Andembry

This medicinal product should be initiated under the supervision of a healthcare professional experienced in the management of patients with HAE. Posology 3 The recommended dose of ANDEMBRY, in adults and children 12 years of age and above, is an initial loading dose of 400 mg administered subcutaneously as two 200 mg injections on the first day of treatment, followed by a monthly dose of 200 mg.

1). 4). Missed doses If a dose of ANDEMBRY is missed, the patient should be instructed to administer the dose as soon as possible. 2). 2). Paediatric population The safety and efficacy of garadacimab in children less than 12 years have not been established.

No data are available. Method of administration ANDEMBRY is intended for subcutaneous use only. 6). 2). Rotation of the injection site is recommended. ANDEMBRY may be self-administered or administered by a caregiver only after training on subcutaneous injection technique by a healthcare professional.

Summary of the safety profile The most commonly observed adverse reactions associated with ANDEMBRY were injection site reactions (ISR) including injection site erythema, injection site bruising, injection site pruritus and injection site urticaria, headache and abdominal pain.

Tabulated list of adverse reactions Table 1 summarises adverse reactions observed in the VANGUARD pivotal trial, which included 39 subjects with HAE who received at least 1 dose of ANDEMBRY. The frequency of adverse reactions listed in Table 1 is defined using the following convention: 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).

Table 1:

Adverse drug reactions (ADRs) obtained from clinical studies with ANDEMBRY System organ class Adverse drug reaction Frequency General disorders and administration site conditions Injection site reactions* Common Nervous system disorders Headache Common Gastrointestinal disorders Abdominal pain Common *Injection site reactions include, erythema, bruising, pruritus, and injection site urticaria Paediatric population The safety of ANDEMBRY was evaluated in a subgroup of 11 subjects aged 12 to < 18 years old.

No difference from the overall safety profile was seen between adults and children. 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.

Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. 6

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 4 Hypersensitivity reactions have not been observed but may theoretically occur.

In case of severe hypersensitivity reactions, administration of garadacimab should be discontinued, and appropriate treatment instituted. General ANDEMBRY is not intended for treatment of acute HAE attacks. In case of breakthrough HAE attack, individualized treatment should be initiated with an approved rescue medicinal product.

1). Some subcategories of nC1-INH HAE may not respond to treatment with garadacimab due to alternative pathways that do not include FXII activation. 1). Interference with coagulation test ANDEMBRY can prolong activated partial thromboplastin time (aPTT) due to an interaction of garadacimab with the aPTT assay.

The extent of aPTT prolongation could be variable depending on drug exposure as well as additional parameters, such as natural variation in FXII levels, and other coagulation factors. The reagents used in the aPTT laboratory test initiate intrinsic coagulation through the activation of FXII in the contact system, therefore inhibition of plasma FXIIa by ANDEMBRY can prolong aPTT in this assay.

1 mg/mL. Proline may be harmful for patients with hyperprolinaemia, a rare genetic disorder in which proline builds up in the body. 2 mg/mL. Polysorbates may cause allergic reactions.

1.