Table: Post Marketing Experience
MedDRA System
Preferred Term
Organ Class
Immune system
Hypersensitivity (including anaphylactic shock,
disorders
flushing, urticaria, rash, angioedema)
Vascular disorders
Thromboembolic events (including hepatic artery
thrombosis, myocardial infarction, cerebral infarction,
intestinal infarction, intracardiac thrombus, peripheral
ischemia, portal vein thrombosis, myocardial
ischemia, renal artery thrombosis)
DRUG INTERACTIONS: Avoid simultaneous use of activated prothrombin
complex concentrates or prothrombin complex concentrates. The risk of a potential
interaction between NovoSeven ® RT and coagulation factor concentrates has not
been adequately evaluated in preclinical or clinical studies. Do not mix NovoSeven ®
RT with infusion solutions. Thrombosis may occur if NovoSeven ® RT is administered
concomitantly with Coagulation Factor XIII.
USE IN SPECIFIC POPULATIONS: Pregnancy: Pregnancy Category C. There
are no adequate and well-controlled studies in pregnant women. NovoSeven ® RT
should be used during pregnancy only if the potential benefit justifies the potential
risk to the fetus. Treatment of rats and rabbits with NovoSeven ® in reproduction
studies has been associated with mortality at doses up to 6 mg per kg body weight
and 5 mg per kg body weight respectively. At 6 mg per kg body weight in rats, the
abortion rate was 0 out of 25 litters; in rabbits at 5 mg per kg body weight, the abortion
rate was 2 out of 25 litters. Twenty-three