Adtralza

Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of atopic dermatitis. Posology The recommended dose of tralokinumab for adult and adolescent patients 12 years and older is an initial dose of 600 mg administered either as: - four 150 mg injections given by pre-filled syringes or - two 300 mg injections given by pre-filled pens 3 This initial dose is followed by a 300 mg injection administered every other week either as: - two 150 mg injections given by pre-filled syringes or - one 300 mg injection given by pre-filled pen.

At prescriber’s discretion, every fourth week dosing may be considered for patients who achieve clear or almost clear skin after 16 weeks of treatment. 1). Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment.

Some patients with initial partial response may subsequently improve further with continued treatment every other week beyond 16 weeks. Tralokinumab can be used with or without topical corticosteroids. 1). Topical calcineurin inhibitors may be used, but should be reserved for problem areas only, such as the face, neck, intertriginous and genital areas.

Missed dose If a dose is missed, the dose should be administered as soon as possible. Thereafter, dosing should be resumed at the regular scheduled time. 2). Limited data are available in patients > 75 years of age. Renal impairment No dose adjustment is needed in patients with renal impairment.

2). Hepatic impairment No dose adjustment is needed in patients with hepatic impairment. 2). 2). Paediatric population The safety and efficacy of tralokinumab in children below the age of 12 years have not yet been established. No data are available.

Method of administration For subcutaneous use. The pre-filled syringe or pre-filled pen should not be shaken. After removing the pre-filled syringes or pre-filled pen from the refrigerator, they should be allowed to reach room temperature by waiting for: - 30 minutes before injecting the pre-filled syringe - 45 minutes before injecting the pre-filled pen.

4 Tralokinumab is administered by subcutaneous injection into the thigh or abdomen, except the 5 cm around the navel. If somebody else administers the injection, the upper arm can also be used. For the initial 600 mg dose, four 150 mg pre-filled syringes or two 300 mg pre-filled pens should be administered consecutively in different injection sites within the same body area.

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 Organ Class Frequency Adverse reaction Infections and infestations Very common Common Upper respiratory tract infections Conjunctivitis Blood and lymphatic system disorders Common Eosinophilia Eye disorders Common Uncommon Conjunctivitis allergic Keratitis General disorders and administration site conditions Common Injection site reactions 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. 9%) in the initial treatment period of up to 16 weeks in the pool of 5 studies. 8%; initial treatment period).

Most patients recovered or were recovering during the treatment period. 0 events/100 patient years of exposure. 93 events/100 patient years of exposure. 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.

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.

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. 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.

5 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.

1.