Recent advances- Novoseven Dr S. Parthasarathy MD DA DNB PhD FICA , Dip software based statistics

What is it ? NovoSeven is recombinant human coagulation Factor VIIa (rFVIIa), intended for promoting hemostasis by activating the extrinsic pathway of the coagulation cascade structurally similar to human plasma-derived Factor VIIa.

NovoSeven is supplied as a sterile, white lyophilized powder of r FVIIa in single-use vials. 600 micro gram / ml 2 ml vials supplied

How it acts ? when complexed with tissue factor can activate coagulation Factor X to Factor Xa, coagulation Factor IX to Factor IXa. Factor Xa, in complex with other factors, then converts prothrombin to thrombin, fibrinogen to fibrin formation of a hemostatic plug

Classic description

Where does tranexamic acid acts ? Fibrinolytics

Indications

Hemophilia A and B 35 – 70 µg/kg Average of 2 – 3 doses Results of musculocutaneous joint and other bleeds significantly decreased prevention of bleeding in surgical interventions or invasive procedures in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX and in patients with acquired hemophilia

Other Indications treatment of bleeding episodes in patients with congenital FVII deficiency prevention of bleeding in surgical interventions or invasive procedures in patients with congenital FVII deficiency

Acquired hemophilia No family history Autoimmune disorder Antibodies against factors Develops hemorrhages Novoseven for acquired hemophilia

Other indications Trauma bleeds – GI bleeds Uremia with bleeds Rarely ICH TEG test – get coagulation parameters set right – One dose 80 µg/kg novoseven

Can we assess Prothrombin time – 7 second decrease apTT decrease by 15 seconds Evidence of any active clotting process started – reduce the drug dosage Clinical

Allergic Reactions Allergic rashes, increased, headache, hypotension, injection site reaction, pain, pneumonia, prothrombin decreased, pruritus, purpura, rash, renal function abnormal, therapeutic response decreased, and vomiting. Does it produce thrombosis ?? So far NO

Risks and advantages Don’t use along with prothrombin concentrates But with EACA and tranexamic acid , its ok No mutagenic, teratogenic carcinogenic potential Pregnancy – ok But pediatric use (<6)– not proved

Contra indications patients with known hypersensitivity to NovoSeven or any of the components of NovoSeven. NovoSeven is contraindicated in patients with known hypersensitivity to mouse, hamster, or bovine proteins.

Then what is the problem ? The cost is around 75000 Thank you