EXDENSUR

EXDENSUR should be prescribed by physicians experienced in the diagnosis and treatment of asthma or CRSwNP. Posology Asthma Adults and adolescents aged 12 years and over The recommended dose of depemokimab is 100 mg administered subcutaneously once every 6 months.

Dosing at intervals shorter than 6 months is not recommended. CRSwNP Adults The recommended dose of depemokimab is 100 mg administered subcutaneously once every 6 months. Dosing at intervals shorter than 6 months is not recommended. Missed dose If a dose is missed, administer as soon as possible.

If the missed dose is taken 1 month or longer after the scheduled dose, resume the 6-monthly injection schedule 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 The safety and efficacy in children with CRSwNP below the age of 18 years have not been established. No data are available. Method of administration The pre-filled pen must be used for subcutaneous injection only.

EXDENSUR may be self-administered by adult or adolescent patients or administered by a caregiver if their healthcare professional determines that it is appropriate, and only after the patient or caregiver are trained in injection techniques.

For self-administration the recommended injection sites are the abdomen or thigh. A caregiver can also inject EXDENSUR into the upper arm. Comprehensive instructions for subcutaneous administration of EXDENSUR in a pre-filled pen are provided in the instructions for use in the package leaflet.

Summary of the safety profile The most common adverse reactions reported with depemokimab were local injection site reactions (2%). Tabulated list of adverse reactions The safety of depemokimab was studied in a clinical development programme in adult and adolescent patients aged 12 years and older with asthma (SWIFT-1 and SWIFT-2 studies) and in adult patients with CRSwNP (ANCHOR-1 and ANCHOR-2 studies).

In these 4 randomised, 52-week, placebo-controlled, multicentre studies, patients received either subcutaneous (SC) depemokimab or placebo once every 6 months. A total of 773 patients received at least one dose of depemokimab 100 mg in these studies.

Other phase 3 clinical studies include an open-label 52-week extension study (AGILE) involving asthma patients (n = 629) who had previously completed either of the two asthma studies (SWIFT-1 or SWIFT-2), and an ongoing 52-week study (NIMBLE) involving asthma patients who were previously treated with other anti- IL5/IL-5R biological medicines prior to study entry (n = 538).

Adverse reactions associated with depemokimab 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 Immune system disorders Hypersensitivity reactions (systemic allergic)a b Uncommon Skin and subcutaneous tissue disorders Pruritus Common General disorders and administration site conditions Administration-related systemic reactions (non- allergic)b c Local injection site reactionsd Common a Observed in a phase 1 study and in an open-label extension study b The majority of events (85%) resolved in ≤7 days, with most events (65%) resolving in ≤2 days from their onset.

c Symptoms include headache, fatigue, rash. d Symptoms include pain, erythema, swelling, and itching. The majority of events were mild in intensity and 79% resolved in ≤7 days, with most events (56%) resolving in ≤2 days from their onset.

Paediatric population A total of fifteen adolescents (aged 12-17) received depemokimab in two placebo- controlled studies for asthma (SWIFT-1 and SWIFT-2) of 52 weeks duration. The safety profile was generally similar to that seen in adults.

No additional adverse reactions were identified. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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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 reactions Acute and delayed systemic reactions, including hypersensitivity reactions (such as urticaria and pruritus), have occurred following administration of depemokimab.

, days). In the event of a hypersensitivity reaction, appropriate treatment should be initiated and clinical judgement must be used regarding re- administration of depemokimab. Asthma-related adverse events or exacerbations Depemokimab must not be used to treat acute asthma symptoms or acute exacerbations.

Asthma-related adverse events or exacerbations may occur during treatment with depemokimab. Patients should be instructed to seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with depemokimab.

Reduction of corticosteroid dosage Abrupt discontinuation of background medications (including systemic and inhaled corticosteroids) after initiation of depemokimab therapy is not recommended. Reductions in the dosages of background medications, 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 participation in 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, consider delaying administration of the next depemokimab dose until the infection resolves. Excipients This medicinal product contains polysorbate 80 (see section 2), which may cause allergic reactions.

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

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