Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Bimzelx

Bimzelx 160 mg solution for injection in pre-filled syringe Bimzelx 320 mg solution for injection in pre-filled syringe Bimzelx 160 mg solution for injection in pre-filled pen Bimzelx 320 mg solution for injection in pre-filled pen · Abschnitt 4.3 · PDF-Seite 4

HOS-146265 · Präparat HOS-099486

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Gegenanzeigen · Bimzelx

Bimzelx 160 mg solution for injection in pre-filled syringe Bimzelx 320 mg solution for injection in pre-filled syringe Bimzelx 160 mg solution for injection in pre-filled pen Bimzelx 320 mg solution for injection in pre-filled pen · Abschnitt 4.3 · PDF-Seite 4

HOS-146266 · Präparat HOS-099486

Clinically important active infections (e.g. active tuberculosis, see section 4.4).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Bimzelx

Bimzelx 160 mg solution for injection in pre-filled syringe Bimzelx 320 mg solution for injection in pre-filled syringe Bimzelx 160 mg solution for injection in pre-filled pen Bimzelx 320 mg solution for injection in pre-filled pen · Abschnitt 4.5 · PDF-Seite 5–6

HOS-146267 · Präparat HOS-099486

No interaction studies have been performed. There is no direct evidence for the role of IL-17A or IL-17F in the expression of CYP450 enzymes. The formation of some CYP450 enzymes is suppressed by increased levels of cytokines during chronic inflammation. Thus, anti-inflammatory treatments, such as with the IL-17A and IL-17F inhibitor bimekizumab, may result in normalisation of CYP450 levels with accompanying lower exposure of CYP450-metabolised medicinal products. Therefore, a clinically relevant effect on CYP450 substrates with a narrow therapeutic index, in which the dose is individually adjusted (e.g. 5 warfarin) cannot be excluded. On initiation of bimekizumab therapy in patients being treated with these types of medicinal products, therapeutic monitoring should be considered.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): warfarin (HOS-085950)

Wechselwirkungen · Bimzelx

Bimzelx 160 mg solution for injection in pre-filled syringe Bimzelx 320 mg solution for injection in pre-filled syringe Bimzelx 160 mg solution for injection in pre-filled pen Bimzelx 320 mg solution for injection in pre-filled pen · Abschnitt 4.5 · PDF-Seite 6

HOS-146269 · Präparat HOS-099486

Population pharmacokinetic (PK) data analyses indicated that concomitant administration of conventional disease modifying antirheumatic drugs (cDMARDs) including methotrexate or prior exposure to biologics have no clinically relevant impact on the clearance of bimekizumab.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): methotrexate (HOS-087522)

Wechselwirkungen · Bimzelx

Bimzelx 160 mg solution for injection in pre-filled syringe Bimzelx 320 mg solution for injection in pre-filled syringe Bimzelx 160 mg solution for injection in pre-filled pen Bimzelx 320 mg solution for injection in pre-filled pen · Abschnitt 4.5 · PDF-Seite 6

HOS-146271 · Präparat HOS-099486

Live vaccines should not be given concurrently with bimekizumab (see section 4.4).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Bimzelx

Bimzelx 160 mg solution for injection in pre-filled syringe Bimzelx 320 mg solution for injection in pre-filled syringe Bimzelx 160 mg solution for injection in pre-filled pen Bimzelx 320 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 6

HOS-146272 · Präparat HOS-099486

Summary of the safety profile

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Bimzelx

Bimzelx 160 mg solution for injection in pre-filled syringe Bimzelx 320 mg solution for injection in pre-filled syringe Bimzelx 160 mg solution for injection in pre-filled pen Bimzelx 320 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 6

HOS-146273 · Präparat HOS-099486

The most frequently reported adverse reactions were upper respiratory tract infections (14.5%, 14.6%, 16.3%, 8.8% in plaque psoriasis, psoriatic arthritis, axial spondyloarthritis (axSpA) and hidradenitis suppurativa respectively) and oral candidiasis (7.3%, 2.3%, 3.7%, 5.6% in PSO, PsA, axSpA and HS respectively).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Bimzelx

Bimzelx 160 mg solution for injection in pre-filled syringe Bimzelx 320 mg solution for injection in pre-filled syringe Bimzelx 160 mg solution for injection in pre-filled pen Bimzelx 320 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 6

HOS-146274 · Präparat HOS-099486

Tabulated list of adverse reactions

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Bimzelx

Bimzelx 160 mg solution for injection in pre-filled syringe Bimzelx 320 mg solution for injection in pre-filled syringe Bimzelx 160 mg solution for injection in pre-filled pen Bimzelx 320 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 6

HOS-146275 · Präparat HOS-099486

Adverse reactions from clinical studies and post-marketing reports (Table 1) are classified by MedDRA System Organ Class and frequency, using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), 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.

