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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Gemtuzumab ozogamicin is a humanized anti-CD33 monoclonal antibody linked to the cytotoxic agent calicheamicin. It is a targeted therapy for acute myeloid leukemia (AML).
## Primary Indications
* Treatment of newly diagnosed CD33-positive AML in adults.
* Treatment of relapsed or refractory CD33-positive AML in adults.
## Adult Dosing
**Newly Diagnosed AML:**
* Induction: 6 mg/m² on days 1, 4, and 7. A second dose of 3 mg/m² may be given on day 7 if the patient achieves remission.
* Consolidation: 3 mg/m² every 2 weeks for up to 4 cycles.
**Relapsed or Refractory AML:**
* 6 mg/m² on day 1.
* A second dose of 3 mg/m² may be given on day 4 if tolerated.
* A third dose of 3 mg/m² may be given on day 7 if tolerated.
Maximum cumulative dose is 24 mg/m² over the course of therapy.
## Pediatric Dosing
No established pediatric dosing. Use in pediatric patients should be based on expert consultation and available data, which is limited.
## Dose Adjustments
* **Hepatotoxicity:** Dose interruption or discontinuation may be necessary. If total bilirubin > 3 mg/dL or AST > 5 times the upper limit of normal (ULN), delay gemtuzumab ozogamicin. Resume when bilirubin is ≤ 3 mg/dL and AST is ≤ 2 times ULN.
* **Thrombocytopenia:** Gemtuzumab ozogamicin can cause severe thrombocytopenia. Monitor platelet counts closely.
## Contraindications
* None absolute, but caution is warranted in patients with severe hepatic impairment.
## Adverse Effects
* **Hepatotoxicity:** Common, potentially severe, and can be fatal (e.g., veno-occlusive disease/sinusoidal obstruction syndrome).
* **Myelosuppression:** Including neutropenia, thrombocytopenia, and anemia.
* **Infusion-related reactions:** Fever, chills, rash, dyspnea.
* Gastrointestinal: Nausea, vomiting, diarrhea, stomatitis.
* Bleeding events.
* Infections.
## Key Drug Interactions
* **Hepatotoxic Agents:** Concomitant use with other hepatotoxic agents may increase the risk of liver toxicity.
## Monitoring
* Complete blood counts (CBC) with differential and platelet counts regularly, especially during and after treatment.
* Liver function tests (LFTs), including bilirubin and AST, prior to each dose and as clinically indicated.
* Signs and symptoms of infusion reactions.
* Signs and symptoms of bleeding.
* Signs and symptoms of VOD/SOS (e.g., weight gain, ascites, hepatomegaly, jaundice, right upper quadrant pain).
## Clinical Pearls
* Premedication with an antiemetic and potentially an antihistamine or corticosteroid may be considered to mitigate infusion-related reactions.
* Close monitoring for VOD/SOS is critical, as it can occur even after discontinuation of therapy.
* Gemtuzumab ozogamicin is administered intravenously.
**Disclaimer:** This information is intended for healthcare professionals. Always consult the most current prescribing information and relevant guidelines for complete details and to verify accuracy before making clinical decisions.
