HCPCS
J9145
10 mg = 1 unit
Phase 1
Identify what you're billing
Confirm IV vs SC, weight-based dose, and the type-and-screen prerequisite before billing.
Darzalex IV vs. Darzalex Faspro SC FDA verified May 2026
Same active antibody, completely different billing. Most new starts now use SC Faspro — verify which formulation the order specifies.
Janssen markets daratumumab in two formulations: the original intravenous Darzalex (J9145, since 2015) and the subcutaneous Darzalex Faspro (daratumumab + hyaluronidase-fihj, J9144, since May 2020). Same active antibody, different billing infrastructure entirely — including separate HCPCS codes, separate NDCs, separate admin CPTs, and separate prior auth pathways.
| Darzalex (IV) | Darzalex Faspro (SC) | |
|---|---|---|
| HCPCS | J9145 | J9144 |
| Generic | daratumumab | daratumumab + hyaluronidase-fihj |
| NDC | 57894-502-05 (100 mg) / 57894-502-20 (400 mg) | 57894-502-15 (1,800 mg / 15 mL) |
| Manufacturer | Janssen Biotech | Janssen Biotech |
| FDA approval | November 2015 (BLA 761036) | May 2020 (BLA 761145) |
| Adult dose | 16 mg/kg IV (weight-based) | 1,800 mg SC (fixed, all weights) |
| Administration time | 3–8 hours (first 6–8 hr; subsequent ≥3 hr) | 3–5 minutes |
| Admin CPT | 96413 + 96415 (chemo IV) | 96401 (chemo SC) |
| Pediatric approved? | No | No |
| Indications | Multiple myeloma (mono + combos), AL amyloidosis (combo) | Multiple myeloma (mono + combos), AL amyloidosis (combo) |
| Premed required? | Yes (steroid + APAP + antihistamine) | Yes (same regimen) |
Why most patients are now on Faspro: SC injection takes 3–5 minutes vs IV's 3–8 hours.
Massive chair-time savings; first-infusion reactions roughly halved. Many practices and payers now treat
Faspro as the default, with IV reserved for sites that have not yet operationalized SC or for specific
clinical scenarios.
Cannot substitute Faspro for IV without payer authorization. Different J-codes, different
NDCs, different billing pathway. Submit a separate PA if switching from IV to SC mid-therapy.
Dosing & unit math FDA label verified May 2026
From the FDA prescribing information (BLA 761036, most recent label revision).
Standard monotherapy / combination schedule
- 16 mg/kg IV weekly for weeks 1–8 (8 doses)
- 16 mg/kg IV every 2 weeks for weeks 9–24 (8 doses)
- 16 mg/kg IV every 4 weeks from week 25 onward until disease progression (~10 doses/year)
- Year 1 total: ~26 doses; Year 2+: ~13 doses/year
- Combo regimen schedules (DRd, DVd, DKd, D-VMP, D-VTd, D-RVd, D-VCd for AL) are regimen-specific — verify against the protocol
Split-first-dose option
- First infusion can be split: 8 mg/kg Day 1 + 8 mg/kg Day 2
- Reduces infusion-reaction severity vs. single 16 mg/kg first dose
- Bill the actual mg administered each day with separate claim lines (separate dates of service)
Premedication (required for every infusion)
- Corticosteroid: methylprednisolone 100 mg IV (or equivalent dex) 1 hr pre — reduce to 60 mg from infusion 3 onward if no reaction
- Antipyretic: acetaminophen 650–1,000 mg PO 1 hr pre
- Antihistamine: diphenhydramine 25–50 mg IV/PO 1 hr pre
- Post-infusion: oral methylprednisolone 20 mg (or equivalent) days 1–2 post-infusion
- Antiviral: herpes zoster prophylaxis (e.g., valacyclovir) for duration of therapy and 3 months after
- Premeds bill under their own J-codes / CPTs — not bundled with daratumumab
Worked example — first-year billing for a 75 kg multiple myeloma patient
