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Prophylaxis On-Demand Bleed Control Dosing options Clinical History Important Safety Information Abbreviated Prescribing Information
Dosing options

Flexible dosing

On demand treatment & Prophylaxis

Dosing optimisation

Administration, reconstitution and storage

Dosing that’s as individual as your patients1

Flexible dosing

BeneFIX comes in a range of vial sizes offering a flexible dosing for your patients1

BeneFIX offers frequent, flexible dosing1

BeneFIX comes in a range of vial sizes, so you can individualize factor IX coverage for your patients1
BeneFIX can be given as on-demand treatment or as prophylaxis1
                              BeneFIX offers patients storage flexibility through room temperature                                 from 2°C to 30°C1

FIX: factor IX.


  1. Benefix Egyptian Drug Authority leaflet approval date: 14/11/2021. Revision Date: November 2020.

BeneFIX can be given as on-demand treatment or as prophylaxis

On demand treatment1

The calculation of the required dose of BeneFIX can be based on the finding that one unit of factor IX activity per kg body weight is expected to increase the circulating level of factor IX, an average of 0.8 IU/dL (range from 0.4 to 1.4 IU/dL) in patients ≥12 years.1

The required dose is determined using the following formula: number of factor IX IU required = body weight (in kg) X desired factor IX increase (%) or (IU/dL) X reciprocal of observed recovery.1

The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.!

In the case of the following haemorrhagic events, the factor IX activity should not fall below the given plasma activity levels (in percentage of normal or in IU/dL) in the corresponding period. The following table can be used to guide dosing in bleeding episodes and surgery:1


Long term Prophylaxis Treatment

  • BeneFIX may be administered for long-term prophylaxis against bleeding in patients with severe haemophilia B. In a clinical study for routine secondary prophylaxis the average dose for PTPs was 40 IU/kg (range 13 to 78 IU/kg) at intervals of 3 to 4 days1                                                                                                                              
  • In some cases, especially in younger patients, shorter dosage intervals or higher doses may be necessary1
For Routine Prophylaxis (in pediatric populationa)
  • Mean dosage (± SD) for prophylaxis was 63.7 (±19.1) IU/kg at intervals of 3 to 7 days1

FIX: factor IX; IU: international unit; PTP: previously treated patient.


  1. Benefix Egyptian Drug Authority leaflet approval date: 14/11/2021. Revision Date: November 2020.

Dosing Optimisation with BeneFIX

Achieving Medicines Optimisation with BeneFIX

What is medicines optimisation and what are the benefits?

The goal of medicines optimisation is to help patients to:2

  • improve their outcomes                                                                                                                                                   
  • take their medicines correctly                                                                                                                                  
  • avoid taking unnecessary medicines                                                                                                                                                                       
  • reduce wastage of medicines                                                                                                                         
  • and improve medicines safety                                                                                                                          

How can BeneFIX allow for improved medicines optimisation?

  • Range of vial sizes1                                                                                                                                                                                                                                                                                                                                
  • Storage flexibility –can be stored at room temperature or refrigerated, from 2°C to 30°C1                                                                       
  • Shelf life – 2 years. Do not freeze1                                                                                                                                                                                     

FIX: factor IX.


  1. Benefix Egyptian Drug Authority leaflet approval date: 14/11/2021. Revision Date: November 2020.
  2. Medicines optimisation. Available at: is external). Accessed on February 2022.


BeneFIX is administered by intravenous infusion after reconstitution of the lyophilised powder for solution for injection with sterile 0.234% sodium chloride solution.

BeneFIX should be administered at a slow infusion rate. In most of the cases, an infusion rate of up to 4 mL per minute has been used. The rate of administration should be determined by the patient’s comfort level.

If any suspected hypersensitivity reaction takes place that is thought to be related to the administration of BeneFIX, the rate of infusion should be decreased or the infusion stopped.

Contents of the container1

  • A sterile vial adapter reconstitution device                                                                                                                 
  • A sterile infusion set                                                                                                                                        
  • Gauze pad, plaster, 2 alcohol swabs                                                                                                                     
  • Prefilled diluent syringe                                                                                                                                           

Special precautions for storage1

  • Store at 2°C to 30°C                                                                                                                                                  
  • Shelf life – 2 years                                                                                                                                                          
  • Do not use BeneFIX after the expiration date which is stated on the Vial label                                                           
  • Do not freeze                                                                                                                                                   
  • The reconstituted product does not contain a preservative and should be used immediately, but no longer than 3 hours after reconstitution                             

FIX: factor IX.


  1. Benefix Egyptian Drug Authority leaflet approval date: 14/11/2021. Revision Date: November 2020.
Approval No. : BV0098A2259/032022

Invalidation Date: 17/02/2025

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