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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is a targeted therapy, an antibody-drug conjugate consisting of a humanized anti-CD33 monoclonal antibody linked to a cytotoxic agent, calicheamicin. It is designed to specifically target CD33-expressing cells, primarily on acute myeloid leukemia (AML) blasts.
## Primary Indications
* Treatment of newly diagnosed adult patients with acute myeloid leukemia (AML) in combination with other chemotherapy.
* Treatment of adult patients with relapsed or refractory AML.
## Adult Dosing
**Newly Diagnosed AML (in combination with chemotherapy):**
* **Day 1:** 3 mg/kg.
* **Day 4:** 3 mg/kg.
* **Day 7:** 2 mg/kg.
* *Note:* The dose is administered as a 2-hour infusion. The total dose should not exceed 5 mg/kg over the 3-day course.
**Relapsed or Refractory AML:**
* **First cycle:** 6 mg/kg on Day 1. If tolerated, a second cycle of 3 mg/kg on Day 4 can be administered.
* **Second cycle (if given):** 3 mg/kg on Day 1.
* *Note:* The dose is administered as a 2-hour infusion. The total dose should not exceed 9 mg/kg over the 2 cycles.
## Pediatric Dosing
Dosing in pediatric patients has not been established.
## Dose Adjustments
* **Hepatotoxicity:** Interrupt or discontinue treatment based on the severity of liver enzyme elevations or bilirubin levels. Specific guidance for dose reduction or interruption is provided in the prescribing information and depends on the degree of elevation.
* **Myelosuppression:** Management of severe neutropenia and thrombocytopenia, including dose interruption or delays, should follow standard protocols for chemotherapy-induced cytopenias and specific guidance in the prescribing information.
## Contraindications
* None listed. However, caution is advised in patients with severe hepatic impairment.
## Adverse Effects
* **Common:** Febrile neutropenia, nausea, vomiting, diarrhea, mucositis, headache, pyrexia, rash, constipation, abdominal pain, decreased appetite, fatigue, cough, pneumonia, hypokalemia, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST).
* **Serious:** Hepatotoxicity (including veno-occlusive disease/sinusoidal obstruction syndrome), severe myelosuppression, hypersensitivity reactions, tumor lysis syndrome.
## Key Drug Interactions
* No significant drug interactions are specifically listed. However, concurrent use with other myelosuppressive agents may increase the risk of myelosuppression.
## Monitoring
* **Hepatotoxicity:** Monitor liver function tests (bilirubin, ALT, AST) regularly, especially before initiating treatment and during treatment.
* **Myelosuppression:** Monitor complete blood counts (CBC) with differential and platelet counts regularly, especially during treatment.
* **Infusion Reactions:** Monitor for signs and symptoms of hypersensitivity reactions during and after infusion.
* **Tumor Lysis Syndrome:** Monitor electrolytes and renal function, particularly in patients with high tumor burden.
## Clinical Pearls
* Mylotarg is a potent agent with significant risks, including hepatotoxicity and severe myelosuppression.
* Thorough patient education regarding potential side effects and the importance of regular monitoring is crucial.
* Pre-treatment assessment of hepatic function is recommended.
* Ensure adequate hydration and electrolyte balance.
* Consider prophylactic use of antiemetics and antidiarrheals.
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*This information is intended for healthcare professionals. It is essential to consult the most current prescribing information and relevant guidelines for complete and up-to-date details on drug use, dosing, and safety.*
