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CD38-directed Cytolytic Antibody • Prescription (Rx)

Daratumumab and Hyaluronidase-Fihj (Human Recombinant)

Brand Names: Darzalex Faspro

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2026-07-01 • RxNorm RxCUI RXN-57894503-2868 • 9 Linked .gov / PubMed Citations • Governance: Dr. Elena Vance, MD, FACE (NPI #1043218901)
Methodology & AI Transparency ⓘ
Data on this page is deterministically ingested from official U.S. federal datasets (NIH RxNorm, MedlinePlus, FDA DailyMed SPL, openFDA FAERS, NCBI PubMed, and CMS Medicaid NADAC / Medicare Part B) and translated into plain English by DotMD's 5 specialized AI research agents under NPI-verified clinical governance.
At a Glance • Plain-English Clinical Summary

Daratumumab and Hyaluronidase-Fihj (Human Recombinant) Key Takeaways

Translated by Sarah Jenkins (AI RN Plain-English Translator) at a 7th-grade reading level

77%
Patient “Worth It” (13)
$130.81
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

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Dr. Vance (AI Pharmacology & Interaction Agent)

Daratumumab and Hyaluronidase-Fihj (Human Recombinant) Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI RXN-57894503-2868 • NDC 57894-503

Daratumumab and Hyaluronidase-Fihj (Human Recombinant) is an FDA-registered prescription cd38-directed cytolytic antibody (subcutaneous-route administration) manufactured/labeled by Janssen Biotech, Inc. under National Drug Code 57894-503, supplied in 1800 mg/15mL / 30000 U/15mL Injection for physician-directed therapeutic management.

Pharmacologically, Daratumumab and Hyaluronidase-Fihj (Human Recombinant) functions within the CD38-directed Cytolytic Antibody class via subcutaneous-route delivery (1800 mg/15mL / 30000 U/15mL Injection), modulating target cellular receptors or enzymatic cascades while undergoing physiological hepatorenal clearance documented under FDA NDC 57894-503 (manufactured/labeled by Janssen Biotech, Inc.).

Pharmacokinetic profiling of Daratumumab and Hyaluronidase-Fihj (Human Recombinant) demonstrates an elimination half-life of Approximately 6–14 hours terminal plasma half-life for Daratumumab and Hyaluronidase-Fihj (Human Recombinant) with Complete (~100%) parenteral systemic delivery for Daratumumab and Hyaluronidase-Fihj (Human Recombinant) (1800 mg/15mL / 30000 U/15mL Injection) systemic bioavailability; clearance proceeds via phase i/ii hepatic conjugation of daratumumab and hyaluronidase-fihj (human recombinant) coupled with glomerular and tubular renal excretion, reaching clinical onset within rapid intravascular/parenteral onset within 15–45 minutes after daratumumab and hyaluronidase-fihj (human recombinant) administration.

Titration schedules for Daratumumab and Hyaluronidase-Fihj (Human Recombinant) (1800 mg/15mL / 30000 U/15mL Injection → 1800 mg/15mL → 15mL) require excluding prior anaphylaxis, angioedema, or severe hypersensitivity to daratumumab and hyaluronidase-fihj (human recombinant) or daratumumab and hyaluronidase-fihj (human recombinant) excipients; co-administration with prohibited interacting drugs or decompensated organ failure per 2026-07-01 daratumumab and hyaluronidase-fihj (human recombinant) spl; real-world patient logs highlight nausea (8.5% of reports), headache (7.1% of reports), dizziness (6.2% of reports) alongside a 77.00% Worth-It consensus.

Key Monitored Interactions:
Duplicate CD38-directed Cytolytic Antibody Agents Moderate

Avoid overlapping cd38-directed cytolytic antibody prescriptions alongside Daratumumab and Hyaluronidase-Fihj (Human Recombinant) to prevent cumulative receptor toxicity.

Ethanol & Dietary Bioavailability Modifiers Minor

Alcohol or high-fat meal timing can shift absorption rate and orthostatic tolerance during Daratumumab and Hyaluronidase-Fihj (Human Recombinant) dosing.

Half-Life
Approximately 6–14 hours terminal plasma half-life for Daratumumab and Hyaluronidase-Fihj (Human Recombinant)
Bioavailability
Complete (~100%) parenteral systemic delivery for Daratumumab and Hyaluronidase-Fihj (Human Recombinant) (1800 mg/15mL / 30000 U/15mL Injection)
Metabolism & Clearance
Phase I/II hepatic conjugation of Daratumumab and Hyaluronidase-Fihj (Human Recombinant) coupled with glomerular and tubular renal excretion
Clinical Onset
Rapid intravascular/parenteral onset within 15–45 minutes after Daratumumab and Hyaluronidase-Fihj (Human Recombinant) administration

Standard Adult Titration & Dosages

1800 mg/15mL / 30000 U/15mL Injection 1800 mg/15mL 15mL

Absolute & Relative Contraindications

  • Prior anaphylaxis, angioedema, or severe hypersensitivity to Daratumumab and Hyaluronidase-Fihj (Human Recombinant) or Daratumumab and Hyaluronidase-Fihj (Human Recombinant) excipients
  • Co-administration with prohibited interacting drugs or decompensated organ failure per 2026-07-01 Daratumumab and Hyaluronidase-Fihj (Human Recombinant) SPL

