Generic Name and Formulations:
C1 esterase inhibitor (recombinant) 2100 IU; per vial; lyophilized pwd for IV inj after reconstitution; preservative-free.
Pharming Healthcare Inc.
Indications for RUCONEST:
Treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).
Limitations Of use:
Efficacy not established in HAE patients with laryngeal attacks.
Give by slow IV inj over 5 mins. <84kg: 50 IU/kg. ≥84kg: 4200 IU. Max 4200 IU/dose. May give second dose if attack symptoms persist; max 2 doses/24hrs.
Allergy to rabbits or rabbit-derived products.
Discontinue if hypersensitivity reactions occur. Monitor patients with known risk factors for thrombotic events (eg, indwelling venous catheter, history of thrombosis, atherosclerosis, morbid obesity, immobility). Labor & delivery. Pregnancy (Cat.B). Nursing mothers.
Risk of thrombotic events with concomitant oral contraceptives or certain androgens.
Headache, nausea, diarrhea; thrombotic events, hypersensitivity reactions (may be severe).