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MONJUVI Tafasitamab-cxix 200 mg/5mL Injection, Powder, Lyophilized, For Solution — NDC 73535-0208-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

MONJUVI Tafasitamab-cxix 200 mg/5mL Injection, Powder, Lyophilized, For Solution — NDC 73535-208-01 (Billing 73535-0208-01)

by Incyte Corporation · 1 VIAL in 1 CARTON / 5 mL in 1 VIAL

This is a package of MONJUVI Tafasitamab-cxix 200 mg/5mL Injection, Powder, Lyophilized, For Solution from Incyte Corporation, marketed since Aug 2020 and currently FDA-listed. It is this product's only package size.

NDC 73535-0208-01
🏷️ FDA NDC (as labeled) 73535-208-01 billing pads the product segment with a zero
Rx only Brand On market Non-controlled 🛡 REMS ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 73535-208-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
73535 labeler · 208 product · 01 package
Package marketed since
Aug 5, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0373535208013
Medicaid fills, this package
29 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 73535-208-01
Product NDC 73535-208
11-digit billing NDC 73535020801
NCPDP billing unit EA — each (per item)
RxCUI 2387338, 2387343
UNII QQA9MLH692
UPC 0373535208013
Application # BLA761163
SPL Set ID ec13ac6b-bfde-4e84-907a-83bd69584d95
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-08-05
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance TAFASITAMAB
Biologic (Purple Book) 351(a)

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

GPI-14 21351467202120
GPI class Monjuvi
GCN Seq No 081356
GCN 48441
HICL code 046758
Ingredient (HICL) Tafasitamab-Cxix
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V13
Therapeutic class — specific (HIC3) Antineoplastic - Cd19 (B Lymphocyte) Mc Antibody
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name MONJUVI 200 MG VIAL
FDB brand name Monjuvi
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 081356
  • GCN: 48441
  • GPI-14 (Medi-Span): 21351467202120
  • HICL (First Databank): 046758
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 2387338
Why two NDCs? The FDA registers this code as 73535-208-01 — 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 → 73535-0208-01. 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 Other monoclonal antibodies and antibody drug conjugates class.

Drug family (ATC) Other monoclonal antibodies and antibody drug conjugates
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 MONJUVI 200 MG VIAL Ingredient Tafasitamab-Cxix
📖 What it is MedlinePlus · NLM

Tafasitamab-cxix injection is used to treat certain types of non-Hodgkin's lymphoma (types of cancer that begin in a type of white blood cells that normally fights infection) and follicular lymphoma (FL; a type of cancer that begins in the white blood cells). Tafasitamab-cxix injection is in a class of medications called monoclonal antibodies. It works by helping the body to slow or stop the growth of cancer cells.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats adults with relapsed or refractory diffuse large B-cell lymphoma (with lenalidomide) or relapsed or refractory follicular lymphoma (with lenalidomide and rituximab). Rela...
  • It is given as an IV infusion by a healthcare professional, not at home. You'll get medicines beforehand to lower the chance of an infusion reaction. Your care team will set the sc...
  • Common ones include infections like colds and cough, low blood counts, tiredness, diarrhea, constipation, and rash. Tell your team about any fever or signs of infection, since seri...
  • Reactions can include fever, chills, rash, flushing and trouble breathing. Tell the staff right away. They can pause or slow the infusion and treat the symptoms.
📖 Read our full Tafasitamab-cxix Injection guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 $2,047.87 $10,239.35 / 5 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J9349 $14.429 / J9349 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)73535-208-01
11-digit billing NDC73535-0208-01
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ9349
DescriptorInjection, tafasitamab-cxix, 2 mg
Billing units / pkg100 units
How the units are derivedThis package is 1; the HCPCS unit is 2 MG, so one package = 100 billing units.
Medicare Part B spend (2026 (Q1))$12,354,479 · 1,625 claims · $7,602.76 per claim (all NDCs under J9349)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
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
73535-0208-01 You're viewing this Main listing 1 VIAL in 1 CARTON / 5 mL in 1 VIAL 2020-08-05 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Monjuvi 200 mg/5mL 50881-0013-03 Incyte 1 vial — — FDA listed —
Monjuvi 200 mg/5mLthis 73535-0208-01 Incyte 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

🏛️
2020
First FDA approval
Jul 2020
📍
2026
Currently FDA-listed
6 years listed
🛡️
2032
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 Jul 2032. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Jul 31, 2020 ⏳ ~5.8 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
Monjuvitafasitamab-cxix
🔒 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
2020 2022 2024 2026 2028 2030 2032
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 dateJul 31, 2032
Common questions
Is there a biosimilar for MONJUVI 200 MG 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.

