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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is a CD33-directed antibody and DNA intercalator conjugate.
## Primary Indications
* Treatment of adults and pediatric patients (1 month or older) with newly diagnosed acute myeloid leukemia (AML) in remission that is refractory or in relapse.
* Treatment of adults and pediatric patients (1 month or older) with AML that is newly diagnosed and ineligible for intensive induction chemotherapy.
## Adult Dosing
* **Treatment of Relapsed/Refractory AML:**
* For patients eligible for hematopoietic stem cell transplant: 3 mg/kg once.
* For patients ineligible for hematopoietic stem cell transplant: 6 mg/kg once, followed by 3 mg/kg once 2 to 4 weeks later.
* **Treatment of Newly Diagnosed AML (Ineligible for Intensive Induction Chemotherapy):**
* 6 mg/kg on day 1, 3 mg/kg on day 4, and 3 mg/kg on day 7 of the first cycle.
* If a second cycle is given, administer 3 mg/kg on days 1, 3, and 5.
* Maximum cumulative dose should not exceed 27.3 mg/kg for the first 5 cycles.
## Pediatric Dosing
* **Age ≥ 1 month:** Dosing is based on weight and indication. Refer to the full prescribing information for specific regimens and dose adjustments, particularly for patients with different body surface areas.
## Dose Adjustments
* **Hepatotoxicity:** Consider dose modification or interruption based on severity of liver enzyme elevations and bilirubin.
* **Thrombocytopenia:** Dose interruption may be necessary.
## Contraindications
* None specific beyond hypersensitivity to the drug or its components.
## Adverse Effects
* **Life-threatening:** Hepatic Veno-Occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS), myelosuppression (thrombocytopenia, neutropenia, febrile neutropenia, anemia), hypersensitivity reactions, tumor lysis syndrome.
* **Common:** Nausea, vomiting, diarrhea, mucositis, headache, fever, rash, fatigue, bleeding events.
## Key Drug Interactions
* No significant drug interactions are established with other chemotherapy agents or supportive care medications.
## Monitoring
* **Hematologic:** Frequent monitoring of CBC with differential and platelet count.
* **Liver Function:** Monitor ALT, AST, and bilirubin before and regularly during treatment.
* **Renal Function:** Monitor SCr.
* **Signs of Infusion Reactions:** Monitor closely during and after infusion.
* **Signs of VOD/SOS:** Monitor for symptoms such as jaundice, hepatomegaly, ascites, weight gain.
## Clinical Pearls
* Administer infused over 1 to 2 hours.
* Premedication with an antiemetic is recommended.
* Monitor for signs and symptoms of VOD/SOS, which can be irreversible and fatal.
* Consider dose capping for obese patients, especially at higher doses.
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*This information is intended for healthcare professionals. Always consult the most current prescribing information and institutional protocols for definitive guidance.*
