"The US Food and Drug Administration (FDA) today approved asfotase alfa (Strensiq, Alexion Pharmaceuticals) as the first-ever therapy for patients who develop hypophosphatasia, a rare metabolic bone disorder, in childhood.
(Anti-Inhibitor Coagulant Complex) Vapor Heated
- Thromboembolic events have been reported during post-marketing surveillance following infusion of FEIBA, particularly following the administration of high doses and/or in patients with thrombotic risk factors.
- Monitor patients receiving FEIBA for signs and symptoms of thromboembolic events.
FEIBA (Anti-Inhibitor Coagulant Complex) is a freeze-dried sterile human plasma fraction with factor VIII inhibitor bypassing activity to be reconstituted for intravenous administration. Factor VIII inhibitor bypassing activity is expressed in arbitrary units. One unit of activity is defined as that amount of FEIBA that shortens the aPTT of high titer factor VIII inhibitor reference plasma to 50% of the blank value.
FEIBA contains mainly non-activated factors II, IX, and X and mainly activated factor VII. It contains approximately equal unitages of factor VIII inhibitor bypassing activity and prothrombin complex factors. In addition, the preparation contains 1-6 units of factor VIII coagulant antigen (FVIII C:Ag) per mL. The product contains traces of factors of the kinin generating system. It contains no heparin. Reconstituted FEIBA contains 4 mg of trisodium citrate and 8 mg of sodium chloride per mL.
FEIBA is manufactured from large pools of human plasma. Screening against potentially infectious agents begins with the donor selection process and continues throughout plasma collection and plasma preparation. Each individual plasma donation used in the manufacture of FEIBA is collected at FDA approved blood establishments and is tested by FDA licensed serological tests for Hepatitis B Surface Antigen (HBsAg), and for antibodies to Human Immunodeficiency Virus (HIV-1/HIV-2) and Hepatitis C Virus (HCV) Mini-pools of the plasma are tested and found negative for the presence of HIV-1 and HCV by FDA licensed Nucleic Acid Testing (NAT).
To reduce the risk of viral transmission, the manufacturing process of FEIBA includes two dedicated and independent virus removal/inactivation steps namely 35 nm nanofiltration and a vapor heat treatment process. In addition, the DEAE-Sephadex adsorption contributes to the virus safety profile of FEIBA.
In vitro spiking studies have been used to validate the capability of the manufacturing process to remove and inactivate viruses. Table 3 summarizes the results of the viral clearance studies for FEIBA.
Table 3 : Virus Reduction Factors (log10) During
|Virus Type||Enveloped RNA||Enveloped DNA||Non- enveloped RNA||Non- enveloped DNA|
|DEAE Sephadex Adsorption||3.2||1.8||ND||2.5||1.5||1.7||1.2|
|35 nm Nanofiltration||> 5.3||2.1||4.7||> 5.7||2.6||0.2f||1.0|
|Vapor-Heat Treatment||> 5.9||> 5.6||> 8.1||> 6.7||> 5.2||3.5||0.9†|
|Overall virus reduction factor (log10)||> 14.4||> 9.5||> 12.8||> 14.9||> 9.3||5.2||2.2|
|* Abbreviations: HIV-1, Human Immunodeficiency Virus Type
1; BVDV, Bovine Viral Diarrhea Virus (model for Hepatitis C Virus and other
lipid enveloped RNA viruses); WNV, West Nile Virus; PRV, Pseudo rabies Virus (model
for lipid enveloped DNA viruses, including Hepatitis B Virus); HAV, Hepatitis A
Virus; MMV, Mice Minute Virus (model for non-lipid enveloped DNA viruses,
including B19 virus [B19V]). ND not done
** Reduction factor for Parvovirus B19 claimed for the Vapor Heat Treatment is based on results derived from experimental infectivity and titration assays.
† Reduction factors < 1 log are not used for calculation of the overall reduction factor.
What are the possible side effects of anti-inhibitor coagulant complex (Autoplex T, Feiba NF, Feiba VH Immuno)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), feeling like you might pass out;
- fever, chills, runny nose, and drowsiness, followed by rash and joint pain about 2 weeks later;
- sudden numbness or weakness, especially on one side of the body;
What are the precautions when taking anti-inhibitor coagulant complex, vapor heated (Feiba VH)?
Last reviewed on RxList: 3/7/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Feiba VH Information
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