Prescription medicine
Tafasitamab Brand names: Monjuvi
Tafasitamab (Monjuvi) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the tafasitamab FDA label on DailyMed (effective February 2, 2026); every tafasitamab label on DailyMed.
Highlights of the record
FDA label of February 2, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageMONJUVI, 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).
Forms and strengths
- 200 mg/5ml
Injection (powder) (lyophilized) for solution.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 898 through July 30, 2026
What is tafasitamab used for?
From the label: indications and usageMONJUVI, 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). […]
Conditions named in the indications of tafasitamab's FDA labels, with every medicine labeled for each:
Source: FDA drug label (MONJUVI), Incyte Corporation, effective February 2, 2026 (SPL set ec13ac6b-bfde-4e84-907a-83bd69584d95), via openFDA; the full label on DailyMed
Is there a generic for tafasitamab (Monjuvi)?
No generic tafasitamab is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the tafasitamab label say about other medicines?
The tafasitamab label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Lenalidomide | warnings and precautions | The combination of MONJUVI with lenalidomide is contraindicated in pregnant women because lenalidomide can cause birth defects and death of the unborn child. |
Source: FDA drug label (MONJUVI), Incyte Corporation, effective February 2, 2026 (SPL set ec13ac6b-bfde-4e84-907a-83bd69584d95), via openFDA; the full label on DailyMed
What do FAERS reports show for tafasitamab?
The FDA Adverse Event Reporting System holds 898 reports that list tafasitamab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 130 are coded as a death and 143 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as tafasitamab?
36 other medicines are given the same way (intravenous) and in the same FDA class as tafasitamab or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Cyclophosphamide | Leukemia, lymphoma and myeloma | 15 labelers | n/a | No current entry |
| Doxorubicin | Leukemia, lymphoma and myeloma | 16 labelers | n/a | No current entry |
| Bortezomib | Leukemia, lymphoma and myeloma | 22 labelers | n/a | No current entry |
| Arsenic trioxide | Leukemia, lymphoma and myeloma | 16 labelers | n/a | A presentation being discontinued |
| Bendamustine | Leukemia, lymphoma and myeloma | 4 labelers | n/a | A presentation being discontinued |
| Nelarabine | Leukemia, lymphoma and myeloma | 12 labelers | n/a | No current entry |
| Idarubicin | Leukemia, lymphoma and myeloma | 2 labelers | n/a | No current entry |
| Clofarabine | Leukemia, lymphoma and myeloma | 9 labelers | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Tafasitamab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other