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MYLOTARG™ (gemtuzumab ozogamicin)

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MYLOTARG™ Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

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WARNING: HEPATOTOXICITY

Hepatotoxicity, including severe or fatal hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), has been reported in association with the use of MYLOTARG as a single agent...

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1 INDICATIONS AND USAGE

1.1 Newly-Diagnosed CD33-positive Acute Myeloid Leukemia (AML)

MYLOTARG is indicated for the treatment of newly-diagnosed CD33-...

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2 DOSAGE AND ADMINISTRATION

2.1 Premedication and Special Considerations

  • Premedicate adults with acetaminophen 650 mg orally and diphenhydramine 50 mg orally or...
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3 DOSAGE FORMS AND STRENGTHS

For injection: 4.5 mg as a white to off-white lyophilized cake or powder in a single-dose vial for reconstitution and further dilution.

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4 CONTRAINDICATIONS

MYLOTARG is contraindicated in patients with a history of hypersensitivity to the active substance in MYLOTARG or any of its components or to any of the excipients. Reactions have included anaphylaxis...

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5 WARNINGS AND PRECAUTIONS

5.1 Hepatotoxicity, Including Veno-occlusive Liver Disease (VOD)

Hepatotoxicity, including life-threatening and sometimes fatal hepatic VOD...

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6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Hepatotoxicity, including VOD [see

    6.1 Clinical Trials...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Based on its mechanism...

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11. DESCRIPTION

Chemical Structure

Gemtuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of the CD33-directed monoclonal antibody (...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Gemtuzumab ozogamicin is a CD33-directed antibody-drug conjugate (ADC). The antibody portion (hP67.6) recognizes...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

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

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14 CLINICAL STUDIES

14.1 Newly-Diagnosed CD33-positive AML

Study ALFA-0701

...

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15 REFERENCES

1. OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

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16 HOW SUPPLIED/STORAGE AND HANDLING

MYLOTARG (gemtuzumab ozogamicin) for injection is a white to off-white lyophilized cake or powder supplied in a carton (NDC 0008-4510-01) containing one 4.5 mg single-dose vial...

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17. PATIENT COUNSELING INFORMATION

Hepatotoxicity, Including Veno-occlusive Liver Disease (VOD)

Inform patients that liver problems,...

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This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

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