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Dose limiting toxicities of NovoSeven have not been investigated in clinical trials.
Four cases of overdose have been reported in patients with haemophilia in 16 years. The only complication reported in connection with an overdose was a slight transient increase in blood pressure in a 16-year-old patient receiving 24 mg rFVIIa instead of 5.5 mg.
No cases of overdose have been reported in patients with acquired haemophilia or Glanzmann's thrombasthenia.
In patients with factor VII deficiency, where the recommended dose is 15-30 µg/kg rFVIIa, one episode of overdose has been associated with a thrombotic event (occipital stroke) in an elderly (> 80 years) male patient treated with 10-20 times the recommended dose. In addition, the development of antibodies against NovoSeven and FVII has been associated with overdose in one patient with factor VII deficiency.
The dose schedule should not be intentionally increased above the recommended doses due to the absence of information on the additional risk that may be incurred.