What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

🧪 Avoiding an ingredient? See Tafasitamab-cxix Injection inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 3.7 mg / 5 mL UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • 1 mg / 5 mL UNII 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • 378.3 mg / 5 mL UNII 7YIN7J07X4
    A natural sugar derived from plants and microorganisms. It acts as a filler to give the medication bulk and stability, and helps preserve the active ingredient during storage and manufacturing.
  • 31.6 mg / 5 mL UNII B22547B95K
    A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.

4 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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

LabelerIncyte Corporation
FDA applicationBLA761163 (BLA)
Labeler code73535
First marketedAug 2020
Product typeHuman Prescription Drug
Portfolio22 products on file
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.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 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 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 165 words ▾

1 INDICATIONS AND USAGE MONJUVI, in combination with lenalidomide, 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 low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

MONJUVI is a CD19-directed cytolytic antibody indicated in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Administer premedications prior to starting MONJUVI. ( 2.2 ) The recommended dosage of MONJUVI is 12 mg/kg as an intravenous infusion according to the following dosing schedule: ( 2.1 ) Cycle 1: Days 1, 4, 8, 15 and 22 of the 28-day cycle. Cycles 2 and 3: Days 1, 8, 15 and 22 of each 28-day cycle.

Cycle 4 and beyond: Days 1 and 15 of each 28-day cycle. Administer MONJUVI in combination with lenalidomide for a maximum of 12 cycles and then continue MONJUVI as monotherapy until disease progression or unacceptable toxicity. ( 2.1 ) See Full Prescribing Information for instructions on preparation and administration.

( 2.3 , 2.4 )

2.1Recommended Dosage The recommended dose of MONJUVI is 12 mg/kg based on actual body weight administered as an intravenous infusion according to the dosing schedule in Table 1. Administer MONJUVI in combination with lenalidomide 25 mg for a maximum of 12 cycles, then continue MONJUVI as monotherapy until disease progression or unacceptable toxicity [see Clinical Studies (14) ] . Refer to the lenalidomide prescribing information for lenalidomide dosage recommendations.

Table 1: MONJUVI Dosing Schedule Cycle Each treatment cycle is 28-days. Dosing Schedule Cycle 1 Days 1, 4, 8, 15 and 22 Cycles 2 and 3 Days 1, 8, 15 and 22 Cycle 4 and beyond Days 1 and 15 MONJUVI should be administered by a healthcare professional with immediate access to emergency equipment and appropriate medical support to manage infusion-related reactions (IRRs) [see Warnings and Precautions (5.1) ] .

2.2Recommended Premedications Administer premedications 30 minutes to 2 hours prior to starting MONJUVI infusion to minimize infusion-related reactions [see Warnings and Precautions (5.1) ]. Premedications may include acetaminophen, histamine H 1 receptor antagonists, histamine H 2 receptor antagonists, and/or glucocorticosteroids. For patients not experiencing infusion-related reactions during the first 3 infusions, premedication is optional for subsequent infusions.

If a patient experiences an infusion-related reaction, administer premedications before each subsequent infusion.

2.3Dosage Modifications for Adverse Reactions The recommended dosage modifications for adverse reactions are summarized in Table 2. Table 2: Dosage Modifications for Adverse Reactions Adverse Reaction Severity Dosage Modification Infusion-related reactions [see Warnings and Precautions (5.1) ] Grade 2 (moderate) Interrupt infusion immediately and manage signs and symptoms. Once signs and symptoms resolve or reduce to Grade 1, resume infusion at no more than 50% of the rate at which the reaction occurred.

If the patient does not experience further reaction within 1 hour and vital signs are stable, the infusion rate may be increased every 30 minutes as tolerated to the rate at which the reaction occurred. Grade 3 (severe) Interrupt infusion immediately and manage signs and symptoms. Once signs and symptoms resolve or reduce to Grade 1, resume infusion at no more than 25% of the rate at which the reaction occurred.

If the patient does not experience further reaction within 1 hour and vital signs are stable, the infusion rate may be increased every 30 minutes as tolerated to a maximum of 50% of the rate at which the reaction occurred. If after rechallenge the reaction returns, stop the infusion immediately. Grade 4 (life-threatening) Stop the infusion immediately and permanently discontinue MONJUVI.

Myelosuppression [see Warnings and Precautions (5.2) ] Platelet count of 50,000/ mcL or less Withhold MONJUVI and lenalidomide and monitor complete blood count (CBC) weekly until platelet count is 50,000/mcL or higher. Resume MONJUVI at the same dose and lenalidomide at a reduced dose. Refer to lenalidomide prescribing information for dosage modifications.

