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# Mylodermat (Correction: Likely referring to **Mylotarg** / Gemtuzumab ozogamicin)
## Overview
Gemtuzumab ozogamicin is a CD33-directed antibody-drug conjugate (ADC). It delivers a cytotoxic agent (calicheamicin) to CD33-expressing leukemia cells, inducing double-stranded DNA breaks and apoptosis.
## Primary Indications
* Treatment of newly diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients aged 1 month and older.
* Treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients aged 2 years and older.
## Adult Dosing
* **Newly Diagnosed AML (Combination Therapy):** 3 mg/m² (up to a maximum dose of 4.5 mg per single dose) on Days 1, 4, and 7.
* **Relapsed/Refractory AML (Monotherapy):** 9 mg/m² as a single dose.
* *Note: Dosing is based on body surface area (BSA).*
## Pediatric Dosing
* **Newly Diagnosed AML:**
* BSA ≥0.6 m²: 3 mg/m² on Days 1, 4, and 7.
* BSA <0.6 m²: 0.1 mg/kg on Days 1, 4, and 7.
* **Relapsed/Refractory AML:**
* BSA ≥0.6 m²: 9 mg/m²/dose.
* BSA <0.6 m²: 0.3 mg/kg/dose.
* *Maximum weight-based dose: 5 mg.*
## Dose Adjustments
* **Hepatic Impairment:** Avoid in patients with total bilirubin >2x ULN or AST/ALT >2.5x ULN. No formal studies in renal impairment; clinical judgment required.
* **Toxicity:** Hold doses for severe infusion-related reactions (IRRs) or persistent grade 3/4 hepatotoxicity (e.g., VOD/SOS).
## Contraindications
* Known hypersensitivity to gemtuzumab ozogamicin.
* History of veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS).
## Adverse Effects
* **Hepatotoxicity:** Including fatal veno-occlusive disease (VOD/SOS).
* **Infusion-Related Reactions:** Fever, chills, hypotension, and dyspnea.
* **Myelosuppression:** Prolonged neutropenia, thrombocytopenia, and anemia.
* **Infection:** High risk for opportunistic infections.
* **Hemorrhage:** Associated with thrombocytopenia.
## Key Drug Interactions
* **Hepatotoxic Agents:** Risk of VOD/SOS is increased with co-administration of other hepatotoxic drugs or concomitant hematopoietic stem cell transplant (HSCT).
* **Live Vaccines:** Avoid; immune response may be compromised.
## Monitoring
* **Hepatic Function:** Monitor bilirubin, GGT, AST, ALT, and alkaline phosphatase baseline and prior to each dose. Monitor closely for signs of VOD/SOS (e.g., jaundice, weight gain, ascites).
* **CBC:** Monitor weekly during induction and consolidation.
* **Infusion:** Continuous pulse oximetry and vitals during administration to screen for IRRs.
## Clinical Pearls
* **Pre-medication:** Mandatory premedication with a corticosteroid, antihistamine, and antipyretic 1 hour prior to infusion to mitigate IRRs.
* **Hepatotoxicity Warning:** VOD/SOS is a significant clinical risk, particularly in patients undergoing HSCT after treatment.
* **Handling:** Must be protected from light during preparation and administration; utilize a 0.2-micron polyethersulfone (PES) filter.
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*Disclaimer: This information is for educational purposes only. Always consult the official manufacturer label (Prescribing Information) and local institutional protocols before prescribing or administering medication.*
