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## Overview
Mylotarg (gemtuzumab ozogamicin) is a humanized antibody-drug conjugate. It targets CD33, a protein expressed on the surface of myeloid leukemia cells, and delivers the cytotoxic agent calicheamicin to these cells.
## Primary Indications
* Treatment of adults with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive induction chemotherapy.
* Treatment of adults with relapsed or refractory AML.
## Adult Dosing
**Newly Diagnosed AML (in combination with other agents):**
* **First cycle:** 6 mg/m² on days 1, 4, and 7.
* **Second cycle (if needed):** 3 mg/m² on days 1, 4, and 7.
**Relapsed or Refractory AML:**
* **First cycle:** 6 mg/m² on day 1.
* **Second cycle (if needed):** 3 mg/m² on day 1.
Maximum cumulative dose: 27 mg/m².
## Pediatric Dosing
Mylotarg is not approved for use in pediatric patients.
## Dose Adjustments
* **Hepatotoxicity:** Dose reduction or interruption may be necessary. Refer to specific prescribing information for detailed guidance based on liver function tests (LFTs).
* **Infusion-Related Reactions:** Interruption or slowing of infusion may be required.
## Contraindications
* None specifically listed, but caution is advised in patients with severe hepatic impairment.
## Adverse Effects
**Common:**
* Thrombocytopenia, neutropenia, leukopenia, anemia
* Hepatotoxicity (including VOD/SOS)
* Infusion-related reactions (fever, chills, rash, dyspnea)
* Nausea, vomiting, diarrhea, stomatitis
* Headache, fatigue, cough
* Pneumonitis
**Serious:**
* Hepatotoxicity, particularly Veno-Occlusive Disease/Sinusoidal Obstruction Syndrome (VOD/SOS)
* Hemorrhage
* Severe infusion-related reactions
* Embryo-fetal toxicity
## Key Drug Interactions
* **Hepatotoxic Agents:** Concomitant use with other drugs known to cause liver injury (e.g., certain chemotherapy agents, azathioprine) may increase the risk of hepatotoxicity.
* **Myelosuppressive Agents:** Mylotarg itself is myelosuppressive. Concurrent use with other myelosuppressive agents will potentiate neutropenia, thrombocytopenia, and anemia.
## Monitoring
* Complete blood counts (CBC) with differential and platelet count: frequently during treatment and for at least 30 days after the last dose.
* Liver function tests (LFTs), including bilirubin and ALT/AST: frequently during treatment.
* Signs and symptoms of infusion-related reactions and VOD/SOS.
* Pregnancy status in women of childbearing potential.
## Clinical Pearls
* Mylotarg carries a Black Box Warning for hepatotoxicity, including VOD/SOS, and for bleeding events.
* Patients should be monitored closely for signs and symptoms of VOD/SOS (e.g., jaundice, right upper quadrant pain, ascites, hepatomegaly) and bleeding.
* Consider pre-treatment with corticosteroids to mitigate infusion-related reactions.
* Due to the risk of embryo-fetal toxicity, women of childbearing potential should be advised of the potential risk and use effective contraception.
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**Disclaimer:** This information is intended for healthcare professionals. Always consult the most current prescribing information and relevant clinical guidelines for definitive patient management.
