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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is an antibody-drug conjugate that targets CD33-expressing cells. It consists of a humanized anti-CD33 monoclonal antibody linked to a cytotoxic agent, calicheamicin.
## Primary Indications
* Acute Myeloid Leukemia (AML):
* Newly diagnosed CD33-positive AML in adult patients in combination with standard induction and consolidation chemotherapy.
* CD33-positive AML in adult patients who have relapsed or are refractory and are not candidates for hematopoietic stem cell transplantation.
## Adult Dosing
* **Newly Diagnosed CD33-positive AML (in combination):**
* Day 1: 3 mg/m² IV infusion.
* Day 4: 3 mg/m² IV infusion.
* Day 7: 2 mg/m² IV infusion.
* Subsequent cycles: 3 mg/m² IV infusion every 2-4 weeks.
* Maximum total dose per cycle: 9 mg/m².
* **Relapsed or Refractory CD33-positive AML:**
* First cycle: 3 mg/m² IV infusion on day 1.
* Second cycle (if tolerated and meeting criteria): 3 mg/m² IV infusion on day 1.
* Maximum total dose per patient: 6 mg/m².
## Pediatric Dosing
Dosing in pediatric patients is not established.
## Dose Adjustments
* **Hepatotoxicity:** Dose reduction or discontinuation may be necessary based on the severity of liver enzyme elevations and bilirubin levels. Refer to specific guidelines or prescribing information for detailed recommendations.
* **Thrombocytopenia:** Close monitoring of platelet counts is essential. Dose adjustments or delays may be indicated, particularly in patients with severe thrombocytopenia.
* **Infusion Reactions:** Slowing or stopping the infusion may be necessary for infusion-related reactions.
## Contraindications
* Known hypersensitivity to gemtuzumab ozogamicin or any component of the formulation.
* Active or recent invasive fungal or bacterial infection.
## Adverse Effects
The most common adverse effects include:
* Hepatotoxicity (e.g., hyperbilirubinemia, elevated transaminases, sinusoidal obstruction syndrome/veno-occlusive disease)
* Thrombocytopenia
* Neutropenia
* Leukopenia
* Anemia
* Fever
* Nausea, vomiting, diarrhea
* Mucositis
* Fatigue
* Bleeding events
* Infusion-related reactions
## Key Drug Interactions
* **Hepatotoxic Agents:** Concomitant use with other drugs known to cause hepatotoxicity may increase the risk of liver injury.
* **Myelosuppressive Agents:** Mylotarg is myelosuppressive. Avoid concomitant use with other potent myelosuppressive agents unless clinically indicated and carefully monitored.
## Monitoring
* Complete blood counts (CBC) with differential and platelet count frequently.
* Liver function tests (LFTs), including bilirubin and transaminases, regularly.
* Monitor for signs and symptoms of infusion reactions, bleeding, and infection.
* Monitor for signs and symptoms of sinusoidal obstruction syndrome (SOS)/veno-occlusive disease (VOD).
## Clinical Pearls
* Mylotarg carries a significant risk of hepatotoxicity, including SOS/VOD, which can be fatal. Close monitoring of liver function is critical.
* Due to the risk of severe myelosuppression, patients should be closely monitored for signs of infection and bleeding.
* Infusion reactions are common. Premedication with corticosteroids, antihistamines, and antipyretics may be considered.
* The dosage and schedule should be carefully followed as per the prescribing information.
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*This information is intended for healthcare professionals and should not be a substitute for professional medical advice. Always consult the most current prescribing information and relevant guidelines before making clinical decisions.*
