DARZALEX FASPRO®
(daratumumab and hyaluronidase-fihj)
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DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)
Medical Information
DARZALEX FASPRO - Injection Set Materials and Manufacturers
Last Updated: 10/15/2024
SUMMARY
- DARZALEX FASPRO is compatible with polypropylene or polyethylene syringe material; polypropylene, polyethylene, or polyvinyl chloride (PVC) subcutaneous infusion sets; and stainless steel transfer and injection needles.1
- Janssen Biotech, Inc. does not have a recommendation for a specific manufacturer of injection set materials to be used. Injection set materials tested for compatibility include those listed as acceptable in the product labeling.
PRODUCT LABELING
DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX+Faspro-pi.pdf
CLINICAL DATA
- In DARZALEX FASPRO clinical studies, the following injection set materials were utilized as shown in: Injection Set Materials Used in DARZALEX FASPRO Clinical Studies.2
- In DARZALEX FASPRO clinical studies, the winged infusion set was administered either unprimed or primed with DARZALEX FASPRO. The winged infusion set was not flushed once the 15 mL of DARZALEX FASPRO was administered. The fill volume per DARZALEX FASPRO vial was 16.6 mL.3
- There are no systematically collected data to support the use of 0.9% sodium chloride with DARZALEX FASPRO.3
| Product | Quantity for Unit Operation |
|---|---|
| Appropriately sized Luer-Lock syringe made of PP and/or PE | 1 |
| Appropriately sized general use sterile Luer-Lock needle for preparationa | As needed |
| Venting Needle with 0.2-micron hydrophobic vent for preparation | Optional |
| Appropriately sized general use sterile hypodermic Luer-Lock needle for subcutaneous administration (if not using a winged infusion set) | 1 |
| Appropriately sized winged infusion set for subcutaneous administration made of PP, PE, and/or PVC with less than or equal to 0.5 mL hold-up volume | Optional |
| Syringe tip cap Luer-Lock compatible | Optional |
| Abbreviations: PE, polyethylene; PP, polypropylene; PVC, polyvinyl chloride.aIf a disk filter is used during preparation, attach an appropriately sized general use sterile preparation needle to the filter. | |
- In the DARZALEX FASPRO clinical studies, 23-25G 3/8"-1" delivery needles and 23-25G winged infusion set (PVC material construction, ≤0.5 mL hold up volume, 12" tubing) was used. Clinical judgement should be exercised to choose the most appropriately sized needle as needed depending on patient presentation.4
- In the DARZALEX FASPRO clinical studies, 18G 1 ½" transfer needles were used. With DARZALEX FASPRO, 18-22G transfer needles are also acceptable. Clinical judgement should be exercised to choose the most appropriately sized needle, as needed.5
Literature Search
A literature search of MEDLINE®
References
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