Molecule
Inotuzumab ozogamicin is a CD22-directed immunoconjugate 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. MedsAcross supplies Inotuzumab ozogamicin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
1. INDICATIONS 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.
Source: US FDA prescribing information
Inotuzumab ozogamicin is a CD22-directed antibody drug conjugate (ADC). Inotuzumab recognizes human CD22. The small molecule, N-acetyl-gamma-calicheamicin, is a cytotoxic agent that is covalently attached to the antibody via a linker. Nonclinical data suggest that the anticancer activity of inotuzumab ozogamicin is due to the binding of the ADC to CD22-expressing tumor cells, followed by internalization of the ADC-CD22 complex, and the intracellular release of N-acetyl-gamma-calicheamicin dimethylhydrazide via hydrolytic cleavage of the linker. Activation of N-acetyl-gamma-calicheamicin dimethylhydrazide induces double-strand DNA breaks, subsequently inducing cell cycle arrest and apoptotic cell death.
Source: US FDA prescribing information
2. DOSAGE AND ADMINISTRATION • Administer by intravenous infusion only. • Pre-medicate with a corticosteroid, antipyretic, and antihistamine prior to all infusions. • Dosing regimens for Cycle 1 and subsequent cycles, depending on the response to treatment, are shown below. See full prescribing information for dosing details. 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).
Source: US FDA prescribing information
4. CONTRAINDICATIONS None. None
Source: US FDA prescribing information
Boxed warning: Hepatotoxicity, including fatal and life-threatening VOD occurred in patients who received BESPONSA. • A higher post-HSCT non-relapse mortality rate occurred in patients receiving BESPONSA. HEPATOTOXICITY, INCLUDING VOD • Hepatotoxicity, including fatal and life-threatening VOD occurred in patients with relapsed or refractory acute lymphoblastic leukemia (ALL) who received BESPONSA. 5. WARNINGS AND PRECAUTIONS • Myelosuppression: Monitor complete blood counts, for signs and symptoms of infection, bleeding/hemorrhage, or other effects of myelosuppression during treatment, manage appropriately. • Infusion related reactions: Monitor for infusion related reactions during and for at least 1 hour after infusion ends. • QT interval prolongation: Obtain electrocardiograms (ECGs) and electrolytes at baseline and monitor during treatment.
Source: US FDA prescribing information
6. ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: • Hepatotoxicity, including hepatic VOD (also known as SOS) • Increased risk of post-transplant non-relapse mortality • Myelosuppression • Infusion related reactions • QT interval prolongation 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.
Source: US FDA prescribing information
7. 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. 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.
Source: US FDA prescribing information
Refrigerate (2-8°C, 36-46°F) BESPONSA vials and store in the original carton to protect from light. Do not freeze.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Inotuzumab ozogamicin, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Besponsa 0.25 mg/mL powder for injectionIntravenous Cold chain | Wyeth Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Inotuzumab ozogamicin and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Inotuzumab ozogamicin, including Besponsa.
Yes. The US FDA first approved Inotuzumab ozogamicin on 17 August 2017, according to Drugs@FDA.
Yes. Inotuzumab ozogamicin has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Inotuzumab ozogamicin must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Inotuzumab ozogamicin is classified under ATC code L01FB01 (Inotuzumab ozogamicin).
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