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EPKINLY epcoritamab-bysp 4 mg/.8mL Injection, Solution, 1 vial — NDC 82705-0002-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

EPKINLY epcoritamab-bysp 4 mg/.8mL Injection, Solution, 1 vial — NDC 82705-002-01 (Billing 82705-0002-01)

by Genmab US, Inc. · 1 VIAL, GLASS in 1 CARTON / .8 mL in 1 VIAL, GLASS

This is a package of 1 vial of EPKINLY epcoritamab-bysp 4 mg/.8mL Injection, Solution from Genmab US, Inc., marketed since May 2023 and currently FDA-listed. It is this product's only package size.

NDC 82705-0002-01
🏷️ FDA NDC (as labeled) 82705-002-01 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 82705-002-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
82705 labeler · 002 product · 01 package
Package marketed since
May 19, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8270500201 6
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 82705-002-01
Product NDC 82705-002
11-digit billing NDC 82705000201
NCPDP billing unit ML — per mL (volume)
RxCUI 2637399, 2637405, 2637408, 2637411
UNII D6OMY2L0WA
Application # BLA761324
SPL Set ID d7836711-b677-412d-bf2d-0f7c8444103a
Established class (EPC) Bispecific CD20-directed CD3 T Cell Engager
Mechanism of action CD20-directed Antibody Interactions; CD3-directed Antibody Interactions; CD3 Receptor Agonists; Cytochrome P450 Inhibitors
Physiologic effect Increased Cytokine Activity
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-05-19
Route SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance EPCORITAMAB
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 21352031202020
GCN Seq No 084813
GCN 54197
HICL code 048945
Ingredient (HICL) Epcoritamab-Bysp
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1K
Therapeutic class — specific (HIC3) Antineoplastics Antibody/Antibody-Drug Complexes
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name EPKINLY 4 MG/0.8 ML VIAL
FDB brand name Epkinly
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 084813
  • GCN: 54197
  • GPI-14 (Medi-Span): 21352031202020
  • HICL (First Databank): 048945
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 2637399
Why two NDCs? The FDA registers this code as 82705-002-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 82705-0002-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Bispecific CD20-directed CD3 T Cell Engager class.

Pharmacologic class Bispecific CD20-directed CD3 T Cell Engager
Drug family (ATC) Other monoclonal antibodies and antibody drug conjugates
How it works CD20-directed Antibody Interactions, CD3-directed Antibody Interactions, CD3 Receptor Agonists, Cytochrome P450 Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name EPKINLY 4 MG/0.8 ML VIAL Ingredient Epcoritamab-Bysp
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J9321 $57.992 / J9321 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)82705-002-01
11-digit billing NDC82705-0002-01
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ9321
DescriptorINJECTION, EPCORITAMAB-BYSP, 0.16 MG
Billing units / pkg31.25 units
How the units are derivedThis package is 0.8 ML; the HCPCS unit is 0.16 MG, so one package = 31.25 billing units.
Medicare Part B spend (2026 (Q1))$21,110,281 · 1,430 claims · $14,762.43 per claim (all NDCs under J9321)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
82705-0002-01 You're viewing this Main listing 1 VIAL, GLASS in 1 CARTON / .8 mL in 1 VIAL, GLASS 2023-05-19 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Epkinly 4 mg/.8mLthis 82705-0002-01 Genmab 1 vial — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
2023
First FDA approval
May 2023
📍
2026
Currently FDA-listed
3 years listed
🛡️
2035
Latest patent/protection listed
not a guaranteed launch date
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through May 2035. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved May 19, 2023 ⏳ ~8.6 yr to latest listed protection

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Epkinlyepcoritamab-bysp
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2023 2025 2027 2029 2031 2033 2035
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
Biologic patent
A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity
A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity
The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE)
The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateMay 19, 2035
Common questions
Is there a biosimilar for EPKINLY 4 MG/0.8 ML VIAL?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerGenmab US, Inc.
FDA applicationBLA761324 (BLA)
Labeler code82705
First marketedMay 2023
Product typeHuman Prescription Drug
Portfolio2 products on file

More NDCs from Genmab US, Inc. labeler code 82705

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~1 min read ▾

WARNING: CYTOKINE RELEASE SYNDROME AND IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine release syndrome (CRS), including serious or fatal reactions, can occur in patients receiving EPKINLY. Initiate treatment with the EPKINLY step-up dosage schedule to reduce the incidence and severity of CRS. Withhold EPKINLY until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.1 , 2.2 , 2.6) and Warnings and Precautions (5.1) ] .

Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), including life-threatening and fatal reactions, can occur with EPKINLY. Monitor patients for neurological signs or symptoms of ICANS during treatment. Withhold EPKINLY until ICANS resolves or permanently discontinue based on severity [see Dosage and Administration (2.1 , 2.2 , 2.6) and Warnings and Precautions (5.2) ] .

WARNING: CYTOKINE RELEASE SYNDROME and IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME See full prescribing information for complete boxed warning. Cytokine release syndrome (CRS), including serious or fatal reactions, can occur in patients receiving EPKINLY. Initiate treatment with the EPKINLY step-up dosage schedule to reduce the incidence and severity of CRS.

Withhold EPKINLY until CRS resolves or permanently discontinue based on severity. ( 2.1 , 2.2 , 2.6 , 5.1 ) Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), including life-threatening and fatal reactions, can occur with EPKINLY. Monitor patients for neurological signs or symptoms of ICANS during treatment.

