Tafasitamab-cxix Injection
Tafasitamab-cxix is an injectable antibody used to treat relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) in adults.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Tafasitamab-cxix Injection: Patient Information Guide
A plain-language walkthrough of Tafasitamab-cxix Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Monjuvi (tafasitamab-cxix) is an intravenous antibody approved to treat two types of relapsed or refractory (returned or treatment-resistant) blood cancers in adults:
- Monjuvi, in combination with lenalidomide, is approved for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) — not otherwise specified, including DLBCL that developed from a lower-grade lymphoma — who are not candidates for autologous stem cell transplant. This approval is based on overall response rate and may require further confirmatory trial data.
- Monjuvi, in combination with lenalidomide and rituximab, is approved for adults with relapsed or refractory follicular lymphoma (FL).
- Monjuvi is not approved for and is not recommended in relapsed or refractory marginal zone lymphoma except within controlled clinical trials.
⚙️How it works▾
Tafasitamab-cxix is an engineered monoclonal antibody — a targeted protein designed to seek out a specific molecule called CD19, which sits on the surface of B-cells (a type of immune cell) and on certain blood cancer cells, including those in DLBCL and FL. When it latches onto CD19, it triggers cell death in several ways: it causes the cancer cell to self-destruct (a process called apoptosis) and activates the immune system to attack and engulf the cancer cells through mechanisms called ADCC (antibody-dependent cellular cytotoxicity) and ADCP (antibody-dependent cellular phagocytosis).
In lab studies using DLBCL tumor cells, combining tafasitamab-cxix with lenalidomide produced stronger immune-driven cancer cell killing than either agent used alone — which is why they are given together.
💊How it's taken▾
Monjuvi is given as an intravenous (IV) infusion in a clinical setting by a trained healthcare professional. For DLBCL, infusions start more frequently — multiple times a week in the first cycle — and gradually space out to twice a month as treatment continues. For FL, a similar tapering schedule is used across treatment cycles. For both conditions, Monjuvi is given in 28-day cycles.
- Pre-medications (such as acetaminophen or antihistamines) are given before each infusion to reduce the chance of a reaction.
- After the first few infusions pass without a reaction, pre-medication before later infusions may be optional at your care team's discretion.
- Your care team will determine your exact schedule — do not change it on your own.
🤒Side effects — in detail▾
The most common side effects reported with Monjuvi include:
- Neutropenia (very low infection-fighting white blood cells)
- Respiratory tract infections (colds, bronchitis, pneumonia)
- Fatigue or weakness
- Anemia (low red blood cells, causing tiredness)
- Diarrhea
- Low platelet counts (thrombocytopenia), which can cause bruising or bleeding
- Cough
- Fever
- Rash
- Decreased appetite
Serious reactions to watch for include signs of severe infection (high fever, chills, difficulty breathing), signs of a severe infusion reaction during the drip, or unusual bruising and bleeding from very low blood counts — contact your care team immediately if any of these occur.
⚠️Warnings & precautions▾
- Infusion reactions: Monjuvi can cause reactions during or shortly after the IV drip — including fever, chills, rash, flushing, shortness of breath, and high blood pressure. These happen most often during the first two cycles. Pre-medications help prevent them, and your team will monitor you throughout each infusion.
- Severely low blood counts (myelosuppression): Monjuvi frequently lowers white blood cells, red blood cells, and platelets to dangerous levels. This can lead to serious infections, bleeding, and anemia. Regular blood tests are needed throughout treatment, and your dose may be paused or adjusted if counts drop too low.
- Serious and fatal infections: Because Monjuvi suppresses the immune system, bacterial, fungal, and viral infections — including opportunistic infections like pneumonia and (rarely) a serious brain infection called PML — can occur during and after treatment. Fatal infections have occurred in patients receiving Monjuvi.
- Embryo-fetal toxicity: Monjuvi can deplete immune cells in a developing baby. It is used with lenalidomide, which can cause birth defects and fetal death. Women who can become pregnant must use effective contraception during treatment and for 3 months after the last dose. Do not breastfeed during treatment or for 3 months after stopping.
🔀What it interacts with▾
No formal clinical drug interaction studies have been conducted with tafasitamab-cxix, but the following are important to know:
- Lenalidomide: Always given together with Monjuvi for DLBCL and FL; lenalidomide carries its own serious risks (including birth defects) and is available only through a special safety program called REMS — follow its prescribing information carefully.
- Rituximab: Used with Monjuvi and lenalidomide for FL; follow rituximab's own safety guidelines and dosing instructions.
- Live vaccines in exposed newborns: Babies born to mothers who received Monjuvi during pregnancy should not receive live vaccines until a blood evaluation is completed, since the drug can cross the placenta and affect the baby's immune cells.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Pregnancy: Monjuvi may deplete immune cells in a developing baby. It is given with lenalidomide, which causes birth defects and fetal death — pregnancy must be avoided. Women of reproductive potential must use effective contraception during treatment and for 3 months after the last dose.
