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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Gemtuzumab ozogamicin is an antibody-drug conjugate targeting CD33, a protein found on the surface of myeloid leukemia cells. It delivers a cytotoxic agent (calicheamicin) directly to these cells, leading to cell death.
## Primary Indications
* Treatment of newly diagnosed adult patients with acute myeloid leukemia (AML) who are younger than 60 years and are suitable for intensive chemotherapy.
* Treatment of relapsed or refractory adult patients with AML.
## Adult Dosing
**Newly Diagnosed AML (in combination with chemotherapy):**
* **Day 1:** 3 mg/kg IV infusion over 2 hours.
* **Day 4:** 3 mg/kg IV infusion over 2 hours.
* **Day 7:** 2 mg/kg IV infusion over 2 hours.
* **Maximum cumulative dose:** 10 mg/kg.
**Relapsed or Refractory AML:**
* **First cycle:** 6 mg/kg IV infusion over 2 hours.
* **If not discontinued, second cycle (at least 14 days after the first):** 3 mg/kg IV infusion over 2 hours.
* **Maximum cumulative dose:** 10 mg/kg.
**Note:** Dosing may vary based on specific chemotherapy regimens and institutional protocols.
## Pediatric Dosing
* Information on the use of gemtuzumab ozogamicin in pediatric patients is limited. Its use in this population is generally not established and should be based on expert consultation and available pediatric data, if any.
## Dose Adjustments
* **Hepatic Impairment:** Data is limited. Exercise caution. If bilirubin > 5 mg/dL, the drug should not be administered.
* **Renal Impairment:** Data is limited. Exercise caution.
## Contraindications
* Hypersensitivity to gemtuzumab ozogamicin or any of its components.
## Adverse Effects
* **Common:** Febrile neutropenia, nausea, vomiting, diarrhea, stomatitis, headache, fatigue, rash, pyrexia, liver dysfunction (including veno-occlusive disease/sinusoidal obstruction syndrome), myelosuppression (anemia, thrombocytopenia, neutropenia), bleeding events.
* **Serious:** Veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS), severe myelosuppression, liver toxicity, infusion-related reactions, tumor lysis syndrome.
## Key Drug Interactions
* **Chemotherapy agents:** Gemtuzumab ozogamicin is often used in combination with chemotherapy. Close monitoring for additive toxicities, especially myelosuppression and hepatotoxicity, is crucial.
* **Other hepatotoxic agents:** Concurrent use with other drugs known to cause liver injury may increase the risk of severe hepatotoxicity, including VOD/SOS.
## Monitoring
* **Hematologic parameters:** Complete blood counts with differential and platelet count should be monitored frequently (e.g., twice weekly during treatment, then weekly) due to the risk of severe myelosuppression.
* **Liver function tests:** Bilirubin, AST, ALT, alkaline phosphatase should be monitored regularly.
* **Signs and symptoms of VOD/SOS:** Monitor for weight gain, hepatomegaly, ascites, jaundice, and thrombocytopenia.
* **Infusion-related reactions:** Monitor vital signs during and after infusion.
## Clinical Pearls
* Gemtuzumab ozogamicin carries a Black Box Warning for hepatotoxicity, including fatal VOD/SOS, and for myelosuppression.
* Hepatotoxicity, particularly VOD/SOS, is a serious risk and can occur even after discontinuation of the drug. Early recognition and management are critical.
* The risk of bleeding events may be increased, especially in patients with severe thrombocytopenia.
* Consider prophylactic measures for common side effects such as nausea, vomiting, and stomatitis.
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**Disclaimer:** This information is intended for healthcare professionals. Always consult the most current prescribing information and institutional guidelines before initiating or modifying therapy.
