BESPONSA™ Highlights

(inotuzumab ozogamicin)

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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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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