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Important Safety Information

ANDEMBRY® (garadacimab-gxii) injection, for subcutaneous use, is an activated Factor XII (FXIIa) inhibitor (monoclonal antibody) indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.

The most common adverse reactions in the pivotal trial (incidence ≥7%) were nasopharyngitis and abdominal pain. In the pivotal trial and the open-label extension study, injection-site reactions (eg, injection-site bruising, injection-site erythema, injection-site hematoma, injection-site pruritus, injection-site urticaria) were reported in 23 (14%) patients.

No dedicated drug interaction studies have been conducted, nor is there data concerning the use of ANDEMBRY in women who are pregnant or breastfeeding. The safety and efficacy of ANDEMBRY in patients under 12 years of age have not been established.

Drug Interference with Laboratory Test: ANDEMBRY can prolong activated partial thromboplastin time (aPTT) due to an interaction of garadacimab-gxii with the aPTT assay.

Please see full prescribing information for ANDEMBRY.

To report SUSPECTED ADVERSE REACTIONS, contact the CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Important Safety Information

ANDEMBRY® (garadacimab-gxii) injection, for subcutaneous use, is an activated Factor XII (FXIIa) inhibitor (monoclonal antibody) indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.

The most common adverse reactions in the pivotal trial (incidence ≥7%) were nasopharyngitis and abdominal pain. In the pivotal trial and the open-label extension study, injection-site reactions were reported in 23 (14%) patients.

No dedicated drug interaction studies have been conducted, nor is there data concerning use during pregnancy or breastfeeding.

Drug Interference with Laboratory Test: ANDEMBRY can prolong activated partial thromboplastin time (aPTT).

Please see full prescribing information for ANDEMBRY.

To report suspected adverse reactions, contact CSL Behring at 1‑866‑915‑6958 or FDA at 1‑800‑FDA‑1088.

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ANDEMBRY is manufactured by CSL Behring GmbH and distributed by CSL Behring LLC.
ANDEMBRY® is a registered trademark of CSL Behring LLC.
ANDEMBRY Connect℠ is a service mark of CSL Behring LLC.

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