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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is a CD33-directed antibody and an intercalating agent. It targets the CD33 antigen, which is found on the surface of myeloid leukemia cells.
## Primary Indications
* Treatment of adults with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive induction chemotherapy.
* Treatment of adults with relapsed or refractory AML.
## Adult Dosing
**Newly Diagnosed AML (ineligible for intensive induction chemotherapy):**
* **Cycle 1:** 3 mg/m² on day 1, 2 mg/m² on day 4, and 2 mg/m² on day 7.
* **Cycle 2 (if chemotherapy is completed and patient has not progressed):** 3 mg/m² on day 1.
* **Cycle 3 (if Cycle 2 is completed and patient has not progressed):** 3 mg/m² on day 1.
**Relapsed or Refractory AML:**
* **First Relapse:** 3 mg/m² on day 1, 2 mg/m² on day 4, and 2 mg/m² on day 7.
* **Second or Subsequent Relapse:** 3 mg/m² on day 1.
Maximum single dose is 3 mg/m².
## Pediatric Dosing
The safety and efficacy of Mylotarg in pediatric patients have not been established.
## Dose Adjustments
* **Hepatotoxicity:** Dose interruption or discontinuation may be required based on the severity of liver enzyme elevation. Specific guidance depends on AST/ALT levels and bilirubin.
* **Hyperbilirubinemia:** Dose interruption or discontinuation may be required based on bilirubin levels.
## Contraindications
* None specifically listed for Mylotarg itself. However, contraindications related to specific chemotherapy regimens or patient comorbidities should be considered.
## Adverse Effects
* **Common:** Nausea, vomiting, diarrhea, stomatitis, constipation, headache, fever, rash, fatigue, cough, pneumonia, decreased appetite, abdominal pain, arthralgia, muscle spasms.
* **Serious:**
* **Hepatotoxicity (including Veno-Occlusive Disease/Sinusoidal Obstruction Syndrome):** This is a serious and potentially fatal adverse event. Risk factors include prior stem cell transplant and prior liver disease.
* **Thrombocytopenia and Neutropenia:** Can increase the risk of bleeding and infections.
* **Infusion-related reactions:** Fever, chills, rash, shortness of breath.
* **Hemorrhage:** Especially gastrointestinal bleeding.
## Key Drug Interactions
* **Hepatotoxic agents:** Concurrent use with other medications known to cause hepatotoxicity may increase the risk of liver injury. Careful monitoring is essential.
* **Myelosuppressive agents:** Concurrent use with other chemotherapy agents will likely lead to additive myelosuppression.
## Monitoring
* **Liver function tests (LFTs):** Including bilirubin, AST, ALT, alkaline phosphatase, and INR, prior to each dose and regularly thereafter.
* **Complete blood counts (CBCs):** Including differential and platelet count, frequently during treatment.
* **Signs and symptoms of bleeding:** Monitor for petechiae, bruising, epistaxis, hematuria, and melena.
* **Signs and symptoms of infection:** Monitor for fever, chills, cough, and other signs of infection.
* **Signs and symptoms of infusion-related reactions:** Monitor vital signs and for signs of hypersensitivity.
* **Signs and symptoms of Veno-Occlusive Disease/Sinusoidal Obstruction Syndrome:** Monitor for jaundice, hepatomegaly, ascites, weight gain, and abdominal pain.
## Clinical Pearls
* Mylotarg is administered intravenously. Premedication with an antipyretic, antihistamine, and corticosteroid may be considered to reduce infusion-related reactions.
* Veno-Occlusive Disease/Sinusoidal Obstruction Syndrome is a significant risk; especially important in patients with prior stem cell transplant or liver disease.
* Close monitoring of liver function and hematologic parameters is critical.
***
**Disclaimer:** This information is intended for healthcare professionals. Always consult the most current prescribing information and relevant literature before making clinical decisions. Dosing and management may vary based on individual patient factors and institutional protocols.
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