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 |

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
MYLOTARG™ Highlights (gemtuzumab ozogamicin)
Resources
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.
(800)-332-1088.