DARZALEX + DARZALEX FASPRO - Administration Setting

SUMMARY

• Johnson & Johnson does not recommend the use of DARZALEX for intravenous (IV) use or DARZALEX FASPRO for subcutaneous (SC) use in a manner that is inconsistent with the approved labeling.
• Among the 5 studies of DARZALEX FASPRO for SC use summarized below (COLUMBA,¹ ANDROMEDA,² PERSEUS,³ CEPHEUS,⁴ and AQUILA⁵), all doses of DARZALEX FASPRO were to be administered at outpatient visits per their clinical trial protocols.
• Among the 7 studies of DARZALEX for IV use summarized below (GEN501,⁶ SIRIUS,⁷ GRIFFIN,⁸ POLLUX,⁹ CASTOR,¹⁰ CASSIOPEIA,^11,12 and MAIA¹³), all doses of DARZALEX were to be administered at outpatient visits per their clinical trial protocols.
• Binder et al (2025)¹⁴ reported the results from an open-label, single-arm study that assessed implementation of home-based administration of DARZALEX FASPRO by a home infusion nurse for patients with multiple myeloma (MM). No significant difference was identified in the primary outcome (Satisfaction with Therapy [SWT] score) or  quality of life (QoL) when comparing home care (HC) with treatment at the infusion center. There were no barriers to home administration identified and no unique adverse events (AEs) related to home administration were reported.
• Rosenberg et al (2025)¹⁵ reported the results from a prospective, nonrandomized, single-center study that assessed home-based administration of DARZALEX FASPRO by a hematology nurse for patients with relapsed MM. On average, patients saved 177 minutes per administration given at home by a nurse (29 minutes) vs at the hospital (206 minutes).
• De Angelis et al (2023)¹⁶ presented results of DARZALEX FASPRO administered at home by a nurse or physician to frail patients with MM. Among 12 patients who were evaluable for response, 1 achieved stringent complete remission (sCR) and 4 achieved very good partial remission (VGPR), yielding an overall response rate (ORR) of 42%; furthermore, 5 patients had stable disease (SD), and 2 patients had progressive disease (PD). The main AEs that occurred during domiciliary treatment included infections (pneumonia [n=4], sepsis [n=2], cystitis [n=1]), and deep vein thrombosis (n=1). In the long-term residential accommodation (LTRA) group, 80% of patients (4/5) experienced infections, which were fatal in 3 cases. Conversely, in the HC group, 30% of patients (3/10) experienced infections, with only 1 resulting in death. At the last follow-up, 8 patients were alive (2 were awaiting a transplant procedure) and 7 patients were reported to have died (PD, n=3; infective complications, n=3; and heart disease, n=1).

PRODUCT LABELING

• DARZALEX (daratumumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX-pi.pdf 
• 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 PROTOCOLS