Neutrophil count of 1,000/ mcL or less for at least 7 days OR Neutrophil count of 1,000/ mcL or less with an increase of body temperature to 100.4°F (38°C) or higher OR Neutrophil count l… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 42 words ▾

3 DOSAGE FORMS AND STRENGTHS For injection: 200 mg of tafasitamab-cxix as white to slightly yellowish lyophilized powder in single-dose vial for reconstitution and further dilution. For injection: 200 mg of tafasitamab-cxix as lyophilized powder in single-dose vial for reconstitution.( 3 )

⛔ Contraindications 4 words ▾

4 CONTRAINDICATIONS None. None.

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Infusion-Related Reactions : Monitor patients frequently during infusion. Interrupt or discontinue infusion based on severity. ( 2.3 , 5.1 ) Myelosuppression : Monitor complete blood counts.

Manage using dose modifications and growth factor support. Interrupt or discontinue MONJUVI based on severity. ( 2.3 , 5.2 ) Infections : Bacterial, fungal and viral infections can occur during and following MONJUVI.

Monitor patients for infections. ( 2.3 , 5.3 ) Embryo-Fetal Toxicity : May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception.

( 5.4 )

5.1Infusion-Related Reactions MONJUVI can cause infusion-related reactions [see Adverse Reactions (6.1) ] . In L-MIND, infusion-related reactions occurred in 6% of the 81 patients. Eighty percent of infusion-related reactions occurred during cycle 1 or 2.

Signs and symptoms included fever, chills, rash, flushing, dyspnea, and hypertension. These reactions were managed with temporary interruption of the infusion and/or with supportive medication. Premedicate patients prior to starting MONJUVI infusion [see Dosage and Administration (2.2) ] .

Monitor patients frequently during infusion. Based on the severity of the infusion-related reaction, interrupt or discontinue MONJUVI [ see Dosage and Administration (2.3) ] . Institute appropriate medical management.

5.2Myelosuppression MONJUVI can cause serious or severe myelosuppression, including neutropenia, thrombocytopenia, and anemia [see Adverse Reactions (6.1) ] . In L-MIND, Grade 3 neutropenia occurred in 25% of patients, thrombocytopenia in 12%, and anemia in 7%. Grade 4 neutropenia occurred in 25% and thrombocytopenia in 6%.

Neutropenia led to treatment discontinuation in 3.7% of patients. Monitor CBC prior to administration of each treatment cycle and throughout treatment. Monitor patients with neutropenia for signs of infection.

Consider granulocyte colony-stimulating factor administration. Withhold MONJUVI based on the severity of the adverse reaction [see Dosage and Administration (2.3) ]. Refer to the lenalidomide prescribing information for dosage modifications.

5.3Infections Fatal and serious infections, including opportunistic infections, occurred in patients during treatment with MONJUVI and following the last dose [see Adverse Reactions (6.1) ]. In L-MIND, 73% of the 81 patients developed an infection. The most frequent infections were respiratory tract infection (24%), urinary tract infection (17%), bronchitis (16%), nasopharyngitis (10%) and pneumonia (10%).

Grade 3 or higher infection occurred in 30% of the 81 patients. The most frequent grade 3 or higher infection was pneumonia (7%). Infection-related deaths were reported in 2.5% of the 81 patients.

Monitor patients for signs and symptoms of infection and manage infections as appropriate.

5.4Embryo-Fetal Toxicity Based on its mechanism of action, MONJUVI may cause fetal B-cell depletion when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with MONJUVI and for at least 3 months after the last dose [see Use in Specific Populations (8.1 , 8.3) ] .

MONJUVI is initially administered in combination with lenalidomide. The combination of MONJUVI with lenalidomide is contraindicated in pregnant women because lenalidomide can cause birth defects and death of the unborn child. Refer to the lenalidomide prescribing information on use during pregnancy.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Infusion-related reactions [see Warnings and Precautions (5.1) ] Myelosuppression [see Warnings and Precautions (5.2) ] Infections [see Warnings and Precautions (5.3) ] The most common adverse reactions (≥20%) are neutropenia, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, respiratory tract infection, and decreased appetite. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact MORPHOSYS US INC. at 1-844-667-1992 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 clinical trials of a drug cannot be directly compared to rates in other clinical trials of another drug and may not reflect the rates observed in practice. Relapsed or Refractory Diffuse Large B-Cell Lymphoma The safety of MONJUVI was evaluated in L-MIND [see Clinical Studies (14) ]. Patients (n=81) received MONJUVI 12 mg/kg intravenously in combination with lenalidomide for a maximum of 12 cycles, followed by MONJUVI as monotherapy until disease progression or unacceptable toxicity as follows: Cycle 1: Days 1, 4, 8, 15 and 22 of the 28-day cycle; Cycles 2 and 3: Days 1, 8, 15 and 22 of each 28-day cycle; Cycles 4 and beyond: Days 1 and 15 of each 28-day cycle.

