Product description:
The trademark of Reptilase® was originally registered by Pentapharm in 1954 for the Active Pharmaceutical Ingredient Haemocoagulase.
Haemocoagulase is an isolated and purified snake venom enzyme system from Bothrops atrox.
It is a haemocoagulant enzyme system free of any toxic protein substances and composed of two different enzymes acting on blood coagulation:
- A thrombin like enzyme which is serine protease that cleaves Aα of fibrinogen to yield Fibrinopeptide A and Fibrin I monomer (Des A-monomer). This enzyme is not inhibited by AT III-heparin complex; inhibited by a 2-macroglobulin
- A thromboplastin like enzyme which is a metalloprotein leading to activation of FX into FXa, as soon as negatively charged phospholipids become available (at the site of a lesion). FXa converts prothrombin into thrombin which displays multiple actions on platelet aggregation, on activation of plasma factors and on fibrin formation.
Pharmacological activity:
- In vitro, Haemocoagulase causes coagulation of fibrinogen by gradually splitting off fibrinopeptide A, giving rise to des-A-fibrin monomers, which polymerise end-to-end to fibrin. In the presence of platelet factor 3 Haemocoagulase activates factor X.
- In vivo, therapeutic doses of Haemocoagulase will not initiate intravasal coagulation. The des-A-fibrin monomer produced by Haemocoagulase remains in solution because it forms a complex with native fibrinogen. Haemocoagulase accordingly promotes and accelerates the physiological processes of haemostasis. Haemocoagulase shortens the bleeding and coagulation time.
Main therapeutic applications:
Reptilase® injection leads to a shortening of the bleeding time and the coagulation time and thus used for haemostasis purposes since 1950s such as:
- Pulmonary bleeding
- Oral bleeding
- Traumatic bleeding
- Postoperative bleeding
- Other internal and external hemorrhages
API current registration status: