Inotuzumab Ozogamicin: uses, dosing, side effects & brands
Inotuzumab Ozogamicin is a cd22-directed immunoconjugate sold in the U.S. under one brand, for precursor cell lymphoblastic leukemia-lymphoma. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Cd22-Directed Immunoconjugate
- Treats
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Available as
- Injectable
- Sold as
- Besponsa
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
How inotuzumab ozogamicin is dosed
From the FDA label for Besponsa (application BLA761040). Other inotuzumab ozogamicin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Administer by intravenous infusion only. (2.1) • Pre-medicate with a corticosteroid, antipyretic, and antihistamine prior to all infusions. ( 2.2 ) • Dosing regimens for Cycle 1 and subsequent cycles, depending on the response to treatment, are shown below. See full prescribing information for dosing details. ( 2 ) Day 1 Day 8 Day 15 Dosing regimen for Cycle 1 All patients: Dose 0.8 mg/m 2 0.5 mg/m 2 0.5 mg/m 2 Cycle length 21 days For patients who achieve a CR or a CRi, and/or to allow for recovery from toxicity, the cycle length may be extended up to 28 days (i.e., 7-day treatment-free interval starting on Day 21). Dosing regimen for subsequent cycles depending on response to treatment Patients who have achieved a CR or CRi: Dose 0.5 mg/m 2 0.5 mg/m 2 0.5 mg/m 2 Cycle length 28 days Patients who have not achieved a CR or CRi: Dose 0.8 mg/m 2 0.5 mg/m 2 0.5 mg/m 2 Cycle length 28 days • See full prescribing information for instructions on reconstitution of lyophilized powder, and preparation and administration of reconstituted drug. ( 2.4 ) 2.1 Recommended Dosage • Pre-medicate before each dose [see Dosage and Administration (2.2) ] . • Administer by intravenous infusion only. • For the first cycle, the recommended total dose of BESPONSA for all patients is 1.8 mg/m 2 per cycle, administered as 3 divided doses on Day 1 (0.8 mg/m 2 ), Day 8 (0.5…
Inotuzumab Ozogamicin side effects
The following adverse reactions are discussed in greater detail in other sections of the label: • Hepatotoxicity, including hepatic VOD (also known as SOS) [see Warnings and Precautions (5.1) ] • Increased risk of post-transplant non-relapse mortality [see Warnings and Precautions (5.2) ] • Myelosuppression [see Warnings and Precautions (5.3) ] • Infusion related reactions [see Warnings and Precautions (5.4) ] • QT interval prolongation [see Warnings and Precautions (5.5) ] The most common (≥ 20%) adverse reactions, including laboratory abnormalities, in adult and pediatric patients are thrombocytopenia, pyrexia, neutropenia, infection, anemia, vomiting, leukopenia, hemorrhage, fatigue, nausea, febrile neutropenia, headache, transaminases increased, abdominal pain, and gamma-glutamyltransferase increased, and hyperbilirubinemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Relapsed or Refractory B-cell Precursor ALL Adult Patients The safety of BESPONSA was evaluated in adult patients with relapsed…
Who shouldn’t take inotuzumab ozogamicin
None. None ( 4 )
Inotuzumab Ozogamicin drug interactions
Drugs That Prolong the QT Interval Concomitant use of BESPONSA with drugs known to prolong the QT interval or induce Torsades de Pointes may increase the risk of a clinically significant QTc interval prolongation [see Clinical Pharmacology (12.2) ] . Discontinue or use alternative concomitant drugs that do not prolong QT/QTc interval while the patient is using BESPONSA. When it is not feasible to avoid concomitant use of drugs known to prolong QT/QTc, obtain ECGs and electrolytes prior to the start of treatment, after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment [see Warnings and Precautions (5.5) ] .
Every inotuzumab ozogamicin product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Besponsa.
Inotuzumab Ozogamicin and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for inotuzumab ozogamicin: levels in milk, effects in breastfed infants, and the drugs it would consider insteadNo information is available on the clinical use of inotuzumab ozogamicin during breastfeeding. Because inotuzumab is a large protein molecule with a molecular weight of 168,000 Da the amount in milk is likely to be very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. Ozogamicin (N-acetyl gamma calicheamicin) is a small-molecule that causes double-stranded DNA that might enter milk and be absorbed by the infant. Because of the potential for serious adverse reactions in the breastfed infant, the manufacturer recommends that breastfeeding be discontinued during inotuzumab ozogamicin therapy for at least 2 months after the last dose.
National Institute of Child Health and Human Development, record revised January 15, 2025. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about inotuzumab ozogamicin
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 2,197 reports naming inotuzumab ozogamicin, and the FDA flagged 98% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- febrile neutropenia225 reports
- venoocclusive liver disease174 reports
- pyrexia146 reports
- acute lymphocytic leukaemia recurrent139 reports
- cytokine release syndrome125 reports
- sepsis118 reports
- thrombocytopenia115 reports
- venoocclusive disease104 reports
Read these as a signal, not a rate. A report does not mean inotuzumab ozogamicin caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is inotuzumab ozogamicin?
Besponsa (Inotuzumab Ozogamicin) is a cd22-directed immunoconjugate used to treat Precursor Cell Lymphoblastic Leukemia-Lymphoma.
What kind of drug is inotuzumab ozogamicin?
The FDA classifies inotuzumab ozogamicin as a cd22-directed immunoconjugate. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take inotuzumab ozogamicin with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run inotuzumab ozogamicin against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does inotuzumab ozogamicin come in?
Across the brands we track, inotuzumab ozogamicin is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic inotuzumab ozogamicin?
We do not currently list a generic-labelled inotuzumab ozogamicin product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Inotuzumab Ozogamicin: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/inotuzumab-ozogamicin
- MLA
- “Inotuzumab Ozogamicin: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/inotuzumab-ozogamicin.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for inotuzumab ozogamicin on DailyMed (NIH) ↗ — including its boxed warning in full.