How to dose?

 
ELOCTA - Dosing on prophylaxis1,2 

 

For the long-term prophylaxis with ELOCTA, the recommended dose is 50 IU/kg administered every 3-5 days.1 The dose may be adjusted based on individual response in the range of 25–65 IU/kg.1

Data
  • In some cases, especially in younger patients, shorter dosing intervals or higher doses may be necessary1
  • Patients may be switched empirically with no need for extensive PK assessment2

See ELOCTA SmPC for more details on dosing:

https://www.ema.europa.eu/documents/product-information/ELOCTA-epar-product-information_en.pdf

On-demand treatment with ELOCTA1
Data

*In some patients and circumstances the dosing interval can be extended up to 36 hours.1

For the above haemorrhagic events, the FVIII activity should not fall below the given plasma activity level (in % of normal or IU/dL) in the corresponding period.1

The calculation of the required dose of rFVIII Fc is based on the empirical finding that 1 International Unit (IU) FVIII per kg body weight raises the plasma FVIII activity by 2 IU/dL. The required dose is determined using the following formula: 

Required units = body weight (kg) x desired FVIII rise (%) (IU/dL) x 0.5 (IU/kg per IU/dL) 

The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case (see section 5.2 in the ELOCTA SmPC). The time to peak activity is not expected to be delayed. 

https://www.ema.europa.eu/documents/product-information/ELOCTA-epar-product-information_en.pdf

ELOCTA - Dosing guide for surgery1
Data

For the above surgery types, the FVIII activity should not fall below the given plasma activity level (in % of normal or IU/dL) in the corresponding period.1

See ELOCTA SmPC for more details on dosing:

 https://www.ema.europa.eu/documents/product-information/ELOCTA-epar-product-information_en.pdf

FVIII, Factor VIII; IU, international units; PK, pharmacokinetics; rFVIII, recombinant Factor VIII.

References

  1. ELOCTA, Summary of Product Characteristics, 2020.

  2. Shapiro AD, Ragni MV, Kulkarni R, Oldenberg J, Srivastava A, Quon DV, et al. Recombinant factor VIII Fc fusion protein: extended interval dosing maintains low bleeding rates and correlates with von Willebrand factor levels. J Thromb Haemost. 2014 Nov;12(11):1788–800.

How to dose?

 
ELOCTA - Dosing on prophylaxis1,2 

 

For the long-term prophylaxis with ELOCTA, the recommended dose is 50 IU/kg administered every 3-5 days.1 The dose may be adjusted based on individual response in the range of 25–65 IU/kg.1

Data
  • In some cases, especially in younger patients, shorter dosing intervals or higher doses may be necessary1
  • Patients may be switched empirically with no need for extensive PK assessment2

See ELOCTA SmPC for more details on dosing:

https://www.ema.europa.eu/documents/product-information/ELOCTA-epar-product-information_en.pdf

On-demand treatment with ELOCTA1
Data

*In some patients and circumstances the dosing interval can be extended up to 36 hours.1

For the above haemorrhagic events, the FVIII activity should not fall below the given plasma activity level (in % of normal or IU/dL) in the corresponding period.1

The calculation of the required dose of rFVIII Fc is based on the empirical finding that 1 International Unit (IU) FVIII per kg body weight raises the plasma FVIII activity by 2 IU/dL. The required dose is determined using the following formula: 

Required units = body weight (kg) x desired FVIII rise (%) (IU/dL) x 0.5 (IU/kg per IU/dL) 

The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case (see section 5.2 in the ELOCTA SmPC). The time to peak activity is not expected to be delayed. 

https://www.ema.europa.eu/documents/product-information/ELOCTA-epar-product-information_en.pdf

ELOCTA - Dosing guide for surgery1
Data

For the above surgery types, the FVIII activity should not fall below the given plasma activity level (in % of normal or IU/dL) in the corresponding period.1

See ELOCTA SmPC for more details on dosing:

 https://www.ema.europa.eu/documents/product-information/ELOCTA-epar-product-information_en.pdf

FVIII, Factor VIII; IU, international units; PK, pharmacokinetics; rFVIII, recombinant Factor VIII.

References

  1. ELOCTA, Summary of Product Characteristics, 2020.

  2. Shapiro AD, Ragni MV, Kulkarni R, Oldenberg J, Srivastava A, Quon DV, et al. Recombinant factor VIII Fc fusion protein: extended interval dosing maintains low bleeding rates and correlates with von Willebrand factor levels. J Thromb Haemost. 2014 Nov;12(11):1788–800.