A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Novoseven Side Effects, and Drug Interactions - Coagulation Factor VIIa Recombinant
Novoseven Side Effects, and Drug Interactions - Coagulation Factor VIIa Recombinant
SIDE EFFECTS
NovoSeven has been generally well tolerated in clinical studies
in 298 patients with hemophilia A or B with inhibitors treated for 1,939 bleeding
episodes. The table below lists adverse events that were reported in ³
2% of NovoSeven patients and were considered to be at least possibly related
or of unknown relationship to NovoSeven administration.
|
Body System
|
# of episodes reported
|
# of unique patients
|
|
Event
|
(n=1,939 treatments)
|
(n=298 patients)
|
|
Body as a whole
|
|
Fever
|
16
|
13
|
|
Platelets, Bleeding, and Clotting
|
|
Hemorrhage NOS
|
15
|
8
|
|
Fibrinogen plasma decreased
|
10
|
5
|
|
Skin and Musculoskeletal
|
|
Hemarthrosis
|
14
|
8
|
|
Cardiovascular
|
|
Hypertension
|
9
|
6
|
Events which were reported in 1% of patients and were considered
to be at least possibly or of unknown relationship to NovoSeven administration
were: allergic reaction, arthrosis, bradycardia, coagulation disorder, DIC,
edema, fibrinolysis increased, headache, hypotension, injection site reaction,
pain, pneumonia, prothrombin decreased, pruritus, purpura, rash, renal function
abnormal, therapeutic response decreased, and vomiting.
In the 298 hemophilia patients, thrombosis was reported in
two patients.
Serious adverse events that were probably or possibly related,
or where the relationship to NovoSeven was not specified occurred in 14 of the
298 patients (4.7%). Six of these 14 patients died of the following conditions:
worsening of chronic renal failure, anesthesia complications during proctoscopy,
renal failure complicating a retroperitoneal bleed, ruptured absess leading
to sepsis and DIC, pneumonia, and splenic hematoma and GI bleeding.
DRUG INTERACTIONS
The risk of a potential interaction between NovoSeven and coagulation
factor concentrates has not been adequately evaluated in preclinical or clinical
studies. Simultaneous use of activated prothrombin complex concentrates or prothrombin
complex concentrates should be avoided.
Although the specific drug interaction was not studied in a
clinical trial, there have been more than 50episodes of concomitant use of antifibrinolytic
therapies (i.e., tranexamic acid, aminocaproic acid) and NovoSeven.
NovoSeven should not be mixed with infusion solutions until
clinical data are available to direct this use.
top