• Among the 5 studies of DARZALEX FASPRO for SC use summarized below, all doses of DARZALEX FASPRO were to be administered at outpatient visits per their clinical trial protocols.
  • COLUMBA (MMY3012) was a phase 3, randomized, open-label, multicenter, non-inferiority study evaluating the efficacy, pharmacokinetics, and safety of DARZALEX vs DARZALEX FASPRO in patients with relapsed or refractory multiple myeloma (RRMM).¹
    • All doses of DARZALEX or DARZALEX FASPRO were to be administered at outpatient visits.¹⁷
  • ANDROMEDA (AMY3001) was a prospective, randomized, active-controlled, multicenter, phase 3 study evaluating the efficacy and safety of DARZALEX FASPRO in combination with bortezomib, cyclophosphamide, and dexamethasone (D-VCd) compared to bortezomib, cyclophosphamide, and dexamethasone (VCd) alone in newly diagnosed patients with systemic immunoglobulin light-chain amyloidosis.²
    • All doses of DARZALEX FASPRO were performed as outpatient visits.¹⁸
  • PERSEUS (MMY3014) is an ongoing, open-label, multicenter, randomized, phase 3 study evaluating the efficacy and safety of DARZALEX FASPRO in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) vs bortezomib, lenalidomide, and dexamethasone (VRd) induction and consolidation followed by maintenance with lenalidomide and daratumumab (D-R) in D-VRd group or lenalidomide (R) in VRd group in patients with newly diagnosed multiple myeloma (NDMM) eligible for autologous stem cell transplant (ASCT).³ 
    • All injections of DARZALEX FASPRO will be administered in an outpatient setting.¹⁹  
  • CEPHEUS (MMY3019) is an ongoing, phase 3, randomized, open-label, multicenter study evaluating the efficacy and safety of DARZALEX FASPRO in combination with VRd or VRd alone in patients with NDMM who are transplant ineligible or for whom transplant is not planned as initial therapy (transplant deferred).⁴ 
    • All DARZALEX FASPRO administrations will be in an outpatient setting.²⁰ 
  • AQUILA (SMM3001) is an ongoing, phase 3, randomized, open-label, multicenter study evaluating the safety and efficacy of DARZALEX FASPRO versus active monitoring in patients with high-risk smoldering multiple myeloma (HR-SMM).⁵ 
    • All doses of DARZALEX FASPRO will be administered at outpatient visits.²¹ 
• Among the 7 studies of DARZALEX for IV use summarized below, all doses of DARZALEX were to be administered at outpatient visits per their clinical trial protocols.
  • GEN501 was an open-label, multicenter, dose-escalating (Part 1) and dose-expansion (Part 2) phase 1/2 study assessing the safety of DARZALEX monotherapy in patients with MM who had relapsed after or were refractory to ≥2 prior lines of therapy, including proteasome inhibitors (PIs), immunomodulatory agents, chemotherapy, and ASCT.⁶
    • All infusions during part 2 of the study were performed as outpatient visits.²²
  • SIRIUS (MMY2002) was an open-label, multicenter, international, phase 2 study evaluating the efficacy and safety of DARZALEX monotherapy in patients with MM who have received ≥3 prior lines of therapy, including a PI and an immunomodulatory agent, or have disease refractory to both a PI and an immunomodulatory agent.⁷
    • All infusions were performed as outpatient visits.²³
  • GRIFFIN (MMY2004) was a 2-part, open-label, multicenter, phase 2, randomized, active-controlled study in United States evaluating the safety and efficacy of DARZALEX in combination with VRd in patients with NDMM eligible for high-dose therapy and ASCT.⁸
    • All infusions were planned as outpatient visits.²⁴
  • POLLUX (MMY3003) was a randomized, open-label, multicenter, phase 3 study evaluating the safety and efficacy of lenalidomide and dexamethasone (Rd) and DARZALEX + Rd in patients with RRMM.⁹
    • All infusions could be performed as outpatient visits.²⁵
  • CASTOR (MMY3004) was a multicenter, randomized, open-label, active controlled, phase 3 study that evaluated the safety and efficacy of bortezomib and dexamethasone (Vd) alone and DARZALEX + Vd in patients with RRMM.¹⁰
    • All infusions were planned as outpatient visits.²⁶
  • CASSIOPEIA (MMY3006) was an open-label, randomized, multicenter, active-controlled study evaluating the safety and efficacy of treatment with bortezomib, thalidomide, and dexamethasone (VTd) alone and DARZALEX + VTd in patients with NDMM eligible for ASCT.^11,12
    • In MMY3006, all infusions were planned as outpatient visits.²⁷
  • MAIA (MMY3008) was an international, phase 3, randomized, open-label, active-controlled, multicenter study evaluating the safety and efficacy of DARZALEX in combination with Rd compared to Rd in transplant-ineligible patients with NDMM.¹³
    • All infusions were planned as outpatient visits.²⁸

CLINICAL DATA

Open-label Study Assessing DARZALEX FASPRO Home Administration

Binder et al (2025)¹⁴ reported results from an open-label, single-arm study assessed implementation of home-based administration of DARZALEX FASPRO by a home infusion nurse for patients with MM.

