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Factor VIIa, recombinant (Rx)Brand and Other Names:NovoSeven, NovoSeven RT, more...Factor VIIa, eptacog alfa, NiaStase

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

solution reconstituted

  • 1mg
  • 2mg
  • 5mg
  • 8mg
more...

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

Dosage Forms & Strengths

solution reconstituted

  • 1mg
  • 2mg
  • 5mg
  • 8mg
more...

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 

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Adverse 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

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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
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Pregnancy & 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.

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Pharmacology

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

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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

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Images

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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