Exdensur

This medicinal product should be prescribed by physicians experienced in the diagnosis and treatment of asthma or CRSwNP. 3 Posology This medicinal product is intended for long-term treatment. A decision to continue the therapy should be made at least annually based on the patient’s level of disease control.

Asthma Adults and adolescents aged 12 years and over The recommended dose of depemokimab is 100 mg administered subcutaneously once every 6 months. CRSwNP Adults The recommended dose of depemokimab is 100 mg administered subcutaneously once every 6 months.

Missed dose If a dose is missed, it should be administered as soon as possible. If the missed dose is taken 1 month or longer after the scheduled dose, the 6-monthly injection schedule should be resumed from the date when the missed dose was given.

2). 2). Paediatric population Asthma The safety and efficacy of depemokimab in children aged less than 12 years have not yet been established. No data are available. CRSwNP There is no relevant use of depemokimab in the paediatric population for the treatment of CRSwNP.

Method of administration The pre-filled pen or pre-filled syringe must be used for subcutaneous injection only. This product may be self-administered by adult or adolescent patients or administered by a caregiver if their healthcare professional determines that it is appropriate, and the patient or caregiver are trained in injection techniques.

For self-administration the recommended injection sites are the abdomen or thigh, except for the 5 cm around the navel. A caregiver can also inject the solution into the upper arm. It should not be injected into areas where the skin is bruised, tender, erythematous, or hardened.

4 Comprehensive instructions for administration are provided in the instructions for use at the end of the package leaflet.

Summary of the safety profile The most common adverse reactions reported with depemokimab are local injection site reactions (2%). 6 Tabulated list of adverse reactions Adverse reactions reported during clinical trials are presented in the table below (Table 1).

Frequencies are defined as 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) and very rare (< 1/10 000). Within each frequency grouping, where relevant, adverse reactions are presented in order of decreasing seriousness.

Table 1. Adverse reactions System Organ Class Adverse reactions Frequency Skin and subcutaneous tissue disorders Pruritus Common General disorders and administration site conditions Administration-related systemic reactions (non- allergic) Common Local injection site reactions Common Description of selected adverse reactions Systemic reactions (allergic) Hypersensitivity reactions, such as anaphylaxis and angioedema, have been reported with other monoclonal antibodies that target IL-5 or its receptor.

4). , headache, fatigue, rash) were reported in 1% of patients receiving depemokimab in the entire clinical development programme. In the 52-week placebo-controlled studies in asthma and CRSwNP, systemic non-allergic reactions were reported in < 1% of patients receiving depemokimab.

Systemic reactions (non-allergic) reported with depemokimab were non-serious and were either mild or moderate in intensity. The majority of events were transient: 88% of events resolved ≤ 7 days from onset whereas, 67% of events resolved ≤ 2 days from their onset.

, pain, erythema, swelling, itching) were reported in 2% of patients receiving depemokimab in the entire clinical development programme. The reactions reported with depemokimab were non-serious, mild in intensity and were transient (79% resolved in ≤ 7 days, with most events (56%) resolving in ≤ 2 days from their onset).

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. 8). , days). In the event of a hypersensitivity reaction, appropriate treatment as clinically indicated, is recommended.

Upon re-administration of depemokimab monitoring to detect signs of recurring hypersensitivity reactions is recommended. In case of a severe or recurring hypersensitivity reaction, permanent discontinuation of depemokimab should be considered.

Acute asthma exacerbations Depemokimab must not be used to treat acute asthma symptoms or acute exacerbations. Asthma-related adverse symptoms or exacerbations may occur during treatment with depemokimab. It is recommended that patients be instructed to seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with depemokimab.

Corticosteroids Abrupt discontinuation of background treatments (including systemic and inhaled corticosteroids) after initiation of depemokimab therapy is not recommended. Reductions in the doses of background treatments, if appropriate, must be gradual and performed under the supervision of a physician.

Parasitic (helminth) infections Eosinophils may be involved in the immunological response to some helminth infections. Patients with pre-existing helminth infections were excluded from the clinical programme. Patients with pre- existing helminth infections should be treated for their infection prior to depemokimab therapy.

If patients become infected while receiving treatment with depemokimab and do not respond to anti- helminth treatment, delaying administration of the next depemokimab dose until the infection resolves should be considered. 2 mg of polysorbate 80 per 100 mg dose (see section 2).

Polysorbates may cause allergic reactions. Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per 100 mg dose, that is to say essentially “sodium-free”.

1.