Factor VIIa, recombinant

Factor VIIa, recombinant is a prescription medication used for the treatment of hemophilia A and B, congenital factor VII deficiency, and Glanzmann thrombasthenia.

• Factor VIIa, recombinant is available under the following different brand names: NovoSeven RT, Sevenfact, factor VIIa recombinant-jncw

Adult and pediatric dosage

Injection, lyophilized powder for reconstitution

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

Hemophilia A or B

Adult and pediatric dosage

Bleeding episodes (NovoSeven RT)

• 90 mcg/kg IV bolus every 2 hours until hemostasis achieved  
• Range: 35-120 mcg/kg every 2 hours until hemostasis
• Post-hemostatic doses for severe bleeds: Continue with dosing every 3-6 hours after hemostasis is achieved as per clinical judgment

Bleeding episodes (Sevenfact)

Mild or moderate

• 75 mcg/kg IV every 3 hours until hemostasis achieved OR  
• 225 mcg/kg IV; if hemostasis is not achieved within 9 hours, may administer additional doses of 75 mcg/kg IV every 3 hours or as needed to achieve hemostasis  
• Consider alternant treatments if successful control of bleeding is not achieved within 24 hours of the initial dose

Severe

• 225 mcg/kg IV initially; followed if necessary 6 hr later with 75 mcg/kg IV every 2 hours until hemostasis achieved

Surgical intervention (NovoSeven RT)

• 90 mcg/kg IV immediately before the intervention, THEN every 2 hours for surgery duration
• Postsurgical dosing for minor surgery: 90 mcg/kg IV bolus every 2 hours for 48 hours, THEN every 2-6 hours until healing has occurred
• Postsurgical dosing for major surgery: 90 mcg/kg IV bolus every 2 hours for 5 days, THEN q4hr until healing has occurred

Congenital Factor VII Deficiency

Adult and pediatric dosage

NovoSeven RT only

• Bleeding episodes or surgery: 15-30 mcg/kg IV bolus every 4-6 hours until hemostasis achieved  
• Doses as low as 10 mcg/kg shown to be effective

Acquired Hemophilia

Adult dosage

NovoSeven RT only

• Bleeding episodes or surgery: 70-90 mcg/kg IV bolus every 2-3 hours until hemostasis achieved  

Glanzmann Thrombasthenia

Adult dosage

NovoSeven RT only

• Bleeding episodes: 90 mcg/kg every 2-6 hours until hemostasis achieved

Peri-operative management

• 90 mcg/kg immediately before surgery and repeat every 2 hours for the duration of the procedure
• 90 mcg/kg every 2-6 hours to prevent post-operative bleeding

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Factor VIIa, recombinant include:

• mild headache;
• joint pain;
• nausea, vomiting;
• swelling;
• mild itching or rash; or
• pain, redness, swelling, or irritation at the injection site.

Serious side effects of Factor VIIa, recombinant include:

• sudden numbness or weakness, especially on one side of the body;
• sudden severe headache,
• confusion, 
• problems with vision, speech, or balance,
• chest pain,
• sudden cough,
• wheezing, 
• rapid breathing,
• coughing up blood,
• pain, swelling, warmth, or redness in one or both legs,
• fever,
• little or no urination,
• dizziness, or
• any bleeding that will not stop.

Rare side effects of Factor VIIa, recombinant include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Factor VIIa, recombinant has no noted severe interactions with any other drugs.
• Factor VIIa, recombinant has no noted serious interactions with any other drugs.
• Factor VIIa, recombinant has no noted moderate interactions with any other drugs.
• Factor VIIa, recombinant has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

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

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Factor VIIa, recombinant?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Factor VIIa, recombinant?”

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 the development of antibodies and perform testing as clinically indicated
• Thromboembolism
  • Serious arterial and venous thrombotic reactions can occur with FVIIa
  • The risk may be further increased with a 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 the risk of serious thrombotic events

Pregnancy and Lactation

• 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