Overview
11 DESCRIPTION RUCONEST is a recombinant analogue of human complement component 1 esterase inhibitor for intravenous injection. RUCONEST is purified from the milk of transgenic rabbits, and supplied as a sterile, preservative-free, white/off-white lyophilized powder for reconstitution for injection.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action C1 esterase inhibitor (C1INH) is a normal constituent of human blood and is one of the serine protease inhibitors (serpins). The primary function of C1INH is to regulate the activation of the complement and contact system pathways. Regulation of these systems is performed through the formation of complexes between the protease and the inhibitor, resulting in inactivation of both and consumption of the C1INH. C1INH exerts its inhibitory effect by irreversibly binding several proteases (target proteases) of the contact and complement systems. The effect of RUCONEST on the following target proteases was assessed in vitro : activated C1s, kallikrein, factor XIIa and factor XIa.
Indications
- 1 INDICATIONS AND USAGE RUCONEST is a C1 esterase inhibitor [recombinant] indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE). Limitation of Use: Effectiveness was not established in HAE patients with laryngeal attacks. RUCONEST is a C1 esterase inhibitor [recombinant] indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE). ( 1 ) Limitation of Use: Effectiveness was not established in HAE patients with laryngeal attacks.
Common Doses
- 14 mL
- 28 mL
Dosage
2 DOSAGE AND ADMINISTRATION For intravenous use after reconstitution only. For Intravenous Use Only. Reconstitute each vial (2100 U) by adding 14 mL sterile Water for Injection per vial to obtain a solution of 150 U per mL. ( 2.3 ) Administer the reconstituted solution at room temperature as a slow intravenous injection over approximately 5 minutes. ( 2.4 ) Appropriately trained patients may self-administer upon recognition of an HAE attack. ( 2.
Contraindications
- 4 CONTRAINDICATIONS RUCONEST is contraindicated in patients with a history of allergy to rabbits or rabbit-derived products. RUCONEST is contraindicated in patients with a history of life-threatening immediate hypersensitivity reactions to C1 esterase inhibitor preparations, including anaphylaxis. Known or suspected allergy to rabbits and rabbit-derived products. ( 4 ) History of immediate hypersensitivity reactions, including anaphylaxis, to C1 esterase inhibitor preparations. ( 4 )
Side Effects
- 6 ADVERSE REACTIONS The serious adverse reaction in clinical studies of RUCONEST was anaphylaxis. The most common adverse reactions (≥ 2%) reported in all clinical trials were headache, nausea, and diarrhea. The serious adverse reaction reported in clinical trials was anaphylactic reaction. ( 6 ) The common adverse reactions (≥ 2%) reported in clinical trials were headache, nausea, and diarrhea. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pharming Healthcare Inc. at 1-800-930-5221 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.