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MYLOTARG™ (gemtuzumab ozogamicin) Highlights

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

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

Indications and Usage, Newly-Diagnosed CD33-positive Acute Myeloid Leukemia (AML) (1.1)06/2020
Dosage and Administration, Recommended Dosage (2.2)06/2020
Dosage and Administration, Dose Modifications for Toxicities (2.3)06/2020
Warnings and Precautions, Hepatotoxicity, Including Veno-occlusive Liver Disease (VOD) (5.1)06/2020
Warnings and Precautions, Hemorrhage (5.3)06/2020

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)
    Adults:
    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).
    Pediatric patients 1 month and older:
    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):
    Adults:
    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).

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, 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).

ADVERSE REACTIONS

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.

Revised: 6/2020

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