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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is an antibody-drug conjugate that targets CD33, a protein expressed on the surface of myeloid leukemia cells. It is a cytotoxic agent.
## Primary Indications
* Treatment of newly diagnosed CD33-positive acute myeloid leukemia (AML) in adult patients in combination with cytarabine and daunorubicin or idarubicin.
* Treatment of relapsed or refractory CD33-positive AML in adult patients.
## Adult Dosing
* **Newly Diagnosed AML (Combination Therapy):**
* **Induction:** 3 mg/m² on days 1, 4, and 7. If achieving remission, subsequent courses of induction therapy are not recommended.
* **Consolidation:** 3 mg/m² on day 1 of each cycle for up to 4 cycles.
* **Relapsed or Refractory AML:**
* **First Relapse:** 3 mg/m² on day 1. If achieving remission, a second dose of 3 mg/m² may be administered on day 4.
* **Second or Subsequent Relapse:** 3 mg/m² on day 1.
## Pediatric Dosing
Dosing in pediatric patients has not been established.
## Dose Adjustments
* **Hepatic Impairment:** Use with caution. If total bilirubin is > 1.5 mg/dL and ≤ 3 mg/dL, reduce dose by 50%. If total bilirubin is > 3 mg/dL, do not administer.
* **Veno-occlusive Disease (VOD) / Sinusoidal Obstruction Syndrome (SOS):** Discontinue Mylotarg if VOD/SOS is diagnosed.
## Contraindications
* None listed for gemtuzumab ozogamicin itself. However, contraindications of combination chemotherapy agents should be considered.
## Adverse Effects
* **Common:** Febrile neutropenia, nausea, vomiting, diarrhea, mucositis, headache, pyrexia, rash, fatigue, abdominal pain, cough, decreased appetite.
* **Serious:** Hepatotoxicity (including VOD/SOS), myelosuppression (leading to neutropenia, thrombocytopenia, anemia), hypersensitivity reactions, tumor lysis syndrome, embryo-fetal toxicity.
## Key Drug Interactions
* **Hepatotoxic Agents:** Increased risk of hepatotoxicity. Concomitant use requires caution and close monitoring.
## Monitoring
* **Blood Counts:** Monitor complete blood counts frequently, including neutrophils, platelets, and hemoglobin.
* **Liver Function Tests:** Monitor LFTs (AST, ALT, bilirubin) before and regularly during treatment.
* **Signs/Symptoms of VOD/SOS:** Monitor for abdominal pain, ascites, jaundice, and hepatomegaly.
* **Pregnancy Status:** Counsel patients of childbearing potential on the risks and need for contraception.
## Clinical Pearls
* The risk of hepatotoxicity, particularly VOD/SOS, is a significant concern. Early recognition and management are crucial.
* Administer prophylactic antiemetics, antidiarrheals, and other supportive care measures as needed.
* Infusion reactions can occur; monitor patients closely during and after infusion.
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*Disclaimer: This information is intended for clinical professionals and does not replace institutional protocols or the official prescribing information. Always verify current prescribing information and consult relevant guidelines before making clinical decisions.*