Among patients who received MONJUVI, 57% were exposed for 6 months or longer, 42% were exposed for greater than one year, and 24% were exposed for greater than two years. Serious adverse reactions occurred in 52% of patients who received MONJUVI. Serious adverse reactions in ≥6% of patients included infections (26%), including pneumonia (7%), and febrile neutropenia (6%).

Fatal adverse reactions occurred in 5% of patients who received MONJUVI, including cerebrovascular accident (1.2%), respiratory failure (1.2%), progressive multifocal leukoencephalopathy (1.2%) and sudden death (1.2%). Permanent discontinuation of MONJUVI or lenalidomide due to an adverse reaction occurred in 25% of patients and permanent discontinuation of MONJUVI due to an adverse reaction occurred in 15%. The most frequent adverse reactions which resulted in permanent discontinuation of MONJUVI were infections (5%), nervous system disorders (2.5%), respiratory, thoracic and mediastinal disorders (2.5%).

Dosage interruptions of MONJUVI or lenalidomide due to an adverse reaction occurred in 69% of patients and dosage interruption of MONJUVI due to an adverse reaction occurred in 65%. The most frequent adverse reactions which required a dosage interruption of MONJUVI were blood and lymphatic system disorders (41%), and infections (27%). The most common adverse reactions (≥ 20%) were neutropenia, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, respiratory tract infection, and decreased appetite.

Table 3 summarizes the adverse reactions in L-MIND. Table 3: Adverse Reactions (≥10%) in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma Who Received MONJUVI in L-MIND Adverse Reaction MONJUVI (N=81) All Grades (%) Grade 3 or 4 (%) Blood and lymphatic system disorders Neutropenia 51 49 Anemia 36 7 Thrombocytopenia 31 17 Febrile neutropenia 12 12 General disorders and administration site conditions Fatigue Fatigue includes asthenia and fatigue 38

3.7 Pyrexia 24

1.2 Peripheral edema 24 0 Gastrointestinal disorders Diarrhea 36

1.2Constipation 17 0 Abdominal pain Abdominal pain includes abdominal pain, abdominal pain lower, and abdominal pain upper 15

1.2 Nausea 15 0 Vomiting 15 0 Respiratory, thoracic and mediastinal disorders Cough 26

1.2 Dyspnea 12

1.2Infections Respiratory tract infection Respiratory tract infection includes: lower respiratory tract infection, upper respiratory tract infection, respiratory tract infection 24

4.9Urinary tract infection Urinary tract infection includes: urinary tract infection, Escherichia… [Excerpted — this section continues on DailyMed.]

👥 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 its mechanism of action, MONJUVI may cause fetal B-cell depletion when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on MONJUVI use in pregnant women to evaluate for a drug-associated risk. Animal reproductive toxicity studies have not been conducted with tafasitamab-cxix.

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. MONJUVI is administered in combination with lenalidomide for up to 12 cycles. Lenalidomide can cause embryo-fetal harm and is contraindicated for use in pregnancy.

Refer to the lenalidomide prescribing information for additional information. Lenalidomide is only available through a REMS program. Clinical Considerations Fetal/Neonatal Adverse Reactions Immunoglobulin G (IgG) monoclonal antibodies are transferred across the placenta.

Based on its mechanism of action, MONJUVI may cause depletion of fetal CD19 positive immune cells. Defer administering live vaccines to neonates and infants exposed to tafasitamab-cxix in utero until a hematology evaluation is completed. Data Animal Data Animal reproductive studies have not been conducted with tafasitamab-cxix.

Tafasitamab-cxix is an IgG antibody and thus has the potential to cross the placental barrier permitting direct fetal exposure and depleting fetal B lymphocytes.

8.2Lactation Risk Summary There are no data on the presence of tafasitamab-cxix in human milk or the effects on the breastfed child or milk production. Maternal immunoglobulin G is known to be present in human milk. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to MONJUVI are unknown.

Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with MONJUVI and for at least 3 months after the last dose. Refer to lenalidomide prescribing information for additional information.

