Novoeight (Turoctocog alfa) is an antihemophilic factor VIII produced via recombinant technology. This medication is generally prescribed to treat or prevent bleeding episodes in patients with hemophilia A.
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Patients with hemophilia A lack clotting factor VIII (a blood clotting protein), and Novoeight replaces the missing clotting factor VIII, thereby helping the blood to clot.
Novoeight was first approved by the US Food and Drug Administration (FDA) in February 2013 due to its effective results in one of the largest clinical trials to date.
This medication can only be obtained via a doctor’s prescription and is self-administered after training is received from a healthcare professional.
What Is Novoeight Used To Treat?
Novoeight is used to treat hemophilia A in children and adults. It is used to:
- Control bleeding episodes in hemophilia A patients
- Reduce the frequency (number) of bleeding episodes in hemophilia A patients
- Prevent bleeding during minor or major surgery in patients with hemophilia A
Novoeight cannot be used for the treatment of von Willebrand disease in patients.
How Does Novoeight Work?
In patients with hemophilia A, clotting Factor VIII is either missing or does not work properly, which causes bleeding in joints, muscles, or internal organs.
Novoeight contains an active substance, “Turoctocog alfa,” which mimics the function of naturally occurring coagulation factor VIII and helps the blood to form a clot.
The recombinant Novoeight corrects the factor VIII deficiency by replacing the missing clotting factor VIII, thereby temporarily controlling the bleeding disorder.
What Are the Available Dosage Forms and Strengths?
Novoeight is available in lyophilized powder form in a single-dose vial with the following concentrations (strengths): 250, 500, 1000, 1500, 2000, and 3000 IU per vial.
The powder is reconstituted with 4 ml of 0.9% sodium chloride solution. Each ml of reconstituted solution contains:
- 250 IU (62.5 IU/ml)
- 500 IU (125 IU/ml)
- 1,000 IU (250 IU/ml)
- 1,500 IU (375 IU/ml)
- 2,000 IU (500 IU/ml)
- 3,000 IU (750 IU/ml)
What Is the Usual Dose for Patients With Hemophilia A?
Dosing Information
The dosage of Novoeight is adjusted according to the patient’s body weight, frequency of bleeding episodes, severity of factor VIII deficiency, and the type of bleeding they are experiencing.
For Minor-To-Moderate Bleeding or Minor Surgery
Maintain a plasma factor VIII activity level of 20% – 40% of normal IU in cases of minor bleeding, such as minor muscle or oral bleeding, and 30% – 60% of normal IU in cases of moderate bleeding, such as bleeding into the oral cavity or mild head trauma. Additional units of Novoeight are given every 12 – 24 hours until the bleeding is resolved.
For minor surgery such as tooth extraction, 30% – 60% of normal IU factor VIII activity level is administered every 24 hours for at least 1 day until healing is achieved.
For Major Bleeding or Surgical Procedures:
If a patient has major bleeding, maintain a plasma factor VIII activity level of 60% – 80% of normal IU, followed by a repeat dosage given every 8 to 24 hours until bleeding has resolved.
In major surgeries like joint replacement, trauma, or tonsillectomy, 60% – 80% of normal IU factor VIII activity level is given every 8 to 24 hours until adequate wound healing is achieved.
Dosing for Routine Prophylaxis
The following are the recommended dosages of Novoeight to reduce the number (frequency) of bleeding episodes in children and adult patients with hemophilia A:
- For adults: 20 – 50 IU/kg of Novoeight three times a week or 20 – 40 IU/kg of Novoeight every other day.
- For children (under 12 years of age): 25 – 60 IU/kg of Novoeight three times a week or 25 – 50 IU/kg of Novoeight every other day.
How Is Novoeight Given?
Novoeight is given as an intravenous (via a vein) infusion (slowly over 2 to 5 minutes) directly into the bloodstream.
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What Are the Common Side Effects of Novoeight?
Along with its promising results in hemophilia A patients, Novoeight can cause some adverse effects. The most common side effects observed during clinical trials (≥ 1% of patients) are:
- Injection site reaction, such as swelling, itching, pain, or redness
- Pyrexia (high fever)
Novoeight rarely causes hypersensitivity (allergic) reactions, and in some cases, they can progress into severe anaphylaxis (including anaphylactic shock). The early signs of allergic reactions, which can progress to anaphylaxis, may include:
- Rashes or hives
- Difficulty breathing or swallowing
- Swelling of the lips and tongue
- Light-headedness
- Dizziness or loss of consciousness
- Pale and cold skin
- Fast heartbeat
- Red or swollen face or hands
If you experience these symptoms, discontinue use and consult your healthcare provider immediately to seek appropriate treatment.
An allergic reaction could occur due to Factor VIII inhibitors — a type of antibody produced by the immune system against Factor VIII. Factor VIII inhibitors stop Novoeight from working properly, which results in the loss of bleeding control.
Therefore, patients experiencing allergic reactions should be evaluated for the presence of an inhibitor.
What Precautions Should You Take While Taking Novoeight?
Always consult your healthcare provider before taking this medication. Tell your doctor if you:
- Are pregnant or planning to become pregnant
- Are breastfeeding
- Are allergic to any component of Novoeight recombinant product
- Are allergic to hamster proteins
- Are taking any medicines, including non-prescription medicines (herbal medicines) and dietary supplements
- Have tested positive for Factor VIII inhibitors
Does Novoeight Remain Stable at High Temperatures?
Yes, Novoeight has the longest duration of stability and can be stored at up to 104˚F for up to 3 months. It can also be stored for up to 12 months at 86˚F (room temperature).
After reconstitution, you can store the medication for 2 hours at 104˚F and 4 hours at up to 86˚F.
Cost
Novoeight (recombinant) intravenous powder costs around $12 for a supply of one lyophilized powder vial for injection. However, the cost can differ depending on the pharmacy you visit.
REFERENCES:
- Santagostino, E. (2014). A new recombinant factor VIII: From genetics to clinical use. Drug Design, Development and Therapy, 8, 2507-2515. https://doi.org/10.2147/DDDT.S73241
- US Food and Drug Administration (FDA). Novoeight Prescribing Information: https://www.fda.gov/media/119099/download
- European Medicine Agency (EMU). Novoeight Prescribing Information: https://www.ema.europa.eu/en/medicines/human/EPAR/novoeight#:~:text=NovoEight%20is%20a%20medicine%20used,by%20lack%20of%20factor%20VIII.
- Portability | NovoEight® (Antihemophilic Factor [Recombinant]). (n.d.). https://www.novoeight.com/why-novoeight/portability.html
- Kulkarni, R., Karim, F. A., Glamocanin, S., Janic, D., Vdovin, V., Ozelo, M., Rageliene, L., Carboni, E., Laguna, P., Dobaczewski, G., Seremetis, S., Lindblom, A., & Santagostino, E. (2013). Results from a large multinational clinical trial (guardianTM3) using prophylactic treatment with turoctocog alfa in paediatric patients with severe haemophilia A: safety, efficacy and pharmacokinetics. Haemophilia, 19(5), 698–705. https://doi.org/10.1111/hae.12165
- Lentz, S. R., Cerqueira, M., Janic, D., Kempton, C., Matytsina, I., Misgav, M., Oldenburg, J., Ozelo, M., Recht, M., Rosholm, A., Savic, A., Suzuki, T., Tiede, A., & Santagostino, E. (2016). Interim results from a large multinational extension trial (guardianTM2) using turoctocog alfa for prophylaxis and treatment of bleeding in patients with severe haemophilia A. Haemophilia, 22(5). https://doi.org/10.1111/hae.12990
