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
See full prescribing information for complete boxed warning.
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. (5.1, 6.1)
RECENT MAJOR CHANGES
|Indications and Usage, Newly-Diagnosed CD33-positive Acute Myeloid Leukemia (AML) (1.1)
|Dosage and Administration, Recommended Dosage (2.2)
|Dosage and Administration, Dose Modifications for Toxicities (2.3)
|Warnings and Precautions, Hepatotoxicity, Including Veno-occlusive Liver Disease (VOD) (5.1)
|Warnings and Precautions, Hemorrhage (5.3)
INDICATIONS AND USAGE
MYLOTARG is a CD33-directed antibody and cytotoxic drug conjugate indicated for:
- treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older (1.1).
- treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients 2 years and older (1.2).
DOSAGE AND ADMINISTRATION
- Newly-diagnosed, de novo AML (combination regimen)
Pediatric patients 1 month and older:
Induction: 3 mg/m2 (up to one 4.5 mg vial) on Days 1, 4, and 7 in combination with daunorubicin and cytarabine (2.2).
Consolidation: 3 mg/m2 on Day 1 (up to one 4.5 mg vial) in combination with daunorubicin and cytarabine (2.2).
- 3 mg/m2 for patients with body surface area (BSA) 0.6 m2 or greater (2.2).
- 0.1 mg/kg for patients with BSA less than 0.6 m2 (2.2).
- See Full Prescribing Information for complete dosing information (2.2).
- Newly-diagnosed AML (single-agent regimen):
Induction: 6 mg/m2 (not limited to one 4.5 mg vial) on Day 1 and 3 mg/m2 (not limited to one 4.5 mg vial) on Day 8 (2.2).
Continuation: For patients without evidence of disease progression following induction, up to 8 continuation courses of MYLOTARG 2 mg/m2 (not limited to one 4.5 mg vial) on Day 1 every 4 weeks (2.2).
- Relapsed or refractory AML (single-agent regimen):
- Adults and pediatric patients 2 years and older:
- 3 mg/m2 (up to one 4.5 mg vial) on Days 1, 4, and 7 (2.2).
- Premedicate with a corticosteroid, antihistamine, and acetaminophen (2.1).
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
- Infusion-related reactions (including anaphylaxis): Premedicate with a corticosteroid, acetaminophen, and diphenhydramine. Monitor patients during and for at least 1 hour after the end of the infusion. Interrupt the infusion, administer steroids or antihistamines, or permanently discontinue treatment as necessary (2.1, 5.2, 6).
- Hemorrhage: Severe, including fatal, hemorrhage may occur when MYLOTARG is used at recommended doses. Monitor platelet counts frequently (5.3, 6.1).
- Embryo-fetal toxicity: Can cause fetal harm. Advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception (5.6, 8.1, 8.3).
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.