SUMMARY OF SAFETY
AND TOLERABILITY^1,2

ANDEMBRY^® (garadacimab) is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older.¹

The person represented in this material is not an actual patient.

Safety of ANDEMBRY^® was evaluated in all randomly assigned patients who received at least one treatment dose and in a subgroup of 11 adolescent patients aged 12 to 18 years old.^1,2 The safety profile was similar to that observed in adults.¹

ADVERSE REACTIONS (SmPC SUMMARY)¹

System organ class	Adverse drug reaction	Frequency
General disorders and administration site conditions	Injection-site reaction*	Common
Nervous system disorders	Headache	Common
Gastrointestinal disorders	Abdominal pain	Common

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), very rare (<1/10,000), not known (cannot be estimated from the available data).¹

* ISRs are summarised by System Organ Class and Preferred Term forming a virtual System Organ Class of Injection Site Reactions.^1,2 ISRs include erythema, bruising, pruritus, and injection site urticaria.¹ One patient in the placebo group had a vaccination-site reaction that was reported as an ISR.²

LONG-TERM SAFETY³

The safety profile in the Phase 3 OLE was consistent with the VANGUARD pivotal trial (median follow-up of 13.8 months).^*†3

*At the data cut-off for this interim analysis (February 13, 2023), the median treatment exposure was 13.8 months (IQR, 11.86–16.33; range, 3.0–21.1).³

^†All views are those of the expert speaker and supported by the body of literature summarised at the end of the video.

	ANDEMBRY^®200mg group (n=39)	Placebo group (n=25)
Treatment-emergent adverse events	25 (64%)	15 (60%)
Common treatment-emergent adverse events in ≥5% of patients by Preferred Term
Upper-respiratory tract infection	4 (10%)	2 (8%)
Nasopharyngitis	3 (8%)	1 (4%)
Headache	3 (8%)	4 (16%)
Treatment-emergent adverse events related to study treatment	4 (10%)	3 (12%)
Serious treatment-emergent adverse events	1 (3%)^*	0
Treatment-emergent adverse events of special interest	0	0
Severe hypersensitivity or anaphylaxis	0	0
Thromboembolic events	0	0
Bleeding events	0	0

	ANDEMBRY^®200mg group (n=39)	Placebo group (n=25)
Treatment-emergent adverse events leading to study discontinuation	0	0
Treatment-emergent adverse events leading to death	0	0
Injection-site reactions^†	2 (5%)	3 (12%)^‡
Injection-site erythema	1 (3%)	2 (8%)
Injection-site bruising	1 (3%)	0
Injection-site pruritus	1 (3%)	0
Other	0	1 (4%)^‡
Prothrombin fragment 1+2 increased	1 (3%)	0

Data are number of patients, presented as n (%).²
*One severe, serious adverse event (laryngeal attack) was assessed as not related to trial treatment: the patient made a full recovery and was kept under hospital observation overnight.²
^†ISRs are summarised by System Organ Class and Preferred Term forming a virtual System Organ Class of Injection Site Reactions.²
^‡One patient in the placebo group had a vaccination-site reaction that was reported as an ISR.²

	ANDEMBRY^®200mg group (n=39)	Placebo group (n=25)
Treatment-emergent adverse events	25 (64%)	15 (60%)
Common treatment-emergent adverse events in ≥5% of patients by Preferred Term
Upper-respiratory tract infection	4 (10%)	2 (8%)
Nasopharyngitis	3 (8%)	1 (4%)
Headache	3 (8%)	4 (16%)
Treatment-emergent adverse events related to study treatment	4 (10%)	3 (12%)
Serious treatment-emergent adverse events	1 (3%)^*	0
Treatment-emergent adverse events of special interest	0	0
Severe hypersensitivity or anaphylaxis	0	0
Thromboembolic events	0	0
Bleeding events	0	0

