Leukemias, lymphomas, and other hematologic cancers:

Indications for MYLOTARG:

Newly-diagnosed CD33-positive acute myeloid leukemia (AML) in patients ≥1month. Relapsed or refractory CD33-positive AML in patients ≥2yrs.

Adult:

Premedicate with acetaminophen (oral) and diphenhydramine (oral or IV) 1hr prior to infusion, and corticosteroid within 30mins prior to infusion. For hyperleukocytosis patients: cytoreduction is recommended prior to initiation. Give by IV infusion over 2hrs. Newly-diagnosed (combination regimen): (treatment course = 1 induction cycle + 2 consolidation cycles): 3mg/m2 (max 4.5mg) on Days 1, 4, and 7 with daunorubicin + cytarabine for induction cycle (do not give Mylotarg if 2nd induction cycle is required); 3mg/m2 (max 4.5mg) on Day 1 with daunorubicin + cytarabine for consolidation cycles. Newly-diagnosed (single-agent regimen): (treatment course = 1 induction cycle + up to 8 continuation therapy cycles): 6mg/m2 on Day 1, and 3mg/m2 on Day 8 for induction cycle; 2mg/m2 on Day 1 every 4 weeks for continuation cycles. Relapsed/refractory (single-agent regimen): 3mg/m2 (max 4.5mg) on Days 1, 4, 7. Dose modifications for toxicities: see full labeling.

Children:

Premedicate with acetaminophen and diphenhydramine 1hr prior to infusion, and corticosteroid (oral or IV) within 30mins prior to infusion. For hyperleukocytosis patients: cytoreduction is recommended prior to initiation. Give by IV infusion over 2hrs. Newly-diagnosed (combination regimen): <1month: not established. ≥1month (BSA ≥0.6m2): 3mg/m2; (BSA <0.6m2): 0.1mg/kg. Induction 1: give Mylotarg once with standard chemotherapy; Induction 2: do not administer Mylotarg. For 1st or 3rd intensification cycles: do not administer Mylotarg. 2nd intensification cycle: give Mylotarg once with standard chemotherapy. Relapsed/refractory (single-agent regimen): <2yrs: not established. ≥2yrs: 3mg/m2 (max 4.5mg) on Days 1, 4, 7. Dose modifications for toxicities: see full labeling.

Boxed Warning:

Hepatotoxicity.

Warnings/Precautions:

Hepatotoxicity (including hepatic veno-occlusive liver disease [VOD] events); withhold, discontinue, and treat if occurs. Hemorrhage. Assess LFTs, CBCs prior to each dose; monitor frequently thereafter. Monitor for infusion-related reactions during and for ≥1hr post infusion; discontinue if anaphylaxis (including severe respiratory symptoms or significant hypotension) develops. History of or predisposition for QTc prolongation. Electrolyte disturbances. Obtain ECGs and electrolytes prior to initiation and during therapy as needed. Embryo-fetal toxicity. Advise to use effective contraception during and for ≥6months (females of reproductive potential) or ≥3months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for ≥1month after the last dose).

Pharmacologic Class:

CD33-directed antibody-drug conjugate.

Interactions:

Caution with drugs known to prolong the QT interval.

Adverse Reactions:

Hemorrhage, infection, fever, nausea, vomiting, constipation, headache, increased AST/ALT, rash, mucositis, febrile neutropenia, decreased appetite; thrombocytopenia, infusion-related reactions.

Generic Availability:

NO

How Supplied:

Single-dose vial—1