Adtralza · 4.8 Undesirable effects · 1

HOS-099372 · has-adverse-reaction-information · PDF-Seite 6

Summary of the safety profile 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%). Tabulated list of adverse reactions 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. Table 1: List of adverse reactions MedDRA System Frequency Adverse reaction Organ Class Infections and Very common Upper respiratory tract infections infestations Common Conjunctivitis Blood and lymphatic Common Eosinophilia system disorders Eye disorders Common Conjunctivitis allergic Uncommon Keratitis General disorders and Common Injection site reactions administration site conditions 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. Description of selected adverse reactions 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

Auszug; vollständigen Abschnitt im Original lesen.

HOS-099368 · has-contraindication-information · PDF-Seite 4

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

HOS-099367 · has-indication-information · PDF-Seite 2

Adtralza is indicated for the treatment of moderate-to-severe atopic dermatitis in adult and adolescent patients 12 years and older who are candidates for systemic therapy.

HOS-099370 · has-interaction-information · PDF-Seite 5

The safety and efficacy of concurrent use of tralokinumab with live and live attenuated vaccines has not been studied. 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. For information on live and live attenuated vaccines, see section 4.4. Interactions with cytochrome P450 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. 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.

HOS-099371 · has-pregnancy-information · PDF-Seite 5

Pregnancy There is limited amount of data from the use of tralokinumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of tralokinumab during pregnancy. Breast-feeding It is unknown whether tralokinumab is excreted in human milk or absorbed systemically after ingestion. A decision must be made whether to discontinue breast-feeding or to discontinue tralokinumab therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. 5 Fertility Animal studies did not show any effects on male and female reproductive organs and on sperm count, motility and morphology (see section 5.3).

HOS-099369 · has-warning-information · PDF-Seite 4

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Hypersensitivity If a systemic hypersensitivity reaction (immediate or delayed) occurs, administration of tralokinumab should be discontinued and appropriate therapy initiated. Conjunctivitis Patients treated with tralokinumab who develop conjunctivitis that does not resolve following standard treatment should undergo ophthalmological examination (see section 4.8). Helminth infection Patients with known helminth infections were excluded from participation in clinical studies. It is unknown if tralokinumab will influence the immune response against helminth infections by inhibiting IL-13 signalling. Patients with pre-existing helminth infections should be treated before initiating treatment with tralokinumab. If patients become infected while receiving tralokinumab and do not respond to antihelminth treatment, treatment with tralokinumab should be discontinued until infection resolves. Vaccinations Live and live attenuated vaccines should not be given concurrently with tralokinumab as clinical safety and efficacy have not been established. Immune responses to the non-live tetanus and meningococcal vaccines were assessed (see section 4.5). It is recommended that patients should be brought up to date with live and live attenuated immunisations in agreement with current immunisation guidelines prior to treatment with tralokinumab. 4 Excipients Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per 150 mg dose, that is to say essentially “sodium-free”. Adverse reactions to excipients Adtralza contains polysorbate 80 (E 433) as an excipient, which may cause allergic reactions.