Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Adtralza

Adtralza 150 mg solution for injection in pre-filled syringe Adtralza 300 mg solution for injection in pre-filled pen · Abschnitt 4.3 · PDF-Seite 4

HOS-145532 · Präparat HOS-099366

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.

Wechselwirkungen · Adtralza

Adtralza 150 mg solution for injection in pre-filled syringe Adtralza 300 mg solution for injection in pre-filled pen · Abschnitt 4.5 · PDF-Seite 5

HOS-145533 · Präparat HOS-099366

The safety and efficacy of concurrent use of tralokinumab with live and live attenuated vaccines has not been studied.

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): tralokinumab (HOS-145531)

Wechselwirkungen · Adtralza

Adtralza 150 mg solution for injection in pre-filled syringe Adtralza 300 mg solution for injection in pre-filled pen · Abschnitt 4.5 · PDF-Seite 5

HOS-145534 · Präparat HOS-099366

Immune responses to non-live vaccines were assessed in a study in which adult patients with atopic dermatitis were treated with an initial dose of 600 mg (four 150 mg injections) followed by 300 mg every second (other) week administered as subcutaneous injection. After 12 weeks of tralokinumab administration, patients were vaccinated with a combined tetanus, diphtheria, and acellular pertussis vaccine, and a meningococcal vaccine and immune responses were assessed 4 weeks later. Antibody responses to both tetanus vaccine and meningococcal vaccine were similar in tralokinumab-treated and placebo-treated patients. No adverse interactions between either of the non-live vaccines or tralokinumab were noted in the study. Therefore, patients receiving tralokinumab may receive concurrent inactivated or non-live vaccinations.

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): tralokinumab (HOS-145531)

Wechselwirkungen · Adtralza

Adtralza 150 mg solution for injection in pre-filled syringe Adtralza 300 mg solution for injection in pre-filled pen · Abschnitt 4.5 · PDF-Seite 5

HOS-145535 · Präparat HOS-099366

For information on live and live attenuated vaccines, see section 4.4.

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

Wechselwirkungen · Adtralza

Adtralza 150 mg solution for injection in pre-filled syringe Adtralza 300 mg solution for injection in pre-filled pen · Abschnitt 4.5 · PDF-Seite 5

HOS-145536 · Präparat HOS-099366

Interactions with cytochrome P450

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

Wechselwirkungen · Adtralza

Adtralza 150 mg solution for injection in pre-filled syringe Adtralza 300 mg solution for injection in pre-filled pen · Abschnitt 4.5 · PDF-Seite 5

HOS-145537 · Präparat HOS-099366

Tralokinumab is not expected to undergo metabolism by hepatic enzymes or renal elimination. Clinically relevant interactions between tralokinumab and inhibitors, inducers, or substrates of metabolising enzymes are not expected, and no dose adjustment is needed.

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): tralokinumab (HOS-145531)

Wechselwirkungen · Adtralza

Adtralza 150 mg solution for injection in pre-filled syringe Adtralza 300 mg solution for injection in pre-filled pen · Abschnitt 4.5 · PDF-Seite 5

HOS-145538 · Präparat HOS-099366

The effects of tralokinumab on the pharmacokinetics (PK) of CYP substrates, caffeine (CYP1A2), warfarin (CYP2C9), metoprolol (CYP2D6), omeprazole (CYP2C19) and midazolam (CYP3A), were evaluated in atopic dermatitis patients after repeated administration. No effects were observed for caffeine and warfarin. Small numerical changes, which were not clinically significant, were observed for Cmax of omeprazole, AUC of metoprolol and AUC and Cmax of midazolam (the largest difference being for midazolam Cmax with a decrease of 22%). Therefore, clinically relevant impact of tralokinumab on the pharmacokinetics of concomitant medicinal products metabolised by the CYP enzymes is not expected.

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): caffeine (HOS-085902) tralokinumab (HOS-145531) metoprolol (HOS-090094) warfarin (HOS-085950) midazolam (HOS-086167) omeprazole (HOS-085912)

Nebenwirkungen · Adtralza

Adtralza 150 mg solution for injection in pre-filled syringe Adtralza 300 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 6

HOS-145539 · Präparat HOS-099366

Summary of the safety profile

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

Nebenwirkungen · Adtralza

Adtralza 150 mg solution for injection in pre-filled syringe Adtralza 300 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 6

HOS-145540 · Präparat HOS-099366

The most common adverse reactions are upper respiratory tract infections (23.4%; mainly reported as common cold), injection site reactions (7.2%), conjunctivitis (5.4%) and conjunctivitis allergic (2.0%).

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

Nebenwirkungen · Adtralza

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HOS-145541 · Präparat HOS-099366

Tabulated list of adverse reactions

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

Nebenwirkungen · Adtralza

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HOS-145542 · Präparat HOS-099366

Adverse reactions observed from clinical trials and post-marketing experience are presented in Table 1 by system organ class and frequency, using the following categories: 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). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. The frequencies are based on the initial treatment period of up to 16 weeks in the pool of 5 studies in the atopic dermatitis population.