Study Design/Methods

• Key eligibility criteria: age >18 years, MM diagnosis, received DARZALEX FASPRO monthly either as monotherapy or in combination with oral agents.¹⁴
• Patients received 8 cycles of DARZALEX FASPRO (2 cycles at the infusion center, followed by 4 cycles at home and 2 cycles again at the infusion center).¹⁴
  • On the day of at-home treatment, a home infusion nurse assessed vital signs and symptoms and administered the DARZALEX FASPRO injection. No post-administration monitoring was required.
• Primary endpoint: patients’ treatment satisfaction, assessed using the SWT domain of the Cancer Therapy Satisfaction Questionnaire (CTSQ), when receiving HC vs standard-of-care treatment at the infusion center.¹⁴
• Secondary endpoints: QoL (EORTC QLG Core Questionnaire [EORTC QLQ-C30]), financial burden (COST survey), and other CTSQ domains.¹⁴
  • Surveys were completed at each monthly visit, and semistructured qualitative interviews were conducted at the end of the study.

Results

• From December 2022 to April 2024, 20 patients (mean age, 66 years [range, 49-89]) who were receiving DARZALEX FASPRO monthly as either monotherapy or in combination with oral agents for MM were included in the study.¹⁴
  • Ten patients (50%) were female, and 10 patients (50%) identified as Black or African American.
  • One patient withdrew from the trial after cycle 2, and 1 patient came off the trial for cycle 8 after significant treatment delays due to infectious complications.
  • Nineteen patients completed the home infusion portion of the study.
• No significant difference in satisfaction with treatment assessed by CTSQ-SWT was identified when comparing HC vs treatment at the infusion center (mean difference, 0.70; 95% confidence interval [CI], -3.02 to 1.62; P=0.551).¹⁴
  • Feelings about side effects, another variable in the CTSQ, was similar between HC and treatment at the infusion center (mean difference, -1.81; 95% CI, -5.66 to 2.04; P=0.353).
• For EORTC-QLQ30, global QoL was similar between sites of care (mean difference, -3.21; 95% CI, -8.13 to 1.70; P=0.198).¹⁴
  • The EORTC-QLQ30 Physical Functioning score was worse for the HC vs infusion center administration (mean difference, -5.72; 95% CI, -9.81 to -1.62; P=0.007).
  • The EORTC-QLQ30 Emotional Functioning score was similar between sites of care for all participants; post-hoc analysis demonstrated improvement for African American patients compared to Caucasian patients (mean difference, 9.14 [P=0.10]).
• Females reported a significantly higher financial toxicity compared to males (FACIT-COST score, 7.37 points [P=0.026]).¹⁴
• No barriers to home administration were identified and there were no unique AEs related to home administration.¹⁴

Prospective Study Assessing Home-Based Administration of DARZALEX FASPRO

Rosenberg et al (2025)¹⁵ reported the results from a prospective, nonrandomized, single-center study that assessed home-based administration of DARZALEX FASPRO by a hematology nurse for patients with relapsed MM.

Study Design/Methods

• Key eligibility criteria: age ≥ 18 years, relapsed MM receiving DARZALEX FASPRO, able to receive treatment at the hospital or at home or a local healthcare clinic.¹⁵
• Eligible patients were included in one of two groups¹⁵:
  • New on DARZALEX FASPRO: first 2 treatments of cycle 1 day 1 (C1D1), cycle 1 day 8 (C1D8), cycle 2 day 1 (C1D1), and day 1 of cycles 3-6 were all administered in the hospital; all other administrations took place at home or a healthcare clinic.
  • Ongoing DARZALEX FASPRO (previously completed at least 6 cycles): cycles 1, 4, and 7 administered in the hospital and cycles 2, 3, 5, and 6 administered at home or a healthcare clinic.
• Patients completed a custom-built questionnaire after exiting the study and hematology nurses recorded demographic information, treatment adherence, and time spent on treatment days.¹⁵

