ANDEMBRY

, Recommended Dose and Dosage Adjustment).

Pediatrics (<12 years):

The safety and efficacy of ANDEMBRY in pediatric patients below the age of 12 have not been established. 4 Geriatrics). No overall differences in safety or efficacy were observed compared to patients 18 to 65 years of age. 2 CONTRAINDICATIONS ANDEMBRY is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

For a complete listing, see

1 Adverse Reaction Overview One hundred and sixty-six (166) unique subjects with HAE were exposed to at least one dose of ANDEMBRY 200 mg in one (1) Phase 2 and two (2) Phase 3 clinical trials. 6%). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.

The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.

The safety of ANDEMBRY is primarily based on a 6-month, randomized, double-blind, parallel-group and placebo-controlled study (Trial 1) in 64 adult and pediatric patients (aged 12 years and older) with Type I or II HAE (see 14 CLINICAL TRIALS).

A total of 39 patients with HAE aged 12 years and older received at least one dose of ANDEMBRY. 2 years. Table 2 below summarizes treatment-emergent adverse events (TEAEs) in ≥5% of patients treated with ANDEMBRY. 8 months were consistent with data in Table 2.

1%) patients who received ANDEMBRY. Temporal relationship (began within 1-3 days after investigational product administration) was identified for all three injection site reactions. All three injection site reactions were assessed as related to ANDEMBRY.

In a Phase 3 open-label extension study (Trial 2), 161 patients with HAE were administered ANDEMBRY 200 mg subcutaneously every month; 57 patients had rolled over from Trial 1. , injection site bruising, injection site erythema, injection site haematoma, injection site pruritus, injection site urticaria) were reported in 16 (10%) patients.

1 Clinical Trial Adverse Reactions – Pediatrics While limited, the safety profile in pediatric patients 12 years of age and older (n=6) was similar to that of the adult population. 5 Post-Market Adverse Reactions Not Applicable.

General Acute HAE attacks ANDEMBRY is not intended for treatment of acute HAE attacks. In case of breakthrough HAE attack, individualised treatment should be initiated with an approved rescue medicine. Normal C1-INH HAE (nC1-INH) Some subcategories of normal C1-INH HAE (nC1-INH) may not respond to treatment with garadacimab due to alternative pathways that do not include FXII activation.

It is recommended to perform genetic testing, if available, according to the current HAE guidelines. Consideration should be given to discontinuing treatment in patients with nC1-INH who have shown insufficient reduction in attacks after 3 months of treatment.

2 mL L-arginine monohydrochloride, L-histidine, L-proline, Polysorbate 80, Water for injection ANDEMBRY® (garadacimab injection) Page 8 of 43 Coagulation disorders & thromboembolism ANDEMBRY has not been studied in patients with clinically significant bleeding due to coagulopathy or with thromboembolism.

There were no garadacimab-related bleeding and thromboembolic events in the clinical studies. 7 Drug-Laboratory Test Interactions).

Reproductive Health:

Female and Male Potential Fertility Effect on fertility has not been evaluated in humans. Sensitivity/Resistance Hypersensitivity Severe hypersensitivity reactions have not been observed but may theoretically occur. The signs and symptoms of hypersensitivity reactions may include hives (local and generalized), tightness of the chest, difficulty breathing, wheezing, hypotension, and/or anaphylaxis during or after injection of ANDEMBRY.

In case of severe hypersensitivity, discontinue ANDEMBRY administration and institute appropriate treatment. 1 Pregnancy There are no studies with ANDEMBRY in pregnant women. The extent of exposure in pregnancy during clinical trials was very limited.

As a precautionary measure, it is preferable to avoid the use of garadacimab during pregnancy. A pre- and postnatal development study conducted in pregnant rabbits administered subcutaneous doses of garadacimab resulted in confirmed exposure to the developing fetus.

ANDEMBRY is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.