Please check your internet connection and try again.
# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is an antibody-drug conjugate consisting of a humanized anti-CD33 monoclonal antibody conjugated to calicheamicin, a cytotoxic agent. It targets CD33-expressing cells, primarily leukemic blasts.
## Primary Indications
* Treatment of newly diagnosed Acute Myeloid Leukemia (AML) in adult patients who are candidates for, but not candidates for, intensive chemotherapy.
* Treatment of relapsed or refractory AML in adult patients.
## Adult Dosing
**Newly Diagnosed AML (in combination with other agents):**
* Day 1: 3 mg/kg IV over 2 hours.
* Day 4: 3 mg/kg IV over 2 hours.
* Day 7: 2 mg/kg IV over 2 hours.
**Relapsed or Refractory AML:**
* Cycle 1: 6 mg/kg IV over 2 hours on Day 1. If tolerated, a second dose of 3 mg/kg IV over 2 hours may be given on Day 4.
* Cycle 2 (if tolerated and disease has not progressed): 3 mg/kg IV over 2 hours on Day 1, Day 4, and Day 7.
Maximum cumulative dose is 26.4 mg/kg.
## Pediatric Dosing
Mylotarg is not indicated for pediatric patients with AML. Safety and efficacy have not been established.
## Dose Adjustments
* **Hepatic Impairment:** Use with caution. If bilirubin is >2.5 x ULN or AST/ALT is >3 x ULN, do not administer.
* **Renal Impairment:** No dose adjustment is recommended for mild to moderate renal impairment (CrCl ≥ 30 mL/min). Use with caution in severe renal impairment.
## Contraindications
* None specific listed for Mylotarg itself, but contraindications for combination chemotherapy agents must be followed.
## Adverse Effects
* **Black Box Warnings:** Hepatotoxicity (including VOD/SOS), myelosuppression (including neutropenia, thrombocytopenia, anemia, febrile neutropenia), infusion-related reactions.
* **Common Adverse Effects:** Febrile neutropenia, neutropenia, thrombocytopenia, anemia, nausea, vomiting, diarrhea, mucositis, headache, fatigue, elevated liver enzymes, rash.
## Key Drug Interactions
* Due to the cytotoxic nature of gemtuzumab ozogamicin, co-administration with other myelosuppressive agents may increase the risk of myelosuppression. Careful monitoring is required.
## Monitoring
* **Hepatotoxicity:** Monitor liver function tests (bilirubin, AST, ALT, alkaline phosphatase) regularly.
* **Myelosuppression:** Monitor complete blood counts (CBC) with differential and platelet counts frequently.
* **Infusion-Related Reactions:** Monitor vital signs during and after infusion.
* **Bleeding:** Monitor for signs and symptoms of bleeding.
## Clinical Pearls
* Administer prophylactic anti-emetics, anti-diarrheals, and anti-infectives as indicated.
* Consider premedication with corticosteroids, antihistamines, and antipyretics to reduce infusion-related reactions.
* Veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS) is a serious and potentially fatal toxicity. Patients with pre-existing hepatic impairment or those who have received prior HSCT or chemotherapy are at increased risk.
***
*This information is intended for healthcare professionals. Always consult the most current prescribing information and relevant clinical guidelines for complete details and to ensure patient safety.*