Withhold EPKINLY until ICANS resolves or permanently discontinue based on severity. ( 2.1 , 2.2 , 2.6 , 5.2 )

🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE EPKINLY is a bispecific CD20-directed CD3 T-cell engager indicated: For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy. ( 1.1 ) This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). ( 1.2 ) As monotherapy for the treatment of adult patients with relapsed or refractory FL after two or more lines of systemic therapy. ( 1.2 )

1.1DLBCL and High-grade B-cell Lymphoma EPKINLY is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14.1) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

1.2Follicular Lymphoma EPKINLY is indicated in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). EPKINLY is indicated as monotherapy for the treatment of adult patients with relapsed or refractory FL after two or more lines of systemic therapy.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION For subcutaneous injection only. ( 2.2 ) Recommended Dosage: ( 2.2 ) DLBCL and High-grade B-cell Lymphoma Cycle Cycle = 28 days Day Dose of EPKINLY Cycle 1 1 Step-up dose 1 0.16 mg 8 Step-up dose 2 0.8 mg 15 First full dose 48 mg 22 48 mg Cycles 2 and 3 1, 8, 15 and 22 48 mg Cycles 4 to 9 1 and 15 48 mg Cycle 10 and beyond 1 48 mg EPKINLY as Monotherapy for FL Cycle Cycle = 28 days Day Dose of EPKINLY Cycle 1 1 Step-up dose 1 0.16 mg 8 Step-up dose 2 0.8 mg 15 Step-up dose 3 3 mg 22 First full dose 48 mg Cycles 2 and 3 1, 8, 15 and 22 48 mg Cycles 4 to 9 1 and 15 48 mg Cycle 10 and beyond 1 48 mg EPKINLY in Combination with Lenalidomide and Rituximab for FL Cycle Cycle = 28 days Day Dose of EPKINLY Cycle 1 1 Step-up dose 1 0.16 mg 8 Step-up dose 2 0.8 mg 15 Step-up dose 3 3 mg 22 First full dose 48 mg Cycles 2 and 3 1, 8, 15, and 22 48 mg Cycles 4 to 12 1 48 mg Monitor all patients for signs and symptoms of CRS and ICANS.

( 2.1 ) For patients with DLBCL or high-grade B-cell lymphoma, assess whether hospitalization or outpatient monitoring is appropriate after administration of the Cycle 1 Day 15 dosage of 48 mg. ( 2.1 ) For patients with FL, assess whether hospitalization or outpatient monitoring is appropriate after administration of the Cycle 1 Day 22 dosage of 48 mg. ( 2.1 ) Administer premedications, post-medications, and prophylaxis as recommended.

( 2.4 , 2.5 ) Dosages of EPKINLY 0.16 mg and 0.8 mg require dilution prior to administration. ( 2.7 , 2.8 ) See Full Prescribing Information for instructions on preparation and administration. ( 2.7 , 2.8 , 2.9 , 2.10 )

2.1Important Dosing Information Certain doses of EPKINLY require dilution prior to administration. There are 2 available methods to prepare diluted EPKINLY: Empty sterile vial method as described in subsection 2.7 [see Dosage and Administration (2.7) ] , or Sterile syringe method as described in subsection 2.8 [see Dosage and Administration (2.8) ] . Preparation of 3 mg and 48 mg EPKINLY doses does not require dilution. [see Dosage and Administration (2.9) ] .

EPKINLY should only be administered by a qualified healthcare professional with appropriate medical support to manage severe reactions such as CRS and ICANS [see Warnings and Precautions (5.1 , 5.2) ] . Administer EPKINLY to well-hydrated patients. Premedicate before each dose in Cycle 1 [see Dosage and Administration (2.4) ] .

Administer EPKINLY subcutaneously according to the recommended step-up dosage schedule to reduce the incidence and severity of CRS [see Dosage and Administration (2.2) ] . Due to the risk of CRS and ICANS, monitor all patients for signs and symptoms [see Dosage and Administration (2.6) ] . Assess whether hospitalization or outpatient monitoring is appropriate based on comorbidities or other situational factors for the first 48 mg dosage of EPKINLY for patients with: DLBCL or high-grade B-cell lymphoma: on Cycle 1 Day 15 [see Dosage and Administration (2.2) ].

FL: on Cycle 1 Day 22 [see Dosage and Administration (2.2) ].

2.2Recommended Dosage EPKINLY is for subcutaneous injection only. The recommended DLBCL dosage for Cycle 1 consists of 2 step-up doses, and the recommended FL dosage (monotherapy or in combination with lenalidomide and rituximab) consists of 3 step-up doses. EPKINLY as Monotherapy: Administer EPKINLY in 28-day cycles until disease progression or unacceptable toxicity.

Table 1: EPKINLY Dosage Schedule for Patients with DLBCL or High-grade B-cell Lymphoma Indication Cycle Cycle = 28 days. Day Dose of EPKINLY DLBCL or High-grade B-cell Lymphoma Cycle 1 1 Step-up dose 1 0.16 mg 8 Step-up dose 2 0.8 mg 15 First full dose 48 mg 22 48 mg Cycles 2 and 3 1, 8, 15 and 22 48 mg Cycles 4 to 9 1 and 15 48 mg Cycle 10 and beyond 1 48 mg Table 2: EPKINLY Dosage Schedule for Patients with FL when Given as Monotherapy Indication Cycle Cycle = 28 days. Day Dose of EPKINLY Follicular Lymphoma Cycle 1 1 Step-up dose 1 0.16 mg 8 Step-up dose 2 0.8 mg 15 Step… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 58 words ▾

3 DOSAGE FORMS AND STRENGTHS EPKINLY is a clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous injection: Injection: 4 mg/0.8 mL in a single-dose vial Injection: 48 mg/0.8 mL in a single-dose vial Injection: 4 mg/0.8 mL in a single-dose vial. ( 3 ) Injection: 48 mg/0.8 mL in a single-dose vial. ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Infections: Can cause fatal or serious infections. Monitor patients for signs or symptoms of infection, including opportunistic infections, and treat appropriately. ( 5.3 ) Cytopenias: Monitor complete blood cell counts during treatment. ( 5.4 ) Embryo-Fetal Toxicity: May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception. ( 5.5 , 8.1 , 8.3 )

5.1Cytokine Release Syndrome EPKINLY can cause CRS, including serious or fatal reactions [see Adverse Reactions (6.1) ] . Relapsed or Refractory Large B-cell Lymphoma CRS occurred in 51% (80/157) of patients with LBCL receiving EPKINLY at the recommended dosage schedule in EPCORE NHL-1, with Grade 1 CRS occurring in 37%, Grade 2 in 17%, and Grade 3 in 2.5% of patients. Recurrent CRS occurred in 31% of these patients.