# Dose calc: 75 kg × 16 mg/kg = 1,200 mg per dose
Drug units billed per dose: 120 (J9145, 10 mg/unit)
Vial draw: 3 × 400 mg vials = 1,200 mg (zero waste — bill JZ)
Admin: 96413 (1st hr) + 96415 × multiple add'l hrs
# Year-1 schedule (single-agent or combo backbone)
Weekly wks 1–8: 8 doses
q2wk wks 9–24: 8 doses
q4wk wks 25–52: ~10 doses
Total Yr-1 doses: 26
Total Yr-1 drug units: 26 × 120 = 3,120
Total Yr-1 drug cost (Q2 2026 ASP+6%): ~$220,815 before sequestration
# Maintenance year (Year 2+)
~13 doses/year × 120 units = 1,560 units
Yr-2 drug cost: ~$110,408 at current ASP+6%
Drug units billed per dose: 120 (J9145, 10 mg/unit)
Vial draw: 3 × 400 mg vials = 1,200 mg (zero waste — bill JZ)
Admin: 96413 (1st hr) + 96415 × multiple add'l hrs
# Year-1 schedule (single-agent or combo backbone)
Weekly wks 1–8: 8 doses
q2wk wks 9–24: 8 doses
q4wk wks 25–52: ~10 doses
Total Yr-1 doses: 26
Total Yr-1 drug units: 26 × 120 = 3,120
Total Yr-1 drug cost (Q2 2026 ASP+6%): ~$220,815 before sequestration
# Maintenance year (Year 2+)
~13 doses/year × 120 units = 1,560 units
Yr-2 drug cost: ~$110,408 at current ASP+6%
Dose calc table by patient weight
| Patient weight | 16 mg/kg dose | J9145 units | Vial draw (typical) |
|---|---|---|---|
| 50 kg | 800 mg | 80 units | 2 × 400 mg = zero waste (JZ) |
| 60 kg | 960 mg | 96 units | 2 × 400 mg + 2 × 100 mg, discard 40 mg (JZ admin + JW 4 units) |
| 70 kg | 1,120 mg | 112 units | 2 × 400 mg + 4 × 100 mg, discard 80 mg (JZ admin + JW 8 units) |
| 75 kg | 1,200 mg | 120 units | 3 × 400 mg = zero waste (JZ) |
| 80 kg | 1,280 mg | 128 units | 3 × 400 mg + 1 × 100 mg, discard 20 mg (JZ admin + JW 2 units) |
| 90 kg | 1,440 mg | 144 units | 3 × 400 mg + 3 × 100 mg, discard 60 mg (JZ admin + JW 6 units) |
| 100 kg | 1,600 mg | 160 units | 4 × 400 mg = zero waste (JZ) |
Vial draw optimization: Whenever possible, design dose volume to draw cleanly from
whole vials — bills cleaner (JZ only) and avoids JW reconciliation. Many practices round to nearest
100 mg if clinical judgment allows; verify against payer rounding tolerances.
NDC reference FDA NDC Directory verified May 2026
| NDC (10/11-digit) | Package | Use |
|---|---|---|
57894-502-05 / 57894-0502-05 |
100 mg / 5 mL single-dose vial (20 mg/mL) | Smaller-dose patients, fine-tuning weight-based dose |
57894-502-20 / 57894-0502-20 |
400 mg / 20 mL single-dose vial (20 mg/mL) | Workhorse vial — standard adult doses build from 400 mg vials |
Use the 11-digit NDC with N4 qualifier on CMS-1500 box 24A shaded line. Vial-only NDC is
what payers expect for single-dose vials (no carton-level NDC for daratumumab). Format:
N4 57894050220 ML 20 for one 400 mg vial.
Darzalex Faspro NDC (separate billing under J9144):
57894-502-15 — 1,800 mg / 15 mL SC single-dose vial. Bill under J9144 with CPT 96401, not J9145.
Type & screen workflow — mandatory before first dose FDA label requirement
This is a clinical-operational gate, not a billing gate — but if it's missed, it becomes a problem.
FDA label requires baseline ABO/Rh typing and antibody screening BEFORE the first dose of daratumumab.
Daratumumab binds CD38 on red blood cells and produces a positive indirect antiglobulin test (Coombs)
that masks underlying alloantibodies and interferes with crossmatching for up to 6 months after the last
dose. Without a baseline T&S, the blood bank cannot reliably establish compatibility for urgent
transfusion later.
