Please check your internet connection and try again.
# 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 acute myeloid leukemia (AML) in adults who are newly diagnosed or have relapsed/refractory disease.
## Adult Dosing
* **Newly Diagnosed CD33-Positive AML:**
* Induction: 3 mg/m² on day 1, 6 mg/m² on day 4, and 9 mg/m² on day 7.
* Consolidation (if achieving remission): 3 mg/m² on day 1, 6 mg/m² on day 4, and 9 mg/m² on day 7 for up to 2 cycles.
* **Relapsed/Refractory CD33-Positive AML:**
* First relapse: 3 mg/m² on day 1, 6 mg/m² on day 4, and 9 mg/m² on day 7. A second cycle of the same dose can be given on day 15 if hematologic remission is not achieved.
* Second or subsequent relapse: 3 mg/m² on day 1, 6 mg/m² on day 4, and 9 mg/m² on day 7.
*Maximum single dose should not exceed 9 mg.*
## Pediatric Dosing
There is no established pediatric dosing for gemtuzumab ozogamicin. Use in pediatric patients is not recommended.
## Dose Adjustments
* **Hepatic Impairment:** If bilirubin >2.5 mg/dL or AST >3 times the upper limit of normal, gemtuzumab ozogamicin should generally be avoided. Limited data available for use with moderate hepatic impairment.
* **Renal Impairment:** No dose adjustment is typically required for mild to moderate renal impairment. Use with caution in severe renal impairment.
## Contraindications
* Known hypersensitivity to gemtuzumab ozogamicin or any of its components.
## Adverse Effects
* **Hepatotoxicity:** Severe and potentially fatal hepatic veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS) is a serious risk, particularly when used with other chemotherapy. Signs include jaundice, hepatomegaly, ascites, and elevated bilirubin.
* **Myelosuppression:** Thrombocytopenia, neutropenia, and anemia are common and expected.
* **Infusion-related reactions:** Fever, chills, rash, dyspnea.
* **Hemorrhage:** Particularly in patients with severe thrombocytopenia.
* **Nausea, vomiting, diarrhea, mucositis.**
## Key Drug Interactions
* **Concurrent chemotherapy:** Increased risk of hepatotoxicity and myelosuppression.
* **CYP450 substrates:** Gemtuzumab ozogamicin is metabolized by the liver, but specific interactions are not well-defined. Monitor for potential interactions.
## Monitoring
* **Liver function tests (LFTs):** Monitor bilirubin, AST, ALT, and alkaline phosphatase frequently, especially before and after each dose, and throughout treatment.
* **Complete blood counts (CBCs):** Monitor for myelosuppression (neutrophils, platelets, hemoglobin).
* **Signs and symptoms of VOD/SOS:** Monitor closely.
* **Signs and symptoms of infusion reactions.**
* **Signs and symptoms of bleeding.**
## Clinical Pearls
* Premedication for infusion reactions (e.g., acetaminophen, antihistamines) may be considered.
* Patients should be closely monitored for signs of VOD/SOS throughout therapy and for a sufficient period after completion.
* Consider withholding gemtuzumab ozogamicin if severe hepatic toxicity occurs.
* Discontinue infusion immediately if a severe infusion reaction occurs.
***
*This information is intended for healthcare professionals. It is essential to consult the most current prescribing information and local protocols before administering this medication.*
