• Phesgo prescribing information does not provide details on administering Phesgo with a subcutaneous infusion set, such as a butterfly or winged needle. It only lists materials compatible with Phesgo.
• Phesgo was not developed to enable the use of subcutaneous infusion sets or syringe pumps. Roche cannot provide guidance on the practical use of infusion sets or pumps, and the decision to use a subcutaneous infusion set is at the discretion of the treating healthcare professionals (HCPs).
• Be aware that infusion sets can retain some of the drug product, known as hold-up volume.
• Use of an infusion set
• The only infusion set tested by Roche that fully meets the product quality and acceptable hold-up volume requirements for Phesgo is the Ypsomed mylife YpsoPump Orbit soft 6mm/60cm or 45cm.
• Use of syringe pumps
• In a technical feasibility study, Roche tested the administration of Phesgo with syringe pumps and winged infusion sets using butterfly needles. Roche found that the B. Braun Perfusor Space and Terumo Terufusion TE-SS800 syringe pumps were suitable for automated flow rate control of Phesgo without triggering the occlusion alarm. The Ypsomed mylife Ypsomed Pump Orbit soft 6mm/60cm infusion set was used with each pump.

No incompatibilities between Phesgo and polypropylene (PP), polycarbonate (PC), polyurethane (PU), polyethylene (PE), polyvinyl chloride (PVC) and fluorinated ethylene polypropylene (FEP) have been observed.[1] 

Roche has no recommendations on administering Phesgo using a butterfly or winged needle. Refer to the locally approved prescribing information for further recommendations on appropriately sized needles for the administration of Phesgo.

Roche has no recommendations on administering Phesgo with a subcutaneous infusion set.[1] The decision to use a subcutaneous infusion set is at the discretion of the treating healthcare professionals (HCPs). Refer to the locally approved prescribing information for further recommendations on appropriately sized needles for the administration of Phesgo.

In-use compatibility

The only infusion set tested by Roche that meets material compatibility with an acceptable hold-up volume requirements for Phesgo is the Ypsomed mylife YpsoPump Orbit soft 6mm/60cm or the 45cm version.[2] Using infusion sets with materials not mentioned in the Phesgo label may impact product quality and pose a potential safety risk to patients.

Hold-up volume

Infusion sets or systems can retain some of the drug product, known as hold-up volume. Phesgo vial fill volumes were not developed to enable the use of subcutaneous infusion sets. Healthcare professionals are responsible for ensuring the entire dose of Phesgo is administered to the patient.

An internal technical study assessed the hold-up volume of the Ypsomed mylife YpsoPump Orbit soft 6mm/60cm infusion set when used to administer Phesgo.[3] The study found that the Ypsomed mylife YpsoPump Orbit soft 6mm/60cm allowed delivery of the entire dose of Phesgo, after withdrawal from the vial using a syringe and transfer needle. The same set, but 45cm tubing would also be considered acceptable for Phesgo.

Roche has no recommendations regarding the administration of Phesgo with a syringe driver or pump. The decision to use a syringe driver is at the discretion of the treating healthcare professionals (HCPs).[1]

Occlusion alarm study for two electronic syringe pumps

In an experimental pressure characterisation study, Roche simulated the administration of a Phesgo 10 mL solution with two syringe drivers [4]:

• B. Braun Perfusor Space — Reference number 8713030
• Terumo Terufusion — Reference number TE-SS800EN1

Both syringe pumps were tested with Ypsomed Orbit SC infusion sets. Back pressure of the skin was not considered in the measurements, with the test simulating injection into the air. Back pressure is thought to be minimal with Phesgo due to the inclusion of recombinant human hyaluronidase. The simulation found that both syringe pumps were suitable for automated flow rate control of Phesgo while using tested infusion sets, without triggering the occlusion alarm.[4]

1. Roche Internal Regulatory Report (Phesgo CDS 5.0).
2. Roche Internal Technical Report (TEC-0172225).
3. Roche Internal Technical Report (TEC-0173596).
4. Roche Internal Technical Report (2018-363C).