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:
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.
HAEGARDA use in specific populations
- In a retrospective case collection study, breastfeeding was documented for neonates from 21 of 35 births with a median duration of 4.8 months (ranging from 1 to 34 months). Mothers were treated postpartum with C1-INH doses up to 1000 IU per IV administration for the treatment of acute HAE attacks
- No adverse events to the mothers were associated with C1-INH treatment after pregnancy. No information regarding the effect on the breastfed infant was reported
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