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BESPONSA™ (inotuzumab ozogamicin)

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BESPONSA™ Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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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

...
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1. INDICATIONS AND USAGE

BESPONSA is indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

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2. DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

  • Pre-medicate before each dose [see

    2.2 Recommended Pre-medications...

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3. DOSAGE FORMS AND STRENGTHS

For Injection: 0.9 mg as a white to off-white lyophilized powder in a single-dose vial for reconstitution and further dilution.

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4. CONTRAINDICATIONS

None.

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5. WARNINGS AND PRECAUTIONS

5.1 Hepatotoxicity, Including Hepatic Veno-occlusive Disease (VOD) (also known as Sinusoidal Obstruction Syndrome)

In the INO-VATE ALL...

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6. ADVERSE REACTIONS

The following adverse reactions are discussed in greater detail in other sections of the label:

  • Hepatotoxicity, including hepatic VOD (also known as SOS) [see

    6.1...

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7. DRUG INTERACTIONS

Drugs That Prolong the QT Interval

Concomitant use of BESPONSA with drugs known to prolong the QT interval or induce...

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8. USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Based on its...

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11. DESCRIPTION

Inotuzumab ozogamicin is a CD22-directed antibody-drug conjugate (ADC) consisting of 3 components: 1) the recombinant humanized immunoglobulin class G subtype 4 (IgG4) kappa antibody inotuzumab, specific for...

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12. CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Inotuzumab ozogamicin is a CD22-directed antibody-drug conjugate (ADC). Inotuzumab recognizes human CD22. The...

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13. NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Formal carcinogenicity studies have not been conducted with inotuzumab ozogamicin...

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14. CLINICAL STUDIES

Patients With Relapsed or Refractory ALL – INO-VATE ALL

The safety and efficacy of BESPONSA were evaluated in INO-VATE ALL...

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15. REFERENCES

  1. OSHA Hazardous Drugs. OSHA. [Accessed on 3 May 2017, from http://www.osha.gov/SLTC/hazardousdrugs/index.html]
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16. HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

BESPONSA (inotuzumab ozogamicin) for Injection is supplied as a white to off-white lyophilized powder in a...

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17. PATIENT COUNSELING INFORMATION

Hepatotoxicity, Including Hepatic Veno-occlusive Disease (VOD) (also known as Sinusoidal Obstruction Syndrome)...

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This product's label may have been updated. For current full prescribing information, please visit www.BESPONSA.com.

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