Workflow
- Order baseline ABO, Rh, and antibody screen before scheduling the first infusion (CPT 86900, 86901, 86850 — bill on the scheduling encounter)
- Notify the blood bank in writing that the patient is starting daratumumab. Most institutions add a problem-list flag and note "anti-CD38 mAb interference" so future T&S uses DTT-treated reagent cells or RBC genotyping
- Patient should carry a wallet card (Janssen provides) noting daratumumab use for ER scenarios at outside facilities
- Effect persists for up to 6 months after the last dose — flag stays active during this period
Other clinical prerequisites (verify before infusion)
- Hepatitis B screening (HBsAg + anti-HBc) — daratumumab can reactivate latent HBV
- Pregnancy test for women of reproductive potential
- Baseline CBC + chemistry for neutropenia / thrombocytopenia monitoring
- Herpes zoster antiviral prophylaxis initiated before or with first dose (continue 3 months post-discontinuation)
Phase 2
Code the claim
Chemo admin codes apply — not therapeutic IV. Plan multiple 96415 units for the first 1–2 doses.
Administration codes CPT verified May 2026
Daratumumab is billed as chemotherapy administration despite being immunotherapy. Long infusion times mean multiple 96415 units per encounter.
| Code | Description | When to use |
|---|---|---|
96413 |
Chemotherapy administration, IV infusion technique; up to 1 hour, single or initial substance/drug | Primary code for the first hour of every Darzalex infusion. Bill x 1 per encounter. |
96415 |
Chemotherapy administration, IV infusion; each additional hour | Bill x N additional hours. First infusion 6–8 hr = 5–7 units of 96415. Second infusion 4 hr = 3 units. Subsequent ≥3 hr = at least 2 units. |
96365 / 96366 |
Therapeutic IV infusion (non-chemo) | NOT appropriate for daratumumab. CPT classifies complex monoclonal antibody administration under chemo codes (96409–96425) per AMA. |
96401 |
Chemotherapy administration, SC/IM; non-hormonal anti-neoplastic | For Darzalex Faspro SC formulation only (J9144), not J9145 IV. |
| Premed admin codes | 96372 (IM/SC inj), 96374 (IV push), 96365 (IV infusion of premed) | Bill premed administration separately from chemo admin codes per CPT hierarchy rules. |
Typical infusion-time billing pattern
| Infusion # | Duration | 96413 | 96415 units |
|---|---|---|---|
| Week 1 (split Day 1 of split-dose) | ~3–4 hr | 1 | 2–3 |
| Week 1 (split Day 2) | ~3–4 hr | 1 | 2–3 |
| Week 1 (single-dose option, if no split) | 6–8 hr | 1 | 5–7 |
| Week 2 (second infusion) | ~4 hr | 1 | 3 |
| Week 3+ (subsequent, if tolerated) | ≥3 hr | 1 | 2 |
Why chemo admin for an immunotherapy: CPT 96409–96425 chemo admin codes apply to
complex monoclonal antibody administration regardless of mechanism. Daratumumab (and other anti-CD38, anti-CD20,
anti-PD-1 mAbs) bill under chemo admin per AMA guidance. This pays materially more than 96365 therapeutic
infusion and is the correct code.
Modifiers CMS verified May 2026
JZ — required when no waste
Effective July 1, 2023, CMS requires the JZ modifier on all single-dose container claims when no drug is discarded. For Darzalex, JZ applies whenever the dose draws cleanly from whole vials (e.g., 800 mg = 2 × 400 mg; 1,200 mg = 3 × 400 mg; 1,600 mg = 4 × 400 mg).
JW — required when waste exists
JW reports the discarded portion of a single-dose vial. Because daratumumab dosing is weight-based, many doses leave partial-vial waste. Example: a 70 kg patient receives 1,120 mg (112 units). Optimal vial draw is 2 × 400 mg + 4 × 100 mg = 1,200 mg available; discard 80 mg. Bill 112 units of J9145 with JZ (or no waste-modifier as locally accepted) on the admin line AND a separate JW line for 8 units of waste. One of JZ or JW must be on every J9145 claim.
Common error: Forgetting the JW line on weight-based doses with partial-vial waste. CMS
audits flag this. Best practice: always reconcile vials drawn vs. mg administered for every J9145 claim and
post the JW units explicitly. Wasted drug is reimbursable but must be reported.
