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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is an antibody-drug conjugate targeting CD33, an antigen expressed on myeloid leukemia cells. It consists of a humanized anti-CD33 monoclonal antibody conjugated to the cytotoxic agent calicheamicin.
## Primary Indications
Treatment of newly diagnosed acute myeloid leukemia (AML) in adult patients who are 75 years of age or older and are not suitable for intensive induction chemotherapy.
Treatment of relapsed or refractory (R/R) AML in adult patients.
## Adult Dosing
### Newly Diagnosed AML (patients >= 75 years, not suitable for intensive induction chemotherapy)
* **Cycle 1:** 3 mg/m² on day 1, 6 mg/m² on day 4, and 3 mg/m² on day 7.
* **Cycle 2 (if patient does not undergo stem cell transplant):** 3 mg/m² on day 1.
### Relapsed or Refractory AML
* **First Relapse:** 3 mg/m² on day 1, 2 mg/m² on day 4, and 2 mg/m² on day 7.
* **Subsequent Relapses or Refractory Disease:** 3 mg/m² on day 1.
**Maximum cumulative dose:** 35 mg/m² over the course of therapy.
## Pediatric Dosing
Mylotarg is not approved for use in pediatric patients.
## Dose Adjustments
### Hepatic Impairment
* **Bilirubin 1.5 to 3 times upper limit of normal (ULN):** Reduce dose by 25%.
* **Bilirubin > 3 times ULN:** Do not administer.
### Renal Impairment
* **Creatinine clearance < 60 mL/min:** Use with caution. Data is limited. Dose adjustments are not specifically defined, but close monitoring is recommended.
## Contraindications
* None specified.
## Adverse Effects
**Black Box Warnings:**
* **Hepatotoxicity:** Severe and potentially fatal hepatotoxicity, including veno-occlusive liver disease (VOD)/sinusoidal obstruction syndrome (SOS), has occurred. Risk factors include prior HCT, prior treatment with certain chemotherapy agents, and elevated bilirubin.
* **Hemorrhage:** Severe and potentially fatal bleeding events, including gastrointestinal and intracranial hemorrhage, have occurred.
**Common Adverse Effects:**
* Thrombocytopenia
* Febrile neutropenia
* Anemia
* Leukopenia
* Nausea
* Vomiting
* Diarrhea
* Mucositis
* Headache
* Fever
* Fatigue
* Peripheral neuropathy
* Rash
* Elevated liver enzymes
## Key Drug Interactions
* There are no specific drug interactions identified as clinically significant. However, caution should be exercised when co-administering with other medications that may increase the risk of bleeding or hepatotoxicity.
## Monitoring
* **Liver function tests:** Including bilirubin, ALT, AST, and alkaline phosphatase, before and regularly during treatment.
* **Complete blood counts (CBC) with differential:** Regularly during treatment to monitor for myelosuppression.
* **Coagulation parameters:** PT, PTT, and INR, especially in patients with risk factors for bleeding.
* **Signs and symptoms of VOD/SOS:** Monitor for jaundice, ascites, hepatomegaly, and thrombocytopenia.
* **Signs and symptoms of bleeding:** Monitor for petechiae, ecchymosis, epistaxis, hematuria, melena, and any signs of internal bleeding.
## Clinical Pearls
* Mylotarg is administered intravenously.
* Consider prophylactic antibiotics, antivirals, and antifungals as per institutional guidelines for patients with AML.
* Patients should be monitored closely for signs of hepatotoxicity and hemorrhage.
* Discontinuation of Mylotarg may be necessary based on the severity of adverse events.
* The decision to re-dose or continue therapy should be based on clinical response and tolerability.
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**Disclaimer:** This information is intended for healthcare professionals and is not a substitute for the complete prescribing information or professional medical advice. Always verify current prescribing information with the manufacturer's official product insert and consult with appropriate specialists before making any treatment decisions.
