DARZALEX FASPRO®
(daratumumab and hyaluronidase-fihj)
Medical inquiries
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DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)
Medical Information
Administration of DARZALEX FASPRO – Use of a Filter
Last Updated: 05/31/2024
SUMMARY
- Use of a filter is not required for appropriate administration of DARZALEX FASPRO commercial product. However, a filter was utilized in the DARZALEX FASPRO clinical studies for all dose preparations per the investigational product preparation instructions.1
The types of filter supplies permitted and utilized in DARZALEX FASPRO clinical studies are summarized in the table: Filter Supplies Used in DARZALEX FASPRO Clinical Studies. - DARZALEX FASPRO commercial product is supplied ready to use.2
- To prepare DARZALEX FASPRO, withdraw 15 mL from the vial into a syringe.2
- After the solution of DARZALEX FASPRO is withdrawn into the syringe, replace the transfer needle with a syringe closing cap.2
- To avoid needle clogging, attach the hypodermic injection needle or subcutaneous infusion set to the syringe immediately prior to injection.2
| Type of Filter | Filter Pore Size | Filter Size | Material of Construction |
|---|---|---|---|
| Disk Filtera | 0.45 μm | 33 mm | PVDF or PES |
| 1.2 μm | 25 mm | PES | |
| 5 μm | 25 mm | PVDF or PES | |
| Filter Needle | 5 μm | 1.2 mm, 18-19 G 1-1.5” needle | Nylon |
| Filter Spike | 5 μm | 25 mm | Acrylic-copolymer membrane/nylon |
| Abbreviations: PES, polyethersulfone; PVDF, polyvinylidene fluoride.aIf a disk filter is used during preparation, attach an appropriately sized general use sterile preparation needle to the filter. | |||
PRODUCT LABELING
Please refer to the following sections of the Full Prescribing Information that are relevant to
your inquiry: DOSAGE AND ADMINISTRATION, PREPARATION AND ADMINISTRATION.
Literature Search
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References
| 1 | Data on File. Technical document Investigational Product Preparation and Administration Instructions for Filtered JNJ-54767414 for Subcutaneous Administration. Janssen Research & Development, LLC. TV-TEC-94323; 2022. |
| 2 |