Most CRS events (92%) occurred during Cycle 1. In Cycle 1, CRS events occurred in 6% of patients after the 0.16 mg dose, 12% after the 0.8 mg dose, 43% after the first 48 mg dose, and 5% after the next 48 mg dose. The median time to onset of CRS from the most recent EPKINLY dose was 24 hours (range: 0 to 10 days).

The median time to onset after the first 48 mg dose was 21 hours (range: 0 to 7 days). For patients with LBCL, assess whether hospitalization or outpatient monitoring for the first 48 mg dose (Cycle 1 Day 15) is appropriate based on comorbidities or other situational factors [see Dosage and Administration (2.1) ]. During outpatient monitoring after the first 48 mg dose, patients should remain in proximity to a healthcare facility that can assess and manage CRS.

Relapsed or Refractory Follicular Lymphoma CRS occurred in 49% (42/86) of patients with FL receiving EPKINLY monotherapy at the recommended dosage schedule in EPCORE NHL-1, with Grade 1 CRS occurring in 45% and Grade 2 in 9% of patients. Recurrent CRS occurred in 48% of patients. Most CRS events (88%) occurred during Cycle 1.

In Cycle 1, CRS events occurred in 12% of patients after the 0.16 mg dose, 6% after the 0.8 mg dose, 15% after the 3 mg dose, and 37% after the first 48 mg dose. The median time to onset of CRS from the most recent EPKINLY dose was 59 hours (range: 0.1 to 7 days). The median time to onset after the first 48 mg dose was 61 hours (range: 0.1 to 7 days).

CRS occurred in 24% (32/131) of patients with FL receiving EPKINLY at the recommended dosage schedule in combination with lenalidomide and rituximab in EPCORE FL-1, with Grade 1 CRS occurring in 19%, Grade 2 in 5% of patients, and serious adverse reactions due to CRS in 12%. Recurrent CRS occurred in 41% of patients. Most CRS events (88%) occurred during Cycle 1.

In Cycle 1, CRS occurred in 5% of patients after the 0.16 mg dose, 3.8% after the 0.8 mg dose, 2.3% after the 3 mg dose, and 18% after the first 48 mg dose. The median time to onset of CRS from the most recent EPKINLY dose was 78 hours (range: 0.2 to 12 days). The median time to onset after the first 48 mg dose was 41 hours (range: 0.3 to 12 days).

For patients with FL, assess whether hospitalization or outpatient monitoring for the first 48 mg dose (Cycle 1 Day 22) is appropriate based on comorbidities or other situational factors [see Dosage and Administration (2.1) ] . During outpatient monitoring after the first 48 mg dose, patients should remain in proximity to a healthcare facility that can assess and manage CRS. Among patients with LBCL or FL who experienced CRS, signs and symptoms included pyrexia, hypotension, hypoxia, dyspnea, chills, and tachycardia.

CRS resolved in 98% of patients, after a median duration of 2 days (range: < 1 to 27 days). Concurrent neurological adverse reactions associated with CRS occurred in 2.5% of patients with LBCL, 4.7% of patients with FL receiving EPKINLY monotherapy, and 1.5% of patients receiving EPKINLY in combination with lenalidomide and rituximab. Concurrent neurological adverse reactions included headache, confusional state, tremors… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Cytokine Release Syndrome [see Warnings and Precautions (5.1) ]. Immune Effector Cell-Associated Neurotoxicity Syndrome [see Warnings and Precautions (5.2) ]. Infections [see Warnings and Precautions (5.3) ].

Cytopenias [see Warnings and Precautions (5.4) ]. EPKINLY as monotherapy for LBCL or FL: The most common (≥ 20%) adverse reactions are CRS, injection site reactions, fatigue, musculoskeletal pain, fever, diarrhea, COVID-19, rash and abdominal pain. The most common Grade 3 to 4 laboratory abnormalities (≥ 10%) are decreases in lymphocyte count, neutrophil count, hemoglobin, and platelets.

( 6.1 ) EPKINLY in combination with lenalidomide and rituximab for FL: The most common (≥ 20%) adverse reactions are rash, upper respiratory tract infections, fatigue, injection site reactions, constipation, diarrhea, CRS, pneumonia, COVID-19, and fever. The most common Grade 3 to 4 laboratory abnormalities (≥ 10%) are decreased neutrophil count, lymphocyte count, and platelets. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genmab US, Inc. at 1-855-4GENMAB (1-855-443-6622) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Relapsed or Refractory Large B-cell Lymphoma (LBCL) EPCORE NHL-1 The safety of EPKINLY was evaluated in EPCORE NHL-1, a single-arm study of patients with relapsed or refractory LBCL after two or more lines of systemic therapy, including DLBCL not otherwise specified, DLBCL arising from indolent lymphoma, high grade B-cell lymphoma, and other B-cell lymphomas [see Clinical Studies (14.1) ] .

A total of 157 patients with LBCL received EPKINLY via subcutaneous injection until disease progression or unacceptable toxicities according to the following 28-day cycle schedule: Cycle 1: EPKINLY 0.16 mg on Day 1, 0.8 mg on Day 8, 48 mg on Days 15 and 22 Cycles 2-3: EPKINLY 48 mg on Days 1, 8, 15, and 22 Cycles 4-9: EPKINLY 48 mg on Days 1 and 15 Cycles 10 and beyond: EPKINLY 48 mg on Day 1 Of the 157 patients treated, the median age was 64 years (range: 20 to 83), 60% were male, and 97% had an ECOG performance status of 0 or 1.

