BESPONSA® (inotuzumab ozogamicin) Highlights

(inotuzumab ozogamicin)

Prescribing Information

Health Professional Information

Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These 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 MORTALITY

See full prescribing information for complete boxed warning.

•: Hepatotoxicity, including fatal and life-threatening VOD occurred in patients who received BESPONSA. (5.1)
•: 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 USAGE

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. (1)

DOSAGE AND ADMINISTRATION

•: 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)

* 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).
	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

•: See full prescribing information for instructions on reconstitution of lyophilized powder, and preparation and administration of reconstituted drug. (2.4)

DOSAGE FORMS AND STRENGTHS

For injection: 0.9 mg lyophilized powder in a single-dose vial for reconstitution and further dilution. (3)

CONTRAINDICATIONS

None (4)

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)
•: Infusion related reactions: Monitor for infusion related reactions during and for at least 1 hour after infusion ends. (5.4)
•: 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)
•: 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 REACTIONS

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.

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed. (8.2)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 3/2024

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