Novoeight® dosing guidelines.1

The required dosage can be determined using the following formula:

Formula for determing Novoeight® dosing. Body weight (kg) X Desirded Factor VIII Increase (IU/dl or % normal) X 0.5 = Dosage (IU).  Example: 50 Kg x 30 (% normal) x 0.5 = 750 IU
Formula for determing Novoeight® dosing. Body weight (kg) X Desirded Factor VIII Increase (IU/dl or % normal) X 0.5 = Dosage (IU).  Example: 50 Kg x 30 (% normal) x 0.5 = 750 IU

Refer to dosing tables below for additional guidance.

For complete dosing information please see the Prescribing Information.

Dosage and duration of treatment depend on the severity of the factor VIII deficiency on the location and extent of bleeding, and the patient’s clinical condition. Careful monitoring of replacement therapy is necessary in cases of major surgery or life-threatening bleeding episodes.

Each vial of Novoeight® contains the labeled amount of recombinant factor VIII in international units (IU). One IU of factor VIII activity corresponds to the quantity of factor VIII in one milliliter of normal human plasma. The calculation of the required dosage of factor VIII is based on the empirical nding that one IU of factor VIII per kg body weight raises the plasma factor VIII activity by two IU/dL. This relationship causes a factor of 0.5 to be present in the dose calculation formula shown above.

Base the dose and frequency of Novoeight® on the individual clinical response. Patients may vary in their pharmacokinetic and clinical responses.

Dosing guide.

Dosing for control and prevention of bleeding episodes.1

Dosing guide for control and prevention of bleeding episodes.

Type of Bleeding Episodes


Minor
Early hemarthrosis, minor muscle or oral bleeding
Factor VIII Level Required (IU/dL or % of normal): 20-40
Frequency of Doses (hours): 12-24
Duration of Therapy (days): At least 1 day until bleeding resolution is achieved


Moderate
Muscle bleeding, bleeding into the oral cavity or mild head trauma
Factor VIII Level Required (IU/dL or % of normal): 30-60
Frequency of Doses (hours): 12-24
Duration of Therapy (days): Until pain and acute disability are resolved (approximately 3-4 days)


Major
Life or limb threatening hemorrhage, Gastrointestinal bleeding, intracranial, intra-abdominal or intrathoracic bleeding, fractures
Factor VIII Level Required (IU/dL or % of normal): 60-100
Frequency of Doses (hours): 8-24
Duration of Therapy (days): Until resolution of bleed (approximately 7-10 days)

Dosing for perioperative management.1

Dosing guilde by type of surgery for perioperative management

Type of Surgery


Minor
Including tooth extraction
Factor VIII Level Required (IU/dL or % of normal): 30-60
Frequency of Doses (hours): 12
Duration of Therapy (days): At least 1 day until healing is achieved


Major
Intracranial, intra abdominal or intrathoracic, or joint replacement surgery
Factor VIII Level Required (IU/dL or % of normal): 80-100 (pre-and postoperative)
Frequency of Doses (hours): 8-24
Duration of Therapy (days): Until adequate wound healing, then continue therapy for at least 7 days to maintain a factor VIII activity of 30% to 60% (IU/dL)

Dosing for Routine Prophylaxis.1

Dosing guilde by patient population for routine prophylaxis

Patient Population


Adults and adolescents (≥ 12 years)
Factor VIII Dose Required (IU/kg): 20-50
Frequency of Doses: 3 times weekly; Factor VIII Dose Required (IU/kg): 20-40
Frequency of Doses: Every other day


Children (<12 years)
Factor VIII Dose Required (IU/kg): 25-60
Frequency of Doses: 3 times weekly; Factor VIII Dose Required (IU/kg): 25-50
Frequency of Doses: Every other day

Dosing forms and strengths.

Novoeight® is available as a white lyophilized powder in single-use vials.1 Color-coded vial caps offer easy recognition of different dose strengths.

Colored Novoeight® labels: 250 IU (Purple), 500 IU (Orange), 1000 IU (Teal), 1500 IU (Light Grey), 3000 IU (Black)

Selected Important Safety Information

Do not use in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis, to Novoeight® or its components, including hamster proteins.

Anaphylaxis and severe hypersensitivity reactions are possible. Patients may develop hypersensitivity to hamster proteins, which are present in trace amounts in the product. Should symptoms occur, discontinue Novoeight® and administer appropriate treatment.

Indications and Usage

Novoeight® (Antihemophilic Factor [Recombinant]) is indicated for use in adults and children with hemophilia A for control and prevention of bleeding, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

Novoeight® is not indicated for the treatment of von Willebrand disease.

Important Safety Information

Do not use in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis, to Novoeight® or its components, including hamster proteins.

Anaphylaxis and severe hypersensitivity reactions are possible. Patients may develop hypersensitivity to hamster proteins, which are present in trace amounts in the product. Should symptoms occur, discontinue Novoeight® and administer appropriate treatment.

Development of activity-neutralizing antibodies (inhibitors) may occur.  If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, perform an assay that measures factor VIII inhibitor concentration.

The most frequently reported adverse reactions (≥0.5%) were injection site reactions, increased hepatic enzymes, and pyrexia.

Please click here for Prescribing Information.

References

  1. Novoeight [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2016.
  2. Lentz SR, Misgav M, Ozelo M, et al. Results from a large multinational clinical trial (guardian™1) using prophylactic treatment with turoctocog alfa in adolescent and adult patients with severe haemophilia A: safety and efficacy. Haemophilia. 2013; 19:691-697.
  3. Kulkarni R, Karim FA, Glamocanin S, et al. Results from a large multinational clinical trial (guardian™3) using prophylactic treatment with turoctocog alfa in paediatric patients with severe haemophilia A: safety, efficacy and pharmacokinetics. Haemophilia. 2013; 19(5):698-705.
  4. Lentz SR, Cerqueira M, Janie D, Kempton C, et al. Interim results from a large multinational extension trial (guardian™2) using turoctocog alfa for prophylaxis and treatment of bleeding in patients with severe haemophilia A. Haemophilia. 2016;22:e445-e44