8.3Females and Males of Reproductive Potential MONJUVI can cause fetal B-cell depletion when administered to a pregnant woman [see Use in Specific Populations (8.1) ]. Pregnancy Testing Refer to the prescribing information for lenalidomide for pregnancy testing requirements prior to initiating the combination of MONJUVI with lenalidomide. Contraception Females Advise females of reproductive potential to use effective contraception during treatment with MONJUVI and for at least 3 months after the last dose.

Additionally, refer to the lenalidomide prescribing information for additional recommendations for contraception. Males Refer to the lenalidomide prescribing information for recommendations.

8.4Pediatric Use The safety and effectiveness of MONJUVI in pediatric patients have not been established.

8.5Geriatric Use Among 81 patients who received MONJUVI and lenalidomide in L-MIND, 72% were 65 years and older, while 38% were 75 years and older. Clinical studies of MONJUVI did not include sufficient numbers of patients aged 65 and older to determine whether effectiveness differs compared to that of younger subjects. Patients 65 years and older had more serious adverse reactions (57%) than younger patients (39%).

🤰 Pregnancy 210 words ▾

8.1Pregnancy Risk Summary Based on its mechanism of action, MONJUVI may cause fetal B-cell depletion when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on MONJUVI use in pregnant women to evaluate for a drug-associated risk. Animal reproductive toxicity studies have not been conducted with tafasitamab-cxix.

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. MONJUVI is administered in combination with lenalidomide for up to 12 cycles. Lenalidomide can cause embryo-fetal harm and is contraindicated for use in pregnancy.

Refer to the lenalidomide prescribing information for additional information. Lenalidomide is only available through a REMS program. Clinical Considerations Fetal/Neonatal Adverse Reactions Immunoglobulin G (IgG) monoclonal antibodies are transferred across the placenta.

Based on its mechanism of action, MONJUVI may cause depletion of fetal CD19 positive immune cells. Defer administering live vaccines to neonates and infants exposed to tafasitamab-cxix in utero until a hematology evaluation is completed. Data Animal Data Animal reproductive studies have not been conducted with tafasitamab-cxix.

Tafasitamab-cxix is an IgG antibody and thus has the potential to cross the placental barrier permitting direct fetal exposure and depleting fetal B lymphocytes.

🧒 Pediatric Use 16 words ▾

8.4Pediatric Use The safety and effectiveness of MONJUVI in pediatric patients have not been established.

🧓 Geriatric Use 67 words ▾

8.5Geriatric Use Among 81 patients who received MONJUVI and lenalidomide in L-MIND, 72% were 65 years and older, while 38% were 75 years and older. Clinical studies of MONJUVI did not include sufficient numbers of patients aged 65 and older to determine whether effectiveness differs compared to that of younger subjects. Patients 65 years and older had more serious adverse reactions (57%) than younger patients (39%).

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Tafasitamab-cxix is an Fc-modified monoclonal antibody that binds to CD19 antigen expressed on the surface of pre-B and mature B lymphocytes and on several B-cell malignancies, including diffuse large B-cell lymphoma (DLBCL). Upon binding to CD19, tafasitamab-cxix mediates B-cell lysis through apoptosis and immune effector mechanisms, including antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). In studies conducted in vitro in DLBCL tumor cells, tafasitamab-cxix in combination with lenalidomide resulted in increased ADCC activity compared to tafasitamab-cxix or lenalidomide alone.

12.2Pharmacodynamics Tafasitamab-cxix reduced peripheral blood B cell counts by 97% after eight days of treatment in patients with relapsed or refractory DLBCL. Nadir, with a reduction of 100%, was reached within 16 weeks of treatment.

12.3Pharmacokinetics Mean trough concentrations (± standard deviation) were 179 (± 53) μg/mL following administration of MONJUVI at 12 mg/kg on Days 1, 8, 15, and 22 in Cycle 1-3 (plus an additional dose on Cycle 1 Day 4), and 153 (± 68) μg/mL following administration of MONJUVI at 12 mg/kg on Days 1 and 15 from Cycle 4 onwards. Overall maximum tafasitamab-cxix serum concentrations were 483 (±109) μg/mL. Distribution The total volume of distribution for tafasitamab-cxix was

9.3L (95% CI: 8.6, 10 L). Elimination The clearance of tafasitamab-cxix was

0.41L/day (CV: 32%) and terminal elimination half-life was 17 days (95% CI: 15, 18 days). Specific Populations Bodyweight (40 to 163 kg) has a significant effect on the pharmacokinetics of tafasitamab-cxix, with higher clearance and volume of distribution expected with higher body weight. No clinically meaningful differences in the pharmacokinetics of tafasitamab-cxix were observed based on age (16 to 90 years), sex, mild to moderate renal impairment (CLcr 30-89 mL/min estimated by the Cockcroft-Gault equation), and mild hepatic impairment (total bilirubin ≤ ULN and AST > ULN, or total bilirubin 1 to 1.5 times ULN and any AST).

