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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is a humanized anti-CD33 monoclonal antibody conjugated to an antitumor antibiotic, calicheamicin. It targets CD33-expressing myeloid cells, including leukemic blasts.
## Primary Indications
Treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are younger than 70 years.
Treatment of adult patients with relapsed or refractory AML.
## Adult Dosing
**Newly Diagnosed AML (in combination with standard induction chemotherapy):**
* **Day 1:** 3 mg/kg
* **Day 4:** 3 mg/kg
* **Day 7:** 2 mg/kg
* **If patient achieves remission:** For patients who achieve remission and proceed to consolidation chemotherapy, an additional dose of 3 mg/kg may be given on Day 1 of the first consolidation cycle.
**Relapsed or Refractory AML:**
* **First cycle:** 6 mg/kg on Day 1.
* **If patient does not achieve remission and receives a second cycle:** 3 mg/kg on Day 1.
**Maximum dose per administration:** 6 mg/kg.
## Pediatric Dosing
Dosing in pediatric patients with AML is not established. Mylotarg is not approved for use in pediatric patients.
## Dose Adjustments
* **Hepatotoxicity:** If liver enzyme elevations or hyperbilirubinemia occur, dose interruption or reduction may be necessary. Specific management guidelines are provided in the full prescribing information.
* **Infusion Reactions:** Slowing or interrupting the infusion may be necessary. Discontinuation may be required for severe reactions.
* **Thrombocytopenia:** Consider delaying Mylotarg if platelet count is below 50,000/µL prior to administration, particularly if veno-occlusive disease (VOD) is suspected or present.
## Contraindications
* None listed in the full prescribing information.
## Adverse Effects
**Common:**
* Thrombocytopenia
* Neutropenia
* Leukopenia
* Febrile neutropenia
* Anemia
* Nausea
* Vomiting
* Diarrhea
* Mucositis
* Headache
* Fever
* Rash
* Elevated liver enzymes (AST, ALT, bilirubin)
**Serious:**
* Hepatotoxicity, including veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS)
* Infusion-related reactions
* Hemorrhage
* Myelosuppression
## Key Drug Interactions
* **Strong CYP3A4 inhibitors/inducers:** Gemtuzumab ozogamicin is metabolized by cellular processes, not CYP enzymes. However, coadministration with drugs that affect liver function or hematologic parameters should be done with caution.
* **Other myelosuppressive agents:** Increased risk of severe myelosuppression.
## Monitoring
* Complete blood counts (CBC) with differential and platelet count prior to each dose.
* Liver function tests (AST, ALT, bilirubin) prior to each dose.
* Monitor for signs and symptoms of Veno-Occclusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS).
* Monitor for signs and symptoms of infusion reactions.
## Clinical Pearls
* Administer as a 2-hour continuous intravenous infusion. Do not administer as a bolus injection.
* Mylotarg carries a Boxed Warning for hepatotoxicity, particularly VOD/SOS, and potential for fatal outcomes. Close monitoring for VOD/SOS is crucial.
* Consider platelet count and risk of hemorrhage when deciding on initiation or continuation of therapy.
* The combination with chemotherapy requires careful management of overlapping toxicities.
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*This information is intended for healthcare professionals. It is essential to consult the full prescribing information and current clinical guidelines for complete details and to verify information before making treatment decisions.*
