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CINRYZE™ (c1 esterase inhibitor human freeze dried powder)
(c1 esterase inhibitor [human]) Freeze Dried Powder
CINRYZE (c1 esterase inhibitor human freeze dried powder) (C1 esterase inhibitor [Human]) is a sterile, stable, lyophilized preparation of C1 esterase inhibitor derived from human plasma. CINRYZE (c1 esterase inhibitor human freeze dried powder) is manufactured from human plasma purified by a combination of filtration and chromatographic procedures. The specific activity of CINRYZE (c1 esterase inhibitor human freeze dried powder) is 4.0 – 9.0 units/mg protein. The purity is ≥ 90% human C1 esterase inhibitor. Following reconstitution with 5 mL of Sterile Water for Injection, USP, each vial contains approximately 500 units of functionally active C1 esterase inhibitor, pH 6.6 - 7.4, and an osmolality between 200 – 400 mosmol/kg. One unit (U) of CINRYZE (c1 esterase inhibitor human freeze dried powder) corresponds to the mean quantity of C1 esterase inhibitor present in 1 ml of normal fresh plasma.
CINRYZE (c1 esterase inhibitor human freeze dried powder) , when reconstituted with 5 mL of Sterile Water for Injection contains the following excipients: 4.1 mg/mL sodium chloride, 21 mg/mL sucrose, 2.6 mg/mL trisodium citrate, 2.0 mg/mL L-Valine, 1.2 mg/mL L-Alanine, and 4.5 mg/mL L-Threonine.
The following manufacturing steps are designed to reduce the risk of viral transmission:
- Screening donors at U.S. licensed blood collection centers to rule out infection with Human Immunodeficiency Virus (HIV-1/HIV-2), Hepatitis B Virus, or Hepatitis C Virus.
- Testing plasma pools by in-process NAT for parvovirus B19 via minipool testing and the limit of B19 in the manufacturing pool is set not to exceed 104 IU of B19 DNA per mL.
- Use of two independent viral reduction steps in the manufacture of CINRYZE (c1 esterase inhibitor human freeze dried powder) : pasteurization (heat treatment at 60°C for 10 hours in solution with stabilizers) and nanofiltration through two sequential 15 nm Planova filters.
These viral reduction steps, along with a step in the manufacturing process, PEG precipitation, have been validated in a series of in vitro experiments for their capacity to inactivate/remove a wide range of viruses of diverse physicochemical characteristics including: Human Immunodeficiency Virus (HIV), Hepatitis A Virus (HAV), and the following model viruses: Bovine Viral Diarrhea Virus (BVDV) as a model virus for HCV, Canine Parvovirus (CPV) as a model virus for Parvovirus B19, Pseudorabies Virus (PRV) as a model virus for large enveloped DNA viruses (e.g. herpes virus). Total mean log10 reductions are shown in Table 3.
Table 3: Log10 Virus Reduction Factor for Selected Viruses
|Process step||Log10 Virus Reduction|
|Enveloped viruses||Non-enveloped viruses|
|PEG precipitation||5.1 ± 0.2||4.5 ± 0.3||6.0 ± 0.3||2.8 ± 0.2||4.2 ± 0.2|
|Pasteurization||> 6.1 ± 0.2||> 6.7 ± 0.3||> 6.7 ± 0.2||2.8 ± 0.3||0.1 ± 0.3|
|Nanofiltration||> 5.6 ± 0.2||> 5.5 ± 0.2||> 6.4 ± 0.3||> 4.9 ± 0.2||> 4.5 ± 0.3|
|Total reduction||> 16.8||> 16.7||> 19.1||> 10.5||> 8.7|
What are the possible side effects of complement C1 esterase inhibitor (Berinert, Cinryze)?
Stop your IV infusion and get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing or difficult breathing; feeling like you might pass out; or swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any other serious side effect, such as:
- new or worsening pain;
- sudden numbness or weakness, especially on one side of the body;
- sudden severe headache, confusion, problems with vision, speech, or balance;
- stomach pain or swelling;
What are the precautions when taking c1 esterase inhibitor [human] freeze dried powder (Cinryze)?
Before using C1-inhibitor, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood clots (such as in the lungs, legs).
This medication is made from human blood. Even though the blood is carefully tested and this medication goes through a special manufacturing process, there is an extremely small chance that you may get infections from the medication (for example, virus infections such as hepatitis). Consult your doctor or pharmacist for more information.
Before having surgery, tell your...
Last reviewed on RxList: 10/2/2009
This monograph has been modified to include the generic and brand name in many instances.
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