HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the... |
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BESPONSA™ (inotuzumab ozogamicin)
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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
BESPONSA™ Quick Finder
Highlights
Boxed Warning
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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Indications and Usage
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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Dosage and Administration
2. DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
- Pre-medicate before each dose [see Dosage and...
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Dosage Forms and Strengths
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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Warnings and Precautions
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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Adverse Reactions
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...
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Drug Interactions
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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Use in Specific Populations
8. USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on its...
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Description
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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Clinical Pharmacology
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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Nonclinical Toxicology
13. NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Formal carcinogenicity studies have not been conducted with inotuzumab ozogamicin...
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Clinical Studies
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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References
15. REFERENCES
- OSHA Hazardous Drugs. OSHA. [Accessed on 3 May 2017, from http://www.osha.gov/SLTC/hazardousdrugs/index.html]
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How Supplied/Storage and Handling
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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Patient Counseling Information
17. PATIENT COUNSELING INFORMATION
Hepatotoxicity, Including Hepatic Veno-occlusive Disease (VOD) (also known as Sinusoidal Obstruction Syndrome)...
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Resources
Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at(800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.