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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is an antibody-drug conjugate that targets CD33, a protein found on the surface of most leukemia cells. It delivers a cytotoxic agent (calicheamicin) directly to cancer cells.
## Primary Indications
* Acute myeloid leukemia (AML) in patients aged 1 month and older who are newly diagnosed or have relapsed/refractory disease.
## Adult Dosing
**Newly Diagnosed AML (in combination with chemotherapy):**
* First cycle: 3 mg/m² on days 1, 4, and 7.
* Second cycle (if achieving remission): 3 mg/m² on days 1 and 4.
**Relapsed/Refractory AML:**
* First cycle: 3 mg/m² on day 1.
* Second cycle (if achieving remission): 3 mg/m² on day 1.
* Subsequent cycles (up to a total of 4): 3 mg/m² every 2 to 4 weeks.
**Maximum cumulative dose:** 10 mg/m².
## Pediatric Dosing
**Newly Diagnosed AML:**
* Ages 1 month to < 2 years: 1.5 mg/m² on days 1, 4, and 7 (for first cycle) or days 1 and 4 (for second cycle).
* Ages 2 years and older: 3 mg/m² on days 1, 4, and 7 (for first cycle) or days 1 and 4 (for second cycle).
**Relapsed/Refractory AML:**
* Ages 1 month to < 2 years: 1.5 mg/m² on day 1 (for first cycle), day 1 (for second cycle), and subsequent cycles.
* Ages 2 years and older: 3 mg/m² on day 1 (for first cycle), day 1 (for second cycle), and subsequent cycles.
**Maximum cumulative dose for pediatric patients:** 10 mg/m².
## Dose Adjustments
* **Hepatotoxicity:** Dose interruption or discontinuation may be necessary. Consult prescribing information for specific guidance based on liver function tests (LFTs) and bilirubin levels.
* **Hypersensitivity Reactions:** Interrupt infusion and manage appropriately. Consider discontinuation.
* **Infusion Reactions:** Slow or interrupt infusion. Premedication may be considered.
## Contraindications
None listed.
## Adverse Effects
* **Hepatotoxicity:** Severe and potentially fatal veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS), elevated transaminases, hyperbilirubinemia.
* **Myelosuppression:** Neutropenia, thrombocytopenia, anemia, febrile neutropenia.
* **Infusion Reactions:** Fever, chills, rash, dyspnea.
* **Hemorrhage:** Including intracranial hemorrhage.
* **Gastrointestinal:** Nausea, vomiting, diarrhea, stomatitis.
* **Infections:** Sepsis.
## Key Drug Interactions
* **Myelosuppressive Agents:** Increased risk of myelosuppression.
* **Hepatotoxic Agents:** Increased risk of hepatotoxicity.
## Monitoring
* **Liver Function Tests (LFTs) and Bilirubin:** Regularly, especially before and during treatment. Monitor closely for VOD/SOS.
* **Complete Blood Count (CBC) with Differential and Platelets:** Before each dose and as clinically indicated.
* **Signs and Symptoms of Infusion Reactions:** During and after infusion.
* **Signs and Symptoms of Bleeding:** Including neurological changes.
* **Signs and Symptoms of Infection:**
## Clinical Pearls
* Mylotarg carries a significant risk of hepatotoxicity, particularly VOD/SOS, which can be fatal. Close monitoring of liver function is critical.
* Infusion reactions can occur, and patients should be monitored closely during and after administration.
* The maximum cumulative dose is 10 mg/m²; exceeding this increases toxicity risk.
* Combination therapy requires careful management of cumulative toxicities.
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*This information is intended for healthcare professionals and does not replace the need to consult the most current prescribing information and clinical guidelines.*
