Factor VIIa, recombinant (Rx)

Brand and Other Names:NovoSeven RT, Sevenfact, more...factor VIIa recombinant-jncw
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 1mg (NovoSeven RT, Sevenfact)
  • 2mg (NovoSeven RT)
  • 5mg (NovoSeven RT, Sevenfact)
  • 8mg (NovoSeven RT)

Hemophilia A or B

Indicated for treatment of bleeding episodes in hemophilia A or B with inhibitors

Bleeding episodes (NovoSeven RT)

  • 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

Bleeding episodes (Sevenfact)

  • Mild or moderate
    • 75 mcg/kg IV q3hr until hemostasis achieved OR  
    • 225 mcg/kg IV; if hemostasis not achieved within 9 hr, may administer additional doses of 75 mcg/kg IV q3hr prn to achieve hemostasis  
    • Consider alternant treatments if successful control of bleeding not achieved within 24 hr of initial dose
  • Severe
    • 225 mcg/kg IV initially; followed if necessary 6 hr later with 75 mcg/kg IV q2hr until hemostasis achieved
    • Subsequent dosing: After achieving hemostasis, base decision for dosing on clinical assessment and bleeding type; consider thrombosis risk with subsequent dosing after achieving hemostatic efficacy

Surgical intervention (NovoSeven RT)

  • 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

Congenital Factor VII Deficiency

NovoSeven RT only

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

NovoSeven RT only

Bleeding episodes or surgery: 70-90 mcg/kg IV bolus q2-3hr until hemostasis achieved  

Glanzmann Thrombasthenia

NovoSeven RT only

Perioperative 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)

Orphan designation for treatment of bleeding in patients experiencing intracranial hemorrhage

Orphan sponsor

  • Novo Nordisk, Inc; 100 College Road West; Princeton, NJ 08540

Alveolar Hemorrhage (Orphan)

Orphan designation for treatment of diffuse alveolar hemorrhage

Orphan sponsor

  • PharmaOrigin ApS; Cobis Building, 2200 Copenhagen; Denmark

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

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 1mg (NovoSeven RT, Sevenfact)
  • 2mg (NovoSeven RT)
  • 5mg (NovoSeven RT, Sevenfact)
  • 8mg (NovoSeven RT)

Hemophilia A or B

Indicated for treatment of bleeding episodes in hemophilia A or B with inhibitors

NovoSeven RT is approved for all ages of children, whereas Sevenfact is approved for adolescents aged >12 yr

Bleeding episodes (NovoSeven RT)

  • 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

Bleeding episodes (Sevenfact)

  • Mild or moderate
    • 75 mcg/kg IV q3hr until hemostasis achieved OR  
    • 225 mcg/kg IV; if hemostasis not achieved within 9 hr, may administer additional doses of 75 mcg/kg IV q3hr prn to achieve hemostasis  
    • Consider alternant treatments if successful control of bleeding not achieved within 24 hr of initial dose
  • Severe
    • 225 mcg/kg IV initially; followed if necessary 6 hr later with 75 mcg/kg IV q2hr until hemostasis achievedSubsequent dosing: After achieving hemostasis, base decision for dosing on clinical assessment and bleeding type; consider thrombosis risk with subsequent dosing after achieving hemostatic efficacy

Surgical intervention

  • NovoSeven RT only
  • Indicated for prevention of bleeding in surgical interventions or invasive procedures in hemophilia 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

NovoSeven RT only

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 (Off-label)

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

1-10%

>1%

  • Headache
  • Dizziness
  • Infusion-site discomfort
  • Infusion-site hematoma
  • Infusion-related reaction
  • Fever

Frequency Not Defined

Plasma fibrinogen decreased

Hypertension

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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

Sevenfact

  • Known allergy to rabbits, rabbit proteins, or any product components; exposure can result in severe hypersensitivity reaction

Cautions

NovoSeven RT: Hypersensitivity to mouse, hamster, bovine protein, or any components of the product

Neutralizing antibodies may develop; if inadequate hemostasis occurs after dosing, suspect development of antibodies and perform testing as clinically indicated

Thromboembolism

  • Serious arterial and venous thrombotic reactions can occur with FVIIa
  • Risk may be further increased with history of congenital or acquired hemophilia receiving concomitant treatment with aPCC/PCC (activated or non-activated prothrombin complex) or other hemostatic agents; history of atherosclerotic disease, coronary artery disease, cerebrovascular disease, crush injury, septicemia, or thromboembolic event
  • Monitor for signs and symptoms
  • Consider dose reduction when laboratory confirmation is available of intravascular coagulation or presence of clinical thrombosis

Drug interaction overview

  • Simultaneous use with activated prothrombin complex concentrates or coagulation factor XIII increases risk of serious thrombotic events
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Pregnancy & Lactation

Pregnancy

There are no adequate and well-controlled studies in pregnant women to determine whether there is a drug-associated risk

Lactation

Data are not available regarding presence in human milk, effect on breastfed infants, and effects on milk production

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, which initiates the common pathway of the coagulation cascade; prothrombin is activated to thrombin, which then converts fibrinogen to fibrin to form a hemostatic plug, thereby achieving clot formation at the site of hemorrhage (hemostasis)

Pharmacokinetics

NovoSeven RT

  • Half-Life: 2.3 hr
  • Clearance: 33 mL/kg/hr
  • Vd: 103 mL/kg
  • Excretion: 33 mL/kg/hr body clearance

Sevenfact

  • Peak plasma concentration
    • 75 mcg/kg: 566.2 ng/mL
    • 225 mcg/kg: 2440.6 ng/mL
  • Clearance
    • 75 mcg/kg: 8 L/hr
    • 225 mcg/kg: 5.8 L/hr
  • AUC
    • 75 mcg/kg: 589.1 ng⋅hr/mL
    • 225 mcg/kg: 2841.2 ng⋅hr/mL
  • Half-life
    • 75 mcg/kg: 1.7 hr
    • 225 mcg/kg: 1.4 hr
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Administration

IV Administration

NovoSeven RT

  • Administer as slow IV bolus over 2-5 minutes depending on the dose administered
  • For perioperative management: 50 mcg/kg/hr by continuous infusion
  • May flush IV before or after with 0.9% NaCl

Sevenfact

  • Infuse over <2 minutes as an IV bolus
  • Do not mix with other infusion solutions

Storage

NovoSeven RT

  • Store vials of lyophilized powder under refrigeration before reconstitution
  • Reconstituted solutions may be stored at room temp or under refrigeration, but must be infused within 3 hr

Sevenfact

  • Unopened vials: Store room temperature, but can be stored between 36-86F (2-30C); protect from light and do not freeze
  • Reconstituted solution may be stored at room temperature or refrigerated, but must be infused within 4 hr; do not freeze or store in syringes
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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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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.