How to use Elocta®

The safety, efficacy, and pharmacokinetics of Elocta® was evaluated in 2 multinational, open-label, pivotal studies (A-LONG and Kids A-LONG) on the following use:1,2,3

  • Prophylaxis
  • Treatment of bleeding
  • Surgery

References

1. Elocta, Summary of Product Characteristics, 2017.

2. Mahlangu J et al. Phase 3 study of recombinant factor VIII Fc fusion protein in severe hemophilia A. Blood. 2014;123(3):317-25.

3. Young G et al. Recombinant factor VIII Fc fusion protein for the prevention and treatment of bleeding in children with severe hemophilia A. J Thromb Haemost. 2015;13:967-77.

How to dose

Dosing on prophylaxis 

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

Dosing on prophylaxis 3, 4 and 5 day interval
  • 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 SmPC for more details on Elocta dosing

References

1. Elocta, Summary of Product Characteristics, 2017.

2. Shapiro AD et al. Recombinant factor VIII Fc fusion protein: extended-interval dosing maintains low beeding rates and correlates with von Willebrand factor levels. J Thromb Haemost. 2014;12:1788–800. 

On demand treatment1

On demand treatment

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

Required units = body weight (kg) x desired factor VIII 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. 

In the case of the following haemorrhagic events, the factor VIII activity should not fall below the given plasma activity level (in % of normal or IU/dL) in the corresponding period.

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

References

1. Elocta, Summary of Product Characteristics, 2017.

Dosing guide for surgery1

Table with information about different types of surgery and frequency of dosage

See Elocta SmPC for more details on dosing.

References

1. Elocta, Summary of Product Characteristics, 2017.

Instructions for use

Elocta® is administered by intravenous (IV) injection after dissolving the powder for injection with the solvent supplied in the pre-filled syringe. Elocta pack contains:

Illustration of what is included in packs

A) 1 Powder vial,  B) 3 mL Solvent in pre-filled syringe,  C) 1 Plunger rod,  D) 1 Vial adapter,  E) 1 Infusion set,  F) 2 Alcohol swabs,  G) 2 Plasters,  H) 1 Gauze pad

Elocta should not be mixed with other solutions for injection or infusion.

Preparation:

Wash your hands before opening the pack.


1. Check the name and strength of the package, to make sure it contains the correct medicine. Check the expiry date on the Elocta carton. Do not use if the medicine has expired.

2. If Elocta has been stored in a refrigerator, allow the vial of Elocta (A) and the syringe with solvent (B) to reach room temperature before use. Do not use external heat.

Remove green lid

3. Place the vial on a clean flat surface. Remove the plastic flip-top cap from the Elocta vial.

Wipe the top of the vial with one of the alcohol swabs

4. Wipe the top of the vial with one of the alcohol swabs (F) provided in the pack, and allow to air dry. Do not touch the top of the vial or allow it to touch anything else once wiped.

5. Peel back the protective paper lid from the clear plastic vial adapter (D). Do not remove the adapter from its protective cap. Do not touch the inside of the vial adapter package.

Hold the vial adapter in its protective cap and place it

6. Hold the vial adapter in its protective cap and place it squarely over the top of the vial. Press down firmly until the adapter snaps into place on top of the vial, with the adapter spike penetrating the vial stopper.

Attach the plunger rod (C) to the solvent syringe

7. Attach the plunger rod (C) to the solvent syringe by inserting the tip of the plunger rod into the opening in the syringe plunger. Turn the plunger rod firmly clockwise until it is securely seated in the syringe plunger.

Break off the white, tamper-resistant, plastic cap.

8. Break off the white, tamper-resistant, plastic cap from the solvent syringe by bending at the perforation cap until it snaps off.  Set the cap aside by placing it with the top down on a flat surface. Do not touch the inside of the cap or the syringe tip.

Lift the protective cap away from the adapter and discard.

9. Lift the protective cap away from the adapter and discard.

Connect the solvent syringe to the vial adapter

10. Connect the solvent syringe to the vial adapter by inserting the tip of the syringe into the adapter opening. Firmly push and turn the syringe clockwise until it is securely connected.

