MYLOTARG™ Highlights

(gemtuzumab ozogamicin)

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

Dosage and Adminstration, Instructions for Reconstitution, Dilution, and Administration (2.4)08/2021

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: 8/2021

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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

Dosage and Adminstration, Instructions for Reconstitution, Dilution, and Administration (2.4)08/2021

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: 8/2021
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