bf4a27d392135ec4288d0d0373a3c4d911e0836 · Passage 3edc99b74a0e743e1c7847077978af08bfdd3623e4e7e7544ed859435e627a0c · Zeichen 27–536 im Abschnitt
Nebenwirkungen · Plegridy
Plegridy 63 micrograms solution for injection in pre-filled syringe Plegridy 94 micrograms solution for injection in pre-filled syringe Plegridy 125 micrograms solution for injection in pre-filled syringe Plegridy 63 micrograms solution for injection in pre-filled pen Plegridy 94 micrograms solution for injection in pre-filled pen Plegridy 125 micrograms solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 8
HOS-130108 · Präparat HOS-096849
Tabulated list of adverse reactions via subcutaneous route of administration
In clinical studies, a total of 1,468 patients received peginterferon beta-1a SC for up to 278 weeks with
an overall exposure equivalent of 4,217 person -years. 1,285 patients received at least 1 year, 1,124
patients have received at least 2 years, 947 patients received at least 3 years, and 658 patients received
at least 4 years of treatment with peginterferon beta-1a. The experience in the randomised,
uncontrolled phase (year 2) of the ADVANCE study and in the extension study ATTAIN (treatment
received for up to 4 years) was consistent with the experience in the 1 year placebo-controlled phase of
the ADVANCE study.
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 2026-10-16T14:15:00Z · SHA-256 9f3fdb5fd5d2821738d9e7759bf4a27d392135ec4288d0d0373a3c4d911e0836 · Passage 21057eb3ee39c73b92a85598107b5edcced095a706e5de3ef5594e33492139be · Zeichen 538–1239 im Abschnitt
Nebenwirkungen · Plegridy
Plegridy 63 micrograms solution for injection in pre-filled syringe Plegridy 94 micrograms solution for injection in pre-filled syringe Plegridy 125 micrograms solution for injection in pre-filled syringe Plegridy 63 micrograms solution for injection in pre-filled pen Plegridy 94 micrograms solution for injection in pre-filled pen Plegridy 125 micrograms solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 8
HOS-130109 · Präparat HOS-096849
Table 2 summarises ADRs (incidence above placebo and with a reasonable possibility of causality)
from 512 patients treated with peginterferon beta-1a 125 micrograms SC every 2 weeks and
500 patients who received placebo for up to 48 weeks and post-marketing data.
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 2026-10-16T14:15:00Z · SHA-256 9f3fdb5fd5d2821738d9e7759bf4a27d392135ec4288d0d0373a3c4d911e0836 · Passage 87b886277476e465a4771a21da45d9975c0b5adbeae0fdf03cba5bbcdc1d603b · Zeichen 1241–1504 im Abschnitt
Nebenwirkungen · Plegridy
Plegridy 63 micrograms solution for injection in pre-filled syringe Plegridy 94 micrograms solution for injection in pre-filled syringe Plegridy 125 micrograms solution for injection in pre-filled syringe Plegridy 63 micrograms solution for injection in pre-filled pen Plegridy 94 micrograms solution for injection in pre-filled pen Plegridy 125 micrograms solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 8
HOS-130110 · Präparat HOS-096849
The ADRs are presented as MedDRA preferred terms under the MedDRA System Organ Class. The
incidence of the adverse reactions below are expressed according to the following categories:
- Very common (≥1/10)
- Common (≥1/100 to <1/10)
- Uncommon (≥1/1,000 to <1/100)
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 2026-10-16T14:15:00Z · SHA-256 9f3fdb5fd5d2821738d9e7759bf4a27d392135ec4288d0d0373a3c4d911e0836 · Passage 2f1c1d52ac89491c6a60581fdf571077ed7397c00cbe87c517473e4535be817f · Zeichen 1506–1788 im Abschnitt
Nebenwirkungen · Plegridy