Modifier 25 — same-day E/M
Use modifier 25 on the E/M code when a significant, separately identifiable evaluation and management service is performed on the same day as the infusion. Routine pre-infusion clinical assessment is bundled.
340B modifiers (JG, TB)
For 340B-acquired daratumumab, follow your MAC's current 340B modifier policy. Janssen does not provide 340B-specific instructions in the prescribing or billing materials.
ICD-10-CM by indication FY2026 verified May 2026
Use the most specific code supported by encounter documentation.
| Indication | ICD-10 family | Notes |
|---|---|---|
| Multiple myeloma, NOS | C90.00 | Without mention of remission |
| Multiple myeloma in remission | C90.01 | Maintenance / consolidation phase |
| Multiple myeloma in relapse | C90.02 | R/R MM — mono or combo (DRd, DVd, DKd) |
| AL amyloidosis (light chain) | E85.81 | For D-VCd combo (newly diagnosed AL) |
| Wild-type transthyretin amyloidosis | E85.82 | If documented; other amyloid codes E85.x as appropriate |
| Personal hx of antineoplastic chemo | Z92.21 | Secondary code for transplant-eligible NDMM patients post-induction |
| Encounter for antineoplastic immunotherapy | Z51.12 | Secondary code on encounter for the infusion |
Indication-specific PA criteria are the norm. Most payers require ICD-10 plus line of
therapy, prior regimens, and combo backbone (e.g., DRd vs DVd vs DKd) documented. ICD-10 alone is not
sufficient for approval. Medicare LCDs cover all FDA-approved indications when documentation supports.
Site of care & place of service Verified May 2026
Multi-hour daratumumab IV infusions create real chair-time pressure on infusion suites. Aetna in particular has steered daratumumab IV toward Faspro SC for site-of-care and chair-time reasons; UHC and BCBS plans run general site-of-care UM that disfavors HOPD after the first 3 months.
| Setting | POS | Claim form | Payer steering |
|---|---|---|---|
| Physician oncology office | 11 | CMS-1500 / 837P | Preferred by commercial UM |
| Ambulatory infusion suite (AIC) | 49 | CMS-1500 / 837P | Preferred by commercial UM |
| Oncology ASC | 24 | CMS-1500 / 837P | Acceptable |
| Hospital outpatient (on-campus) | 22 | UB-04 / 837I | Disfavored after first 3 months |
| Hospital outpatient (off-campus PBD) | 19 | UB-04 / 837I | Disfavored after first 3 months |
| Patient home | 12 | CMS-1500 (with home infusion) | Rare for IV daratumumab; SC Faspro fits home model better |
Aetna pushes Faspro SC for site-of-care reasons. The 3–5 minute SC injection
eliminates infusion-suite chair time. If clinically appropriate, Faspro is often the path of least
resistance through Aetna PA. Verify per-payer policy at the time of submission.
Claim form field mapping Janssen 2026
From Janssen CarePath HCP coding & coverage materials.
| Information | CMS-1500 box | Notes |
|---|---|---|
| NPI | 17b | Rendering provider |
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | N4 + 11-digit vial NDC + ML + total mL administered (e.g., 60 mL for 1,200 mg dose using 3 × 400 mg vials) |
| HCPCS J9145 + JZ (or JW for waste) | 24D (drug line) | One of JZ / JW must be present on every claim |
| Drug units | 24G | mg administered ÷ 10 (e.g., 120 units for 1,200 mg) |
| CPT 96413 + 96415 (admin lines) | 24D (admin line(s)) | 96413 x 1 + 96415 x N additional hours |
| ICD-10 | 21 | C90.00 / C90.01 / C90.02 (MM); E85.81 / E85.82 (AL amyloidosis) |
| Premed claim lines (separate) | 24D | J-codes for steroid/diphenhydramine/acetaminophen if billed separately; admin via 96372/96374/96365 |
| PA number | 23 | Required by all major commercial payers; not required by traditional Medicare for on-label use |
Phase 3
Get paid
PA universal for commercial. Medicare LCDs cover on-label. Janssen CarePath has robust BI/PA support.
