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

Table of HAEGARDA's adverse reactions vs placebo 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

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

vector checkmark

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
vector checkmark

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
vector checkmark

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

icon of mother and child


  • 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
icon of pregnant woman


  • 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.

Image of child jumping

Photo does not depict actual patient.

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.
You are now leaving the current website.

Do you want to continue?