Race was reported in 133 (85%) patients; of these patients, 61% were White, 19% were Asian, and 0.6% were Native Hawaiian or Other Pacific Islander. There were no Black or African American or Hispanic or Latino patients treated in the clinical trial as reported. The median number of prior therapies was 3 (range: 2 to 11).

The study excluded patients with CNS involvement of lymphoma, allogeneic HSCT or solid organ transplant, an ongoing active infection, and any patients with known impaired T-cell immunity. The median duration of exposure for patients receiving EPKINLY was 5 cycles (range: 1 to 20 cycles). Serious adverse reactions occurred in 54% of patients who received EPKINLY.

Serious adverse reactions in ≥ 2% of patients included CRS, infections (including sepsis, COVID-19, pneumonia, and upper respiratory tract infections), pleural effusion, febrile neutropenia, fever, and ICANS. Fatal adverse reactions occurred in 3.8% of patients who received EPKINLY, including COVID-19 (1.3%), hepatotoxicity (0.6%), ICANS (0.6%), myocardial infarction (0.6%), and pulmonary embolism (0.6%). Permanent discontinuation of EPKINLY due to an adverse reaction occurred in 3.8% of patients.

Adverse reactions which resulted in permanent discontinuation of EPKINLY included COVID-19, CRS, ICANS, pleural effusion, and fatigue. Dosage interruptions of EPKINLY due to an adverse reaction occurred in 34% of patients who received EPKINLY. Adverse reactions which required dosage interruption in ≥ 3% of patients included CRS… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 95 words ▾

7 DRUG INTERACTIONS For certain CYP substrates, minimal changes in the concentration may lead to serious adverse reactions. Monitor for toxicity or drug concentrations of such CYP substrates when co-administered with EPKINLY. Epcoritamab-bysp causes release of cytokines [see Clinical Pharmacology (12.2) ] that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates.

Increased exposure of CYP substrates is more likely to occur after the first dose of EPKINLY and up to 14 days after the first 48 mg dose, and during and after CRS [see Warnings and Precautions (5.1) ] .

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation : Advise not to breastfeed. ( 8.2 )

8.1Pregnancy Risk Summary Based on the mechanism of action, EPKINLY may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on the use of EPKINLY in pregnant women to evaluate for a drug-associated risk. No animal reproductive or developmental toxicity studies have been conducted with epcoritamab-bysp.

Epcoritamab-bysp causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance. In addition, based on expression of CD20 on B-cells and the finding of B-cell depletion in non-pregnant animals, epcoritamab-bysp can cause B-cell lymphocytopenia in infants exposed to epcoritamab-bysp in-utero. Human immunoglobulin G (IgG) is known to cross the placenta; therefore, EPKINLY has the potential to be transmitted from the mother to the developing fetus.

Advise women of the potential risk to the fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

8.2Lactation Risk Summary There is no information regarding the presence of epcoritamab-bysp in human milk, the effect on the breastfed child, or milk production. Because maternal IgG is present in human milk, and there is potential for epcoritamab-bysp absorption leading to serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with EPKINLY and for 4 months after the last dose.

8.3Females and Males of Reproductive Potential EPKINLY may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] . Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating EPKINLY. Contraception Females Advise females of reproductive potential to use effective contraception during treatment with EPKINLY and for 4 months after the last dose.

8.4Pediatric Use The safety and efficacy of EPKINLY in pediatric patients have not been established.

8.5Geriatric Use LBCL In patients with relapsed or refractory LBCL who received EPKINLY in EPCORE NHL-1, 77 (49%) were 65 years of age and older, and 29 (19%) were 75 years of age or older. No clinically meaningful differences in safety or efficacy were observed between patients with relapsed or refractory LBCL who were 65 years of age and older compared with younger adult patients. FL In patients with relapsed or refractory FL who received EPKINLY in combination with lenalidomide and rituximab in EPCORE FL-1, 88 (36%) were 65 years of age or older and 20 (8%) were 75 years of age or older.

No clinically meaningful differences in safety or efficacy were observed between patients who were 65 years of age and older compared with younger patients. In patients with relapsed or refractory FL who received EPKINLY in EPCORE NHL-1, 66 (52%) were 65 years of age or older, and 16 (13%) were 75 years of age and older. In patients with relapsed or refractory FL, there was a higher rate of fatal adverse reactions, primarily infections, including COVID-19, in patients older than 65 years of age compared to younger adult patients.

No overall difference in efficacy was observed in patients with relapsed or refractory FL who were 65 years of age and older compared with younger patients.

🤰 Pregnancy 162 words ▾

8.1Pregnancy Risk Summary Based on the mechanism of action, EPKINLY may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on the use of EPKINLY in pregnant women to evaluate for a drug-associated risk. No animal reproductive or developmental toxicity studies have been conducted with epcoritamab-bysp.

Epcoritamab-bysp causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance. In addition, based on expression of CD20 on B-cells and the finding of B-cell depletion in non-pregnant animals, epcoritamab-bysp can cause B-cell lymphocytopenia in infants exposed to epcoritamab-bysp in-utero. Human immunoglobulin G (IgG) is known to cross the placenta; therefore, EPKINLY has the potential to be transmitted from the mother to the developing fetus.

Advise women of the potential risk to the fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

🧒 Pediatric Use 16 words ▾

8.4Pediatric Use The safety and efficacy of EPKINLY in pediatric patients have not been established.

🧓 Geriatric Use 220 words ▾

8.5Geriatric Use LBCL In patients with relapsed or refractory LBCL who received EPKINLY in EPCORE NHL-1, 77 (49%) were 65 years of age and older, and 29 (19%) were 75 years of age or older. No clinically meaningful differences in safety or efficacy were observed between patients with relapsed or refractory LBCL who were 65 years of age and older compared with younger adult patients. FL In patients with relapsed or refractory FL who received EPKINLY in combination with lenalidomide and rituximab in EPCORE FL-1, 88 (36%) were 65 years of age or older and 20 (8%) were 75 years of age or older.

