Factor IX Complex - Konyne 80; Antihemophilic -Factor B
Status: approved; marketed
Organizations involved:
Talecris Biotherapeutics Inc. – Manuf.; R&D; Tech.; USA mark.
Instituto Grifols, S.A. – Parent
NPS Pharmaceuticals Inc – Former
Bayer Corp. – Former
Bayer Schering Pharma AG – Intl. mark.
Cross ref: See the Factor IX Products entry (#727) and other Factor IX product entries.
Description: Konyne 80 is a sterile lyophilized (freeze-dried) Factor IX Complex product obtained from cold ethanol fractionation of pooled human plasma containing a mixture of coagulation factors – Factors IX (antihemophilic factor B), Factor II (prothrombin), Factor X (Stuart-Prower factor), and low levels of Factor VII (proconvertin). manufacture includes heat-treatment (pasteurization; dry heat) of the lyophilized product for viral inactivation at 80˚C for 72 hours. The product is prepared from cold ethanol fractionated pooled Plasma (Human). Konyne 80 is standardized in terms of Factor IX content with each vial labeled with its Factor IX content. Konyne 80 contains no preservatives.
Konyne 80 contains approximately 50 times more Factor IX per volume than plasma, i.e., it is concentrated 50 times relative to normal human plasma. When reconsti-tuted with Sterile Water for Injection, Konyne 80 contains about 1,000 IU of Factor IX in 40 mL, or about 25 times as much Factor IX as an equal volume of plasma (an amount equal to the Factor IX in 1 L of fresh Plasma). An isotonic solution results when it is reconstituted with 20 mL Sterile Water for Injection. The dating period is 24 months from the date of manufacture when stored at 2-8˚C (refrigerated). The date of manufacture is the date of the earliest sterile filtration of the bulk product.
Nomenclature: Factor IX Complex/Talecris [BIO]; Konyne 80 [TR current; since introduction of 80˚C heat treatment]; Konyne-HT [TR; former, from launch of first heat treated product to launch of 80˚C heated product)]; Factor IX Complex [FDA]; Factors IX (Antihemophilic factor B) [SY for component]; Factor II (prothrombin) [SY for component]; Factor X (Stuart-Prower factor) [SY for component]; Factor VII (proconvertin) [SY for component]; 9001-28-9 [CAS RN]; Antihemophilic factor B [SY]; Factor IX [SY]; Christmas factor [SY]; Blood coagulation factor IX [SY]
Companies.: Konyne 80 was developed and previously manufactured by Bayer Corp., now Bayer Schering Corp. (Berkeley, CA; formerly Miles Labs.; before that Cutter Labs.), CBER/FDA est. no. 0008. It was marketed in the U.S. by Bayer Corp., and internationally by Bayer AG affiliates. In April 2005, Talecris Biotherapeutics Inc., then a subsidiary of NPS Pharmaceuticals Inc., acquired the blood/plasma products business of Bayer, including manufacturing and U.S marketing, with Bayer AG, now Bayer Schering Pharma AG, retaining international marketing.
In Feb. 2011, Instituto Grifols acquired Talecris.
FDA class: Biologic PLA
CBER class: Blood And Blood Derivatives
Approvals: Date = 19681231; first approval, PLA; Indication = for the prevention and control of bleeding caused by Factor IX deficiency due to hemophilia B
Date = 19841025; PLA supplement ref. no. 84-289; Indication = addition of a heat treatment step during manufacture (dry heat at 68˚C for 72 hr.)
Date = 19910405; PLA supplement ref. no. 90-394, ELA supplement ref. no. 90-0423; Indication = upgrade of heat treatment process to dry heat at 80˚C for 72 hours; approval also allowed complete manufacture at Clayton, NC
Indications: for the prevention and control of bleeding caused by Factor IX deficiency due to hemophilia B (Christmas disease); See other Factor IX Complex entries.
Market: Average Wholesale Price (AWP) not available (product not in 2007, 2005 or 2004 Red Book).
Medicare reimbursement for Factor IX is set at $0.71/IU for inpatient and home care, and at $0.51/IU for outpatient care. [from NHF].
Companies involvement:
Full monograph
729 Factor IX Complex/Talecris
Nomenclature:
Factor IX Complex/Talecris [BIO]
Konyne 80 [TR (current; since introduction of 80˚C heat treatment0]
Konyne-HT [NAT TR (former; from launch of first heat treated product to launch of 80˚C heate product)]
Factor IX Complex [FDA]
Factor II (prothrombin) [SY for component]
Factor IX (Antihemophilic factor B) [SY for component]
Factor VII (proconvertin) [SY for component]
Factor X (Stuart-Prower factor) [SY for component]
9001-28-9 [CAS RN]
Antihemophilic factor B [SY]
Blood coagulation factor IX [SY]
Christmas factor [SY]
Factor IX [SY]
FDA Class: Biologic PLA
Year of approval (FDA) = 1968
Date of 1st FDA approval = 19681231
(in format YYYYMMDD)
Index Terms:
antihemophilic factors
biopharmaceutical products
blood products
human materials used<!-- humansource -->
ethanol
Factor X
heat treatment (pasteurization)
lyophilized (freeze-dried)
Plasma (Human)
prothrombin, human
Sterile Water for Injection
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
EU200 Currently Approved in EU
UM001 Marketed Product in US
US200 Currently Approved in US
EM001 Marketed Product in EU
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