Please check your internet connection and try again.
# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg 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.
## Primary Indications
* Newly diagnosed Acute Myeloid Leukemia (AML) in adults who are 75 years or older, or who are ineligible for intensive induction chemotherapy.
* Relapsed or refractory AML in adults.
## Adult Dosing
### Newly Diagnosed AML (in combination with other agents)
* **First cycle:** 3 mg/m² on day 1, 6 mg/m² on day 4, and 3 mg/m² on day 7.
* **Second cycle (if achieving remission):** 3 mg/m² on day 1.
* **Subsequent cycles (if achieving remission):** 3 mg/m² once every 2 weeks.
### Relapsed or Refractory AML
* **First cycle:** 3 mg/m² on day 1, 6 mg/m² on day 4, and 3 mg/m² on day 7.
* **Second cycle (if achieving remission):** 3 mg/m² on day 1.
* **Maximum cumulative dose:** 33 mg/m².
## Pediatric Dosing
Safety and efficacy in pediatric patients have not been established.
## Dose Adjustments
* **Hepatotoxicity:** Dose interruption and reduction may be necessary based on the severity of liver enzyme elevations or bilirubin levels. Specific guidelines should be followed based on local protocols and FDA-approved labeling.
* **Myelosuppression:** Dose delays and reductions may be required for severe thrombocytopenia, neutropenia, or febrile neutropenia. Specific guidelines should be followed based on local protocols and FDA-approved labeling.
* **Infusion Reactions:** Interrupt infusion and manage symptoms. Consider dose reduction or discontinuation for severe reactions.
## Contraindications
* None listed in standard prescribing information, but extreme caution and contraindications for other agents used in combination should be considered.
## Adverse Effects
* **Common:** Hepatotoxicity (including VOD/SOS), myelosuppression (thrombocytopenia, neutropenia, febrile neutropenia), nausea, vomiting, diarrhea, mucositis, fatigue, rash, headache, pyrexia.
* **Serious:** Hepatotoxicity (VOD/SOS), severe myelosuppression, infusion reactions, tumor lysis syndrome.
## Key Drug Interactions
* CYP3A4 inhibitors/inducers: Monitor for potential drug interactions, although gemtuzumab ozogamicin is not a substrate of CYP enzymes.
* Other myelosuppressive agents: Increased risk of myelosuppression.
## Monitoring
* **Liver Function Tests (LFTs):** Including bilirubin, AST, ALT, and alkaline phosphatase, at baseline and regularly during treatment.
* **Complete Blood Count (CBC) with differential:** At baseline and frequently during treatment, especially for myelosuppression.
* **Signs and symptoms of infusion reactions:** During and after infusion.
* **Signs and symptoms of VOD/SOS:** Monitor closely, especially in patients with pre-existing liver disease or those receiving other treatments known to cause VOD/SOS.
## Clinical Pearls
* Prior to initiating treatment, assess patient's risk factors for VOD/SOS, including pre-existing liver disease and concurrent chemotherapy.
* Administer as a slow intravenous infusion.
* Prophylaxis for infections is crucial due to myelosuppression.
* Consider granulocyte colony-stimulating factors (G-CSF) for the management of neutropenia and febrile neutropenia.
***
*Disclaimer: This information is intended for healthcare professionals and is not a substitute for professional medical advice. Always consult the most current prescribing information and relevant clinical guidelines for complete details and to verify dosages and safety information before making treatment decisions.*
