For: Acute Myeloid Leukemia
Mylotarg (gemtuzumab ozogamicin) is a D33-directed antibody-drug conjugate indicated for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and the treatment of relapsed or refractory CD33-positive AML in adults and in pediatric patients 2 years and older. 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 [see Dosage and Administration (2)].
16.1 Storage and Handling
Refrigerate (2�"8°C; 36�"46°F) MYLOTARG vials and store in the original carton to protect from light. DO NOT FREEZE.
MYLOTARG is a cytotoxic drug. Follow applicable special handling and disposal procedures.1
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
WARNING: HEPATOTOXICITY
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
Dosage and Administration, Recommended Dosage (2.2) 4/2018
Dosage and Administration, Instructions for Reconstitution, Dilution, and Administration (2.4) 4/2018
INDICATIONS AND USAGE
MYLOTARG is a CD33-directed antibody-drug conjugate indicated for:
treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults (1.1).
treatment of relapsed or refractory CD33-positive AMLin adults and in pediatric patients 2 years and older (1.2).
DOSAGE AND ADMINISTRATION
Newly-diagnosed, de novo AML (combination regimen):
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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).
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Consolidation: 3 mg/m2 on Day 1 (up to one 4.5 mg vial) in combination with daunorubicin and cytarabine. (2.2).
Newly-diagnosed AML (single-agent regimen):
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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).
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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):
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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 1 hour prior to MYLOTARG (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).
CONTRAINDICATIONS
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, and 6).
Hemorrhage: Severe, including fatal, hemorrhage may occur when MYLOTARG is used at recommended doses. Monitor platelet counts frequently (5.3 and 6.1).
Embryo-fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception (5.6, 8.1, and 8.3).
ADVERSE REACTIONS
The most common adverse reactions (greater than 15%) were hemorrhage, infection, fever, nausea, vomiting, constipation, headache, increased AST, increased ALT, rash, and mucositis (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.
Revised: 4/2018