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

Nebenwirkungen · Adtralza

Adtralza 150 mg solution for injection in pre-filled syringe Adtralza 300 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 6

HOS-145543 · Präparat HOS-099366

Table 1: List of adverse reactions MedDRA System Frequency Adverse reaction Organ Class Infections and Very common Upper respiratory tract infections infestations Common Conjunctivitis

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

Nebenwirkungen · Adtralza

Adtralza 150 mg solution for injection in pre-filled syringe Adtralza 300 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 6

HOS-145544 · Präparat HOS-099366

Blood and lymphatic Common Eosinophilia system disorders Eye disorders Common Conjunctivitis allergic Uncommon Keratitis General disorders and Common Injection site reactions administration site conditions

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

Nebenwirkungen · Adtralza

Adtralza 150 mg solution for injection in pre-filled syringe Adtralza 300 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 6

HOS-145545 · Präparat HOS-099366

The long-term safety of tralokinumab was assessed in 2 monotherapy studies up to 52 weeks, and in a combination study with topical corticosteroids up to 32 weeks. The long-term safety of tralokinumab is further assessed in an open-label extension study (ECZTEND) for up to 5 years of treatment in adults and up to 2 years in adolescents 12 years and older with moderate-to-severe AD (atopic dermatitis) receiving 300 mg of tralokinumab every two weeks (Q2W). The long-term safety data were generally consistent with the safety profile observed up to week 16 in the pool of 5 adult studies.

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

Nebenwirkungen · Adtralza

Adtralza 150 mg solution for injection in pre-filled syringe Adtralza 300 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 6

HOS-145546 · Präparat HOS-099366

Description of selected adverse reactions

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

Nebenwirkungen · Adtralza

Adtralza 150 mg solution for injection in pre-filled syringe Adtralza 300 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 6

HOS-145547 · Präparat HOS-099366

Conjunctivitis and related events Conjunctivitis occurred more frequently in atopic dermatitis patients who received tralokinumab (5.4%) compared to placebo (1.9%) in the initial treatment period of up to 16 weeks in the pool of 5 studies. Conjunctivitis was reported at a higher frequency in patients with severe atopic dermatitis compared to subjects with moderate atopic dermatitis in both the tralokinumab group (6.0 vs 3.3%; initial treatment period) and placebo group (2.2 vs 0.8%; initial treatment period). Most patients recovered or were recovering during the treatment period.

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

Nebenwirkungen · Adtralza

Adtralza 150 mg solution for injection in pre-filled syringe Adtralza 300 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 6–7

HOS-145548 · Präparat HOS-099366

6 The rate of conjunctivitis in the initial 16 weeks treatment period was 22.0 events/100 patient years of exposure. The rate of conjunctivitis in the treatment period of the long-term open-label extension study (ECZTEND) was 2.93 events/100 patient years of exposure.

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

Nebenwirkungen · Adtralza

Adtralza 150 mg solution for injection in pre-filled syringe Adtralza 300 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 7

HOS-145549 · Präparat HOS-099366

Keratitis was reported in 0.5% of subjects treated with tralokinumab during the initial treatment period. Of these, half were classified as keratoconjunctivitis, all were non-serious and mild or moderate in severity, and none led to treatment discontinuation. The rate of keratitis in the initial 16 weeks treatment period was 1.7 events/100 patient years of exposure. The rate of keratitis in the treatment period of the long-term open-label extension study (ECZTEND) was 0.11 events/100 patient years of exposure.

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

Nebenwirkungen · Adtralza

Adtralza 150 mg solution for injection in pre-filled syringe Adtralza 300 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 7

HOS-145550 · Präparat HOS-099366

Eosinophilia Adverse reactions of eosinophilia were reported in 1.3% of patients treated with tralokinumab and 0.3% of patients treated with placebo during the initial treatment period of up to 16 weeks in the pool of 5 studies. Tralokinumab-treated patients had a greater mean initial increase from baseline in eosinophil count compared to patients treated with placebo. Eosinophilia (≥ 5 000 cells/mcL) was measured in 1.2% of tralokinumab-treated patients and 0.3% of placebo-treated patients in the initial treatment period. However, the increase in the tralokinumab-treated patients was transient, and mean eosinophil counts returned to baseline during continued treatment. The safety profile for subjects with eosinophilia was comparable to the safety profile for all subjects.

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

Nebenwirkungen · Adtralza

Adtralza 150 mg solution for injection in pre-filled syringe Adtralza 300 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 7

HOS-145551 · Präparat HOS-099366

Eczema herpeticum Eczema herpeticum was reported in 0.3% of the subjects treated with tralokinumab and in 1.5% of subjects in the placebo group in the initial treatment period of up to 16 weeks in the pool of 5 studies in atopic dermatitis. The rate of eczema herpeticum in the initial 16 weeks treatment period was 1.2 events/100 patient years of exposure. The rate of eczema herpeticum in the treatment period of the long-term open-label extension study (ECZTEND) was 0.67 events/100 patient years of exposure.

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