Payer policy snapshot Reviewed May 2026
All major commercial payers require PA. Aetna often prefers Faspro SC for site-of-care reasons. Medicare LCDs cover all FDA-approved indications.
| Payer | PA? | Site/formulation preference | Step therapy |
|---|---|---|---|
| UnitedHealthcare Oncology Med Coverage Policy |
Yes for all MM indications | Reviews IV vs SC at PA; site-of-care UM disfavors HOPD after 3 months | Generally not required for FDA-labeled MM lines; combo backbone scrutinized |
| Aetna Medical Drug + Site-of-Care policy |
Yes | Often prefers Faspro SC for chair-time/site-of-care; IV approved when SC clinically inappropriate | Generally not required; combo regimen documentation required |
| BCBS plans Vary by plan |
Yes | Aligned with NCCN MM guidelines + FDA label; most have ICI/oncology site-of-care steering | Plan-specific; line-of-therapy documentation required |
| Traditional Medicare MAC LCDs |
No (FFS); MA plans yes | Covers IV and SC; MAC LCDs cover all FDA-approved indications with documentation | None for traditional FFS Medicare |
Documentation typically required for PA
- Confirmed multiple myeloma diagnosis (CRAB criteria or biomarker-positive) or AL amyloidosis (biopsy + light-chain typing)
- Line of therapy and prior regimens (with response and reason for discontinuation)
- Combo backbone specified (DRd, DVd, DKd, D-VMP, D-VTd, D-RVd, D-VCd)
- Type & screen baseline result (or scheduled)
- Hepatitis B serology (HBV reactivation risk)
- Performance status / transplant eligibility for NDMM regimens
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.
Q2 2026 payment snapshot — J9145
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions
ASP + 6%
$70.774
per 10 mg unit
1,200 mg dose (75 kg)
$8,492.88
120 units × ASP+6%
1,600 mg dose (100 kg)
$11,323.84
160 units × ASP+6%
Annualized cost (75 kg patient, single-agent or combo backbone): Year 1 ~26 doses × 120 units = 3,120 units ≈ $220,815/year (Medicare ASP+6%). Year 2+ ~13 doses × 120 units = 1,560 units ≈ $110,408/year. After ~2% sequestration: roughly ~$216,400 (Yr 1) and ~$108,200 (Yr 2+) actual paid.
Coverage
No NCD specific to daratumumab. Coverage falls under MAC LCDs for biologics + the generic anti-cancer drug-coverage framework. All MACs cover J9145 for FDA-approved on-label indications (multiple myeloma across NDMM and R/R settings, AL amyloidosis in combo) with appropriate ICD-10 and clinical documentation.
Code history
- J9145 — permanent code, effective January 1, 2018 (initial FDA approval was November 2015; pre-permanent-code period used unclassified J3590 or C9476 temporary code)
Patient assistance — Janssen CarePath Janssen verified May 2026
- Janssen CarePath: 1-877-CarePath (1-877-227-3728) — benefits investigation, prior authorization assistance, appeal support, denials management
- Janssen CarePath Savings Program for DARZALEX (commercial copay): eligible commercially-insured patients pay $0 for the first dose and may save up to ~$20,000/year (verify program limit and eligibility annually). Excludes Medicare, Medicaid, federal program patients.
- Johnson & Johnson Patient Assistance Foundation: free product for uninsured patients meeting income/medical-need requirements
- Foundations for Medicare patients: refer to PAN Foundation (multiple myeloma fund), HealthWell, CancerCare, Leukemia & Lymphoma Society Co-Pay Program — verify open MM funds quarterly
- Web: janssencarepath.com/patient/darzalex
Need to model what a specific patient will actually pay after CarePath copay assistance, deductible,
coinsurance, and OOP max? Run a CareCost Estimate — J9145 pre-loaded.
Phase 4
Fix problems
Wrong admin code, missing JW on weight-based waste, and missing baseline T&S are the top three.
