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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Gemtuzumab ozogamicin is an antibody-drug conjugate that targets CD33, a protein expressed on the surface of myeloid leukemia cells. It delivers calicheamicin, a cytotoxic agent, directly to CD33-expressing cells.
## Primary Indications
* Relapsed or refractory acute myeloid leukemia (AML) in adults who are CD33-positive.
## Adult Dosing
**First Cycle:**
* 3 mg/m² on day 1.
* If tolerated, 3 mg/m² on day 4.
* If tolerated, 3 mg/m² on day 7.
**Subsequent Cycles (if patient achieves response and continues therapy):**
* 3 mg/m² once every 2 to 4 weeks.
**Maximum dose:** Not to exceed 3 mg/m² per dose.
## Pediatric Dosing
Dosing in pediatric patients has not been established.
## Dose Adjustments
* **Hepatotoxicity:** Dose interruption or discontinuation may be necessary based on the severity of liver enzyme elevations or bilirubin increase. Consult prescribing information for specific management guidelines.
* **Thrombocytopenia:** Monitor platelet counts closely. Dose interruption or discontinuation may be necessary.
* **Infusion Reactions:** Slow infusion rate, premedicate, or discontinue based on severity.
## Contraindications
* Active sinusoidal obstruction syndrome (SOS)/veno-occlusive disease (VOD).
## Adverse Effects
* **Common:** Febrile neutropenia, nausea, vomiting, diarrhea, mucositis, headache, pyrexia, hypokalemia, elevated liver enzymes (AST, ALT, bilirubin), thrombocytopenia, anemia, fatigue.
* **Serious:** Hepatotoxicity (including SOS/VOD), myelosuppression, infusion reactions, tumor lysis syndrome, gastrointestinal hemorrhage.
## Key Drug Interactions
* **Strong CYP3A4 Inhibitors/Inducers:** Gemtuzumab ozogamicin is not significantly metabolized by CYP enzymes. However, caution is advised due to potential for additive myelosuppression with other myelosuppressive agents.
## Monitoring
* Complete blood counts (CBC) with differential and platelet count: Frequently during treatment and until recovery.
* Liver function tests (LFTs): Baseline and regularly during treatment.
* Renal function tests: Baseline and regularly during treatment.
* Signs and symptoms of infusion reactions and hepatotoxicity.
## Clinical Pearls
* Premedication with antipyretics, antihistamines, and corticosteroids may be considered to mitigate infusion reactions.
* Close monitoring for hepatotoxicity, particularly SOS/VOD, is crucial, especially in patients with pre-existing liver disease or those receiving other potentially hepatotoxic agents.
* Treatment should be initiated by or under the guidance of a physician experienced in the treatment of AML.
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*This information is intended for healthcare professionals. Always consult the official prescribing information and relevant clinical guidelines for the most up-to-date and complete details before making any treatment decisions.*
