Pre-procedure Administration of C1 Esterase Inhibitor (human) (cinryze™) for the Prevention of Hereditary Angioedema (HAE) Attacks after Medical, Dental, or Surgical Procedures

RATIONALE: Acute HAE attacks may be triggered by trauma such as dental work, elective medical procedures, or surgery and require prophylaxis to prevent an attack. METHODS: Across all completed studies with Cinryze, data were compiled regarding pre-procedure administration prior to medical, dental, or surgical procedures. Cinryze 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-procedure dose of Cinryze were reviewed retrospectively. RESULTS: Forty-one unique subjects (8 children, 33 adults) received Cinryze 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 Cinryze. Seven subjects reported adverse events within 7 days after receiving Cinryze; none were considered related to Cinryze by the investigator. CONCLUSIONS: Pre-procedure administration of Cinryze was effective in preventing HAE attacks during or following 98% of medical, dental, or surgical procedures.