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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Gemtuzumab ozogamicin is an antibody-drug conjugate targeting CD33, a protein found on the surface of myeloid leukemia cells. It delivers a cytotoxic agent (calicheamicin derivative) directly to CD33-expressing cells.
## Primary Indications
* Relapsed or refractory acute myeloid leukemia (AML) in adults who are CD33-positive.
* Newly diagnosed CD33-positive AML in adult patients, in combination with other chemotherapy.
## Adult Dosing
**For relapsed or refractory AML:**
* **First cycle:** 3 mg/m² on days 1, 4, and 7.
* **Second cycle (if response and tolerated):** 3 mg/m² on days 1, 4, and 7.
**For newly diagnosed AML (in combination):**
* **Cycles 1 and 2:** 3 mg/m² on days 1, 4, and 7.
* **Subsequent cycles (if applicable):** Dosing will depend on the specific combination chemotherapy regimen and local protocol.
**Maximum cumulative dose:** 60 mg/m².
## Pediatric Dosing
Dosing in pediatric patients is not established.
## Dose Adjustments
* **Hepatotoxicity:** If elevations in bilirubin or AST/ALT occur, dose interruption or discontinuation may be necessary. Refer to specific prescribing information for detailed guidance on dose modification based on the severity of liver enzyme elevations.
* **Hematologic Toxicity:** If severe myelosuppression occurs, dose interruption or discontinuation may be necessary.
* **Infusion Reactions:** If an infusion reaction occurs, slow the infusion rate, administer supportive care, or discontinue the drug.
## Contraindications
* Hypersensitivity to gemtuzumab ozogamicin or any component of the formulation.
## Adverse Effects
* **Common:** Nausea, vomiting, diarrhea, constipation, stomatitis, fever, headache, fatigue, rash, cough, dyspnea, anemia, thrombocytopenia, neutropenia.
* **Serious:** Hepatotoxicity (including veno-occlusive disease/sinusoidal obstruction syndrome), myelosuppression, infusion reactions, tumor lysis syndrome, bleeding events.
## Key Drug Interactions
* **Hepatotoxic agents:** Concomitant use with other drugs known to cause hepatotoxicity may increase the risk of liver injury.
* **Myelosuppressive agents:** Concomitant use with other myelosuppressive agents may increase the risk and severity of myelosuppression.
## Monitoring
* **Liver function tests:** Monitor bilirubin, AST, ALT, and alkaline phosphatase regularly, especially during and after treatment.
* **Complete blood counts (CBC) with differential and platelet count:** Monitor frequently for myelosuppression.
* **Signs and symptoms of infusion reactions:** Monitor closely during and after infusion.
* **Signs and symptoms of bleeding:** Monitor for any signs of bleeding.
* **Signs and symptoms of tumor lysis syndrome:** Monitor electrolyte levels and clinical status.
## Clinical Pearls
* Gemtuzumab ozogamicin should be administered by healthcare professionals experienced in the treatment of AML.
* Close monitoring for hepatotoxicity is crucial, as this can be severe and life-threatening.
* Infusion reactions can occur, so vigilant monitoring during and after infusion is necessary.
* The cumulative dose limit of 60 mg/m² must not be exceeded.
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**Disclaimer:** This information is intended for healthcare professionals and is not a substitute for professional medical advice. Always consult the most current prescribing information and relevant clinical guidelines before making treatment decisions.