	ANDEMBRY^®200mg group (n=39)	Placebo group (n=25)
Treatment-emergent adverse events leading to study discontinuation	0	0
Treatment-emergent adverse events leading to death	0	0
Injection-site reactions^†	2 (5%)	3 (12%)^‡
Injection-site erythema	1 (3%)	2 (8%)
Injection-site bruising	1 (3%)	0
Injection-site pruritus	1 (3%)	0
Other	0	1 (4%)^‡
Prothrombin fragment 1+2 increased	1 (3%)	0

Data are number of patients, presented as n (%).²
*One severe, serious adverse event (laryngeal attack) was assessed as not related to trial treatment: the patient made a full recovery and was kept under hospital observation overnight.²
^†ISRs are summarised by System Organ Class and Preferred Term forming a virtual System Organ Class of Injection Site Reactions.²
^‡One patient in the placebo group had a vaccination-site reaction that was reported as an ISR.²

VANGUARD safety

In this video, Dr Aleena Banerji, MD, discusses safety endpoints from the VANGUARD trial^†

	ANDEMBRY^®200mg group (n=39)	Placebo group (n=25)
Treatment-emergent adverse events	25 (64%)	15 (60%)
Common treatment-emergent adverse events in ≥5% of patients by Preferred Term
Upper-respiratory tract infection	4 (10%)	2 (8%)
Nasopharyngitis	3 (8%)	1 (4%)
Headache	3 (8%)	4 (16%)
Treatment-emergent adverse events related to study treatment	4 (10%)	3 (12%)
Serious treatment-emergent adverse events	1 (3%)^*	0
Treatment-emergent adverse events of special interest	0	0
Severe hypersensitivity or anaphylaxis	0	0
Thromboembolic events	0	0
Bleeding events	0	0
Treatment-emergent adverse events leading to study discontinuation	0	0
Treatment-emergent adverse events leading to death	0	0
Injection-site reactions^†	2 (5%)	3 (12%)^‡
Injection-site erythema	1 (3%)	2 (8%)
Injection-site bruising	1 (3%)	0
Injection-site pruritus	1 (3%)	0
Other	0	1 (4%)^‡
Prothrombin fragment 1+2 increased	1 (3%)	0

	ANDEMBRY^®200mg group (n=39)	Placebo group (n=25)
Treatment-emergent adverse events leading to study discontinuation	0	0
Treatment-emergent adverse events leading to death	0	0
Injection-site reactions^†	2 (5%)	3 (12%)^‡
Injection-site erythema	1 (3%)	2 (8%)
Injection-site bruising	1 (3%)	0
Injection-site pruritus	1 (3%)	0
Other	0	1 (4%)^‡
Prothrombin fragment 1+2 increased	1 (3%)	0

Data are number of patients, presented as n (%).²
*One severe, serious adverse event (laryngeal attack) was assessed as not related to trial treatment: the patient made a full recovery and was kept under hospital observation overnight.²
^†ISRs are summarised by System Organ Class and Preferred Term forming a virtual System Organ Class of Injection Site Reactions.²
^‡One patient in the placebo group had a vaccination-site reaction that was reported as an ISR.²

	ANDEMBRY^®200mg group (n=39)	Placebo group (n=25)
Treatment-emergent adverse events	25 (64%)	15 (60%)
Common treatment-emergent adverse events in ≥5% of patients by Preferred Term
Upper-respiratory tract infection	4 (10%)	2 (8%)
Nasopharyngitis	3 (8%)	1 (4%)
Headache	3 (8%)	4 (16%)
Treatment-emergent adverse events related to study treatment	4 (10%)	3 (12%)
Serious treatment-emergent adverse events	1 (3%)^*	0
Treatment-emergent adverse events of special interest	0	0
Severe hypersensitivity or anaphylaxis	0	0
Thromboembolic events	0	0
Bleeding events	0	0
Treatment-emergent adverse events leading to study discontinuation	0	0
Treatment-emergent adverse events leading to death	0	0
Injection-site reactions^†	2 (5%)	3 (12%)^‡
Injection-site erythema	1 (3%)	2 (8%)
Injection-site bruising	1 (3%)	0
Injection-site pruritus	1 (3%)	0
Other	0	1 (4%)^‡
Prothrombin fragment 1+2 increased	1 (3%)	0

