HIGHLIGHTS OF PRESCRIBING INFORMATION
These 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 USAGE
MYLOTARG is a CD33-directed antibody and cytotoxic drug conjugate indicated for:
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
For Injection: 4.5 mg as a lyophilized cake or powder in a single-dose vial for reconstitution and dilution (3).
Hypersensitivity to MYLOTARG or any of its components (4).
WARNINGS AND PRECAUTIONS
The 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 POPULATIONS
Lactation: Advise not to breastfeed (8.2).
See 17 for PATIENT COUNSELING INFORMATION.
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