NovoSeven (Recombinant Coagulation Factor VIIa) – Hemophilia A | DengYue

NovoSeven Application Scope

NovoSeven (NovoSeven RT) is a recombinant activated human coagulation Factor VIIa used to treat and prevent bleeding in specific bleeding disorders.

Characteristics

• Ingredients: Recombinant Coagulation Factor VIIa (rFVIIa, eptacog alfa)

• Properties:

  • A sterile, white lyophilized powder for reconstitution

  • The reconstituted solution is clear, colorless, and approximately. 1 mg/mL with pH ~6.0

• Packaging Specification:

  • Single-use vials of 1, 2, 5

  • 8 mg rFVIIa with corresponding volumes of histidine diluent supplied either as a vial or a pre-filled syringe

• Storage:

  • Store below 25 °C, do not freeze, protect from light.

  • Do not store reconstituted solution in syringes.

  • Use within 3 hours of reconstitution

• Expiry Date: Printed on carton, vial, diluent; refers to last day of the stated month

• Executive Standard:

  • Meets FDA and EMA standards per US prescribing info

  • European summary of product characteristics

• Approval Number: FDA marketing approval: March 25, 1999 (initial), and July 7, 2014 for RT formulation

• Date of Revision: Latest US prescribing information revision, July 2020

• Manufacturer:

  • Novo Nordisk A/S (Bagsværd, Denmark)

  • Marketed by Novo Nordisk Inc.

  • Plainsboro, NJ, USA.

Guidelines for the Use of NovoSeven

• Dosage and Administration:

  • Hemophilia A/B with inhibitors:

    • 90 µg/kg IV every 2 h until hemostasis; after hemostasis, 90 µg/kg every 3–6 h

  • Acquired hemophilia: 70–90 µg/kg IV every 2–3 h until hemostasis

  • Congenital FVII deficiency: 15–30 µg/kg every 4–6 h until bleeding stops

  • Glanzmann’s thrombasthenia: 90 µg/kg every 2–6 h until hemostasis

  • Perioperative use:

    • similar dosing immediately before and during surgery: minor bleeding – every 2 h

  • Major – continued intensive dosing for up to 5 days

 

• Adverse Reactions:

  • Most significant:

    • thrombotic events—occurring in 4% of acquired hemophilia and 0.2% in congenital hemophilia cases

  • Also reports of fever, hypertension, headache, nausea, hypersensitivity

• Contraindications: None known; discontinue if allergic/anaphylactic reaction occurs

• Precautions: 

  • Monitor for signs of thrombosis, hypersensitivity risks.
  • Avoid mixing with other infused medications.
  • Careful with patients having cardiovascular disease or using certain concentrates

NovoSeven Interactions

• Drug Interactions:

  • Avoid activated or non-activated prothrombin complex concentrates (aPCC)

  • Avoid simultaneous use with Factor XIII; do not mix with other infusion solutions

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
• It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.