No clinically meaningful differences in safety or efficacy were observed between patients who were 65 years of age and older compared with younger patients. In patients with relapsed or refractory FL who received EPKINLY in EPCORE NHL-1, 66 (52%) were 65 years of age or older, and 16 (13%) were 75 years of age and older. In patients with relapsed or refractory FL, there was a higher rate of fatal adverse reactions, primarily infections, including COVID-19, in patients older than 65 years of age compared to younger adult patients.

No overall difference in efficacy was observed in patients with relapsed or refractory FL who were 65 years of age and older compared with younger patients.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Epcoritamab-bysp is a T-cell engaging bispecific antibody that binds to the CD3 receptor expressed on the surface of T-cells and CD20 expressed on the surface of lymphoma cells and healthy B-lineage cells. In vitro, epcoritamab-bysp activated T-cells, caused the release of proinflammatory cytokines, and induced lysis of B-cells. In nonclinical studies, the combination of epcoritamab-bysp and rituximab resulted in both T-cell mediated cytotoxicity and natural killer (NK) cell mediated antibody-dependent cellular cytotoxicity (ADCC).

12.2Pharmacodynamics Circulating B-Cell Count Circulating B-cells decreased to undetectable levels (< 10 cells/microliter) after administration of the approved recommended dosage of EPKINLY in patients who had detectable B-cells at treatment initiation by Cycle 1 Day 15 and the depletion was sustained while patients remained on treatment. Cytokine Concentrations Plasma concentrations of cytokines (IL-2, IL-6, IL-10, TNF-α, and IFN-γ) were measured. Transient elevation of circulating cytokines was observed at dose levels of 0.04 mg and above.

After administration of the approved recommended dosages of EPKINLY, cytokine levels increased within 24 hours after the first dose on Cycle 1 Day 1, generally reached maximum levels after the first 48 mg dose, and returned to baseline prior to the second 48 mg full dose.

12.3Pharmacokinetics Pharmacokinetic (PK) parameters were evaluated at the approved recommended dosage (48 mg) and are presented as geometric mean (CV%) unless otherwise specified. Epcoritamab-bysp area under the concentration-time curve (AUC) increased more than proportionally over a full dosage range from 1.5 to 60 mg (0.03125 to 1.25 times the approved recommended dosage). Epcoritamab-bysp maximum concentration (10.2 mcg/mL [43.2%]) is achieved after the first dose of the Q2W regimen (i.e., the first dose of Cycle 4).

No clinically significant differences in pharmacokinetic parameters were observed between patients with relapsed or refractory LBCL and patients with relapsed or refractory FL. PK exposures are summarized for the recommended dosage of EPKINLY in Table 17. Table 17: Exposure Parameters of Epcoritamab-bysp in Subjects with Relapsed or Refractory LBCL or FL Following Recommended Dosage C avg (mcg/mL) Values are geometric mean with geometric CV%.

C max (mcg/mL) C trough (mcg/mL) First full 48 mg dose First full 48 mg dose is on the first day of Week 3 in subjects with relapsed or refractory LBCL and on the first day of Week 4 in subjects with relapsed or refractory FL. 1.3 (113.3%) 1.7 (106.7%) 1.4 (100.9%) End of weekly dosing (end of Cycle 3) 9.1 (45.9%) 9.9 (43.4%) 7.8 (52.4%) End of every 2-week dosing (end of Cycle 9) 5.3 (57%) 6.7 (49.4%) 3.6 (81.5%) Steady state Steady state values are approximated at Cycle 15 (Week 60). with every 4-week dosing 2.4 (73.3%) 4.2 (59.8%) 1.1 (134.1%) Absorption The median (range) T max of epcoritamab-bysp after the first full dose and end of the weekly dosing regimen (end of Cycle 3) treatment doses were 4 (0.3 to 7) days and 2.3 (0.3 to 3.2) days, respectively.

Distribution The apparent total volume of distribution is

25.6L (82%). Elimination The half-life of full dose epcoritamab-bysp (48 mg) was approximately 22 days (58%) at the end of Cycle 3, with apparent total clearance of approximately

0.53L/day (40%) after the end of Cycle 3. Metabolism Epcoritamab-bysp is expected to be metabolized into small peptides by catabolic pathways. Specific Populations No clinically significant differences in the PK of epcoritamab-bysp were observed based on age (20 to 89 years), sex, race (White or Asian), mild to moderate renal impairment (creatinine clearance [CLcr] 30 to < 90 mL/min as estimated by Cockcroft-Gault formula), and mild hepatic impairment (total bilirubin ≤ ULN and AST > ULN, or total bilirubin 1 to 1.5 times ULN and any AST) after accounting for differences in bodyweight.

The effects of… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 77 words ▾

12.1Mechanism of Action Epcoritamab-bysp is a T-cell engaging bispecific antibody that binds to the CD3 receptor expressed on the surface of T-cells and CD20 expressed on the surface of lymphoma cells and healthy B-lineage cells. In vitro, epcoritamab-bysp activated T-cells, caused the release of proinflammatory cytokines, and induced lysis of B-cells. In nonclinical studies, the combination of epcoritamab-bysp and rituximab resulted in both T-cell mediated cytotoxicity and natural killer (NK) cell mediated antibody-dependent cellular cytotoxicity (ADCC).

📦 How Supplied / Storage and Handling 90 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied EPKINLY (epcoritamab-bysp) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution, free of visible particles, supplied in glass vials as follows: Carton contents NDC number One 4 mg/0.8 mL single-dose vial NDC 82705-002-01 One 48 mg/0.8 mL single-dose vial NDC 82705-010-01 The vial stopper is not made with natural rubber latex. Storage and Handling Store refrigerated at 2°C to 8°C (36°F to 46°F). Keep in the original carton to protect from light.

