Inotuzumab Ozogamicin

What it is and how it works

Mechanism of Action 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.

Mechanism class: CD22-directed Antibody Interactions

Indications

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.

Dosage and administration (summary)

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).

Contraindications

4. CONTRAINDICATIONS None. None

Warnings and precautions

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. Monitor more frequently when using concomitant mediations known to prolong QT interval. • Embryo-fetal toxicity: Can cause fetal harm.

Pregnancy

Pregnancy Risk Summary Based on its mechanism of action and findings from animal studies , BESPONSA can cause embryo-fetal harm when administered to a pregnant woman . There are no available data on BESPONSA use in pregnant women to inform a drug-associated risk.

Storage and supply

16. HOW SUPPLIED/STORAGE AND HANDLING How Supplied BESPONSA (inotuzumab ozogamicin) for injection is supplied as a white to off-white lyophilized powder in a single-dose vial for reconstitution and further dilution. Each vial delivers 0.9 mg inotuzumab ozogamicin. Each carton (NDC 0008-0100-01) contains one single-dose vial.

Source: Inotuzumab Ozogamicin (Besponsa) — US FDA prescribing information, 2026-02-06, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.