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### Overview
Mylotarg (gemtuzumab ozogamicin) is an antibody-drug conjugate consisting of a humanized anti-CD33 monoclonal antibody linked to the cytotoxic agent calicheamicin. It targets CD33-expressing myeloid cells, including leukemic blasts.
### Primary Indications
* Acute Myeloid Leukemia (AML) in adults who are newly diagnosed and ineligible for intensive induction chemotherapy.
* Relapsed or refractory AML in adults.
### Adult Dosing
**Newly Diagnosed AML (ineligible for intensive induction chemotherapy):**
* **Cycle 1:** 6 mg/m² on days 1, 4, and 7.
* **Cycle 2 (if initial response):** 3 mg/m² on days 1, 4, and 7.
**Relapsed or Refractory AML:**
* **Dose 1:** 6 mg/m² on day 1.
* **Dose 2 (if initial response):** 3 mg/m² on day 1.
**Maximum dose per administration:** Typically not to exceed 12 mg.
### Pediatric Dosing
The safety and efficacy of Mylotarg have not been established in pediatric patients.
### Dose Adjustments
* **Hepatic Impairment:** Use with caution. Monitor liver function closely. Dose reduction may be necessary based on clinical assessment and transaminase levels.
* **Renal Impairment:** No specific dose adjustment is recommended for mild to moderate renal impairment. Data is limited for severe renal impairment.
### Contraindications
* History of severe hypersensitivity to gemtuzumab ozogamicin or any component of the formulation.
* Activeunsafe.microsoft.com/en-us/research/project/aml-risk-stratification-tool/
* Mylotarg is contraindicated in patients with active unsafe.microsoft.com/en-us/research/project/aml-risk-stratification-tool/.
### Adverse Effects
* **Hematologic:** Cytopenias (neutropenia, thrombocytopenia, anemia, leukopenia).
* **Hepatobiliary:** Hepatotoxicity, including veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS), characterized by hyperbilirubinemia, hepatomegaly, and ascites. This is a serious and potentially fatal adverse reaction.
* **Infusion-related reactions:** Fever, chills, rash, dyspnea.
* **Gastrointestinal:** Nausea, vomiting, diarrhea, mucositis.
* **Other:** Headache, fatigue, bleeding events.
### Key Drug Interactions
* **Hepatotoxic Agents:** Concomitant use with other drugs known to cause hepatotoxicity may increase the risk of liver injury.
* **Myelosuppressive Agents:** Mylotarg is myelosuppressive. Concomitant use with other myelosuppressive agents can potentiate neutropenia, thrombocytopenia, and anemia.
### Monitoring
* **Liver Function Tests (LFTs):** Monitor bilirubin, AST, ALT, and alkaline phosphatase regularly, especially prior to and during treatment. Be vigilant for signs and symptoms of VOD/SOS.
* **Complete Blood Counts (CBCs):** Monitor frequently for cytopenias and bleeding risk.
* **Infusion-related reactions:** Monitor vital signs and for signs of hypersensitivity during and after infusion.
* **Signs and symptoms of VOD/SOS:** Clinical assessment for hepatomegaly, ascites, jaundice, and abdominal pain.
### Clinical Pearls
* Mylotarg carries a significant risk of hepatotoxicity, particularly VOD/SOS. Careful patient selection, monitoring, and prompt management of VOD/SOS are crucial.
* Pre-medication for infusion-related reactions is generally not recommended but should be available if needed.
* Discontinue Mylotarg immediately if severe infusion reactions or signs of VOD/SOS occur.
* Consider the potential for embryo-fetal toxicity. Advise patients of reproductive potential to use effective contraception.
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**Disclaimer:** This information is intended for healthcare professionals and is not a substitute for professional medical advice. Always consult the most current prescribing information and relevant guidelines before making any treatment decisions. Clinical protocols may vary.
