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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is an antibody-drug conjugate targeting CD33, a cell surface antigen expressed on myeloid leukemia cells. It delivers a cytotoxic agent (calicheamicin) to kill these cells.
## Primary Indications
* Newly diagnosed Acute Myeloid Leukemia (AML) in adults who are candidates for intensive chemotherapy.
* Relapsed or refractory AML in adults.
## Adult Dosing
**Newly Diagnosed AML (in combination with chemotherapy):**
* **Day 1:** 3 mg/m² intravenously over 2 hours.
* **Day 4:** 3 mg/m² intravenously over 2 hours.
* **Day 7:** 3 mg/m² intravenously over 2 hours.
Subsequent cycles may have different dosing schedules and are determined by the specific chemotherapy regimen.
**Relapsed or Refractory AML:**
* **First dose:** 6 mg/m² intravenously over 2 hours.
* **Second dose (given approximately 3-4 weeks after the first dose, if no unacceptable toxicity):** 3 mg/m² intravenously over 2 hours.
**Maximum cumulative dose:** 21.1 mg/m² over the first 12 months of treatment.
## Pediatric Dosing
Mylotarg is not approved for use in pediatric patients.
## Dose Adjustments
* **Hepatotoxicity:** Dose interruption or delay may be necessary based on the severity of elevation in bilirubin or transaminases. Refer to specific prescribing information for detailed guidelines.
* **Thrombocytopenia:** Dose interruption or delay may be necessary.
* **Other Toxicities:** Dose modifications may be required for other severe toxicities.
## Contraindications
* None listed in standard prescribing information.
## Adverse Effects
**Common (≥20%):**
* Hepatotoxicity (including hepatic veno-occlusive disease/sinusoidal obstruction syndrome)
* Thrombocytopenia
* Febrile neutropenia
* Nausea
* Vomiting
* Diarrhea
* Mucositis
* Pneumonitis
* Headache
* Fatigue
* Anemia
* Hypokalemia
* Hypophosphatemia
* Hyperbilirubinemia
**Serious/Life-threatening:**
* Hepatotoxicity (including hepatic veno-occlusive disease/sinusoidal obstruction syndrome) - **this is a black box warning**
* Hemorrhage
## Key Drug Interactions
* No specific drug interactions have been identified with Mylotarg itself. However, concurrent use with other myelosuppressive agents (chemotherapy) will increase the risk of myelosuppression.
## Monitoring
* **Liver Function Tests:** Regularly monitor bilirubin and transaminases (AST, ALT).
* **Complete Blood Counts (CBC) with differential and platelet count:** Frequently monitor for myelosuppression.
* **Signs and symptoms of hepatic veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS):** Monitor for jaundice, hepatomegaly, ascites, weight gain, and right upper quadrant pain.
* **Signs and symptoms of bleeding/hemorrhage.**
* **Signs and symptoms of infusion-related reactions and hypersensitivity.**
## Clinical Pearls
* Hepatotoxicity, particularly hepatic veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS), is a serious and potentially life-threatening adverse event. Vigilant monitoring and prompt management are crucial.
* Consider patients with pre-existing liver impairment, as they may be at increased risk of hepatotoxicity.
* The cumulative dose limit is important to prevent long-term toxicities.
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**Disclaimer:** This information is intended for clinical pharmacy professionals and is not a substitute for comprehensive prescribing information. Always consult the official drug prescribing information and relevant institutional protocols for complete and up-to-date guidance.
