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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is an antibody-drug conjugate that targets CD33, a protein found on the surface of myeloid leukemia cells. It delivers a cytotoxic agent (calicheamicin) directly to these cells.
## Primary Indications
* Treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive induction and consolidation chemotherapy.
* Treatment of adult patients with relapsed or refractory AML.
## Adult Dosing
**Newly Diagnosed AML (Ineligible for intensive chemotherapy):**
* Day 1: 3 mg/m² intravenously (IV)
* Day 4: 3 mg/m² IV
* Day 7: 2 mg/m² IV
* A second course may be given if hematologic recovery occurs. The dose for the second course is 3 mg/m² IV on Day 1.
**Relapsed or Refractory AML:**
* First course: 6 mg/m² IV on Day 1. If tolerated, a second course of 6 mg/m² IV on Day 1 may be given approximately 2 to 3 weeks after the first course.
* Maximum cumulative dose: 26.4 mg/m² over the lifetime of the patient.
## Pediatric Dosing
Not established.
## Dose Adjustments
* **Hepatic Impairment:** Use with caution. Consider dose reduction if bilirubin is > 2.5 mg/dL or AST is > 10 times the upper limit of normal.
* **Renal Impairment:** No specific dose adjustments are provided, but use with caution in severe renal impairment.
## Contraindications
* None listed.
## Adverse Effects
* **Serious:** Hepatotoxicity (including VOD/SOS), myelosuppression (including neutropenia, thrombocytopenia, anemia), infusion-related reactions, bleeding events, tumor lysis syndrome, gastrointestinal toxicity.
* **Common:** Fever, nausea, vomiting, diarrhea, stomatitis, headache, fatigue, rash.
## Key Drug Interactions
* No specific drug interactions are listed in the prescribing information. However, caution with other myelosuppressive agents.
## Monitoring
* **Hepatotoxicity:** Monitor liver function tests (bilirubin, AST, ALT) regularly, especially before and during treatment.
* **Myelosuppression:** Monitor complete blood counts (CBC) with differential and platelet counts frequently.
* **Infusion-related reactions:** Monitor vital signs during and after infusion.
* **Bleeding:** Monitor for signs and symptoms of bleeding.
## Clinical Pearls
* Consider prophylaxis for tumor lysis syndrome in patients with high tumor burden.
* Veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS) is a serious and potentially fatal adverse effect; monitor closely and manage appropriately.
* Patients with pre-existing liver dysfunction may be at increased risk of hepatotoxicity.
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**Disclaimer:** This information is intended for healthcare professionals. Always consult the current prescribing information and relevant clinical guidelines before making therapeutic decisions. Dosing may vary based on individual patient factors and local protocols.
