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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is a CD33-directed antibody-drug conjugate.
## Primary Indications
* Relapsed or refractory acute myeloid leukemia (AML) in adults.
* Newly diagnosed AML in adults in combination with chemotherapy.
## Adult Dosing
* **For relapsed or refractory AML:**
* Administer 6 mg/m² on day 1.
* If treatment is tolerated, administer 3 mg/m² on day 4 and day 7.
* Can be repeated for a second cycle, using the same dosing schedule (6 mg/m² day 1, 3 mg/m² day 4, 3 mg/m² day 7), if there is evidence of response and the patient tolerates the first cycle.
* **For newly diagnosed AML (in combination with chemotherapy):**
* Administer 3 mg/m² on day 2, day 5, day 8, and day 11 of each cycle of chemotherapy.
## Pediatric Dosing
Mylotarg is not approved for pediatric use. The safety and efficacy have not been established.
## Dose Adjustments
* **Hepatotoxicity:** Dose interruption and/or reduction may be necessary.
* If bilirubin >3 times the upper limit of normal (ULN) or AST >5 times ULN, interrupt treatment. Consider delaying or permanently discontinuing.
* If the patient recovers to bilirubin ≤2 times ULN and AST ≤2.5 times ULN, you may consider resuming at a reduced dose (e.g., 4.5 mg/m² or 3 mg/m²).
* **Thrombocytopenia:** Dose interruption and/or reduction may be necessary.
* If platelets <50,000/mcL, interrupt or delay.
* If platelets <20,000/mcL at any time, consider permanent discontinuation.
## Contraindications
* None listed for gemtuzumab ozogamicin per manufacturer's prescribing information.
## Adverse Effects
* **Most Common:** Fever, nausea, vomiting, diarrhea, headache, infections (including sepsis and pneumonia), low blood cell counts (thrombocytopenia, neutropenia, anemia), fatigue, stomatitis, rash, and elevated liver enzymes (AST, ALT, bilirubin).
* **Serious:** Hepatotoxicity (including VOD/SOS), and severe thrombocytopenia.
## Key Drug Interactions
* **Strong CYP3A4 Inhibitors/Inducers:** Gemtuzumab ozogamicin is a substrate of CYP3A4. Concurrent use with strong CYP3A4 inhibitors
