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Besponsa

inotuzumab ozogamicin
1. Indications and Usage

B-cell precursor acute lymphoblastic leukemia (ALL) — relapsed or refractory, in adults

2. Dosage and Administration

Cycle 1 (for patients achieving CR/CRi): 0.8 mg/m² IV Day 1, 0.5 mg/m² Days 8, 15 (21-day cycle)
Subsequent cycles: 0.5 mg/m² Days 1, 8, 15 (28-day cycle)
Infuse over 1 hour
Pre-medication: Corticosteroid, antipyretic, antihistamine approximately 1 hour before
Duration: Maximum 6 cycles; patients proceeding to HSCT: 2 cycles recommended

3. Dosage Forms and Strengths

For injection: 0.9 mg lyophilized powder in single-dose vial

4. Contraindications

None listed.

5. Warnings and Precautions
⚠ Boxed Warning
HEPATOTOXICITY (INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE/SINUSOIDAL OBSTRUCTION SYNDROME): VOD/SOS, including fatal events, has occurred. The risk is greater in patients who undergo HSCT after treatment. Higher incidence with conditioning regimens containing dual alkylating agents and with last bilirubin ≥ ULN before HSCT. Duration of treatment: limit to 2 cycles if proceeding to HSCT.
  • Hepatotoxicity/VOD/SOS: 14% overall (23% post-HSCT). Fatal events. Risk factors: prior HSCT, age ≥55, liver disease, prior/subsequent HSCT conditioning with thiotepa. Monitor LFTs and signs of VOD (bilirubin elevation, hepatomegaly, rapid weight gain, ascites).
  • Myelosuppression: Thrombocytopenia (51% Grade ≥3), neutropenia (49% Grade ≥3), anemia (18% Grade ≥3). Monitor CBCs prior to each dose.
  • Infusion-Related Reactions: 2%. Pre-medicate and monitor.
  • QT Prolongation: Monitor ECGs and electrolytes.
  • Embryo-Fetal Toxicity
6. Adverse Reactions
Most Common Adverse Reactions

Thrombocytopenia (51%), neutropenia (49%), infection (48%), anemia (36%), leukopenia (35%), fatigue (35%), hemorrhage (33%), pyrexia (32%), nausea (31%), headache (28%), febrile neutropenia (26%), transaminase increased (26%), abdominal pain (23%), GGT increase (21%), hyperbilirubinemia (21%)

Thrombocytopenia
51%
Neutropenia
49%
Infection
48%
Anemia
36%
Leukopenia
35%
Fatigue
35%
Hemorrhage
33%
Pyrexia
32%
Nausea
31%
Headache
28%

Key Safety Signals

Hepatic VOD/SOS in 14% (fatal in 2.1%). Higher risk if HSCT follows treatment. Permanently D/C for VOD/SOS.

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

Key Safety Signals

Hepatic VOD/SOS in 14% (fatal in 2.1%). Higher risk if HSCT follows treatment. Permanently D/C for VOD/SOS.

Consult the complete prescribing information for drug interactions, including effects on CYP enzymes, transporters, and concomitant medications that may require dose adjustments or monitoring.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Inotuzumab ozogamicin is an antibody-drug conjugate composed of a humanized anti-CD22 IgG4 monoclonal antibody conjugated to calicheamicin (N-acetyl-gamma-calicheamicin dimethylhydrazide), a cytotoxic agent, via an acid-labile linker. Upon binding to CD22 on B-cell ALL blasts, the ADC is internalized, and the acidic environment of lysosomes releases calicheamicin, which binds to the minor groove of DNA, causing double-strand breaks and apoptosis.

Pharmacokinetics

Half-life: approximately 12.3 days. Clearance decreases over time as CD22+ cells are depleted. Steady-state reached by Cycle 4. Vd: approximately 12 L. Metabolism via payload (calicheamicin) hydrolysis.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
📋 All Inotuzumab ozogamicin Trials on ClinicalTrials.gov ↗ 📚 PubMed: Inotuzumab ozogamicin Clinical Trials ↗
FDA-Approved Tumor Types

Besponsa has FDA-approved indications across the following cancer types covered on PipelineEvidence:

Acute Lymphoblastic Leukemia
External Resources
📋 DailyMed Label ↗ 🏛️ FDA Drugs@FDA ↗ 🔬 ClinicalTrials.gov ↗ 📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Besponsa. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.
← All Therapies Full Prescribing Information ↗