Slowly depress the plunger rod

11. Slowly depress the plunger rod to inject all the solvent into the Elocta vial.

With the syringe still connected to the adapter and the plunger rod pressed down, gently swirl the vial until the powder is dissolved

12. With the syringe still connected to the adapter and the plunger rod pressed down, gently swirl the vial until the powder is dissolved. Do not shake.

13. The final solution must be inspected visually before administration. The solution should appear clear to slightly opalescent and colourless. Do not use the solution if cloudy or contains visible particles.

Ensuring that the syringe plunger rod is still fully pressed down

14. Ensuring that the syringe plunger rod is still fully pressed down, invert the vial. Slowly pull on the plunger rod to draw back all the solution through the vial adapter into the syringe.

Detatch the syringe

15. Detach the syringe from the vial adapter by gently pulling and turning the vial counterclockwise.

Note: If you use more than one vial of Elocta per injection, each vial should be prepared separately as per the previous instructions (steps 1 to 13) and the solvent syringe should be removed, leaving the vial adapter in place. A single large luer lock syringe may be used to draw back the prepared contents of each of the individual vials.

16. Discard the vial and the adapter. 

Note: If the solution is not to be used immediately, the syringe cap should be carefully put back on the syringe tip. Do not touch the syringe tip or the inside of the cap.

After preparation, Elocta can be stored at room temperature for up to 6 hours before administration. After this time, the prepared Elocta should be discarded. Protect from direct sunlight.

References

1. Elocta, Summary of Product Characteristics, 2017.

Vial sizes and packaging

Several options to meet individual patient needs

Different options of Elocta vails

Elocta® comes as a powder in a vial together with a solvent and is available in 6 strengths: 250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU and 3000 IU.

  • Potential for single-vial dosing
  • 3-ml diluent volume for all potencies
  • Reconstruction with pre-filled syringe, needle-less transfer system and distinct vial adapter

Packaging co-created with patients, nurses and pharmacists

Elocta packaging
Elocta box open

Single box provides patients with all the materials needed for injection.

  • Small size requires less storage space
  • Components displayed in order of use
  • Fold lid for storage of components
  • QR-code with link to instructional videos in the local language
  • Capability to contain the product after use, for user discretion

References

1. Elocta, Summary of Product Characteristics, 2017.

Safety

Adverse reactions reported for Elocta1

MedDRA System Organ Class

Adverse reactions

Frequency category

Blood and lymphatic system disorders

FVIII inhibition

Uncommon (PTPs)*

Nervous system disorders

Headache

Dizziness

Dysgeusia

Uncommon

Uncommon

Uncommon

Cardiac disorders

Bradycardia

Uncommon

Vascular disorders

Hypertension

Hot flush

Angiopathy

Uncommon

Uncommon

Uncommon

Respiratory, thoracic, and mediastinal disorders

Cough

Uncommon

Gastrointestinal disorders

Abdominal pain, lower

Uncommon

Skin and subcutaneous tissue disorders

Rash

Uncommon

Musculoskeletal and connective tissue disorders

Arthralgia

Myalgia

Back pain

Joint swelling

Uncommon

Uncommon

Uncommon

Uncommon

General disorders and administration site conditions

Malaise

Chest pain

Feeling cold

Feeling hot

Uncommon

Uncommon

Uncommon

Uncommon

Injury, poisoning, and procedural complications

Procedural hypotension

Uncommon

 

See SmPC for more information on safety for Elocta. 

*Investigator term: vascular pain after injection of ELOCTA †One adult subject had a positive anti-Factor VIII antibody test result coincident with a single measurement of a neutralising antibody titre of 0.73 Bethesda Units/mL at Week 14. The neutralising antibody was not confirmed upon repeat testing 18 days later and was negative at subsequent visits. There was an increase in clearance (CL) at Week 14 that resolved with continued rFVIIIFc treatment.

References and notes

1. Elocta, Summary of Product Characteristics, 2017.

Monitoring

Elocta® factor VIII activity can be measured using routine assays and reagents1

  • Factor VIII activity measured with comparable precision and accuracy to Advate performed with existing assays and in-house plasma standards used in a clinical haemostasis laboratory

References

1. Sommer JM et al. Comparative field study evaluating the activity of recombinant factor VIII Fc fusion protein in plasma samples at clinical haemostasis laboratories. Haemophilia. 2014;20:294–300.