Plegridy 63 micrograms solution for injection in pre-filled syringe Plegridy 94 micrograms solution for injection in pre-filled syringe Plegridy 125 micrograms solution for injection in pre-filled syringe Plegridy 63 micrograms solution for injection in pre-filled pen Plegridy 94 micrograms solution for injection in pre-filled pen Plegridy 125 micrograms solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 8–9
HOS-130111 · Präparat HOS-096849
8
- Rare (≥1/10,000 to <1/1,000)
- Very rare (<1/10,000)
- Not known (cannot be estimated from the available data)
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 2026-10-16T14:15:00Z · SHA-256 9f3fdb5fd5d2821738d9e7759bf4a27d392135ec4288d0d0373a3c4d911e0836 · Passage c96b7132d5ef2df436c9c05299c8e25a6886bfb8e273752911313414a43fe439 · Zeichen 1842–1972 im Abschnitt
Nebenwirkungen · Plegridy
Plegridy 63 micrograms solution for injection in pre-filled syringe Plegridy 94 micrograms solution for injection in pre-filled syringe Plegridy 125 micrograms solution for injection in pre-filled syringe Plegridy 63 micrograms solution for injection in pre-filled pen Plegridy 94 micrograms solution for injection in pre-filled pen Plegridy 125 micrograms solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 9
HOS-130112 · Präparat HOS-096849
Table 2: Tabulated summary of adverse drug reactions
MedDRA system organ class Adverse reaction Frequency category
Blood and lymphatic system Thrombocytopenia Uncommon
disorders Thrombotic microangiopathy Rare
including thrombotic
thrombocytopenic
purpura/haemolytic uraemic
syndrome*
Immune system disorders Angioedema Uncommon
Hypersensitivity
Anaphylaxis1 Not known
Psychiatric disorders Depression Common
Nervous system disorders Headache Very common
Seizure Uncommon
Respiratory, thoracic and Pulmonary arterial Not known
mediastinal disorders hypertension┼
Gastrointestinal disorders Nausea Common
Vomiting
Skin and subcutaneous tissue Alopecia$ Common
disorders Pruritus
Urticaria Uncommon
Musculoskeletal and Myalgia Very common
connective tissue disorders Arthralgia
Renal and urinary disorders Nephrotic syndrome, Rare
glomerulosclerosis
General disorders and Influenza like illness Very common
administration site conditions Pyrexia
Chills
Injection site erythema
Injection site pain
Injection site pruritus
Asthenia
Hyperthermia Common
Injection site inflammation
Pain
Injection site haematoma
Injection site swelling
Injection site oedema
Injection site rash
Injection site warmth
Injection site discolouration
Injection site necrosis Rare
Investigations Alanine aminotransferase Common
increased
Aspartate aminotransferase
increased
Gamma-glutamyltransferase
increased
White blood cell count
decreased
Haemoglobin decreased
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 2026-10-16T14:15:00Z · SHA-256 9f3fdb5fd5d2821738d9e7759bf4a27d392135ec4288d0d0373a3c4d911e0836 · Passage 1a4e12c94991ac6056d5058a2674009cfd3c6a5a1ec228bff3d0b91912cdcc1a · Zeichen 1974–4941 im Abschnitt
Nebenwirkungen · Plegridy
Plegridy 63 micrograms solution for injection in pre-filled syringe Plegridy 94 micrograms solution for injection in pre-filled syringe Plegridy 125 micrograms solution for injection in pre-filled syringe Plegridy 63 micrograms solution for injection in pre-filled pen Plegridy 94 micrograms solution for injection in pre-filled pen Plegridy 125 micrograms solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 9–10
HOS-130113 · Präparat HOS-096849
9
MedDRA system organ class Adverse reaction Frequency category
Body temperature increased
Platelet count decreased Uncommon
*Class label for interferon beta products (see section 4.4).
