HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use BESPONSA™ safely and effectively. See full prescribing information for BESPONSA.
BESPONSA (inotuzumab ozogamicin) for injection, for intravenous use Initial U.S. Approval: 2017 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 MORTALITYSee full prescribing information for complete boxed warning.- •
- Hepatotoxicity, including fatal and life-threatening VOD occurred in patients who received BESPONSA. (5.1)
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- A higher post-HSCT non-relapse mortality rate occurred in patients receiving BESPONSA (5.2)
RECENT MAJOR CHANGES Indications and Usage (1) | 3/2024 | Dosage and Administration, Instructions for Reconstitution, Dilution and Administration (2.4) | 3/2024 | Warnings and Precautions, Hepatotoxicity, Including Hepatic Veno-occlusive Disease (VOD) (also known as Sinusoidal Obstruction Syndrome) (5.1) | 3/2024 | Warnings and Precautions, Increased Risk of Post-Transplant Non-Relapse Mortality (5.2) | 3/2024 | Warnings and Precautions, Myelosuppression (5.3) | 3/2024 | Warnings and Precautions, Infusion Related Reactions (5.4) | 3/2024 | Warnings and Precautions, QT Interval Prolongation (5.5) | 3/2024 |
INDICATIONS AND USAGEBESPONSA 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. (1) DOSAGE AND ADMINISTRATION- •
- Administer by intravenous infusion only. (2.1)
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- Pre-medicate with a corticosteroid, antipyretic, and antihistamine prior to all infusions. (2.2)
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- 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/m2 | 0.5 mg/m2 | 0.5 mg/m2 | Cycle length | 21 days* | Dosing regimen for subsequent cycles depending on response to treatment | Patients who have achieved a CR or CRi: | Dose | 0.5 mg/m2 | 0.5 mg/m2 | 0.5 mg/m2 | Cycle length | 28 days | Patients who have not achieved a CR or CRi: | Dose | 0.8 mg/m2 | 0.5 mg/m2 | 0.5 mg/m2 | Cycle length | 28 days |
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- See full prescribing information for instructions on reconstitution of lyophilized powder, and preparation and administration of reconstituted drug. (2.4)
DOSAGE FORMS AND STRENGTHSFor injection: 0.9 mg lyophilized powder in a single-dose vial for reconstitution and further dilution. (3) 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. (5.3)
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- Infusion related reactions: Monitor for infusion related reactions during and for at least 1 hour after infusion ends. (5.4)
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- 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. (5.5)
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- Embryo-fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. (5.6, 8.1, 8.3)
ADVERSE REACTIONSThe 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.
USE IN SPECIFIC POPULATIONSLactation: Advise not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION. Revised: 3/2024 |