HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use MYLOTARG safely and effectively. See full prescribing information for MYLOTARG. MYLOTARG™ (gemtuzumab ozogamicin) for injection, for intravenous use Initial U.S. Approval: 2000 RECENT MAJOR CHANGES
INDICATIONS AND USAGEMYLOTARG is a CD33-directed antibody and cytotoxic drug conjugate indicated for: DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHSFor Injection: 4.5 mg as a lyophilized cake or powder in a single-dose vial for reconstitution and dilution (3). CONTRAINDICATIONSHypersensitivity to MYLOTARG or any of its components (4). WARNINGS AND PRECAUTIONS
ADVERSE REACTIONSThe most common adverse reactions (greater than 15%) were hemorrhage, infection, fever, nausea, vomiting, constipation, headache, increased AST, increased ALT, rash, mucositis, febrile neutropenia, and decreased appetite (6). 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 POPULATIONSLactation: Advise not to breastfeed (8.2). See 17 for PATIENT COUNSELING INFORMATION. Revised: 8/2021 |

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MYLOTARG™ Highlights (gemtuzumab ozogamicin)
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