The effect of severe renal impairment to end-stage renal disease (CLcr < 30 mL/min), moderate to severe hepatic impairment (total bilirubin > 1.5 times ULN and any AST), and race/ethnicity on tafasitamab-cxix pharmacokinetics is unknown. Drug Interaction Studies No clinically meaningful differences in tafasitamab-cxix pharmacokinetics were observed when used concomitantly with lenalidomide.

🧬 Mechanism of Action 85 words ▾

12.1Mechanism of Action Tafasitamab-cxix is an Fc-modified monoclonal antibody that binds to CD19 antigen expressed on the surface of pre-B and mature B lymphocytes and on several B-cell malignancies, including diffuse large B-cell lymphoma (DLBCL). Upon binding to CD19, tafasitamab-cxix mediates B-cell lysis through apoptosis and immune effector mechanisms, including antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). In studies conducted in vitro in DLBCL tumor cells, tafasitamab-cxix in combination with lenalidomide resulted in increased ADCC activity compared to tafasitamab-cxix or lenalidomide alone.

📦 How Supplied / Storage and Handling 63 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING MONJUVI (tafasitamab-cxix) for injection is a sterile, preservative-free, white to slightly yellowish lyophilized powder for reconstitution supplied as a 200 mg single-dose vial. Each 200 mg vial is individually packaged in a carton (NDC 73535–208–01). Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. Do not shake. Do not freeze.

📦 Storage and Handling 23 words ▾

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

📋 Description 127 words ▾

11 DESCRIPTION Tafasitamab-cxix is a humanized CD19-directed cytolytic monoclonal antibody that contains an IgG1/2 hybrid Fc-domain with 2 amino acid substitutions to modify the Fc-mediated functions of the antibody. It is produced by recombinant DNA technology in mammalian cells (Chinese hamster ovary). Tafasitamab-cxix has a molecular weight of approximately 150 kDa.

MONJUVI (tafasitamab-cxix) for injection is supplied as a sterile, preservative-free, white to slightly yellowish lyophilized powder in a single-dose vial for intravenous use after reconstitution and further dilution. After reconstitution with 5 mL of Sterile Water for Injection, USP, the resulting concentration is 40 mg/mL with a pH of 6.0. Each single-dose vial contains 200 mg tafasitamab-cxix, citric acid monohydrate (3.7 mg), polysorbate 20 (1 mg), sodium citrate dihydrate (31.6 mg) and trehalose dihydrate (378.3 mg).

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Infusion-Related Reactions Advise patients to contact their healthcare provider if they experience signs and symptoms of infusion-related reactions [see Warnings and Precautions (5.1) ] . Myelosuppression Inform patients about the risk of myelosuppression.

Advise patients to immediately contact their healthcare provider for a fever of 100.4°F (38°C) or greater or signs or symptoms of bruising or bleeding. Advise patients of the need for periodic monitoring of blood counts [see Warnings and Precautions (5.2) ] . Infections Inform patients about the risk of infections.

Advise patients to immediately contact their healthcare provider for a fever of 100.4°F (38°C) or greater or signs or symptoms of infection [see Warnings and Precautions (5.3) ] . Embryo-Fetal Toxicity Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.4) , Use in Specific Population (8.1) ].

Advise females of reproductive potential to use effective contraception during treatment with MONJUVI and for at least 3 months after the last dose [see Use in Specific Populations (8.3) ] . Advise patients that lenalidomide has the potential to cause fetal harm and has specific requirements regarding contraception, pregnancy testing, blood and sperm donation, and transmission in sperm. Lenalidomide is only available through a REMS program [see Use in Specific Populations (8.1 , 8.3) ] .

Lactation Advise women not to breastfeed during treatment with MONJUVI and for at least 3 months after the last dose [see Use in Specific Populations (8.2) ].