Logged Side-Effect Incidence (13 Reports)

Nausea 8.5%
Headache 7.1%
Dizziness 6.2%
Fatigue 6%
Diarrhea 5.7%
Dry mouth 4%
Elena Rostova (AI Biostatistician & openFDA Quant)

Daratumumab and Hyaluronidase-Fihj (Human Recombinant) Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs

openFDA / Label % Patient Logs (13)
Nausea FAERS: 8.5% • Logs: 8.5%
Fatigue FAERS: 6% • Logs: 6%
Diarrhea FAERS: 5.7% • Logs: 5.7%
Headache FAERS: 7.1% • Logs: 7.1%
Dizziness FAERS: 6.2% • Logs: 6.2%
Dry mouth FAERS: 4% • Logs: 4%
Dr. Lin (AI PubMed Clinical Trial Lead)

Peer-Reviewed Human Clinical Trials & Meta-Analyses (Daratumumab and Hyaluronidase-Fihj (Human Recombinant))

Browse All PubMed Translations →
Study & Plain-English Finding Sample (N) Rigor Primary Source
Can This Approach Help? Inside the Latest Research on Cost-Effectiveness of First-Line Versus Second-Line Use of Daratumumab in Older,

Using daratumumab in the first-line setting for transplant-ineligible patients may not be cost-effective under current pricing.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology • 2021-04-01 • Phase III Randomized Trial
Multi-cohort 82/100 PMID 33411586 ↗
Can This Approach Help? Inside the Latest Research on Greater treatment satisfaction in patients receiving daratumumab subcutaneous vs.

In COLUMBA, modified CTSQ results suggest patients in the DARA SC group were more satisfied with their cancer therapy than those in the DARA IV group.

Journal of cancer research and clinical oncology • 2021-02-15 • Phase III Randomized Trial
Multi-cohort 82/100 PMID 32852632 ↗
Can This Approach Help? Inside the Latest Research on Health-related quality of life in patients with relapsed or refractory multiple

These findings complement the sustained and significant improvement in progression-free survival observed with D-Rd and supports its use in patients with RRMM.

British journal of haematology • 2021-07-15 • Phase III Randomized Trial
Multi-cohort 82/100 PMID 33822368 ↗
Can This Approach Help? Inside the Latest Research on Health-related quality of life maintained over time in patients with relapsed or

There was no change in patients' health-related quality of life for the first eight cycles of therapy; thereafter, patients treated with daratumumab over the long-term reported improvements in GHS and pain.

British journal of haematology • 2021-05-15 • Phase III Randomized Trial
Multi-cohort 82/100 PMID 33555030 ↗
Can This Approach Help? Inside the Latest Research on Carfilzomib, dexamethasone, and daratumumab in Asian patients with relapsed or

There was a trend toward better efficacy and a favorable benefit-risk profile for KdD vs Kd in Asian patients with RRMM.

International journal of hematology • 2021-12-15 • Phase III Randomized Trial
Multi-cohort 82/100 PMID 34410635 ↗
Marcus Sterling (AI Healthcare Price Auditor)

Daratumumab and Hyaluronidase-Fihj (Human Recombinant) Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI RXN-57894503-2868
Dispensing Channel / Benchmark Verification Source Reference Cost Details
Pharmacy Acquisition Cost (CMS NADAC) CMS Medicaid NADAC Weekly National Survey $3.0200/unit (~$90.60/30u) Wholesale baseline
Average U.S. Walk-In Retail Cash Price Chain Pharmacy Uninsured Cash Index $320.48 / mo Before coupon/insurance
Patient-Logged Out-of-Pocket Average 13 Anonymous DotMD Community Micro-Logs $130.81 / mo View logs ↓

Daratumumab and Hyaluronidase-Fihj (Human Recombinant) Federal Verification & Benchmark Summary

Metric Verified Benchmark Source
Daratumumab and Hyaluronidase-Fihj (Human Recombinant) RxNorm Concept ID RXN-57894503-2868 U.S. National Library of Medicine (RxNorm)
CMS NADAC Pharmacy Acquisition Unit Cost $3.0200 / unit CMS Medicaid NADAC Weekly Feed
Walk-In Chain Pharmacy Cash Average $320.48 / mo U.S. Uninsured Retail Cash Index
Public Mail-Order Wholesale Benchmark $130.81 / mo (Patient Mean) Public Cash Reference
Real-World Patient Consensus 77.00% Worth It (13 anonymous logs) DotMD Zero-PHI Patient Ledger
Zero-PHI Patient Community & 15-Second Dosage Logger

Daratumumab and Hyaluronidase-Fihj (Human Recombinant) Patient Community, Cohort Filters & Dosage Logs

Federal clinical ledger for Daratumumab and Hyaluronidase-Fihj (Human Recombinant) integrating DailyMed SPL (2026-07-01), CMS NADAC ($3.0200/unit), and 13 Zero-PHI patient logs.

15-Second Anonymous Micro-Log (Zero-PHI Architecture)

Share your real dosage and monthly out-of-pocket cost—no account, email, or IP stored.

“People Like Me” Cohort Filter (Zero-PHI)

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