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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is a humanized antibody-drug conjugate that targets CD33, a protein found on myeloid leukemia cells.
## Primary Indications
* Newly diagnosed acute myeloid leukemia (AML) in adults who are 75 years of age or older or who have co-morbidities that preclude intensive induction chemotherapy.
* Relapsed or refractory AML in adults.
## Adult Dosing
For newly diagnosed AML (in combination with other agents, per local protocol):
* 6 mg/m² on day 4 of induction and day 5 of consolidation.
* Alternatively, 3 mg/m² on days 1, 4, and 7 of induction and days 1, 4, and 7 of consolidation.
For relapsed or refractory AML:
* First cycle: 3 mg/m² on day 1, 6 mg/m² on day 4, and 3 mg/m² on day 7.
* Subsequent cycles (if response): 3 mg/m² on days 1, 4, and 7.
* Maximum of 4 cycles.
Dosing is based on total body surface area.
## Pediatric Dosing
Mylotarg is not approved for use in pediatric patients. Efficacy and safety have not been established.
## Dose Adjustments
* **Hepatotoxicity:** Dose interruption or discontinuation may be necessary. Consult prescribing information for specific guidance based on ALT/AST and bilirubin levels.
* **Thrombocytopenia:** Dose interruption or discontinuation may be necessary. Consult prescribing information for specific guidance based on platelet counts.
* **Hyperbilirubinemia:** Dose interruption or discontinuation may be necessary.
## Contraindications
* Known hypersensitivity to gemtuzumab ozogamicin or any of its components.
## Adverse Effects
* **Common:** Febrile neutropenia, thrombocytopenia, nausea, vomiting, diarrhea, mucositis, headache, rash, peripheral neuropathy, pyrexia, abdominal pain, hypokalemia, elevated liver enzymes.
* **Serious:** Hepatotoxicity (including VOD/SOS), severe thrombocytopenia, hypersensitivity reactions, tumor lysis syndrome.
## Key Drug Interactions
* No significant drug interactions have been identified. However, caution should be exercised when administering with other myelosuppressive agents.
## Monitoring
* Complete blood counts (CBC) with differential and platelet counts frequently, especially during and after treatment.
* Liver function tests (LFTs), including bilirubin, ALT, and AST, regularly.
* Monitor for signs and symptoms of hypersensitivity reactions, VOD/SOS, and tumor lysis syndrome.
## Clinical Pearls
* Mylotarg is administered intravenously over 2 hours.
* Premedication with a corticosteroid, antihistamine, and antipyretic is recommended before each infusion.
* Liver toxicity, particularly veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS), is a serious and potentially fatal adverse effect. Patients with certain risk factors (e.g., prior HSCT, pre-existing liver disease) may be at higher risk.
* Thrombocytopenia is common and may necessitate dose adjustments or interruption.
* Consider the risk of tumor lysis syndrome, especially in patients with a high tumor burden.
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*Please verify the current prescribing information for the most up-to-date and complete drug details.*