┼
Class label for interferon products, see below Pulmonary arterial hypertension
$
Class label for interferon products
1
Adverse reactions derived only during post marketing experience
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 2026-10-16T14:15:00Z · SHA-256 9f3fdb5fd5d2821738d9e7759bf4a27d392135ec4288d0d0373a3c4d911e0836 · Passage ca2703f13c5a451d44bea624fdeca9369019d8279c998fa29a56d0a91f3466af · Zeichen 4990–5479 im Abschnitt
Nebenwirkungen · Plegridy
Plegridy 63 micrograms solution for injection in pre-filled syringe Plegridy 94 micrograms solution for injection in pre-filled syringe Plegridy 125 micrograms solution for injection in pre-filled syringe Plegridy 63 micrograms solution for injection in pre-filled pen Plegridy 94 micrograms solution for injection in pre-filled pen Plegridy 125 micrograms solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 10
HOS-130114 · Präparat HOS-096849
Description of selected adverse reactions via subcutaneous route of administration
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 2026-10-16T14:15:00Z · SHA-256 9f3fdb5fd5d2821738d9e7759bf4a27d392135ec4288d0d0373a3c4d911e0836 · Passage 61e9857bc7d25722301adf7dc90aa961af6292f5342455bc50c45e70edff3e4e · Zeichen 5481–5563 im Abschnitt
Nebenwirkungen · Plegridy
Plegridy 63 micrograms solution for injection in pre-filled syringe Plegridy 94 micrograms solution for injection in pre-filled syringe Plegridy 125 micrograms solution for injection in pre-filled syringe Plegridy 63 micrograms solution for injection in pre-filled pen Plegridy 94 micrograms solution for injection in pre-filled pen Plegridy 125 micrograms solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 10
HOS-130115 · Präparat HOS-096849
Flu-like symptoms
Influenza -like illness was experienced by 47% of patients receiving peginterferon beta-1a
125 micrograms every 2 weeks and 13% of patients receiving placebo. The incidence of flu-like
symptoms (e.g. influenza -like illness, chills, hyperpyrexia, musculoskeletal pain, myalgia, pain,
pyrexia) was highest at the initiation of treatment and generally decreased over the first 6 months. Of
the patients who reported flu-like symptoms 90% reported them as mild or moderate in severity. None
were considered serious in nature. Less than 1% of patients who received peginterferon beta-1a during
the placebo-controlled phase of the ADVANCE study discontinued treatment due to flu-like
symptoms. An open -label study in patients switching from interferon beta therapy to peginterferon
beta-1a evaluated the onset and duration of prophylactically treated flu-like symptoms. In patients
experiencing flu-like symptoms, the median time to onset was 10 hours (interquartile range, 7 to
16 hours) after injection, and the median duration was 17 hours (interquartile range, 12 to 22 hours).
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 2026-10-16T14:15:00Z · SHA-256 9f3fdb5fd5d2821738d9e7759bf4a27d392135ec4288d0d0373a3c4d911e0836 · Passage 13b808a999d7b0be35b4ba29d9595d4bc8af35f4010da938f2f86d488b5a2698 · Zeichen 5565–6660 im Abschnitt
Nebenwirkungen · Plegridy
Plegridy 63 micrograms solution for injection in pre-filled syringe Plegridy 94 micrograms solution for injection in pre-filled syringe Plegridy 125 micrograms solution for injection in pre-filled syringe Plegridy 63 micrograms solution for injection in pre-filled pen Plegridy 94 micrograms solution for injection in pre-filled pen Plegridy 125 micrograms solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 10
HOS-130116 · Präparat HOS-096849
Injection site reactions (ISRs)
ISRs (e.g. injection site erythema, pain, pruritus, or oedema) were reported by 66% of patients who
received peginterferon beta-1a 125 micrograms every 2 weeks compared to 11% of patients receiving
placebo. Injection site erythema was the most commonly reported injection site reaction. Of the
patients who experienced injection site reactions 95% reported them as mild or moderate in severity.
One patient out of 1,468 patients who received peginterferon beta-1a in clinical studies experienced an
injection site necrosis which resolved with standard medical treatment.
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 2026-10-16T14:15:00Z · SHA-256 9f3fdb5fd5d2821738d9e7759bf4a27d392135ec4288d0d0373a3c4d911e0836 · Passage c099156895867df7304480993991f58076f75fc42bc2deedeee83e8fe282aa58 · Zeichen 6662–7264 im Abschnitt
Nebenwirkungen · Plegridy
Plegridy 63 micrograms solution for injection in pre-filled syringe Plegridy 94 micrograms solution for injection in pre-filled syringe Plegridy 125 micrograms solution for injection in pre-filled syringe Plegridy 63 micrograms solution for injection in pre-filled pen Plegridy 94 micrograms solution for injection in pre-filled pen Plegridy 125 micrograms solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 10
HOS-130117 · Präparat HOS-096849
Hepatic transaminase abnormalities
The incidence of hepatic transaminase increases was greater in patients receiving peginterferon beta-1a
compared to placebo. The majority of enzyme elevations were <3 times the upper limit of normal
(ULN). Elevations of alanine aminotransferase and aspartate aminotransferase (>5 times ULN), were
reported in 1% and <1% of placebo-treated patients and 2% and <1% of patients treated with
peginterferon beta-1a respectively. Elevations of serum hepatic transaminases combined with elevated
bilirubin were observed in two patients who had pre-existing liver test abnormalities prior to receiving
peginterferon beta-1a in the clinical trials. Both cases resolved following discontinuation of the
medicinal product.