	ANDEMBRY^®200mg group (n=39)	Placebo group (n=25)
Treatment-emergent adverse events leading to study discontinuation	0	0
Treatment-emergent adverse events leading to death	0	0
Injection-site reactions^†	2 (5%)	3 (12%)^‡
Injection-site erythema	1 (3%)	2 (8%)
Injection-site bruising	1 (3%)	0
Injection-site pruritus	1 (3%)	0
Other	0	1 (4%)^‡
Prothrombin fragment 1+2 increased	1 (3%)	0

Data are number of patients, presented as n (%).²
*One severe, serious adverse event (laryngeal attack) was assessed as not related to trial treatment: the patient made a full recovery and was kept under hospital observation overnight.²
^†ISRs are summarised by System Organ Class and Preferred Term forming a virtual System Organ Class of Injection Site Reactions.²
^‡One patient in the placebo group had a vaccination-site reaction that was reported as an ISR.²

Adverse event, n (%) [E]*	ANDEMBRY^® 200mg (n=161)
Primary safety endpoints in patients with HAE-C1INH (n=159)^†
Patients with ≥1 TEAE	133 (83.6) [524]
TEAE rate per administration of study drug	0.23
TEAE rate per patient-year	2.84
TEAEs leading to death	0
TEAEs leading to study discontinuation	1 (1)^‡
TEAEs by severity
Mild	101 (62.7) [328]
Moderate	81 (50.3) [184]
Severe	9 (5.6) [13]
SAEs	3 (2)^§
AESI per protocol	0^¶

Adverse event, n (%) (E)*	ANDEMBRY^® 200mg (n=161)
Common TEAEs in ≥5% of patients by Preferred Term
COVID-19	58 (36)
Nasopharyngitis	27 (17)
Injection-site reactions^#	19 (12)
Injection-site erythema	11 (7)
Pruritus	4 (3)
Urticaria	2 (1)
Bruising	1 (1)
Haematoma	1 (1)
Irritation	1 (1)
Headache	10 (6)
Influenza	11 (7)
Upper respiratory tract infection	9 (6)

Abbreviations: AE, adverse event; AESI, adverse event of special interest; E, number of events; HAE-C1INH, hereditary angioedema with C1 inhibitor deficiency or dysfunction; SAE, serious adverse event; TEAE, treatment-emergent adverse event.

Data are the number of patients who experienced events presented as n (%), and number of events presented as [E].
*AEs were coded according to System Organ Class and Preferred Term using the Medical Dictionary for Regulatory Activities (v25.1); percentages are based on patients in the overall population (n=161) who received ≥1 dose, unless stated otherwise.³
^†Primary endpoints were assessed based on the primary analysis safety set of patients with HAE-C1INH (n=159).³
^‡Injection-site irritation related to ANDEMBRY^® leading to study discontinuation.³
^§Three SAEs assessed as not related to ANDEMBRY^® were reported (COVID-19, n=2; abdominal HAE attack, n=1).³
^¶Abnormal bleeding, thromboembolic events, severe hypersensitivity, and anaphylaxis.³
^#TEAEs are categorised as ISRs based on medical review of all relevant Preferred Terms.³

Adverse event, n (%) [E]*	ANDEMBRY^® 200mg (n=161)
Primary safety endpoints in patients with HAE-C1INH (n=159)^†
Patients with ≥1 TEAE	133 (83.6) [524]
TEAE rate per administration of study drug	0.23
TEAE rate per patient-year	2.84
TEAEs leading to death	0
TEAEs leading to study discontinuation	1 (1)^‡
TEAEs by severity
Mild	101 (62.7) [328]
Moderate	81 (50.3) [184]
Severe	9 (5.6) [13]
SAEs	3 (2)^§
AESI per protocol	0^¶