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics Mean trough concentrations (± standard deviation) were 179 (± 53) μg/mL following administration of MONJUVI at 12 mg/kg on Days 1, 8, 15, and 22 in Cycle 1-3 (plus an additional dose on Cycle 1 Day 4), and 153 (± 68) μg/mL following administration of MONJUVI at 12 mg/kg on Days 1 and 15 from Cycle 4 onwards. Overall maximum tafasitamab-cxix serum concentrations were 483 (±109) μg/mL. Distribution The total volume of distribution for tafasitamab-cxix was

9.3L (95% CI: 8.6, 10 L). Elimination The clearance of tafasitamab-cxix was

0.41L/day (CV: 32%) and terminal elimination half-life was 17 days (95% CI: 15, 18 days). Specific Populations Bodyweight (40 to 163 kg) has a significant effect on the pharmacokinetics of tafasitamab-cxix, with higher clearance and volume of distribution expected with higher body weight. No clinically meaningful differences in the pharmacokinetics of tafasitamab-cxix were observed based on age (16 to 90 years), sex, mild to moderate renal impairment (CLcr 30-89 mL/min estimated by the Cockcroft-Gault equation), and mild hepatic impairment (total bilirubin ≤ ULN and AST > ULN, or total bilirubin 1 to 1.5 times ULN and any AST).

The effect of severe renal impairment to end-stage renal disease (CLcr < 30 mL/min), moderate to severe hepatic impairment (total bilirubin > 1.5 times ULN and any AST), and race/ethnicity on tafasitamab-cxix pharmacokinetics is unknown. Drug Interaction Studies No clinically meaningful differences in tafasitamab-cxix pharmacokinetics were observed when used concomitantly with lenalidomide.

🧬 Pharmacodynamics 36 words ▾

12.2Pharmacodynamics Tafasitamab-cxix reduced peripheral blood B cell counts by 97% after eight days of treatment in patients with relapsed or refractory DLBCL. Nadir, with a reduction of 100%, was reached within 16 weeks of treatment.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES The efficacy of MONJUVI in combination with lenalidomide followed by MONJUVI as monotherapy was evaluated in L-MIND, an open-label, multicenter, single arm trial (NCT02399085). Eligible patients had relapsed or refractory DLBCL after 1 to 3 prior systemic therapies, including a CD20-directed cytolytic antibody, and were not candidates for high dose chemotherapy (HDC) followed by autologous stem cell transplantation (ASCT). Patients received MONJUVI 12 mg/kg intravenously in combination with lenalidomide (25 mg orally on Days 1 to 21 of each 28-day cycle) for a maximum of 12 cycles, followed by MONJUVI as monotherapy until disease progression or unacceptable toxicity as follows: Cycle 1: Days 1, 4, 8, 15 and 22 of the 28-day cycle; Cycles 2 and 3: Days 1, 8, 15 and 22 of each 28-day cycle; Cycles 4 and beyond: Days 1 and 15 of each 28-day cycle.

Of the 71 patients with DLBCL confirmed by central laboratory who received the combination therapy, the median age was 71 years (range: 41 to 86 years); 55% were males, and 100% had received a prior CD20-containing therapy. Race was collected in 92% of patients; of these, 95% were White, and 3% were Asian. The median number of prior therapies was two; 49% had one prior line of treatment, and 51% had 2 to 4 prior lines.

Thirty-two patients (45%) were refractory to their last prior therapy and 30 (42%) were refractory to rituximab. Nine patients (13%) had received prior ASCT. The primary reasons patients were not candidates for ASCT included age (47%), refractoriness to salvage chemotherapy (27%), comorbidities (13%) and refusal of high dose chemotherapy/ASCT (13%).

Efficacy was established based on best overall response rate, defined as the proportion of complete and partial responders, and duration of response, as assessed by an Independent Review Committee using the International Working Group Response Criteria (Cheson, 2007). Results are summarized in Table 5 . Table 5: Efficacy Results in L-MIND N = 71 Best overall response rate , n (%) 39 (55%) (95% CI) (43%, 67%) Complete response rate 37% Partial response rate 18% Duration of Response Median (range) in months Kaplan Meier estimates 21.7 (0, 24)

🧪 Nonclinical Toxicology 72 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity and genotoxicity studies have not been conducted with tafasitamab-cxix. Fertility studies have not been conducted with tafasitamab-cxix. In the 13-week repeat-dose general toxicity study in cynomolgus monkeys, no adverse effects on male and female reproductive organs were observed up to the highest dose tested, 100 mg/kg/week (approximately 9 times the human exposure based on AUC at the clinical dose of 12 mg/kg/week).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 69 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity and genotoxicity studies have not been conducted with tafasitamab-cxix. Fertility studies have not been conducted with tafasitamab-cxix. In the 13-week repeat-dose general toxicity study in cynomolgus monkeys, no adverse effects on male and female reproductive organs were observed up to the highest dose tested, 100 mg/kg/week (approximately 9 times the human exposure based on AUC at the clinical dose of 12 mg/kg/week).

