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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.
## Primary Indications
* Treatment of newly diagnosed acute myeloid leukemia (AML) in adult patients who are 75 years of age or older and are not candidates for induction chemotherapy.
* Treatment of relapsed or refractory AML in adult patients.
## Adult Dosing
**Newly diagnosed AML (patients not candidates for induction chemotherapy):**
* 6 mg/m² on Day 1, Day 4, and Day 7 of the first cycle.
* If not achieving CR and no unacceptable toxicity, a second cycle of 3 mg/m² on Day 1, Day 4, and Day 7 may be administered.
* Maximum dose per infusion: 6 mg/m².
**Relapsed or refractory AML:**
* 3 mg/m² on Day 1, Day 4, and Day 7.
* Maximum dose per infusion: 3 mg/m².
All doses should be administered as an intravenous infusion over 2 to 3 hours.
## Pediatric Dosing
Dosing for pediatric patients is not established.
## Dose Adjustments
* **Hepatotoxicity:** If AST > 3 times ULN, ALT > 3 times ULN, or total bilirubin > 2 times ULN, dose interruption or reduction may be necessary. Refer to specific guidelines for precise adjustments.
* **Infusion Reactions:** Slow infusion rate, consider premedication, or interrupt/discontinue infusion.
* **Thrombocytopenia:** Monitor platelet counts closely. Dose interruption or delay may be required. Gemtuzumab ozogamicin carries a Black Box Warning for **Hemorrhage**, particularly in patients with severe thrombocytopenia.
## Contraindications
* None listed for gemtuzumab ozogamicin itself, but clinical context and patient factors are critical.
## Adverse Effects
* **Black Box Warnings:**
* **Hepatotoxicity:** Severe, potentially fatal hepatotoxicity, including hepatic veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS), has occurred. Risk factors include prior stem cell transplant, prior liver disease, and concomitant chemotherapy.
* **Myelosuppression:** Severe neutropenia, thrombocytopenia, and anemia, which may lead to increased risk of infection and hemorrhage.
* **Common Adverse Reactions:** Fever, nausea, vomiting, diarrhea, headache, fatigue, stomatitis, rash, chills, abdominal pain, muscle pain, cough, peripheral edema, and decreased appetite.
## Key Drug Interactions
* **Hepatotoxic agents:** Concomitant use with other agents known to cause hepatotoxicity may increase the risk of severe liver injury. Caution and close monitoring are advised.
## Monitoring
* **Liver Function Tests:** Regularly monitor AST, ALT, and total bilirubin, especially prior to and during treatment.
* **Complete Blood Counts (CBC):** Monitor CBC with differential and platelet count frequently throughout treatment.
* **Signs and Symptoms of Infusion Reactions:** Monitor patients during and after infusion.
* **Signs and Symptoms of Bleeding:** Monitor closely, particularly in patients with thrombocytopenia.
* **Signs and Symptoms of VOD/SOS:** Monitor for signs such as jaundice, ascites, hepatomegaly, and thrombocytopenia.
## Clinical Pearls
* Premedication with an antipyretic, antihistamine, and corticosteroid may be considered to reduce the risk of infusion reactions.
* Close monitoring for hepatotoxicity and hemorrhagic events is paramount.
* Patients with underlying liver disease or those who have undergone stem cell transplantation may be at higher risk for severe hepatotoxicity.
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*Disclaimer: This information is intended for clinical decision-making and is not a substitute for professional medical advice. Always consult the most current prescribing information and institutional protocols.*