Do not freeze. Do not shake.

📦 Storage and Handling 27 words ▾

Storage and Handling Store refrigerated at 2°C to 8°C (36°F to 46°F). Keep in the original carton to protect from light. Do not freeze. Do not shake.

📋 Description 130 words ▾

11 DESCRIPTION Epcoritamab-bysp is a bispecific CD20-directed CD3 T-cell engager; it is a humanized bispecific IgG1 antibody. Epcoritamab-bysp is manufactured in Chinese hamster ovary (CHO) cells using recombinant DNA technology and has an approximate molecular weight of 149 kDa. EPKINLY (epcoritamab-bysp) injection for subcutaneous use is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution, free of visible particles.

Each single-dose 4 mg/0.8 mL vial contains epcoritamab-bysp (4 mg), acetic acid (0.19 mg), polysorbate 80 (0.32 mg), sodium acetate (1.7 mg), sorbitol (21.9 mg) and Water for Injection, USP. The pH is 5.5. Each single-dose 48 mg/0.8 mL vial contains epcoritamab-bysp (48 mg), acetic acid (0.19 mg), polysorbate 80 (0.32 mg), sodium acetate (1.7 mg), sorbitol (21.9 mg) and Water for Injection, USP.

The pH is 5.5.

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Cytokine Release Syndrome (CRS) Inform patients of the risk of CRS, and to immediately contact their healthcare provider should signs and symptoms associated with CRS (e.g., pyrexia, hypotension, hypoxia, chills, tachycardia, headache, and dyspnea) occur at any time. Advise patients with DLBCL or high-grade B-cell lymphoma that they may be hospitalized after administration of the Cycle 1 Day 15 dosage of 48 mg and patients with FL after administration of the Cycle 1 Day 22 dosage of 48 mg.

Patients who receive Cycle 1 Day 15 and patients who receive Cycle 1 Day 22 first full dosage of 48 mg at an outpatient facility should remain in proximity of a healthcare facility that can assess and manage CRS afterwards. Advise all patients who experience symptoms that impair consciousness not to drive and refrain from operating heavy or potentially dangerous machinery until events resolve [see Warnings and Precautions (5.1) ]. Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) Advise patients of the risk of ICANS, to immediately contact their healthcare provider for signs and symptoms associated with ICANS, which may manifest, for example, as confusional state, lethargy, tremor, dysgraphia, aphasia, and non-convulsive status epilepticus, and that the onset of events may be delayed .

Advise patients who experience symptoms of ICANS that impair consciousness to refrain from driving or operating heavy or potentially dangerous machinery until symptoms of ICANS resolve [see Warnings and Precautions (5.2) ]. Infections Advise patients of the risk of serious infections, and to contact their healthcare professional for signs or symptoms of serious infection [see Warnings and Precautions (5.3) ]. Cytopenias Discuss the signs and symptoms associated with cytopenias, including neutropenia and febrile neutropenia, anemia, and thrombocytopenia [see Warnings and Precautions (5.4) ] .

Embryo-Fetal Toxicity Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider if they are pregnant or become pregnant [see Use in Specific Populations (8.1) ] . Advise females of reproductive potential to use effective contraception during treatment with EPKINLY and for 4 months after the last dose [see Use in Specific Populations (8.3) ] .

Lactation Advise women not to breastfeed during treatment with EPKINLY and for 4 months after the last dose [see Use in Specific Populations (8.2) ] .

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: June 2026 MEDICATION GUIDE EPKINLY ® (ep-KIN-lee) (epcoritamab-bysp) injection, for subcutaneous use What is the most important information I should know about EPKINLY?

EPKINLY can cause serious side effects, including: Cytokine Release Syndrome (CRS) . CRS is common during treatment with EPKINLY and can also be serious or lead to death. Tell your healthcare provider or get medical help right away if you develop any signs or symptoms of CRS, including: fever of 100.4°F (38°C) or higher dizziness or light-headedness trouble breathing chills fast heartbeat feeling anxious headache confusion shaking (tremors) problems with balance and movement, such as trouble walking Due to the risk of CRS, you will receive EPKINLY on a "step-up dosing schedule".

The step-up dosing schedule is when you receive 2 or 3 smaller "step-up" doses of EPKINLY during your first cycle of treatment (Cycle 1). You will receive your first full dose of EPKINLY a week after your last step-up dose (this will be Day 15 or Day 22 of Cycle 1). If your dose of EPKINLY is delayed for any reason, you may need to repeat the "step-up dosing schedule".

Before each dose in Cycle 1, you will receive medicines to help reduce your risk of CRS. You will also receive medicine for 3 days after each dose in Cycle 1. Your healthcare provider will decide if you need to receive medicine to help reduce your risk of CRS with future cycles.

See " How will I receive EPKINLY? " for more information about how you will receive EPKINLY. Neurologic problems. EPKINLY can cause serious neurologic problems that can be life-threatening and lead to death.

Neurologic problems may happen days or weeks after you receive EPKINLY. Your healthcare provider may refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems, including: trouble speaking or writing confusion and disorientation drowsiness tiredness or lack of energy muscle weakness shaking (tremors) seizures memory loss Your healthcare provider will monitor you for signs and symptoms of CRS and neurologic problems during treatment with EPKINLY, as well as other side effects and treat you if needed.

Your healthcare provider may temporarily stop or completely stop your treatment with EPKINLY if you develop CRS, neurologic problems, or any other side effects that are severe. People with diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma may be hospitalized after receiving their first full dose of EPKINLY on Day 15 of Cycle 1 due to the risk of CRS and neurologic problems. People with follicular lymphoma (FL) may be hospitalized after receiving their first full dose of EPKINLY on Day 22 of Cycle 1 due to the risk of CRS and neurologic problems.

