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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 a cytotoxic agent (calicheamicin). It is used to treat CD33-positive acute myeloid leukemia (AML).
## Primary Indications
* Newly diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients ≥1 month.
* Relapsed or refractory CD33-positive AML in adults and pediatric patients ≥2 years.
## Adult Dosing
* **Newly diagnosed AML (Combination):** 3 mg/m² (up to a max of 4.5 mg) on days 1, 4, and 7 in combination with daunorubicin and cytarabine.
* **Newly diagnosed AML (Monotherapy):** 6 mg/m² on day 1; then 3 mg/m² on day 8.
* **Relapsed/Refractory AML:** 3 mg/m² on days 1, 4, and 7.
## Pediatric Dosing
* **Newly diagnosed AML (≥1 month):** Based on body surface area (BSA) if ≥0.6 m²: 3 mg/m² (max 4.5 mg) on days 1, 4, and 7. For patients <0.6 m², dose is 0.1 mg/kg.
* **Relapsed/Refractory AML (≥2 years):** 3 mg/m² (max 4.5 mg) on days 1, 4, and 7.
## Dose Adjustments
* **Hepatic Impairment:** Avoid in patients with severe hepatic impairment (total bilirubin >2x ULN, AST/ALT >2.5x ULN). Dosage reductions may be required for mild/moderate impairment based on strict institutional protocol.
* **Toxicity:** Treatment may require delay or permanent discontinuation for persistent severe non-hematologic toxicity or prolonged hematologic recovery.
## Contraindications
* Known hypersensitivity to gemtuzumab ozogamicin or any component of the formulation.
* Active uncontrolled infection.
## Adverse Effects
* **Hepatotoxicity:** Including veno-occlusive disease (VOD/sinusoidal obstruction syndrome).
* **Infusion-Related Reactions:** Fever, chills, hypotension, or dyspnea.
* **Hematologic:** Severe neutropenia, thrombocytopenia, and anemia.
* **Infections:** Risk of opportunistic infections due to immunosuppression.
* **Hemorrhage:** Often associated with thrombocytopenia.
## Key Drug Interactions
* **Hepatotoxic Agents:** Risk of additive liver injury; avoid concomitant administration where possible.
* **Live Vaccines:** Avoid due to risk of disseminated infection in immunocompromised patients.
* **QT-Prolonging Agents:** Potential additive risk; monitor ECG if co-administered.
## Monitoring
* **Liver Function Tests:** Monitor ALT, AST, bilirubin, and alkaline phosphatase prior to each dose and throughout treatment. Monitor for signs/symptoms of VOD.
* **CBC with Differential:** Monitor blood counts frequently for recovery.
* **Infusion Monitoring:** Monitor vital signs throughout the infusion.
* **Infection Surveillance:** Monitor for signs of sepsis/infection.
## Clinical Pearls
* **Premedication:** Always administer corticosteroids, antihistamines, and antipyretics 1 hour prior to infusion to mitigate reaction risk.
* **VOD Risk:** The risk of VOD is significantly increased in patients undergoing hematopoietic stem cell transplantation (HSCT) post-therapy.
* **Storage:** The drug is light-sensitive; protect from light during reconstitution and infusion.
* **Administration:** Ensure the final concentration is infused over 2 hours via a dedicated line with a low-protein-binding filter.
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**Educational Disclaimer:** This information is for educational purposes only. Clinical practice and dosing protocols vary by institution and patient-specific factors. Always verify prescribing information and current clinical guidelines via official resources (e.g., FDA-approved labeling, Lexicomp, or UpToDate) before prescribing or administering medication.
