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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is a humanized antibody-drug conjugate that targets the CD33 antigen expressed on myeloid leukemia cells. It is an antineoplastic agent.
## Primary Indications
* Treatment of newly diagnosed acute myeloid leukemia (AML) in adults in combination with chemotherapy.
* Treatment of relapsed or refractory AML in adults.
## Adult Dosing
**Newly Diagnosed AML (in combination with chemotherapy):**
* **First Course:** 3 mg/m² on Day 1, Day 4, and Day 7 of induction chemotherapy.
* **Second Course (if indicated):** 3 mg/m² on Day 1, Day 4, and Day 7 of consolidation chemotherapy.
* **Subsequent Courses (if indicated):** 3 mg/m² on Day 1 of each consolidation cycle.
* **Maximum cumulative dose:** 13.8 mg/m² (across all courses over the entire treatment duration).
**Relapsed or Refractory AML:**
* **First dose:** 6 mg/m² on Day 1.
* **Second dose (if no disease progression or unacceptable toxicity):** 3 mg/m² on Day 8.
* **Maximum cumulative dose (in this setting):** 9.6 mg/m² (across the two doses).
Dosing is calculated based on body surface area (BSA). Doses for subsequent cycles should not exceed the dose of the first cycle.
## Pediatric Dosing
The safety and efficacy of Mylotarg have not been established in pediatric patients.
## Dose Adjustments
* **Hepatic Impairment:** No specific dose adjustment is recommended, but caution is advised. Monitor liver function tests.
* **Renal Impairment:** No specific dose adjustment is recommended, but monitor renal function.
Dose interruption or reduction may be necessary for severe adverse events, particularly liver toxicity (e.g., hepatic sinusoidal obstruction syndrome [SOS]) or myelosuppression.
## Contraindications
* Known hypersensitivity to gemtuzumab ozogamicin or any component of the formulation.
## Adverse Effects
Common adverse effects include:
* Nausea, vomiting, diarrhea
* Fever, chills
* Myelosuppression (thrombocytopenia, neutropenia, anemia)
* Hepatotoxicity, including hepatic sinusoidal obstruction syndrome (SOS) - potentially fatal.
* Bleeding events
* Infusion reactions
* Hypokalemia
* Headache
* Fatigue
## Key Drug Interactions
* **Chemotherapy Agents:** Mylotarg is often used in combination with chemotherapy. The specific interactions depend on the concomitant chemotherapy regimen.
* **Hepatotoxic Agents:** Concomitant use of drugs known to be hepatotoxic may increase the risk of liver toxicity.
## Monitoring
* **Complete Blood Counts (CBC) with differential and platelets:** Frequently, especially before and after each dose, to monitor for myelosuppression.
* **Liver Function Tests (LFTs):** Regularly, to monitor for hepatotoxicity, including signs and symptoms of SOS.
* **Renal Function Tests:** Regularly.
* **Infusion Reactions:** Monitor vital signs during and after infusion.
* **Signs and Symptoms of SOS:** Monitor for abdominal pain, ascites, jaundice, hepatomegaly, splenomegaly, and elevated bilirubin or prothrombin time.
## Clinical Pearls
* Mylotarg carries a **black box warning** for hepatic toxicity (SOS) and for myelosuppression.
* A **premedication regimen** including acetaminophen and an antihistamine is recommended to reduce the risk of infusion reactions.
* Close monitoring for SOS is critical, especially in patients with pre-existing liver disease or those receiving other hepatotoxic agents.
* Due to the risk of severe myelosuppression, prophylactic antibiotics, antivirals, and antifungals are often recommended.
* Discontinue Mylotarg permanently if SOS occurs.
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**Disclaimer:** This information is intended for healthcare professionals. It is essential to consult the most current prescribing information and relevant clinical guidelines for complete details regarding dosage, administration, safety, and efficacy before making any treatment decisions. Drug information is subject to change.
