Methods: Across all completed studies with C1 INH-nf, data were compiled regarding pre-procedural administration prior to medical, dental, or surgical procedures. C1 INH-nf 1000U IV was administered within 24 hours before a procedure. HAE attacks reported within 72 hours and adverse events reported within 7 days after a pre-procedural dose of C1 INH-nf were reviewed retrospectively.
Results: Forty-one unique subjects (8 children, 33 adults) received C1 INH-nf for 91 procedures (40 in children, 51 in adults). Approximately 55% of procedures involved dental work and 37% involved surgeries or interventional diagnostic procedures. Among the 8 children (aged 6-17 years), 90% of procedures involved dental work. A single 1000U dose was administered for 96% of procedures; 2 separate 1000U doses were used for two coronary artery bypass surgeries, one GI endoscopy, and during labor/delivery of one pregnancy. Only 2 HAE attacks were reported within 72 hours after dosing: 1 genitourinary attack after dental work and 1 laryngeal attack after laparoscopy. Both resolved after treatment with an additional dose of C1 INH-nf. Seven subjects reported adverse events within 7 days after receiving C1 INH-nf; none were considered related to C1 INH-nf by the investigator.
Conclusions: Pre-procedural administration of C1 INH-nf was effective in preventing HAE attacks during or following medical, dental, or surgical procedures.