HAEGARDA SAFETY AND TOLERABILITY

Adverse reactions occurring in >4% of patients while taking HAEGARDA in the pivotal trial

Table of HAEGARDA's adverse reactions vs placebo

*Includes patients who were treated with 40 IU/kg and 60 IU/kg.

^†Injection-site reactions included bruising, erythema, pain, swelling, edema, hemorrhage, and induration.

^‡Hypersensitivity included pruritus, rash, and urticaria.

No injection-site reactions were serious or led to discontinuation of treatment¹

1 patient discontinued HAEGARDA because of a treatment-related adverse reaction (urticaria)¹

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In the COMPACT^§ open-label extension study investigating the long-term safety of HAEGARDA²:

No related thromboembolic events (TEs) were reported

TEs have been reported with IV administration of C1-INH products, usually at high doses as well as with the use of ports due to venous access issues

No anaphylaxis was reported

HAEGARDA is contraindicated in individuals who have experienced life-threatening hypersensitivity reactions, including anaphylaxis, to C1-INH preparations or their excipients

No anti-C1-INH neutralizing antibodies were reported

Long-term use of C1-INH provides safe, sustained prophylactic effect from HAE attacks.²

^§ Clinical study for Optimal Management of Preventing Angioedema with low-volume subcutaneous C1-inhibitor replacement Therapy.

Pediatric and pregnancy information from HAEGARDA clinical trials

Pediatrics

In the COMPACT III pivotal study and the COMPACT open-label extension study, the safety and effectiveness of HAEGARDA were evaluated in a subgroup of 9 patients 8 to <17 years of age
Results of subgroup analysis by age were consistent with overall study results

Pregnancy

In the COMPACT open-label extension study, 4 pregnant women with type I HAE and ranging in age from 19 to 32 years received HAEGARDA
Patients received 40–60 IU/kg per S.C. administration for 4–8 weeks (9–15 doses) during the first trimester
These women reported no complications during delivery and all women delivered healthy babies

To find additional data on the use of C1-INH during pregnancy and lactation, refer to section 8 of the prescribing information.

Photo does not depict actual patient.

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References: 1. Longhurst H, Cicardi M, Craig T, et al. Prevention of hereditary angioedema attacks with a subcutaneous C1 inhibitor. N Engl J Med. 2017;376(12):1131-1140. 2. Craig T, Zuraw B, Longhurst H, et al. Long-term outcomes with subcutaneous C1-inhibitor replacement therapy for prevention of hereditary angioedema attacks. J Allergy Clin Immunol Pract. 2019;7(6):1793-1802.e2. doi:10.1016/j.jaip.2019.01.054.