NovoSeven RT

NovoSeven RT

factor viia, recombinant

Manufacturer:

Novo Nordisk
Concise Prescribing Info
Contents
Eptacog α (recombinant factor VIIa, activated)
Indications/Uses
Bleeding episodes & prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups: In patients w/ congenital haemophilia w/ inhibitors to coagulation factors VIII or IX >5 Bethesda Units (BU) or expected to have a high anamnestic response to factors VIII or IX, acquired haemophilia, congenital FVII deficiency, Glanzmann's thrombasthenia w/ Abs to GP IIb-IIIa &/or HLA & past or present refractoriness to platelet transfusions.
Dosage/Direction for Use
Haemophilia A or B w/ inhibitors or expected to have a high anamnestic response Administer initial dose of 90 mcg/kg by IV bolus inj at 2-3 hr dose interval, further inj may be given if required until haemostasis is obtained. Mild to moderate bleeding episodes 2-3 inj of 90 mcg/kg at 3 hr dose interval & 1 additional dose of 90 mcg/kg if required; or 1 inj of 270 mcg/kg. Serious bleeding episodes Initially 90 mcg/kg. The following dose varies according to the type & severity of the haemorrhage. Dosing frequency should initially be every 2nd hr until clinical improvement is observed. If continued therapy is indicated, the dose interval can then be increased to 3 hr for 1-2 days. Interval may be increased to every 4, 6, 8 or 12 hr as per indication in 2-3 wk treatment period. Invasive procedure/surgery Initially 90 mcg/kg before intervention, repeat after 2 hr, then administer at 2-3 hr dose interval for the 1st 24-48 hr. In major surgery, continue treatment at 2-4 hr interval for 6-7 days, may be increased to 6-8 hr interval for another 2 wk in a 2-3 wk treatment period until healing has occurred. Acquired haemophilia Administer initial dose of 90 mcg/kg by IV bolus inj at 2-3 hr dose interval, further inj may be given if required. Once haemostasis is achieved, interval may be increased to every 4, 6, 8 or 12 hr as long as treatment is indicated. Factor VII deficiency 15-30 mcg/kg at 4-6 hr interval until haemostasis is obtained. Glanzmann's thromboasthenia 90 mcg (range: 80-120 mcg)/kg at 2 hr (1.5-2.5 hr) interval. At least 3 doses should be given to secure effective haemostasis. Administer slowly via IV bolus inj over 2-5 min.
Contraindications
Hypersensitivity to eptacog α or to any of the excipients of NovoSeven RT or to mouse, hamster or bovine protein.
Special Precautions
Discontinue if allergic or anaphylactic-type reactions occur. Consider antihistamine IV treatment if hypersensitivity occurs. Patients w/ a history of CHD, patients post-op, or those at risk of thromboembolic phenomena or disseminated intravascular coagulation (DIC). Hospital care is mandatory if bleeding is not controlled. Monitor prothrombin time & factor VII coagulant activity in factor VII deficient patients before & after administration. Analysis for Abs should be performed if bleeding is not controlled after treatment w/ recommended doses & if factor VIIa activity fails to reach expected level. Patients w/ liver disease. Pregnancy & lactation. Neonates.
Adverse Reactions
Decreased therapeutic response, pyrexia, rash, venous thromboembolic events, pruritus, urticaria.
Drug Interactions
Concomitant use w/ prothrombin complex conc. Not recommended to combine rFVIIa & rFXIII. Limited experience in concomitant use of anti-fibrinolytics & rFVIIa.
MIMS Class
ATC Classification
B02BD08 - coagulation factor VIIa ; Belongs to the class of blood coagulation factors. Used in the treatment of hemorrhage.
Presentation/Packing
Form
NovoSeven RT powd for inj 1 mg
Packing/Price
(+ solvent in pre-filled syringe) 1's; (+ solvent in vial) 1's (Rp11,500,000.00/vial)
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in