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

FIX: factor IX.
 

Reference:

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

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

• 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

• 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.
 

Reference:

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

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.
 

References:

1. Benefix Egyptian Drug Authority leaflet approval date: 14/11/2021. Revision Date: November 2020.
2. Medicines optimisation. Available at: https://www.england.nhs.uk/medicines-2/medicines-optimisation/(link 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.

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

• 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.
 

Reference:

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