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| Wrong admin code (96365) | Therapeutic IV billed instead of chemo IV | Resubmit with 96413 + 96415. Daratumumab is chemo admin per CPT classification despite being immunotherapy. |
| Insufficient 96415 hours billed | Long infusion duration not captured (only 96413 billed) | Add 96415 x N for each additional hour beyond the first. Document infusion start/stop times for audit defense. |
| JW missing on weight-based dose with waste | Wasted drug not reported on partial-vial draw | Add JW line for discarded units (JW required since 1/1/2017; one of JZ/JW required since 7/1/2023). |
| JZ missing on adult claim | Single-dose vial claim without JZ when no waste | Resubmit with JZ. Required since 7/1/2023 on every claim with no waste. |
| Wrong NDC format | 10-digit NDC submitted; missing N4 qualifier or UoM | Use 11-digit NDC (57894-0502-20 or 57894-0502-05) with N4 + ML + total mL administered. |
| Site of care (HOPD) | HOPD administration after first 3 months on commercial plan with site-of-care UM | Move to office (POS 11) or AIC (POS 49); or document medical necessity for HOPD; or transition to Faspro SC. |
| Indication-specific PA criteria not met | ICD-10 alone insufficient; line of therapy or combo backbone not documented | Submit complete clinical history including prior regimens, response, transplant status, and current regimen. |
| Faspro billed as Darzalex IV | SC formulation billed under J9145 | Faspro bills under J9144 (permanent code). Submit corrected claim with J9144 + CPT 96401 + NDC 57894-502-15. |
| Premed bundling denial | Premed admin codes denied as bundled | Verify CPT hierarchy: 96413 (chemo IV initial) is the primary; bill premed admin (96372 SC, 96374 IV push, or 96365 IV infusion) as concurrent / sequential per CPT rules. |
Frequently asked questions
What is the HCPCS code for Darzalex?
Darzalex (daratumumab IV) is billed under HCPCS J9145 — "Injection, daratumumab,
10 mg." Each 10 mg equals one billable unit. The subcutaneous formulation Darzalex Faspro
(daratumumab + hyaluronidase-fihj) is a different product with its own permanent code, J9144
— bill that, not J9145, for SC administration.
How many units of J9145 do I bill for a Darzalex dose?
Calculate mg administered (16 mg/kg × patient weight in kg), then divide by 10. A 60 kg patient receives 960 mg = 96 units. A 75 kg patient receives 1,200 mg = 120 units. A 90 kg patient receives 1,440 mg = 144 units. Use JZ on every claim if the dose draws cleanly from whole vials with no waste; use JW for any discarded portion of a single-dose vial.
What administration CPT do I use for Darzalex IV?
CPT 96413 (chemotherapy administration, IV infusion technique; up to 1 hour) for the first
hour, plus CPT 96415 (each additional hour) for subsequent hours. Daratumumab is classified
as chemotherapy admin per AMA guidelines for complex monoclonal antibody administration. First infusion
typically runs 6–8 hours (split-dose option available); second infusion 4 hours; subsequent
infusions ~3 hours minimum if tolerated. Plan multiple 96415 units for the first 1–2 doses.
Do I bill JZ or JW for Darzalex?
Both modifiers can apply, depending on vial draw. Vials are 100 mg/5 mL and 400 mg/20 mL single-dose. A 1,200 mg dose draws from three 400 mg vials with zero waste (bill JZ on the 120 units administered). A 1,000 mg dose draws from two 400 mg vials + two 100 mg vials with zero waste (JZ on 100 units administered). A 950 mg dose draws from two 400 mg vials + two 100 mg vials, discards 50 mg (bill the admin line on 95 units AND JW on 5 units waste on a separate line). One of JZ or JW must be on every J9145 claim per CMS's July 2023 single-dose container policy.
What is the Medicare reimbursement for J9145?
For Q2 2026, the Medicare Part B payment limit for J9145 is $70.774 per 10 mg unit (ASP + 6%). A 1,200 mg dose for a 75 kg patient (120 units) reimburses at approximately $8,492.88. Annualized cost is regimen-dependent: ~26 doses Year 1 ≈ $220,815 for a 75 kg patient at Medicare ASP+6%, before sequestration. Sequestration (~2%) reduces actual paid to roughly ASP + 4.3%.
Why does Darzalex require a type and screen before the first dose?
