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

BRAND FORM. UNIT PRICE PILL IMAGE
Novoseven RT intravenous
-
8 mg (8,000 mcg) vial
Novoseven RT intravenous
-
2 mg (2,000 mcg) vial
Novoseven RT intravenous
-
1 mg (1,000 mcg) vial
Novoseven RT intravenous
-
5 mg (5,000 mcg) vial

Copyright © 2010 First DataBank, Inc.

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Patient Handout

Patient Education
coagulation factor VIIa recombinant intravenous

FACTOR VIIA, RECOMBINANT - INJECTION

(factor VIIA,ree-KOM-bin-unt)

COMMON BRAND NAME(S): Novoseven

WARNING: This medication has caused very serious blood clots (such as heart attack, stroke, pulmonary embolus-PE, deep vein thrombosis-DVT). You may be at increased risk for blood clots if you have a history of blood clots, heart/blood vessel disease, liver disease, or if you are immobile (such as being bedridden after surgery). Talk with your doctor about the risks and benefits of this medication. Get medical help right away if you develop symptoms of a blood clot, such as pain/swelling/redness/weakness of the arms or legs, calf pain/swelling that is warm to the touch, shortness of breath, coughing up blood, chest/jaw/left arm pain, sudden vision changes, weakness on one side of the body, trouble speaking, or confusion.

USES: This medication is used to treat and prevent bleeding in people with certain conditions (such as hemophilia type A or B, low levels of factor VII, Glanzmann's thrombasthenia). People with these conditions are at risk for bleeding longer after an injury/surgery and for bleeding inside the body (especially into the joints and muscles). This product contains a man-made form of factor VIIa, which is a protein (clotting factor) in the blood that works with other clotting factors to help the blood clot and stop bleeding.

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.This medication is given by injection into a vein usually over several minutes. The dose is usually repeated every 2 to 6 hours or as directed by your doctor. The dosage is based on your medical condition, weight, and response to treatment.Do not inject the mixing solution directly into the medication powder because this may cause the medication to become ineffective. Aim the syringe so that the water flows gently down the side of the vial. Do not shake the vial. Gently swirl the mixture until all the powder has dissolved. Do not mix this medication with any other drugs.If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.Tell your doctor if your condition does not improve or if it worsens.

SIDE EFFECTS: See also Warning Section.Fever, headache, pain/redness/irritation at the injection site, dizziness, nausea, or vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: swelling ankles/feet, new or worsening bleeding/bruising, new or worsening joint pain/swelling, fast/slow heartbeat, signs of kidney problems (such as change in the amount of urine).A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using factor VIIa, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: other bleeding/clotting problems (e.g., disseminated intravascular coagulation-DIC), blood vessel problems (e.g., atherosclerosis), recent serious infection in the blood, recent serious injury.Newborns may be at greater risk for blood clots while using this drug.Older adults may be at greater risk for blood clots while using this drug.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.This product should not be given at the same time as certain other clotting factor products (activated and non-activated prothrombin complex concentrates).

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.Laboratory and/or medical tests (e.g., clotting time tests, factor VII activity) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

STORAGE: Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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Formulary

FormularyPatient Discounts

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Adding plans allows you to:

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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.