Adverse event, n (%) (E)*	ANDEMBRY^® 200mg (n=161)
Common TEAEs in ≥5% of patients by Preferred Term
COVID-19	58 (36)
Nasopharyngitis	27 (17)
Injection-site reactions^#	19 (12)
Injection-site erythema	11 (7)
Pruritus	4 (3)
Urticaria	2 (1)
Bruising	1 (1)
Haematoma	1 (1)
Irritation	1 (1)
Headache	10 (6)
Influenza	11 (7)
Upper respiratory tract infection	9 (6)

Abbreviations: AE, adverse event; AESI, adverse event of special interest; E, number of events; HAE-C1INH, hereditary angioedema with C1 inhibitor deficiency or dysfunction; SAE, serious adverse event; TEAE, treatment-emergent adverse event.

Data are the number of patients who experienced events presented as n (%), and number of events presented as [E].
*AEs were coded according to System Organ Class and Preferred Term using the Medical Dictionary for Regulatory Activities (v25.1); percentages are based on patients in the overall population (n=161) who received ≥1 dose, unless stated otherwise.³
^†Primary endpoints were assessed based on the primary analysis safety set of patients with HAE-C1INH (n=159).³
^‡Injection-site irritation related to ANDEMBRY^® leading to study discontinuation.³
^§Three SAEs assessed as not related to ANDEMBRY^® were reported (COVID-19, n=2; abdominal HAE attack, n=1).³
^¶Abnormal bleeding, thromboembolic events, severe hypersensitivity, and anaphylaxis.³
^#TEAEs are categorised as ISRs based on medical review of all relevant Preferred Terms.³

IMPORTANT SAFETY INFORMATION

Special warnings and precautions, drug interactions and specific populations

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Abbreviations: AE, adverse event; aPTT, activated partial thromboplastin time; AUC, area under the curve; C1-INH, C1-esterase inhibitor; FXII, Factor XII; FXIIa, activated Factor XII; HAE, hereditary angioedema; HAE-C1INH, hereditary angioedema with C1 inhibitor deficiency or dysfunction; IgG, immunoglobulin G; ISR, injection-site reactions; IQR, interquartile range; nC1-INH HAE, HAE with normal functioning C1-INH; OLE, open-label extension; PK, pharmacokinetics; SAE, serious adverse event; SmPC, Summary of Product Characteristics; TEAE, treatment-emergent adverse events.

References:
1. ANDEMBRY^® (garadacimab). Summary of Product Characteristics.
2. Craig J, et al. Lancet. 2023; 401(10382):1079–1090.
3. Reshef A, et al. Allergy. 2025; 80:545–556.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple store. Adverse events should also be reported to CSL Behring UK Ltd. on 01444 447405.

GBR-AND-0215 | May 2026.

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SUMMARY OF SAFETYAND TOLERABILITY1,2

SUMMARY OF SAFETYAND TOLERABILITY1,2

ADVERSE REACTIONS (SmPC SUMMARY)1

LONG-TERM SAFETY3

LONG-TERM SAFETY3

VANGUARD safety

IMPORTANT SAFETY INFORMATION

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Learn how ANDEMBRY® is changing the path in HAE

Welcome to CSL Behring

Help us guide you to the right place.

SUMMARY OF SAFETY
AND TOLERABILITY^1,2

SUMMARY OF SAFETY
AND TOLERABILITY^1,2

ADVERSE REACTIONS (SmPC SUMMARY)¹

LONG-TERM SAFETY³

LONG-TERM SAFETY³

Explore how to administer ANDEMBRY^®

Learn how ANDEMBRY^® is changing the path in HAE