Daratumumab binds CD38 on red blood cells and causes a positive indirect antiglobulin (Coombs) test, interfering with routine pre-transfusion compatibility testing for up to 6 months after the last dose. The FDA label requires baseline ABO/Rh typing and antibody screening BEFORE the first dose so that subsequent transfusion compatibility can be established. Notify the blood bank that the patient is on daratumumab — they will use DTT-treated reagent cells or genotyping to bypass the interference. Failure to type-and-screen before the first dose can delay urgent transfusion later.
What is the dosing schedule for Darzalex IV?
16 mg/kg IV: weekly for weeks 1–8 (8 doses), every 2 weeks for weeks 9–24 (8 doses), then every 4 weeks from week 25 until disease progression. In combo regimens (DRd, DVd, DKd, D-VMP, D-VTd, D-RVd, D-VCd) the schedule is regimen-specific — verify against the protocol used. The split-first-dose option (8 mg/kg on Day 1 + 8 mg/kg on Day 2) reduces first-infusion reaction severity and is widely used; bill the actual mg administered each day with separate claim lines.
What is Darzalex Faspro and how does it differ from Darzalex IV?
Darzalex Faspro (daratumumab + hyaluronidase-fihj) is the subcutaneous formulation, FDA-approved May 2020.
It bills under a separate permanent HCPCS code J9144 — never under J9145. Faspro is
administered SC over 3–5 minutes at a fixed dose of 1,800 mg regardless of body weight (single
15 mL vial, NDC 57894-502-15), uses CPT 96401 (chemo SC), and dramatically reduces chair time and
first-infusion reactions. Most new starts and most existing patients have transitioned from IV to SC.
Cannot substitute Faspro for IV (or vice versa) on a single PA — payers require separate
authorization. See Darzalex Faspro reference →
Reference
Sources & methodology
Every claim on this page is sourced. Methodology and review history below.
Source documents
- DARZALEX (daratumumab) Prescribing Information — Janssen / FDA-approved label
- DailyMed — DARZALEX (daratumumab) label
- Janssen CarePath — DARZALEX HCP coding & coverage
- Janssen CarePath — Patient savings program (DARZALEX)
- CMS — Medicare Part B Drug ASP Pricing File
- SEER CanMED — HCPCS J9145 reference
- UnitedHealthcare — Oncology Medication Clinical Coverage Policy
- Aetna Medical Drug Policy — Daratumumab (Darzalex / Darzalex Faspro)
- NCCN Clinical Practice Guidelines — Multiple Myeloma
- FDA National Drug Code Directory
- AABB — Anti-CD38 mAb interference with pre-transfusion testing (technical bulletins)
About this page
We maintain this page as a living reference. Medicare ASP pricing is bound to our underlying CareCost data layer and refreshes automatically when CMS publishes new quarterly files. Coding and policy content is reviewed at least quarterly and updated whenever a source document changes.
Found an error? Email hello@carecostestimate.com.
Refresh cadence
| Element | Cadence | How it's refreshed |
|---|---|---|
| Medicare ASP pricing | Quarterly | Auto-bound to CareCost ASP layer; updates on CMS file release. |
| Payer policies (UHC, Aetna, BCBS) | Semi-annual | Manual review against published payer policy documents. |
| HCPCS / CPT / modifier rules | Annual | Reviewed against CMS HCPCS quarterly files and AMA CPT releases. |
| NDC, dosing, FDA label, indication list | Event-driven | Tied to manufacturer document version + FDA label revision date. |
Reviewer
Pending SME review. This page is staff-authored from primary sources (FDA label, CMS,
Janssen CarePath, AABB technical bulletins, payer policy documents — all linked above). Final
review by the CareCost editorial team, the CareCost editorial team, is in progress. Until that review is complete, treat this as a
draft reference and verify each cited source for high-stakes claims.
Change log
- — Initial publication. ASP data: Q2 2026 ($70.774/10 mg unit). Manufacturer source: Janssen CarePath HCP materials. FDA label: most recent revision (BLA 761036). Sister product Darzalex Faspro (J9144, SC) cross-referenced.
Methodology
Every claim on this page is sourced inline. Pricing reflects the current CMS Part B Drug ASP Pricing File. Payer policies are read directly from each payer's published medical/pharmacy policy documents. Indication list and dosing are verified against the current FDA label revision. Type-and-screen workflow follows AABB technical bulletins on anti-CD38 mAb interference. We do not paraphrase from billing-software vendor blogs.