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 2026-10-16T14:15:00Z · SHA-256 9f3fdb5fd5d2821738d9e7759bf4a27d392135ec4288d0d0373a3c4d911e0836 · Passage 26ad479abeced33a8dd3deeb87e90d08cfbc1cbef4c33b84623544f4ce47545e · Zeichen 7266–8012 im Abschnitt
Nebenwirkungen · Plegridy
Plegridy 63 micrograms solution for injection in pre-filled syringe Plegridy 94 micrograms solution for injection in pre-filled syringe Plegridy 125 micrograms solution for injection in pre-filled syringe Plegridy 63 micrograms solution for injection in pre-filled pen Plegridy 94 micrograms solution for injection in pre-filled pen Plegridy 125 micrograms solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 10
HOS-130118 · Präparat HOS-096849
Haematological disorders
Decreases in white blood cell (WBC) counts of <3.0 x 109/L were observed in 7% of patients
receiving peginterferon beta-1a and in 1% receiving placebo. Mean WBC counts remained within
normal limits in patients treated with peginterferon beta-1a. Decreases in WBC counts were not
associated with an increased risk of infections or serious infections. The incidence of potentially
clinically significant decreases in lymphocyte counts (<0.5 x 109/L) (<1%), neutrophil counts
(≤1.0 x 109/L) (<1%) and platelet counts (≤100 x 109/L) (≤1%) was similar in peginterferon beta-1a-
treated patients compared to placebo-treated patients. Two serious cases were reported in patients
treated with peginterferon beta-1a: one patient (<1%) experienced severe thrombocytopenia (platelet
count <10 x 109/L), another patient (<1%) experienced severe neutropenia (neutrophil count
<0.5 x 109/L). In both patients, cell counts recovered after discontinuation of peginterferon beta-1a.
Slight decreases in mean red blood cell (RBC) counts were observed in peginterferon beta-1atreated
patients. The incidence of potentially clinically significant decreases in RBC counts (<3.3 x 1012/L)
was similar in peginterferon beta-1a treated patients compared to placebo- treated- patients.
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 2026-10-16T14:15:00Z · SHA-256 9f3fdb5fd5d2821738d9e7759bf4a27d392135ec4288d0d0373a3c4d911e0836 · Passage 3cf6fffbca81d83fee0c70e68ac098b4592d5d331c19e15ef5d2c5b7921b845a · Zeichen 8014–9299 im Abschnitt
Nebenwirkungen · Plegridy
Plegridy 63 micrograms solution for injection in pre-filled syringe Plegridy 94 micrograms solution for injection in pre-filled syringe Plegridy 125 micrograms solution for injection in pre-filled syringe Plegridy 63 micrograms solution for injection in pre-filled pen Plegridy 94 micrograms solution for injection in pre-filled pen Plegridy 125 micrograms solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 10–11
HOS-130119 · Präparat HOS-096849
10
Hypersensitivity reactions
Hypersensitivity events were reported in 16% of patients treated with peginterferon beta-1a
125 micrograms every 2 weeks and 14% of patients who received placebo. Less than 1% of
peginterferon beta-1a treated patients experienced a serious hypersensitivity event (e.g. angioedema,
urticaria) and they recovered promptly after treatment with anti-histamines and/or corticosteroids. In
post marketing experience, serious hypersensitivity events including cases of anaphylaxis (frequency
not known) have been reported following peginterferon beta-1a administration.
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 2026-10-16T14:15:00Z · SHA-256 9f3fdb5fd5d2821738d9e7759bf4a27d392135ec4288d0d0373a3c4d911e0836 · Passage 70e38c8d895204fcd9dcb7869299c1aa093f16b956b820b10a5020b3150dda3a · Zeichen 9353–9946 im Abschnitt
Nebenwirkungen · Plegridy
Plegridy 63 micrograms solution for injection in pre-filled syringe Plegridy 94 micrograms solution for injection in pre-filled syringe Plegridy 125 micrograms solution for injection in pre-filled syringe Plegridy 63 micrograms solution for injection in pre-filled pen Plegridy 94 micrograms solution for injection in pre-filled pen Plegridy 125 micrograms solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 11
HOS-130120 · Präparat HOS-096849
Pulmonary arterial hypertension
Cases of pulmonary arterial hypertension (PAH) have been reported with interferon beta products.
