Factor VIIa, recombinant (NovoSeven, NovoSeven RT, Factor VIIa, eptacog alfa, NiaStase)
Classes: Hemostatics; Coagulation Factors
Dosing and uses of NovoSeven, NovoSeven RT (Factor VIIa, recombinant)
Adult dosage forms and strengths
solution reconstituted
- 1mg
- 2mg
- 5mg
- 8mg
Hemophilia A or B
Bleeding episodes
- Indicated for treatment of bleeding episodes in hemohilia A or B with inhibitors
- 90 mcg/kg IV bolus q2hr until hemostasis achieved
- Range: 35-120 mcg/kg q2hr until hemostasis
- Post-hemostatic doses for severe bleeds: Continue with dosing q3-6hr after hemostasis achieved as per clinical judgment
Surgical intervention
- Indicated for prevention of bleeding in surgical interventions or invasive procedures in hemophilia A or B with inhibitors and in acquired hemophilia
- 90 mcg/kg IV immediately before intervention, THEN q2hr for surgery duration
- Postsurgical dosing for minor surgery: 90 mcg/kg IV bolus q2h for 48 hr, THEN q2-6 hr until healing has occurred
- Postsurgical dosing for major surgery: 90 mcg/kg IV bolus q2hr for 5 days, THEN q4hr until healing has occurred
Long-acting Factor VIIa-CTP (Orphan)
- Orphan designation for hemophilia A or B with inhibitors to Factor VIII or Factor IX
- This product may be administered SC or IV; SC administration has a longer duration of action and allows for self-administration for prophylaxis
- Sponsor: OPKO Health, Inc
Congenital Factor VII Deficiency
Bleeding episodes or surgery: 15-30 mcg/kg IV bolus q4-6hr until hemostasis achieved
Doses as low as 10 mcg/kg shown to be effective
Acquired Hemophilia
Bleeding episodes or surgery: 70-90 mcg/kg IV bolus q2-3hr until hemostasis achieved
Glanzmann's Thrombasthenia
Peri-operative management of bleeding episodes in patients with Glanzmann's thrombasthenia with refractoriness to platelet transfusions with or without antibodies to platelets
Bleeding episodes: 90 mcg/kg q2-6hr until hemostasis achieved
Peri-operative management
- 90 mcg/kg immediately before surgery and repeat q2hr for duration of procedure
- 90 mcg/kg q2-6hr to prevent post-operative bleeding
Intracranial Hemorrhage (Orphan)
Treatment of bleeding in patients experiencing intracranial hemorrhage
Orphan indication sponsor
- Novo Nordisk, Inc; 100 College Road West; Princeton, NJ 08540
Alveolar Hemorrhage (Orphan)
Treatment of diffuse alveolar hemorrhage
Orphan indication sponsor
- PharmaOrigin ApS; Cobis Building, 2200 Copenhagen; Denmark
Pediatric dosage forms and strengths
solution reconstituted
- 1mg
- 2mg
- 5mg
- 8mg
Hemophilia A or B
Bleeding episodes
- Indicated for treatment of bleeding episodes in hemohilia A or B with inhibitors
- As for adults; dosing based on body weight, not age 90 mcg/kg IV bolus q2hr until hemostasis achieved
- Range: 35-120 mcg/kg q2hr until hemostasis
- Post-hemostatic doses for severe bleeds: Continue with dosing q3-6hr after hemostasis achieved as per clinical judgment
Surgical intervention
- Indicated for prevention of bleeding in surgical interventions or invasive procedures in hiemophilia A or B with inhibitors and in acquired hemophilia
- As for adults; dosing based on body weight, not age 90 mcg/kg IV immediately before intervention, THEN q2hr for surgery duration
- Postsurgical dosing for minor surgery: 90 mcg/kg IV bolus q2h for 48 hr, THEN q2-6 hr until healing has occurred
- Postsurgical dosing for major surgery: 90 mcg/kg IV bolus q2hr for 5 days, THEN q4hr until healing has occurred
Congenital Factor VII Deficiency
As for adults; dosing based on body weight, not age
Bleeding episodes or surgery: 15-30 mcg/kg IV bolus q4-6hr until hemostasis achieved
Doses as low as 10 mcg/kg shown to be effective
Acquired Hemophilia
As for adults; dosing based on body weight, not age
Bleeding episodes or surgery: 70-90 mcg/kg IV bolus q2-3hr until hemostasis achieved
NovoSeven, NovoSeven RT (Factor VIIa, recombinant) adverse (side) effects
>10%
Fever (16%)
Hemorrhage (15%)
Hemarthrosis (14%)
1-10%
Decreased fibrinogen (10%)
Hypertension (9%)
<1%
Headache
Hypotension
Bradycardia
Edema
Vomiting
Decreased prothrombin
DIC
Hypersensitivity
Injection site pain
Rash
Arthrosis
Renal function abnormalities
Warnings
Black box warnings
Serious arterial and venous thrombotic and thromboembolic events following administration reported
Discuss risks and explain signs and symptoms of thromboembolic events with patients
Monitor for signs or symptoms of activation of the coagulation system and for thrombosis
Contraindications
None provided in the FDA-approved labeling
Cautions
Hypersensitivity to mouse, hamster, bovine protein, or any components of the product
Factor VII deficient patients should be monitored for prothrombin time (PT) and factor VII coagulant activity before and after administration
Aterial thromboembolism
- Thrombotic events of possible or probable relationship to Factor VIIa therapy occurred in 0.28% of bleeding episodes treated in clinical trials within the approved indications
- Increased risk of arterial thromboembolic adverse events was demonstrated in 2 meta-analyses of placebo-controlled clinical trials in populations outside the approved indications
- Thrombosis has occurred in women treated with Factor VIIa to control postpartum hemorrhage
Pregnancy and lactation
Pregnancy category: C
Lactation: Not known if excreted in breast milk; not recommended
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of NovoSeven, NovoSeven RT (Factor VIIa, recombinant)
Mechanism of action
Activates conversion of Factor X to Factor Xa, & Factor IX to Factor IXa
Pharmacokinetics
Half-Life: 2.3 hr
Clearance: 33 mL/kg/hr
Vd: 103 mL/kg
Excretion: 33 mL/kg/hr body clearance
Administration
IV Administration
Reconstitute only with the specified volume of SWI
Administer within 3 hr after reconstitution
Storage
NovoSeven & NovoSevenRT: Store under refrigeration before reconstitution
NovoSevenRT: Reconstituted solutions may be stored at room temp or under refrigeration, but must be infused within 3 hr
