"The U.S. Food and Drug Administration yesterday approved Ruconest, the first recombinant C1-Esterase Inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).
(C1 esterase inhibitor [recombinant]) Intravenous Injection
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. One IU of rhC1INH activity is defined as the equivalent of C1 esterase inhibiting activity present in 1 mL of pooled normal plasma.
RUCONEST is a soluble, single-chain glycoprotein containing 478 amino acids, with a molecular mass of 68 kDa, of which approximately 22% comprises oligosaccharide structures. The primary and secondary structures of the molecule and target protease selectivity are consistent with those of plasma-derived C1 esterase inhibitor.
Each vial of RUCONEST contains 2100 IU of rhC1INH, 937 mg of sucrose, 83.3 mg of sodium citrate dihydrate and 1.0 mg of citric acid monohydrate. After reconstitution with 14 mL of sterile Water for Injection, each vial of RUCONEST contains 150 IU of rhC1INH per 1 mL in a 20 mM sodium citrate buffer with a pH of 6.8. RUCONEST does not contain preservatives and each vial is for single use only.
RUCONEST is purified from the milk of transgenic rabbits. The rabbits are maintained in a closed colony that is controlled and routinely monitored for specific pathogens. The skimmed milk is screened for adventitious contaminants prior to further manufacture. The manufacturing process has been validated to demonstrate adequate capacity for removal and/or inactivation of viruses (Table 4). RUCONEST contains less than 0.002% of host-related impurities.
Table 4 : Viral reduction capacity of the rhC1INH
|Step||Virus Reduction Factor(Logio)|
|MLV a||REO 3||ORF||FCV||PPV|
|SP BB chromatographyb||1.8||2.2 c||1.5 c||2.3||1.5 b|
|SD incubationb||≥ 5.8||NAd||3.7||NA||NA|
|Q HP chromatographyb||NT e||4.8||NT||0.8 c||2.2|
|Zn FF chromatographyb||1.1c||3.2 c||3.3||1.9 c||0.4 c|
|Nanofiltration||≥ 5.5||≥ 6.5||≥ 5.8||≥ 6.9||5.8|
|Total reduction factor||≥ 13.1||≥ 11.3||≥ 12.8||≥ 9.2||8.0|
|aMLV: Murine leukemia virus; REO-3: Reovirus
type 3; ORF: Scab-mouth ORF virus; FCV: Feline calicivirus; PPV: Porcine
b SP BB: SP Sepharose BB; SD: Solvent/detergent; Q HP: Q Sepharose HP; Zn FF: Zinc Chelating Sepharose FF;
cNot added to the total reduction factor since independence of clearance mechanism has not been experimentally verified;
d Not applicable since indicated model virus is not enveloped;
e Not tested because SD chemicals are present in the starting material.
Last reviewed on RxList: 7/24/2014
This monograph has been modified to include the generic and brand name in many instances.
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