📄 Patient Package Insert ~3 min read ▾

This Patient Information has been approved by the U.S. Food and Drug Administration. Issued: JUN 2021 PATIENT INFORMATION MONJUVI ® (mon-JOO-vee) (tafasitamab-cxix) for injection What is MONJUVI?

MONJUVI is a prescription medicine given with lenalidomide to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) that has come back (relapsed) or that did not respond to previous treatment (refractory) and who cannot receive a stem cell transplant. It is not known if MONJUVI is safe and effective in children. Before you receive MONJUVI, tell your healthcare provider about all of your medical conditions, including if you: have an active infection or have had one recently. are pregnant or plan to become pregnant.

MONJUVI may harm your unborn baby. You should not become pregnant during treatment with MONJUVI. Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.

You should use an effective method of birth control (contraception) during treatment and for at least 3 months after your last dose of MONJUVI. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with MONJUVI. are breastfeeding or plan to breastfeed. It is not known if MONJUVI passes into your breastmilk.

Do not breastfeed during treatment and for at least 3 months after your last dose of MONJUVI. You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation . Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive MONJUVI? MONJUVI will be given to you by your healthcare provider as an intravenous (IV) infusion into one of your veins. Your healthcare provider will give you medicines before each infusion to decrease your chance of infusion reactions.

If you do not have any reactions, your healthcare provider may decide that you do not need these medicines with later infusions. Each treatment cycle of MONJUVI lasts for 28 days. Your healthcare provider may need to delay or completely stop treatment with MONJUVI if you have severe side effects.

Your healthcare provider will decide how many treatments you need. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. What are the possible side effects of MONJUVI?

MONJUVI may cause serious side effects, including: Infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of MONJUVI. Tell your healthcare provider right away if you get fever, chills, flushing, headache, or shortness of breath during an infusion of MONJUVI.

Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with MONJUVI, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with MONJUVI.

Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or any bruising or bleeding. Infections. Serious infections, including infections that can cause death, have happened in people during treatment with MONJUVI and after the last dose.

Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or develop any signs or symptoms of an infection. The most common side effects of MONJUVI include : feeling tired or weak diarrhea cough fever swelling of lower legs or hands respiratory tract infection decreased appetite These are not all the possible side effects of MONJUVI. Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088. General information about the safe and effective use of MONJUVI. Medicines are sometimes prescribed for purposes other than those listed in this Patient Informati… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 47 words ▾

PRINCIPAL DISPLAY PANEL - 200 mg Vial Carton NDC 73535–208–01 MONJUVI ® (tafasitamab-cxix) For Injection 200 mg/vial For Intravenous Infusion Only. Reconstitute and dilute prior to administration. Single-dose vial Discard unused portion 1 Vial Rx only morphosys | Incyte PRINCIPAL DISPLAY PANEL - 200 mg Vial Carton

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
29
Units reimbursed last 4 qtrs
84
Gross reimbursed last 4 qtrs
$172K
Avg / prescription
$5,931.76
Avg / unit
$2,047.87
Latest quarter Q1 2026
0Rx
Fee-for-service vs managed care ⓘ
62% FFS 38% MCO
Fee-for-service · 18 Rx Managed care · 11 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 54 units · 0.7 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 30 units · 0.2 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.20.7
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Washington 0.7 /100k
2 New York 0.2 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Monjuvi — 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 Monjuvi. 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
$318.2K
Claims incl. refills
28
Beneficiaries
—
Spend / beneficiary
—
Spend / claim
$11,364.06
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.
🛡
This drug has a REMS. A Risk Evaluation & Mitigation Strategy is an FDA-required safety program. It may require enrollment, counseling, or monitoring to manage a serious risk. See the boxed warning & full label below, and REMS@FDA ↗.

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 MONJUVI (this brand).

Top reported reactions

Disease Progression239
Lymphoma166
Death65
Diffuse Large B-cell Lymphoma42
Neutropenia39
Blood Lactate Dehydrogenase Increased38
Malignant Neoplasm Progression37

Age at onset

Infant2
Adult114
Elderly213

Reporter sex

0 reports
Male · 55%
Female · 45%

Serious outcomes

Hospitalization143
Life-threatening23
Disabling3
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 380 0
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) ✓ 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) ✓ Available
“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 Incyte Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Incyte Corporation 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 J9349 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.
← 73528-0410-01 · Zero 73536-0500-01 · PharmaEssentia →
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.