Results

• A total of 30 patients (median age, 78 years [range, 61-87]) were enrolled between March 2022 and June 2023.¹⁵
  • Eighteen patients (60%) were male, 12 patients (40%) were new on DARZALEX FASPRO, and 16 patients (54%) were on DARZALEX FASPRO monotherapy.  
• Of the 269 planned DARZALEX FASPRO administrations, 255 were given (84.8%).¹⁵
  • Of the 125 hospital-planned administrations, 122 (97.6%) were given and 3 were cancelled due to infection (n=2) and disease progression (n=1).
  • Of the 144 home or clinic administrations, 133 (92.4%) were given as planned, 6 were redirected and given at the hospital (2 due to suspicion of infection and 4 for administrative reasons), and 5 were cancelled due to infection (n=3) and nausea and diarrhea (n=2).
• On average, patients saved 177 minutes per administration given at home (29 minutes [range, 5-120]) vs the hospital (206 minutes [range, 135-345]).¹⁵
  • When deducting time for transportation to the hospital (104 minutes [range, 35-258]), time spent for patients treated at home was reduced by a factor of 3.5.
• Hematology nurses spent an average of 3 additional minutes on each administration at home vs at the hospital.¹⁵
• The number of unplanned health contacts did not differ significantly between home/clinic and hospital administrations.¹⁵
• Overall, 84% of patients preferred to continue with home treatment after the study.¹⁵
• Based on the qualitative analysis, home treatment was not preferable for all patients, as some found staying at home waiting for the treatment to be delivered and for the primary care nurse to be bothersome.¹⁵

Study of DARZALEX FASPRO Home Administration in Frail Patients

De Angelis et al (2023)¹⁶ presented results of a study of DARZALEX/DARZALEX FASPRO administered by a nurse or physician to frail patients with MM in an outpatient setting.

Results

Baseline Patient Characteristics

• Per the MyelHome project, 15 patients with MM were treated as outpatients. Of these, 10 received HC and 5 received care in LTRA.¹⁶
• Patients received 2 initial doses of either DARZALEX or DARZALEX FASPRO at a hospital to mitigate side effects and received subsequent doses as outpatients. The first outpatient dose was administered by both a nurse and a physician, whereas subsequent doses were administered by nurses only.¹⁶
• Overall, 110 administrations of DARZALEX FASPRO were performed by Domiciliary Hematologic Care Unit nurses in an outpatient setting.¹⁶
• Baseline patient characteristics are summarized in Table: Baseline Characteristics (MyelHome Project).

Efficacy

• Among 12 patients who were evaluable for response, 1 achieved sCR and 4 achieved VGPR (ORR, 42%); furthermore, 5 and 2 patients had SD and PD, respectively.¹⁶

Safety

• During and/or immediately following home administration, 1 patient experienced a grade 2 allergic reaction (per World Health Organization classification); thus, DARZALEX FASPRO was permanently discontinued after the second dose was administered.¹⁶
• The main AEs that occurred during domiciliary treatment included infections (pneumonia [n=4], sepsis [n=2], cystitis [n=1]), and deep vein thrombosis (n=1).¹⁶
• In the LTRA group, 80% of patients (4/5) experienced infections, which were fatal in 3 cases. Conversely, in the HC group, 30% of patients (3/10) experienced infections, with only 1 resulting in death.¹⁶
• At the last follow-up, 8 patients were alive (2 of whom were awaiting a transplant procedure) and 7 patients were reported to have died (PD, n=3; infective complications, n=3; and heart disease, n=1).¹⁶

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 20 March 2026 pertaining to this topic.