Berinert

Berinert

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

Berinert is a plasma-derived concentrate of C1 Esterase Inhibitor (Human) indicated for the treatment of acute abdominal, facial, or laryngeal attacks of hereditary angioedema (HAE) in adult and adolescent patients.

The safety and efficacy of Berinert for prophylactic therapy have not been established.

History

There is currently no drug history available for this drug.

Other Information

Berinert is a human plasma-derived, purified, pasteurized, lyophilized concentrate of C1 esterase inhibitor to be reconstituted for intravenous administration. Berinert is prepared from large pools of human plasma from US donors. The potency of C1 esterase inhibitor is expressed in International Units (IU), which is related to the current WHO Standard for C1 esterase inhibitor products.

C1 esterase inhibitor is a soluble, single-chain glycoprotein containing 478 amino acid residues organized into three beta-sheets and eight or nine alpha-helices.3 The heavily glycosylated molecule has an apparent molecular weight of 105 kD, of which the carbohydrate chains comprise 26% to 35%.4

Each 500 IU vial of reconstituted Berinert contains 400-625 IU C1 esterase inhibitor, 50 to 80 mg total protein, 85 to 115 mg glycine, 70 to 100 mg sodium chloride, and 25 to 35 mg sodium citrate.

All plasma used in the manufacture of Berinert is obtained from US donors and is tested using serological assays for hepatitis B surface antigen and antibodies to HIV-1/2 and HCV. Additionally, the plasma is tested with Nucleic Acid Testing (NAT) for HBV, HCV, HIV-1 and HAV and found to be non-reactive (negative). In addition, the plasma is also tested by NAT for Human Parvovirus B19. Only plasma that has passed virus screening is used for production, and the limit for Parvovirus B19 in the fractionation pool is set not to exceed 104 IU of Parvovirus B19 DNA per mL.

The manufacturing process for Berinert includes multiple steps that reduce the risk of virus transmission. The virus inactivation/reduction capacity consists of three steps:

  • Pasteurization in aqueous solution at 60°C for 10 hours
  • Hydrophobic interaction chromatography
  • Virus filtration (also called nanofiltration) by two filters, 20 nm and 15 nm, in series

This was evaluated in a series of in vitro spiking experiments. The total mean cumulative virus inactivation/reduction is shown in Table 5.

Table 5: Mean Virus Inactivation/Reductions in Berinert
Virus Studied Pasteurization
[log10]
Hydrophobic Interaction Chromatography
[log10]
Virus Filtration
[log10]
Total Cumulative [log10]
HIV-1, Human immunodeficiency virus type 1, a model for HIV-1 and HIV-2
BVDV, Bovine viral diarrhea virus, a model for HCV
PRV, Pseudorabies virus, a model for large enveloped DNA viruses
WNV, West Nile virus
HAV, Hepatitis A virus
CPV, Canine parvovirus
B19V, Human Parvovirus B19
ND, Not determined
NA, Not applicable
Enveloped Viruses
HIV-1 ≥6.6 ≥4.5 ≥5.1 ≥16.2
BVDV ≥9.2 ≥4.7 ≥5.3 ≥19.2
PRV 6.3 ≥6.5 ≥7.1 ≥19.9
WNV ≥7.0 ND ≥8.0 ≥15.0
Non-Enveloped Viruses
HAV ≥6.4 2.8 ≥5.3 ≥14.5
CPV 1.4 6.4 ≥7.2 ≥15.0
B19V 3.9 ND ND NA

Berinert Manufacturers


  • Csl Behring Gmbh
    Berinert (Human C1-esterase Inhibitor) Kit [Csl Behring Gmbh]

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