Kabikinase
Status: marketed internationally, not in U.S.
Organizations involved:
Octapharma AB – Manuf.; R&D; Tech.; Intl. mark.
Pharmacia Corp. – Former
Kabivitrum AB – R&D; Tech.; Former
Pharmacia & Upjohn AB – Former
Pharmacia AB – Former
Upjohn Co. – Former
Biovitrum AB – Former
Cross ref: See the entries for Streptokinase Products (#623) and Fibrinolytic and Thrombolytic Enzymes (#613). See also Streptokinase from Astra (#624).
Description: Kabikinase is a lyophilized (freeze-dried) formulation of streptokinase purified from fermentation (culture) of group C beta-homolytic Streptococci bacteria.
Kabikinase is packaged in 8 mL vials containing 250,000 or 750,000 I.U. and in 10 mL vials containing 1,500,000 IU (1.5 MIU) for intravenous or intracoronary infusion. Kabiki-nase also contains 11.0 mg sodium L-glutamate and 14.5 mg Albumin (Human) as stabilizers, with no preservatives. The dating period is two years at room temperature. The product is reconstituted with 10 mL Sodium Chloride Injection, USP.
Nomenclature: Streptokinase/Octapharma [BIO]; Kabikinase [TR]; streptokinase [FDA]; 81669-57-0 [CAS RN]; 9002-01-1 [CAS RN]; Anistreplase [SY]; NDC 00016-8025-2; 00016-8026-2; 00016-8027-2 [NDC]
Companies.: Kabikinase was developed (and is still manufactured for international markets) originally by Kabi-Vitrum AB, which became Pharmacia AB, later Pharmacia & Upjohn AB (FDA CBER est. no. 1220), later Biovitrum AB, with the product now manufactured by Octapharma AG. CBER/FDA last listed the license holder as Pharmacia & Upjohn AB. Kabikinase was formerly marketed in the U.S. by Upjohn Co., later Pharmacia & Upjohn, then Pharmacia Corp. (now merged into Pfizer). Octapharma markets the product internationally.
Manufacture: Beta-hemolytic streptococci (confirmed by microscopic examination and hemolytic capacity) from a seed stock are cultured in sterile nutrient broth at constant temperature and pH. When peak streptokinase concentration (> 600 units/µg protein) is obtained in the media, fermentation is stopped, and the bacteria removed by sterile filtration. Streptokinase is purified from the culture media by adsorption, precipitation, and chromatography techniques. Final formulation consists of mixing the streptokinase with sodium phosphate buffer, sodium glutamate, and normal serum albumin. This solution is sterile filtered, tested for potency, filled (20% overfill), and lyophilized (freeze-dried) in final containers.
The final product, prior to adding the stabilizing agents, is tested for potency (streptokinase enzyme activity) as well as for conta-minating streptococcal enzymes – hemolysin and strepto-dornase. The final product is tested for Albumin (Human), sterility, general safety, pyrogens, moisture, pH, and clarity of solution.
FDA class: Biologic PLA
CBER to CDER: Among the products transferred within FDA on June 30, 2003
Approvals: Date = 19591020; first approval, PLA; granted to KabiVitrum AB
Date = 19780725; PLA supplement, ref. 71-12; Indication = addition of use by intravenous injection
Date = 19820809; PLA supplement, ref. 82-183; Indication = lysis of thrombi obstructing coronary arteries associated with evolving transmural myocardial infarction
Date = 19871105; PLA supplement, ref. no, 86-0219; Indication = for management of myocardial infarction in adults when administered by intravenous route
Date = 19900706; PLA supplement, ref. 87-0578; Indication = inclusion of statement in product insert/labeling regarding the reduction of infarct size and the reduction in the incidence of heart failure
Date = 19911001; license revoked from KabiVitrum and granted (reissued) to Kabi Pharmacia AB
Date = 19950607; license revoked from Kabi Pharmacia AB and granted (reissued) to Pharmacia AB
Date = 19970211; license revoked from Pharmacia AB and granted (reissued) to Pharmacia & Upjohn AB
Indications: [from product insert/labeling]:
for management of acute myocardial infarction (AMI) in adults, for the lysis of thrombi obstructing coronary arteries, the reduction of infarct size, the improvement of ventricular function following AMI, and the reduction of mortality associated with AMI
Status: Kabikinase is no longer approved or marketed in the U.S. The product and, apparently, its manufacturing facilities have been acquired by Octapharma AB, which continues to manufacture it for international markets.
No centralized EU approval - country-by-country in Europe.
Tech. transfer: Patent filings related to Kabikinase include WO 9009439, EP 408734, and EP 0382696, “A Method for Cleansing Streptokinases,” filed on Feb. 2, 1990, assigned to Kabivitrum AB. These describe purification of streptokinase by chromatography using a matrix of hydrophobic ligands and elution of the protein from the gel.
Companies involvement:
Full monograph
625 Streptokinase/Octapharma
Nomenclature:
Streptokinase/Octapharma [BIO]
Kabikinase [TR]
Streptokinase [FDA]
81669-57-0 [CAS RN]
9002-01-1 [CAS RN]
Anistreplase [SY]
NDC 00016-8025-2; 00016-8026-2; 00016-8027-2 [NUM NDC (for 250,000; 600,00 and 750,000 IU vials)]
FDA Class: Biologic PLA
Year of approval (FDA) = 1959
Date of 1st FDA approval = 19591020
(in format YYYYMMDD)
Index Terms:
biopharmaceutical products
enzymes
enzymes, fibrinolytic/thrombolytic
human materials used<!-- humansource -->
bacterial culture <!-- bacterialculture -->
Streptococcus, group C beta-hemolytic
Albumin (Human)
lyophilized (freeze-dried)
sodium glutamate
sodium phosphate
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
North American coral snake
EU200 Currently Approved in EU
UM999 Not Available/Not Marketed in US
US011 Approved Formerly in US/withdrawn
EM001 Marketed Product in EU
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