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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is an FDA-approved antibody-drug conjugate for the treatment of acute myeloid leukemia (AML). It targets the CD33 antigen, which is found on most leukemia cells.
## Primary Indications
* Newly diagnosed acute myeloid leukemia (AML) in adult patients in combination with other chemotherapy.
* Relapsed or refractory AML in adult patients.
## Adult Dosing
**Combination Therapy (Newly Diagnosed AML):**
* 3 mg/m² on day 1, day 4, and day 7 of induction cycles.
* 3 mg/m² on day 1 of each consolidation cycle.
* Maximum cumulative dose: 18 mg/m².
**Monotherapy (Relapsed or Refractory AML):**
* First cycle: 3 mg/m² on day 1. If tolerated, a second dose of 3 mg/m² may be administered on day 4.
* Second cycle (if administered): 3 mg/m² on day 1.
* Maximum cumulative dose: 18 mg/m².
Dosing timing and subsequent cycles may vary based on local protocol and patient response.
## Pediatric Dosing
The safety and efficacy of Mylotarg in pediatric patients have not been established.
## Dose Adjustments
* **Hepatotoxicity:** Dose interruption or reduction may be necessary based on the severity of liver enzyme elevations. Management guidelines for veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS) and hyperbilirubinemia should be followed.
* **Hematologic Toxicity:** Dose interruption or reduction may be necessary for severe myelosuppression.
## Contraindications
* None listed. However, caution is advised in patients with pre-existing liver impairment.
## Adverse Effects
* **Hepatotoxicity:** Veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS) and hyperbilirubinemia are serious risks.
* Myelosuppression (neutropenia, thrombocytopenia, anemia).
* Bleeding events.
* Infusion-related reactions.
* Nausea, vomiting, diarrhea, stomatitis.
* Fatigue, headache, fever.
* Increased risk of posterior reversible encephalopathy syndrome (PRES).
## Key Drug Interactions
* **Warfarin:** Increased risk of bleeding. Monitor INR closely.
* **Strong CYP3A4 inhibitors/inducers:** May affect metabolism of downstream metabolites, though clinical significance is uncertain.
## Monitoring
* **Liver function tests (LFTs):** Baseline and regularly during treatment, especially for bilirubin and AST/ALT.
* **Complete blood count (CBC) with differential and platelet count:** Regularly during treatment.
* **Signs and symptoms of VOD/SOS and PRES.**
* **Signs of bleeding.**
## Clinical Pearls
* Mylotarg carries a boxed warning for hepatotoxicity, particularly VOD/SOS, which can be fatal. Strict monitoring and adherence to dose limits are crucial.
* Discontinue Mylotarg if VOD/SOS or PRES is confirmed.
* Pre-hydration and slow infusion rates can help mitigate infusion-related reactions.
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**Disclaimer:** This information is intended for healthcare professionals. Always consult the most current prescribing information and relevant clinical guidelines before making treatment decisions.
