HAEGARDA SAFETY PROFILE

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

The physician should discuss the risks and benefits of this product with the patient before prescribing or administering it to the patient. Initiate individualized treatment in case of an acute HAE attack.

Severe hypersensitivity reactions to HAEGARDA could occur.

At the recommended subcutaneous dose of HAEGARDA, no causal relationship to TEEs* has been established. However, TEEs have been reported with IV use of C1-INH products, usually at high doses.

Because HAEGARDA is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

*TEEs = thromboembolic events

Adverse Reactions in >4% of Subjects Treated with HAEGARDA

MedDRA= Dictionary for Regulatory Activities

N = number of subjects receiving the treatment; n = number of subjects experiencing ≥1 event.

*Includes subjects who were treated with 40 IU/kg or 60 IU/kg HAEGARDA.

^†Includes: Injection site bruising, coldness, discharge, erythema, hematoma, hemorrhage, induration, edema, pain, pruritus, rash, reaction, scar, swelling, urticaria, warmth.

^‡Includes: hypersensitivity, pruritus, rash, and urticaria.

Of the injection site reactions occurring after treatment with HAEGARDA, 95% were of mild intensity and 83% resolved within 1 day after onset.

Overall, safety data from the extension study, consisting of 59 patients who participated in the main study and 61 patients who did not participate in the main study (n=120), were consistent with the safety data from the randomized, double-blind, placebo-controlled, crossover, routine prophylaxis trial.

In the COMPACT^§ open-label, randomized, parallel-arm extension study investigating the LONG-TERM SAFETY (PRIMARY OBJECTIVE) OF HAEGARDA¹:

Safety data from the COMPACT OLE STUDY were consistent with the safety data from the COMPACT Pivotal trial

No related thromboembolic events

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

No anaphylaxis

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

No treatment-related serious adverse events

4 AEs led to discontinuation

1 unrelated serious AE of myocardial infarction
1 each of the nonserious AEs headache, myalgia, and arthralgia

Nontreatment-related SAEs were reported in 9 patients

1 HAE attack resulted in hospitalization and was unrelated to the study drug

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.

Reference: 1. Craig T, Feuersenger H, Pragst I, Dang J. Prophylactic therapy with subcutaneous C1-inhibitor is associated with sustained symptom control in patients with hereditary angioedema. Allergy Asthma Proc. 2022;43(3):202-208. doi:10.2500/aap.2022.43.220016.