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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Gemtuzumab ozogamicin is an antibody-drug conjugate that targets CD33, a protein found on the surface of myeloid leukemia cells. It is used in the treatment of acute myeloid leukemia (AML).
## Primary Indications
* Treatment of newly diagnosed CD33-positive AML in adults in combination with other chemotherapy.
* Treatment of relapsed or refractory CD33-positive AML in adults.
## Adult Dosing
**Newly Diagnosed AML (in combination with chemotherapy):**
* First cycle: 3 mg/m² on days 1, 4, and 7.
* Second cycle (if needed): 3 mg/m² on days 1 and 4.
* Maximum cumulative dose: 13.8 mg/m² over up to 12 months.
**Relapsed or Refractory AML:**
* First cycle: 6 mg/m² on day 1.
* If treatment is not discontinued due to toxicity or disease progression, a second cycle of 6 mg/m² can be given on day 1, approximately 2 to 4 weeks after the first cycle.
* Maximum cumulative dose: 12 mg/m².
**Note:** Dosing may vary based on local protocols, especially regarding the number of cycles and timing.
## Pediatric Dosing
The safety and efficacy of gemtuzumab ozogamicin have not been established in pediatric patients.
## Dose Adjustments
* **Hepatotoxicity:** Dose interruption or discontinuation may be necessary based on the severity of elevation in liver enzymes and bilirubin. Refer to specific prescribing information for detailed guidelines.
* **Thrombocytopenia:** Gemtuzumab ozogamicin can cause severe thrombocytopenia. Dose interruption or discontinuation may be necessary.
* **Infusion Reactions:** Dose interruption or discontinuation may be necessary based on the severity of the reaction.
## Contraindications
* Hypersensitivity to gemtuzumab ozogamicin or any component of the formulation.
## Adverse Effects
* **Common:** Febrile neutropenia, thrombocytopenia, nausea, vomiting, diarrhea, stomatitis, fatigue, headache, fever, rash, liver enzyme elevations, hyperbilirubinemia.
* **Serious:** Hepatotoxicity (including VOD/SOS), severe infusion reactions, myelosuppression.
## Key Drug Interactions
* No specific drug interactions are established in the prescribing information. However, caution should be exercised when administering with other myelosuppressive agents.
## Monitoring
* **Complete Blood Counts (CBC):** Monitor frequently, especially for neutropenia and thrombocytopenia.
* **Liver Function Tests (LFTs):** Monitor bilirubin and transaminases regularly.
* **Signs and symptoms of VOD/SOS:** Monitor for jaundice, hepatomegaly, ascites, weight gain, and dyspnea.
* **Signs and symptoms of infusion reactions:** Monitor during and after infusion.
## Clinical Pearls
* Gemtuzumab ozogamicin carries a boxed warning for hepatotoxicity, including veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS), and for potential for severe myelosuppression.
* Administer prophylactic antiemetics and antidiarrheals as needed.
* Patients should be monitored closely for signs of liver toxicity and VOD/SOS.
* Discontinuation of the drug may be required based on the severity of adverse events.
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**Disclaimer:** This information is intended for healthcare professionals. Always consult the most current prescribing information and institutional guidelines for complete and up-to-date information before making clinical decisions.
