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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is a targeted antibody-drug conjugate consisting of a humanized antibody that targets CD33, conjugated to a cytotoxic agent, calicheamicin.
## Primary Indications
Mylotarg is indicated for the treatment of adults and pediatric patients 1 month and older with newly diagnosed acute myeloid leukemia (AML) who are **ineligible for intensive induction chemotherapy**. It is also indicated for the treatment of adults and pediatric patients 1 month and older with relapsed or refractory AML.
## Adult Dosing
**Newly Diagnosed AML (ineligible for intensive induction chemotherapy):**
* **Day 1:** 3 mg/kg IV
* **Day 4:** 3 mg/kg IV
* **Day 7:** 2 mg/kg IV
**Relapsed or Refractory AML:**
* **Day 1:** 6 mg/kg IV
* **Day 4:** 3 mg/kg IV
**Note:** Do not exceed a total cumulative dose of 10 mg/kg.
## Pediatric Dosing
**Newly Diagnosed AML (1 month and older, ineligible for intensive induction chemotherapy):**
* **Day 1:** 3 mg/kg IV
* **Day 4:** 3 mg/kg IV
* **Day 7:** 2 mg/kg IV
**Relapsed or Refractory AML (1 month and older):**
* **Day 1:** 6 mg/kg IV
* **Day 4:** 3 mg/kg IV
**Note:** Do not exceed a total cumulative dose of 10 mg/kg.
## Dose Adjustments
* **Hepatotoxicity:** Monitor liver function tests closely. Dose interruptions, reductions, or discontinuation may be necessary based on the severity of hepatotoxicity.
* **Thrombocytopenia:** Monitor platelet counts. Dose interruptions may be necessary.
* **Infusion Reactions:** Slow the infusion rate, temporarily stop the infusion, or discontinue Mylotarg based on the severity of the reaction.
## Contraindications
* None listed in prescribing information.
## Adverse Effects
* **Hepatotoxicity:** The most serious adverse effect, characterized by hyperbilirubinemia, elevated AST/ALT, and veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS).
* **Hematologic Toxicity:** Thrombocytopenia, neutropenia, anemia, febrile neutropenia.
* **Infusion Reactions:** Fever, rash, chills, dyspnea.
* **Gastrointestinal:** Nausea, vomiting, diarrhea, mucositis.
* **Hemorrhage:** Bleeding events.
* **Infections:** Sepsis.
## Key Drug Interactions
* **Hepatotoxic Drugs:** Concomitant use with other drugs known to cause hepatotoxicity may increase the risk of liver damage.
* **Drugs affecting coagulation:** Use with caution in patients receiving anticoagulants or antiplatelet agents due to increased risk of bleeding.
## Monitoring
* **Liver Function Tests:** Baseline and regular monitoring of bilirubin, AST, ALT, and alkaline phosphatase.
* **Complete Blood Counts (CBC) with differential:** Baseline and regular monitoring of platelet count, neutrophil count, and hemoglobin.
* **Signs and symptoms of VOD/SOS:** Monitor for jaundice, hepatomegaly, ascites, and abdominal pain.
* **Infusion site reactions.**
## Clinical Pearls
* **Premedication:** Consider premedication with acetaminophen and an antihistamine to reduce the risk of infusion reactions.
* **VOD/SOS:** This is a serious and potentially fatal adverse event. Vigilance is required, especially in patients with pre-existing liver disease or those who have undergone stem cell transplantation.
* **Bleeding Risk:** Patients with severe thrombocytopenia are at increased risk of bleeding.
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*This information is intended for healthcare professionals. Please consult the official prescribing information for Mylotarg for complete details, including any updates or changes. Always verify current prescribing information with the manufacturer or a reliable drug reference.*
