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# Mylod (Mylotarg - Gemtuzumab Ozogamicin)
## Overview
Gemtuzumab ozogamicin is a CD33-directed antibody-drug conjugate (ADC). It consists of a monoclonal antibody linked to calicheamicin, a potent cytotoxic agent that induces double-strand DNA breaks, leading to cell cycle arrest and apoptosis.
## Primary Indications
* Treatment of newly diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older.
* Treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients 2 years and older.
## Adult Dosing
* **Newly Diagnosed AML (Combination Therapy):** 3 mg/m² (up to a maximum dose of one 4.5 mg vial) on days 1, 4, and 7 in combination with daunorubicin and cytarabine.
* **Relapsed/Refractory AML (Monotherapy):** 9 mg/m² as a single dose.
* *Note:* Always verify protocol as regimens vary significantly by cycle and combination.
## Pediatric Dosing
* **Newly Diagnosed AML:** 3 mg/m² (up to a maximum dose of one 4.5 mg vial) on days 1, 4, and 7.
* **Relapsed/Refractory AML:** 3 mg/m² on days 1, 4, and 7.
* *Note:* Pediatric dosing is strictly weight/surface area-based; clinical trial protocols must be confirmed.
## Dose Adjustments
* **Hepatic Impairment:** Reduce dose in patients with baseline total bilirubin >2x ULN.
* **Toxicity:** Hold doses for severe infusion-related reactions or persistent grade 3/4 non-hematologic toxicity. Dosage modifications are protocol-dependent.
## Contraindications
* Known hypersensitivity to gemtuzumab ozogamicin or any component of the formulation.
## Adverse Effects
* **Hepatotoxicity:** Including veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS), particularly in patients undergoing hematopoietic stem cell transplantation (HSCT).
* **Myelosuppression:** Severe neutropenia, thrombocytopenia, and anemia.
* **Infusion-related reactions:** Hypotension, dyspnea, chills, and fever.
* **Infections:** Increased risk due to prolonged myelosuppression.
## Key Drug Interactions
* **Hepatotoxic Agents:** Use caution; may increase risk of VOD/SOS.
* **Live Vaccines:** Avoid concomitant administration; immunocompromised state decreases vaccine efficacy and increases infection risk.
## Monitoring
* **Liver Function:** Baseline and regular monitoring of ALT, AST, alkaline phosphatase, and total bilirubin (watch for signs of VOD/SOS, e.g., weight gain, hepatomegaly, ascites).
* **CBC:** Monitor blood counts frequently for myelosuppression.
* **Infusion:** Monitor vital signs throughout the infusion.
* **Cardiac:** Baseline and periodic ECG/Echocardiogram if used with anthracyclines.
## Clinical Pearls
* **Premedication:** Always administer corticosteroids, antihistamines, and antipyretics 1 hour prior to infusion to mitigate infusion reactions.
* **VOD Risk:** Avoid gemtuzumab ozogamicin within 2 weeks of or post-HSCT whenever possible due to heightened risk of fatal VOD.
* **Handling:** This is a cytotoxic agent; use specialized hazardous drug handling protocols.
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**Educational Disclaimer:** This information is for educational purposes only. Clinical guidelines and prescribing information change frequently. Always consult the most current FDA-approved package insert, institutional protocols, and official drug compendia (e.g., Lexicomp, Micromedex) before prescribing or administering any medication.
