Prescription medicine
Inotuzumab ozogamicin Brand names: Besponsa
Inotuzumab ozogamicin (Besponsa) is a prescription medicine with an FDA approval on record since 2017. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the inotuzumab ozogamicin FDA label on DailyMed (effective February 6, 2026, Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.); the BLA 761040 record on Drugs@FDA; every inotuzumab ozogamicin label on DailyMed.
Highlights of the record
FDA label of February 6, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME).
and INCREASED RISK OF POST-HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT) NON-RELAPSE MORTALITY WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME) and INCREASED RISK OF POST- HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT) NON-RELAPSE MORTALITY See full prescribing information for complete boxed warning.
Hepatotoxicity, including fatal and life-threatening VOD occurred in patients who received BESPONSA. ( 5.1 )
A higher post-HSCT non-relapse mortality rate occurred in patients receiving BESPONSA ( 5.2 ) HEPATOTOXICITY, INCLUDING VOD
Hepatotoxicity, including fatal and life-threatening VOD occurred in patients with relapsed or refractory acute lymphoblastic leukemia (ALL) who received BESPONSA. The risk of VOD was greater in patients who underwent HSCT after BESPONSA treatment; use of HSCT conditioning regimens containing 2 alkylating agents and last total bilirubin level ≥ upper limit of normal (ULN) before HSCT were significantly associated with an increased risk of VOD.
Other risk factors for VOD in patients treated with BESPONSA included ongoing or prior liver disease, prior HSCT, increased age, later salvage lines, and a greater number of BESPONSA treatment cycles. […]
Used for
From the label: indications and usageINDICATIONS AND USAGE BESPONSA is indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older.
Forms and strengths
- 0.25 mg/ml
Injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- August 17, 2017 Besponsa, Wyeth Pharms Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- 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
- 2,937 through July 30, 2026
What is inotuzumab ozogamicin used for?
From the label: indications and usageINDICATIONS AND USAGE BESPONSA is indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older. BESPONSA is a CD22-directed antibody and cytotoxic drug conjugate indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older.
Conditions named in the indications of inotuzumab ozogamicin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: CD22-directed Immunoconjugate.
Source: FDA drug label (Besponsa), Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., effective February 6, 2026 (SPL set cc7014b1-c775-411d-b374-8113248b4077), via openFDA; the full label on DailyMed
Is there a generic for inotuzumab ozogamicin (Besponsa)?
No generic inotuzumab ozogamicin is approved (Drugs@FDA, October 8, 2026).
- 2017 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the inotuzumab ozogamicin label say about other medicines?
The inotuzumab ozogamicin 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 |
|---|---|---|
| Busulfan | warnings and precautions | The risk of VOD was greater in patients who underwent HSCT after BESPONSA treatment; use of HSCT conditioning regimens containing 2 alkylating agents (e.g., busulfan in combination with other alkylating agents) and last total bilirubin level greater than or equal to the ULN before HSCT are significantly associated … |
Source: FDA drug label (Besponsa), Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., effective February 6, 2026 (SPL set cc7014b1-c775-411d-b374-8113248b4077), via openFDA; the full label on DailyMed
What do FAERS reports show for inotuzumab ozogamicin?
The FDA Adverse Event Reporting System holds 2,937 reports that list inotuzumab ozogamicin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 996 are coded as a death and 1,184 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 inotuzumab ozogamicin?
36 other medicines are given the same way (intravenous) and in the same FDA class as inotuzumab ozogamicin 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?
- Inotuzumab ozogamicin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other