- Breastfeeding: Do not breastfeed while taking Monjuvi or for 3 months after the last dose, as the drug may pass into breast milk and harm the infant.
- Children: The safety and effectiveness of Monjuvi in patients under 18 have not been established.
- Older adults: In DLBCL studies, patients 65 and older had more serious side effects than younger patients. In FL studies, no clinically meaningful safety or effectiveness difference was seen, though 20% of FL patients were 75 or older.
- Severe kidney or liver disease: The effect of end-stage kidney disease or severe liver impairment on how the body handles tafasitamab-cxix is not yet known — tell your doctor if you have serious kidney or liver conditions.
- Marginal zone lymphoma: Monjuvi is not approved for this condition and should only be used in this setting within a controlled clinical trial.
📡Pharmacodynamics — effects in the body▾
Tafasitamab-cxix rapidly depletes B-cells — the type of immune cell targeted by the drug — from the bloodstream. In patients with relapsed or refractory DLBCL, B-cell counts dropped by 97% within 8 days of starting treatment, reaching undetectable levels within 16 weeks. In patients with FL, circulating B-cells fell to undetectable levels by Day 15 of the first cycle and stayed at that level as long as treatment continued. This deep and sustained B-cell depletion is central to how the drug fights these lymphomas.
🔬Pharmacokinetics — how your body processes it▾
Tafasitamab-cxix reaches its highest blood concentration at the end of the weekly dosing phase (around the end of Cycle 3). The drug has an estimated elimination half-life of about 13 days — meaning it takes roughly two weeks for the body to clear half of the drug. It distributes into a relatively small volume of fluid in the body, suggesting it stays mostly in the bloodstream. Body weight meaningfully affects how quickly the drug is cleared — higher body weight means faster clearance. Age, sex, race, and mild-to-moderate kidney or liver impairment do not appear to meaningfully change how the drug behaves.
📦How to store it▾
Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. Do not freeze.
📄 Written from Tafasitamab-cxix Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Tafasitamab-cxix Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Monjuvi, and why has my doctor prescribed it for me? ▾
How often will I need to come in for infusions, and how long does each one take? ▾
What side effects should I expect, and which ones should make me call my doctor right away? ▾
Is it safe if I'm pregnant or planning to become pregnant? ▾
Will my blood be checked regularly? What are they looking for? ▾
Are there any other medicines I need to be careful about while on Monjuvi? ▾
Is Tafasitamab-cxix Injection available over the counter? ▾
When was Tafasitamab-cxix Injection first available? ▾
Who makes Tafasitamab-cxix Injection? ▾
💬 Answers drafted from Tafasitamab-cxix Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Tafasitamab-cxix Injection comes
Tafasitamab-cxix Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Monjuvi is used intravenously in combination with lenalidomide to treat adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant
- Monjuvi is used intravenously in combination with lenalidomide and rituximab to treat adults with relapsed or refractory follicular lymphoma (FL)
- Monjuvi is given as an IV infusion by a healthcare professional; pre-medications must be given 30 minutes to 2 hours before each infusion to reduce the risk of infusion reactions
- Monjuvi must be reconstituted and then diluted before administration; the infusion bag should be inspected for particles or discoloration before use
- Monjuvi should not be mixed or infused through the same IV line as other medications
- Monjuvi must be administered by a healthcare professional with immediate access to emergency equipment in case of a serious infusion reaction
📊 Tafasitamab-cxix Injection across the U.S. market
How Tafasitamab-cxix Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Tafasitamab-cxix Injection is used
A general measure of how commonly Tafasitamab-cxix Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Tafasitamab-cxix Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Tafasitamab-cxix Injection prescribed? Of the 1,596 medications we measure, Tafasitamab-cxix Injection ranks #1,498 by Medicaid prescriptions — more than 6% of them.
Utilization by Tafasitamab-cxix Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
tafasitamab-cxix 200 MG Injection
Summed across the 2 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2387338
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Tafasitamab-cxix Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 2 listed Tafasitamab-cxix Injection NDCs with Medicaid activity.
🔍 Compare Tafasitamab-cxix Injection products
A representative set of FDA-listed product records for Tafasitamab-cxix Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 200 mg/5 mL | Intravenous | Incyte Corporation × 2 listings | BLA | View NDC → |
| 200 mg/5 mL | Intravenous | MorphoSys US Inc. × 2 listings | BLA | View NDC → |
Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Tafasitamab-cxix Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Tafasitamab-cxix Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Tafasitamab-cxix Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Tafasitamab-cxix Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2387211 1 dose form · 1 strength
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Dose form (SCDF) Injection RxCUI 2387337In current FDA listingsClinical drug / strength (SCD) cxix 200 MGRxCUI 2387338
Look up RxCUI 2387211 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Tafasitamab-cxix Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Tafasitamab-cxix Injection belongs to the Other monoclonal antibodies and antibody drug conjugates class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 2 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Incyte Corporation is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.