HAEGARDA SAFETY AND TOLERABILITY
Adverse reactions occurring in >4% of patients while taking HAEGARDA in the pivotal trial
*Includes patients who were treated with 40 IU/kg and 60 IU/kg.
†Includes bruising, coldness, discharge, erythema, hematoma, hemorrhage, induration, edema, pain, pruritus, rash, injection-site reaction, scarring, swelling, urticaria, and warmth at the injection site.
‡Includes hypersensitivity, 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:
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
- 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
- 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.
Committed to quality manufacturing
We understand that you want the medications you prescribe your patients to meet the highest safety and quality standards. That’s why HAEGARDA goes through an advanced screening and purification process to reduce the risk of transmitting infection.‖
We are committed to producing high-quality, safe, and effective medicines. To us, that means that each step of the manufacturing process must meet or exceed the most stringent international standards for product safety in accordance with regulatory agencies worldwide.
‖ HAEGARDA is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated.
A quality-driven process that is committed to:
- Providing a consistent supply of HAEGARDA to all patients who start on HAEGARDA
- Having in-place systems of collection, manufacturing, and distribution that meet high-quality and safety standards
- Producing high-quality, safe, and effective biotherapies
Our manufacturing process includes:
- Carefully selecting and screening plasma donors
- Thorough testing for viruses
- Pasteurization (heat treatment for 10 hours)
- Virus nanofiltration with 2 different-sized filters