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Recent advances- Novoseven

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

2 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.

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

4 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

5 Classic description

6 Where does tranexamic acid acts ?
Fibrinolytics

7 Indications

8 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

9 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

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

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

12 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

13 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

14 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

15 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.

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


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