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## Overview
Mylotarg (gemtuzumab ozogamicin) is an antibody-drug conjugate that targets CD33, a protein found on the surface of most acute myeloid leukemia (AML) cells. It delivers a cytotoxic agent (calicheamicin) to these cells, leading to their death.
## Primary Indications
* Treatment of newly diagnosed CD33-positive acute myeloid leukemia (AML) in adults.
* Treatment of relapsed or refractory CD33-positive AML in adults.
## Adult Dosing
**Newly Diagnosed CD33-positive AML:**
* **First cycle:** 3 mg/m² on days 1, 4, and 7. If there is no unacceptable toxicity, the dose can be increased.
* **Second cycle (if applicable):** 3 mg/m² on days 1, 4, and 7.
* **Subsequent cycles (if applicable):** 3 mg/m² on day 1.
**Relapsed or Refractory CD33-positive AML:**
* **First cycle:** 3 mg/m² on day 1.
* **Second cycle (if disease has not progressed and toxicity is acceptable):** 3 mg/m² on day 1.
Maximum cumulative dose is 10 mg/m².
## Pediatric Dosing
Dosing in pediatric patients has not been established and is generally not recommended due to safety concerns.
## Dose Adjustments
* **Hepatic Impairment:** Use with caution. If bilirubin > 2.5 mg/dL or AST > 3 times the upper limit of normal, treatment should be withheld.
* **Renal Impairment:** Use with caution. No dose adjustment is recommended for mild to moderate renal impairment. Data for severe renal impairment is limited.
## Contraindications
* None listed.
## Adverse Effects
* **Hepatotoxicity:** Severe, potentially fatal liver injury, including veno-occlusive liver disease (VOD)/sinusoidal obstruction syndrome (SOS), has occurred. Risk factors include prior stem cell transplant, splenectomy, and high bilirubin levels.
* **Myelosuppression:** Including neutropenia, thrombocytopenia, and anemia.
* **Infusion-related reactions:** Fever, chills, rash, and dyspnea.
* **Gastrointestinal:** Nausea, vomiting, diarrhea, stomatitis.
* **Bleeding events:** Hemorrhage.
* **Infections.**
## Key Drug Interactions
* **Strong CYP3A4 inhibitors/inducers:** May alter the metabolism of calicheamicin, the cytotoxic component. Monitor closely.
* **Other myelosuppressive agents:** Additive myelosuppression may occur.
## Monitoring
* **Liver function tests (LFTs):** Bilirubin, AST, ALT, alkaline phosphatase regularly, especially before and during treatment.
* **Complete blood counts (CBCs) with differential and platelet count:** Frequently, to monitor for myelosuppression.
* **Signs and symptoms of infusion reactions:** During and after infusion.
* **Signs and symptoms of bleeding and infection.**
## Clinical Pearls
* Premedication with an antiemetic and antipyretic is recommended.
* Infusion rate should be carefully monitored and slowed or stopped if infusion-related reactions occur.
* VOD/SOS is a serious and potentially fatal complication; patients require close monitoring.
* Ensure adequate contraception is used during and for at least 6 months after treatment.
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**Disclaimer:** This information is intended for clinical decision support and does not replace the need to consult the official prescribing information and other relevant resources before making any treatment decisions. Always verify the most current drug information with official sources.