Events were reported at various time points including up to several years after starting treatment with
interferon beta.
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 2026-10-16T14:15:00Z · SHA-256 9f3fdb5fd5d2821738d9e7759bf4a27d392135ec4288d0d0373a3c4d911e0836 · Passage 6b3fb004927f7970cb192b72746eefceef2be21ec95c7466ac01b0822a494bd8 · Zeichen 9948–10197 im Abschnitt
Nebenwirkungen · Plegridy
Plegridy 63 micrograms solution for injection in pre-filled syringe Plegridy 94 micrograms solution for injection in pre-filled syringe Plegridy 125 micrograms solution for injection in pre-filled syringe Plegridy 63 micrograms solution for injection in pre-filled pen Plegridy 94 micrograms solution for injection in pre-filled pen Plegridy 125 micrograms solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 11
HOS-130121 · Präparat HOS-096849
Intramuscular route of administration
An open-label, crossover study enrolled 136 subjects to assess the bioequivalence of single doses of
125 micrograms of peginterferon beta-1a administered SC and IM injection in healthy volunteers. The
most commonly reported AEs (with >10% incidence in either arm) across both treatment periods were
chills (35.6% in IM vs 26.9% in SC ), pain (22.0% in IM vs 14.2% in SC), injection site pain (11.4%
in IM vs 14.9% in SC), injection site erythema (2.3% in IM vs 25.4% in SC ), and headache (35.6% in
IM vs 41.0% in SC). Injection site reactions were reported with a lower frequency in IM (14.4%)
compared to SC (32.1%).
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 2026-10-16T14:15:00Z · SHA-256 9f3fdb5fd5d2821738d9e7759bf4a27d392135ec4288d0d0373a3c4d911e0836 · Passage 3e633e36411b104b2cb9146157ea0497dc59c9d459b4d379023a9f966905aa2d · Zeichen 10199–10855 im Abschnitt
Nebenwirkungen · Plegridy
Plegridy 63 micrograms solution for injection in pre-filled syringe Plegridy 94 micrograms solution for injection in pre-filled syringe Plegridy 125 micrograms solution for injection in pre-filled syringe Plegridy 63 micrograms solution for injection in pre-filled pen Plegridy 94 micrograms solution for injection in pre-filled pen Plegridy 125 micrograms solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 11
HOS-130122 · Präparat HOS-096849
Abnormal urine protein was reported in 1/130 (0.8%) for the SC arm and 4/131 (3.1%) in the IM
group without any associated adverse drug reactions.
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 2026-10-16T14:15:00Z · SHA-256 9f3fdb5fd5d2821738d9e7759bf4a27d392135ec4288d0d0373a3c4d911e0836 · Passage b8b512d91e4122c0b914af4eb75025c4c500d2a34a54885e7ff22f17d33776bb · Zeichen 10857–11003 im Abschnitt
Nebenwirkungen · Plegridy
Plegridy 63 micrograms solution for injection in pre-filled syringe Plegridy 94 micrograms solution for injection in pre-filled syringe Plegridy 125 micrograms solution for injection in pre-filled syringe Plegridy 63 micrograms solution for injection in pre-filled pen Plegridy 94 micrograms solution for injection in pre-filled pen Plegridy 125 micrograms solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 11
HOS-130123 · Präparat HOS-096849
Paediatric population
The safety of peginterferon beta-1a in paediatric patients aged 10 to less than 18 years was studied in an
open-label randomized active controlled paediatric trial with 152 paediatric patients with RRMS
(peginterferon beta-1a n=75; interferon beta-1a n=77). Fifty-eight paediatric patients in the
peginterferon beta-1a group completed 96 weeks of this study. The following adverse events which are
very common in the adult population were also reported as very common in the paediatric population:
injection site erythema, influenza like illness, headache and pyrexia. The adverse event alanine
aminotransferase increased was very commonly reported (in adults commonly reported).
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 2026-10-16T14:15:00Z · SHA-256 9f3fdb5fd5d2821738d9e7759bf4a27d392135ec4288d0d0373a3c4d911e0836 · Passage 169fb32fa781efc8bb53d13e27727880fe343098a99c439087866902a72f7ff8 · Zeichen 11005–11706 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.