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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is a targeted antibody-drug conjugate that binds to CD33, an antigen expressed on myeloid leukemia cells. It is composed of a humanized anti-CD33 monoclonal antibody linked to a cytotoxic agent, calicheamicin.
## Primary Indications
* Treatment of newly diagnosed acute myeloid leukemia (AML) in patients aged 75 years or older, in combination with daunorubicin and cytarabine.
* Treatment of relapsed or refractory AML in patients aged 18 years or older.
## Adult Dosing
**For newly diagnosed AML (in combination):**
* **Cycles 1 and 2:** 3 mg/m² administered as a single intravenous (IV) infusion on days 4, 7, and 10 of each 28-day cycle.
* **Following cycles:** 3 mg/m² administered as a single IV infusion on day 4 of each 28-day cycle.
* Maximum of 2 cycles in combination therapy.
**For relapsed or refractory AML:**
* **Cycle 1:** 3 mg/m² administered as a single IV infusion on day 1.
* **Cycle 2:** 3 mg/m² administered as a single IV infusion on day 1, if myelosuppression from Cycle 1 has adequately recovered.
* Maximum of 2 cycles.
**Infusion Rate:**
* Administer over 2 hours. Do not administer as a rapid infusion.
## Pediatric Dosing
The safety and efficacy of Mylotarg have not been established in pediatric patients.
## Dose Adjustments
**Hepatic Impairment:**
* No dose adjustment is recommended. However, close monitoring for adverse events is advised.
**Renal Impairment:**
* No dose adjustment is recommended. However, close monitoring for adverse events is advised.
## Contraindications
* None specifically listed in prescribing information.
## Adverse Effects
* **Hepatotoxicity:** The most serious adverse reaction is veno-occlusive liver disease (also known as sinusoidal obstruction syndrome, SOS). Symptoms can include hyperbilirubinemia, hepatomegaly, and right upper quadrant pain.
* **Myelosuppression:** Thrombocytopenia, neutropenia, and febrile neutropenia are common and expected.
* **Bleeding:** Hemorrhage, including gastrointestinal hemorrhage.
* **Infusion-related reactions:** Fever, chills, rash, dyspnea.
* **Infections:** Sepsis, pneumonia.
* **Nausea and vomiting.**
* **Stomatitis.**
* **Headache.**
* **Pneumonitis.**
## Key Drug Interactions
No specific drug interactions have been identified in clinical trials. However, caution is advised when co-administering agents that may increase the risk of bleeding or hepatotoxicity.
## Monitoring
* **Liver Function Tests (LFTs):** Monitor bilirubin, ALT, AST, and alkaline phosphatase regularly, especially before each dose and as clinically indicated. Be vigilant for signs and symptoms of SOS.
* **Complete Blood Counts (CBCs) with differential and platelet count:** Frequently monitor for myelosuppression.
* **Signs and symptoms of bleeding and infection.**
* **Infusion-related reactions.**
## Clinical Pearls
* Mylotarg carries a Boxed Warning for hepatotoxicity, including fatal SOS. Patients must be closely monitored.
* Consider pre-treatment with corticosteroids and antihistamines to minimize infusion-related reactions.
* The decision to administer the second cycle in relapsed/refractory AML should be based on adequate recovery of myelosuppression.
* Mylotarg is a potent cytotoxic agent; appropriate handling precautions should be followed.
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*This information is intended for healthcare professionals. Always consult the most current prescribing information and relevant clinical guidelines for complete details and patient-specific management.*
