BREAKING NEW GROUND IN HAE PROTECTION

ANDEMBRY is the first and only prophylaxis treatment that inhibits the HAE cascade at the top

CSL Behring is pleased to announce FDA approval for ANDEMBRY, a once-monthly factor Xlla inhibitor (monoclonal antibody), indicated for prophylaxis to prevent attacks of HAE in patients 12 years and older.

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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 (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.