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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 finding 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)

If simple dosing is an important consideration for you and your patients, take a look at Esperoct® [anitihemophilic factor (recombinant), glycopegylated-exei], the extended half-life rFVIII treatment from Novo Nordisk. Routine prophylaxis for patients ≥12 years of age is 50 IU/kg every 4 days—no dose adjustment needed2.

It’s the same 50 IU/kg dose for perioperative dosingb and managing major bleedsc with 40 IU/kg for minor bleeds.

Please click here for Esperoct® Prescribing Information and see Important Safety Information at the bottom of the page.

This regimen may be individually adjusted to less or more frequent dosing2,a
a
Based on bleeding episodes.
bFor minor surgeries, additional dose(s) can be administered after 24 hours; for major surgeries, additional doses can be administered every 24 hours in the first week and then every 48 hours in the second week.1
c
Additional dose can be administered every 24 hours for major or life-threatening bleeding.1

Novoeight® Selected Important Safety Information

Who should not use Novoeight®?
  • You should not use Novoeight® if you are allergic to factor VIII or any of the other ingredients of Novoeight® or if you are allergic to hamster proteins
What is the most important information I need to know about Novoeight®?
  • Do not attempt to do an infusion yourself unless you have been taught how by your healthcare provider or hemophilia center
  • Call your healthcare provider right away and stop treatment if you get any of the following signs of an allergic reaction: rashes or hives, difficulty breathing or swallowing, tightness of the chest, swelling of the lips and tongue, light-headedness, dizziness or loss of consciousness, pale and cold skin, fast heartbeat, or red or swollen face or hands

What is Novoeight®?

Novoeight® (antihemophilic factor, recombinant) is an injectable medicine used to control and prevent bleeding in people with hemophilia A. Your healthcare provider may give you Novoeight when you have surgery

  • Novoeight® is not used to treat von Willebrand Disease

Important Safety Information

Who should not use Novoeight®?
  • You should not use Novoeight® if you are allergic to factor VIII or any of the other ingredients of Novoeight® or if you are allergic to hamster proteins
What is the most important information I need to know about Novoeight®?
  • Do not attempt to do an infusion yourself unless you have been taught how by your healthcare provider or hemophilia center
  • Call your healthcare provider right away and stop treatment if you get any of the following signs of an allergic reaction: rashes or hives, difficulty breathing or swallowing, tightness of the chest, swelling of the lips and tongue, light-headedness, dizziness or loss of consciousness, pale and cold skin, fast heartbeat, or red or swollen face or hands
What should I tell my healthcare provider before using Novoeight®?
  • Before taking Novoeight®, you should tell your healthcare provider if you have or have had any medical conditions, take any medicines (including non-prescription medicines and dietary supplements), are nursing, pregnant or planning to become pregnant, or have been told that you have inhibitors to factor VIII
  • Your body can make antibodies called “inhibitors” against Novoeight®, which may stop Novoeight® from working properly. Call your healthcare provider right away if your bleeding does not stop after taking Novoeight®
What are the possible side effects of Novoeight®?
  • Common side effects of Novoeight® include inhibitors in patients who were not previously treated with factor VIII products, swelling or itching at the location of injection, and fever
Please click here for Novoeight® Prescribing Information.
Novoeight® is a prescription medication.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-10881-800-FDA-1088.

 

 

Esperoct® Selected Important Safety Information

Who should not use Esperoct®?
  • You should not use Esperoct® if you are allergic to factor VIII or any of the other ingredients of Esperoct® or if you are allergic to hamster proteins
What is the most important information I need to know about Esperoct®?
  • Do not attempt to do an infusion yourself unless you have been taught how by your healthcare provider or hemophilia treatment center
  • Call your healthcare provider right away or get emergency treatment right away if you get any signs of an allergic reaction, such as: hives, chest tightness, wheezing, dizziness, difficulty breathing, and/or swelling of the face

What is Esperoct®?

Esperoct® [antihemophilic factor (recombinant), glycopegylated-exei] is an injectable medicine to treat and prevent or reduce the number of bleeding episodes in people with hemophilia A. Your healthcare provider may give you Esperoct® when you have surgery

  • Esperoct® is not used to treat von Willebrand Disease

Important Safety Information

Who should not use Esperoct®?
  • You should not use Esperoct® if you are allergic to factor VIII or any of the other ingredients of Esperoct® or if you are allergic to hamster proteins
What is the most important information I need to know about Esperoct®?
  • Do not attempt to do an infusion yourself unless you have been taught how by your healthcare provider or hemophilia treatment center
  • Call your healthcare provider right away or get emergency treatment right away if you get any signs of an allergic reaction, such as: hives, chest tightness, wheezing, dizziness, difficulty breathing, and/or swelling of the face
What should I tell my healthcare provider before using Esperoct®?
  • Before taking Esperoct®, you should tell your healthcare provider if you have or have had any medical conditions, take any medicines (including non-prescription medicines and dietary supplements), are nursing, pregnant or planning to become pregnant, or have been told that you have inhibitors to factor VIII
  • Your body can make antibodies called “inhibitors” against Esperoct®, which may stop Esperoct® from working properly. Call your healthcare provider right away if your bleeding does not stop after taking Esperoct®
What are the possible side effects of Esperoct®?
  • Common side effects of Esperoct® include rash or itching, and swelling, pain, rash or redness at the location of infusion
Please click here for Esperoct® Prescribing Information.
Esperoct® is a prescription medication.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-10881-800-FDA-1088.

References

  1. Novoeight [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2020.
  2. Esperoct [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2019.
  3. 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.
  4. 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.
  5. 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-e449.