Nebenwirkungen · Bimzelx

Bimzelx 160 mg solution for injection in pre-filled syringe Bimzelx 320 mg solution for injection in pre-filled syringe Bimzelx 160 mg solution for injection in pre-filled pen Bimzelx 320 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 6–7

HOS-146276 · Präparat HOS-099486

A total of 5862 patients have been treated with bimekizumab in blinded and open-label clinical studies in plaque psoriasis (PSO), psoriatic arthritis (PsA), axial spondyloarthritis (nr-axSpA and AS) and 6 hidradenitis suppurativa (HS) representing 11468.6 patient-years of exposure. Of these, over 4660 patients were exposed to bimekizumab for at least one year. Overall, the safety profile of bimekizumab is consistent across all indications.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Bimzelx

Bimzelx 160 mg solution for injection in pre-filled syringe Bimzelx 320 mg solution for injection in pre-filled syringe Bimzelx 160 mg solution for injection in pre-filled pen Bimzelx 320 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 7

HOS-146277 · Präparat HOS-099486

Table 1: List of adverse reactions System Organ Class Frequency Adverse reaction

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Bimzelx

Bimzelx 160 mg solution for injection in pre-filled syringe Bimzelx 320 mg solution for injection in pre-filled syringe Bimzelx 160 mg solution for injection in pre-filled pen Bimzelx 320 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 7

HOS-146278 · Präparat HOS-099486

Infections and infestations Very common Upper respiratory tract infections Common Oral candidiasis, Tinea infections, Ear infections, Herpes simplex infections, Oropharyngeal candidiasis, Gastroenteritis, Folliculitis, Vulvovaginal mycotic infection (including vulvovaginal candidiasis) Uncommon Mucosal and cutaneous candidiasis (including oesophageal candidiasis), Conjunctivitis Blood and lymphatic system Uncommon Neutropenia disorders Nervous system disorders Common Headache Gastrointestinal disorders Uncommon Inflammatory bowel disease Skin and subcutaneous tissue Common Rash, dermatitis and eczema, disorders Acne General disorders and Common Injection site reactionsa, administration site conditions Fatigue a) Includes: injection site erythema, reaction, oedema, pain, swelling, haematoma.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Bimzelx

Bimzelx 160 mg solution for injection in pre-filled syringe Bimzelx 320 mg solution for injection in pre-filled syringe Bimzelx 160 mg solution for injection in pre-filled pen Bimzelx 320 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 7

HOS-146279 · Präparat HOS-099486

Description of selected adverse reactions

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Bimzelx

Bimzelx 160 mg solution for injection in pre-filled syringe Bimzelx 320 mg solution for injection in pre-filled syringe Bimzelx 160 mg solution for injection in pre-filled pen Bimzelx 320 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 7

HOS-146280 · Präparat HOS-099486

Infections

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Bimzelx

Bimzelx 160 mg solution for injection in pre-filled syringe Bimzelx 320 mg solution for injection in pre-filled syringe Bimzelx 160 mg solution for injection in pre-filled pen Bimzelx 320 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 7

HOS-146281 · Präparat HOS-099486

In the placebo-controlled period of Phase III clinical studies in plaque psoriasis, infections were reported in 36.0% of patients treated with bimekizumab for up to 16 weeks compared with 22.5% of patients treated with placebo. Serious infections occurred in 0.3% of patients treated with bimekizumab and 0% treated with placebo.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Bimzelx

Bimzelx 160 mg solution for injection in pre-filled syringe Bimzelx 320 mg solution for injection in pre-filled syringe Bimzelx 160 mg solution for injection in pre-filled pen Bimzelx 320 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 7

HOS-146282 · Präparat HOS-099486

The majority of infections consisted of non-serious mild to moderate upper respiratory tract infections such as nasopharyngitis. There were higher rates of oral and oropharyngeal candidiasis in patients treated with bimekizumab consistent with the mechanism of action (7.3% and 1.2% respectively compared to 0% for placebo-treated patients). More than 98% of cases were non-serious, mild or moderate in severity, and did not require treatment discontinuation. A slightly higher incidence of oral candidiasis was reported in patients <70 kg (8.5% versus 7.0% in patients ≥70 kg).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Bimzelx

Bimzelx 160 mg solution for injection in pre-filled syringe Bimzelx 320 mg solution for injection in pre-filled syringe Bimzelx 160 mg solution for injection in pre-filled pen Bimzelx 320 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 7

HOS-146283 · Präparat HOS-099486

Over the entire treatment period of Phase III studies in plaque psoriasis, infections were reported in 63.2% of patients treated with bimekizumab (120.4 per 100 patient-years). Serious infections were reported in 1.5% of patients treated with bimekizumab (1.6 per 100 patient-years) (see section 4.4).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Bimzelx

Bimzelx 160 mg solution for injection in pre-filled syringe Bimzelx 320 mg solution for injection in pre-filled syringe Bimzelx 160 mg solution for injection in pre-filled pen Bimzelx 320 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 7

HOS-146284 · Präparat HOS-099486

Infection rates observed in PsA and axSpA (nr-axSpA and AS) Phase III clinical studies were similar to those observed in plaque psoriasis apart from oral and oropharyngeal candidiasis rates in patients treated with bimekizumab, which were lower at 2.3% and 0% respectively in PsA and 3.7% and 0.3% respectively in axSpA compared to 0% with placebo.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Bimzelx

Bimzelx 160 mg solution for injection in pre-filled syringe Bimzelx 320 mg solution for injection in pre-filled syringe Bimzelx 160 mg solution for injection in pre-filled pen Bimzelx 320 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 7–8

HOS-146285 · Präparat HOS-099486

Infection rates observed in HS Phase III clinical studies were similar to those observed in other 7 indications. In the placebo-controlled period, oral and oropharyngeal candidiasis rates in patients treated with bimekizumab were 7.1% and 0% respectively compared to 0% with placebo.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Bimzelx

Bimzelx 160 mg solution for injection in pre-filled syringe Bimzelx 320 mg solution for injection in pre-filled syringe Bimzelx 160 mg solution for injection in pre-filled pen Bimzelx 320 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 8

HOS-146286 · Präparat HOS-099486

Neutropenia

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.