SUMMARY  

• There are no systematically collected data to support DARZALEX FASPRO injections at injection sites alternative to those described in the approved labeling. Clinical judgment should be exercised when considering any alternative injection sites outside of those listed in the approved labeling. Janssen cannot recommend any practices, procedures, or dosing modifications that deviate from product labeling and are not approved by the regulatory agencies.
• Inject 15 mL DARZALEX FASPRO into the subcutaneous tissue of the abdomen approximately 3 inches [7.5 cm] to the right or left of the navel over approximately 3-5 minutes. Do not inject DARZALEX FASPRO at other sites of the body as no data are available.¹
• Injection sites should be rotated for successive injections.¹
• DARZALEX FASPRO should never be injected into areas where the skin is red, bruised, tender, hard or areas where there are scars.¹
• Pause or slow down delivery rate if the patient experiences pain. In the event pain is not alleviated by slowing down the injection, a second injection site may be chosen on the opposite side of the abdomen to deliver the remainder of the dose.¹

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File

databases (and/or other resources, including internal/external databases) was conducted on 23 September 2024.