Transcript Recent advances- Novoseven mgmc

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 ?
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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 ?
Tranexamic acid
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
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No family history
Autoimmune disorder
Antibodies against factors
Develops hemorrhages
• Novoseven for acquired hemophilia
Other indications
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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