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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is an antibody-drug conjugate (ADC) consisting of a humanized anti-CD33 monoclonal antibody linked to the cytotoxic agent calicheamicin. It targets CD33-expressing cells, including myeloid leukemia cells.
## Primary Indications
* Newly diagnosed acute myeloid leukemia (AML) in adults, in combination with other chemotherapy.
* Relapsed or refractory AML in adults.
## Adult Dosing
**Newly Diagnosed AML (in combination with chemotherapy):**
* A total of 6 doses is typically given over approximately 3 months.
* **First cycle:** 3 mg/kg on days 1, 4, and 7.
* **Second cycle:** 3 mg/kg on days 1, 4, and 7 (if consolidation chemotherapy is given).
* **Subsequent cycles (up to 4):** 3 mg/kg once every 2 weeks for up to 3 cycles.
**Relapsed or Refractory AML:**
* **First cycle:** 3 mg/kg on day 1.
* **Second cycle:** 3 mg/kg on day 1, approximately 2 to 4 weeks after the first dose.
* **Subsequent cycles (up to 2):** 3 mg/kg once every 2 weeks for up to 2 additional cycles.
**Maximum cumulative dose:** 21.1 mg/kg over the course of therapy.
## Pediatric Dosing
Safety and efficacy in pediatric patients have not been established.
## Dose Adjustments
* **Hepatotoxicity:** Dose interruption or discontinuation may be necessary based on the severity of liver enzyme elevations or bilirubin levels.
* **Thrombocytopenia:** Dose interruption or discontinuation may be necessary.
* **Infusion Reactions:** Slowing or stopping the infusion may be required.
* **Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS):** Discontinue Mylotarg permanently.
## Contraindications
* None listed in prescribing information.
## Adverse Effects
* **Hepatotoxicity:** Including VOD/SOS, hyperbilirubinemia, and elevated AST/ALT. This is a serious and potentially fatal adverse effect.
* **Hemorrhage:** Including intracranial hemorrhage.
* **Myelosuppression:** Including neutropenia, thrombocytopenia, and anemia.
* **Infusion-related reactions:** Fever, chills, rash, dyspnea.
* **Nausea, vomiting, diarrhea, mucositis, fatigue, headache, hyperglycemia.**
## Key Drug Interactions
* **Hepatotoxic agents:** Concomitant use with other agents known to cause liver injury may increase the risk of severe hepatotoxicity.
* **Other myelosuppressive agents:** May exacerbate myelosuppression.
## Monitoring
* **Liver function tests (AST, ALT, bilirubin):** Frequently, especially during the first few cycles and for at least 30 days after the last dose.
* **Complete blood counts (CBC) with differential and platelet count:** Frequently.
* **Signs and symptoms of bleeding and infusion reactions.**
* **Signs and symptoms of VOD/SOS.**
## Clinical Pearls
* **Hepatotoxicity is a significant risk.** Monitor liver function closely and be prepared to interrupt or discontinue therapy.
* **VOD/SOS:** Prompt recognition and management are crucial.
* **Infusion reactions:** Premedication with corticosteroids, antihistamines, and antipyretics is recommended. Administer over 2 hours.
* **Use in combination therapy:** Dosing and management should be coordinated with other chemotherapeutic agents.
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**Disclaimer:** This information is intended for healthcare professionals. Always consult the current prescribing information and relevant clinical guidelines for complete details and to verify dosage and safety information before use.