See " What are the possible side effects of EPKINLY? " for more information about side effects. What is EPKINLY? EPKINLY is a prescription medicine used to treat adults with: certain types of DLBCL or high-grade B-cell lymphoma that has come back (relapsed) or that did not respond (refractory), after 2 or more treatments. follicular lymphoma that has come back or that did not respond to previous treatment, together with lenalidomide and rituximab. follicular lymphoma that has come back or that did not respond after 2 or more treatments.

It is not known if EPKINLY is safe and effective in children. Before receiving EPKINLY, tell your healthcare provider about all of your medical conditions, including if you: have an infection. are pregnant or plan to become pregnant. EPKINLY may harm your unborn baby.

Females who are able to become pregnant: Your healthcare provider should do a pregnancy test before you start treatment with EPKINLY. You should use effective birth control (contraception) during treatment and for 4 months after your last dose of EPKINLY. Tell your healthcare provider if y… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Pharmacokinetic (PK) parameters were evaluated at the approved recommended dosage (48 mg) and are presented as geometric mean (CV%) unless otherwise specified. Epcoritamab-bysp area under the concentration-time curve (AUC) increased more than proportionally over a full dosage range from 1.5 to 60 mg (0.03125 to 1.25 times the approved recommended dosage). Epcoritamab-bysp maximum concentration (10.2 mcg/mL [43.2%]) is achieved after the first dose of the Q2W regimen (i.e., the first dose of Cycle 4).

No clinically significant differences in pharmacokinetic parameters were observed between patients with relapsed or refractory LBCL and patients with relapsed or refractory FL. PK exposures are summarized for the recommended dosage of EPKINLY in Table 17. Table 17: Exposure Parameters of Epcoritamab-bysp in Subjects with Relapsed or Refractory LBCL or FL Following Recommended Dosage C avg (mcg/mL) Values are geometric mean with geometric CV%.

C max (mcg/mL) C trough (mcg/mL) First full 48 mg dose First full 48 mg dose is on the first day of Week 3 in subjects with relapsed or refractory LBCL and on the first day of Week 4 in subjects with relapsed or refractory FL. 1.3 (113.3%) 1.7 (106.7%) 1.4 (100.9%) End of weekly dosing (end of Cycle 3) 9.1 (45.9%) 9.9 (43.4%) 7.8 (52.4%) End of every 2-week dosing (end of Cycle 9) 5.3 (57%) 6.7 (49.4%) 3.6 (81.5%) Steady state Steady state values are approximated at Cycle 15 (Week 60). with every 4-week dosing 2.4 (73.3%) 4.2 (59.8%) 1.1 (134.1%) Absorption The median (range) T max of epcoritamab-bysp after the first full dose and end of the weekly dosing regimen (end of Cycle 3) treatment doses were 4 (0.3 to 7) days and 2.3 (0.3 to 3.2) days, respectively.

Distribution The apparent total volume of distribution is

25.6L (82%). Elimination The half-life of full dose epcoritamab-bysp (48 mg) was approximately 22 days (58%) at the end of Cycle 3, with apparent total clearance of approximately

0.53L/day (40%) after the end of Cycle 3. Metabolism Epcoritamab-bysp is expected to be metabolized into small peptides by catabolic pathways. Specific Populations No clinically significant differences in the PK of epcoritamab-bysp were observed based on age (20 to 89 years), sex, race (White or Asian), mild to moderate renal impairment (creatinine clearance [CLcr] 30 to < 90 mL/min as estimated by Cockcroft-Gault formula), and mild hepatic impairment (total bilirubin ≤ ULN and AST > ULN, or total bilirubin 1 to 1.5 times ULN and any AST) after accounting for differences in bodyweight.

The effects of severe renal impairment (CLcr 15 to < 30 mL/min), end-stage renal disease (CLcr < 15 mL/min), or moderate to severe hepatic impairment (total bilirubin > 1.5 times ULN and any AST) on the PK of epcoritamab-bysp are unknown. Body Weight In patients who received the recommended dosage of EPKINLY, geometric mean average concentration following the first full 48 mg dose was 31% lower in the higher body weight (BW) group (85 to 172 kg) and 13% higher in the lower BW group (39 to 65 kg) compared to patients with BW of 65 to less than 85 kg.

Drug Interaction Studies No clinical studies evaluating the drug interaction potential of epcoritamab-bysp have been conducted.

🧬 Pharmacodynamics 122 words ▾

12.2Pharmacodynamics Circulating B-Cell Count Circulating B-cells decreased to undetectable levels (< 10 cells/microliter) after administration of the approved recommended dosage of EPKINLY in patients who had detectable B-cells at treatment initiation by Cycle 1 Day 15 and the depletion was sustained while patients remained on treatment. Cytokine Concentrations Plasma concentrations of cytokines (IL-2, IL-6, IL-10, TNF-α, and IFN-γ) were measured. Transient elevation of circulating cytokines was observed at dose levels of 0.04 mg and above.

After administration of the approved recommended dosages of EPKINLY, cytokine levels increased within 24 hours after the first dose on Cycle 1 Day 1, generally reached maximum levels after the first 48 mg dose, and returned to baseline prior to the second 48 mg full dose.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1DLBCL and High-grade B-cell Lymphoma The efficacy of EPKINLY was evaluated in EPCORE NHL-1 (Study GCT3013-01; NCT03625037), an open-label, multi-cohort, multicenter, single-arm trial in 157 patients with relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy. The study excluded patients with CNS involvement of lymphoma, allogeneic HSCT or solid organ transplant, ongoing active infection, and any patients with known impaired T-cell immunity. Patients received EPKINLY monotherapy at the recommended 2-step up dosage schedule: Cycle 1: EPKINLY 0.16 mg on Day 1, 0.8 mg on Day 8, 48 mg on Days 15 and 22 Cycles 2-3: EPKINLY 48 mg on Days 1, 8, 15, and 22 Cycles 4-9: EPKINLY 48 mg on Days 1 and 15 Cycles 10 and beyond: EPKINLY 48 mg on Day 1 Patients continued to receive EPKINLY until disease progression or unacceptable toxicity.

In the setting of a suspected tumor flare reaction, continued treatment was permitted. The efficacy population includes 148 patients with DLBCL, not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma. Of the 148 patients, the median age was 65 years (range: 22 to 83), 62% were male, 97% had an ECOG performance status of 0 or 1, and 3% had an ECOG performance status of 2.

Race was reported in 125 (84%) patients; of these patients, 61% were White, 20% were Asian, and 0.7% were Native Hawaiian or Other Pacific Islander. There were no Black or African American or Hispanic or Latino patients treated in the clinical trial as reported. The diagnosis was DLBCL NOS in 86%, including 27% with DLBCL transformed from indolent lymphoma, and high-grade B-cell lymphoma in 14%.

The median number of prior therapies was 3 (range: 2 to 11), with 30% receiving 2 prior therapies, 30% receiving 3 prior therapies, and 40% receiving 4 or more prior therapies. Eighteen percent had prior autologous HSCT, and 39% had prior chimeric antigen receptor (CAR) T-cell therapy. Eighty-two percent of patients had disease refractory to last therapy and 29% of patients were refractory to CAR T-cell therapy.

Efficacy was established based on overall response rate (ORR) and duration of response as assessed by an Independent Review Committee (IRC) using Lugano 2014 criteria. The efficacy results are summarized in Table 18. Table 18: Efficacy Results in EPCORE NHL-1 in Patients with DLBCL and High-grade B-cell Lymphoma Endpoint Determined by Lugano criteria (2014) as assessed by independent review committee (IRC).

EPKINLY (N=148) ORR = overall response rate; CI = confidence interval; CR = complete response; PR = partial response; DOR = duration of response; NR = not reached. ORR Early response assessments were evaluated in the context of potential flare reactions. Of 90 patients who achieved an objective response, 9 patients had early flare reactions identified with objective response demonstrated on subsequent imaging per Lugano criteria. , n (%) 90 (61) (95% CI) (52.5, 68.7) CR, n (%) 56 (38) (95% CI) (30.0, 46.2) PR, n (%) 34 (23) (95% CI) (16.5, 30.6) DOR Median (95% CI), months 15.6 (9.7, NR) 9-month estimate Kaplan-Meier estimate.

(95% CI), % 63 (51.5, 72.4) The median time to response was 1.4 months (range: 1 to 8.4 months). Among responders, the median follow-up for DOR was 9.8 months (range: 0.0 to 17.3 months).

14.2Follicular Lymphoma EPKINLY in Combination with Lenalidomide and Rituximab for FL The efficacy of EPKINLY in combination with lenalidomide and rituximab was evaluated in EPCORE FL-1 (Study M20-638; NCT05409066), an open-label, randomized, multicenter, global trial in patients with relapsed or refractory FL after at least one line of systemic therapy. Patients were randomized to receive EPKINLY in combination with lenalidomide and rituximab, or lenalidomide and rituximab alone. The study excluded patients with known CNS involvement by lymphoma, prior allograft, and known active infection.

Patients received EPKI… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 33 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity or genotoxicity studies have been conducted with epcoritamab-bysp. No dedicated studies have been conducted to evaluate the effects of epcoritamab-bysp on fertility.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 30 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity or genotoxicity studies have been conducted with epcoritamab-bysp. No dedicated studies have been conducted to evaluate the effects of epcoritamab-bysp on fertility.

📄 Recent Major Changes 49 words ▾

Indications and Usage ( 1.2 ) 11/2025 Dosage and Administration ( 2.1 ) 3/2026 Dosage and Administration ( 2.2 , 2.5 , 2.6 ) 11/2025 Warnings and Precautions ( 5.1 ) 3/2026 Warnings and Precautions ( 5.2 , 5.4 ) 11/2025 Warnings and Precautions, Infections ( 5.3 ) 6/2026

📄 Package Label / Principal Display Panel 102 words ▾

PRINCIPAL DISPLAY PANEL - 48 mg/0.8 mL Vial Carton NDC 82705-010-01 Rx only epkinly ® (epcoritamab-bysp) Injection 48 mg/0.8 mL For subcutaneous injection by a healthcare provider only. Provide enclosed Medication Guide to patient. One single-dose vial. Discard unused portion. Genmab abbvie PRINCIPAL DISPLAY PANEL - 48 mg/0.8 mL Vial Carton

PRINCIPAL DISPLAY PANEL - 4 mg/0.8 mL Vial Carton NDC 82705-002-01 Rx only epkinly ® (epcoritamab-bysp) Injection 4 mg/0.8 mL For subcutaneous injection by a healthcare provider only. Provide enclosed Medication Guide to patient. One single-dose vial. Discard unused portion. Genmab abbvie PRINCIPAL DISPLAY PANEL - 4 mg/0.8 mL Vial Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Epkinly — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Epkinly. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$275.3K
Claims incl. refills
13
Beneficiaries
—
Spend / beneficiary
—
Spend / claim
$21,175.25
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for EPKINLY (this brand).

Top reported reactions

Cytokine Release Syndrome450
Diffuse Large B-cell Lymphoma234
Diffuse Large B-cell Lymphoma Refractory228
Pyrexia129
Immune Effector Cell-associated Neurotoxicity Syndrome102
Malignant Neoplasm Progression72
Cytomegalovirus Infection Reactivation55

Age at onset

Adult19
Elderly16

Reporter sex

1,272 reports
Male · 58%
Female · 42%
Unknown · 0%

Serious outcomes

Hospitalization295
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 580 104
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Genmab US, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Genmab US, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J9321 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 82704-3019-01 · SKNVCARE, 82705-0010-01 · Genmab →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.