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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is a humanized immunoglobulin G4 (IgG4) kappa antibody-drug conjugate (ADC) that targets CD33, an antigen expressed on myeloid leukemia cells. It delivers calicheamicin, a potent antineoplastic agent, to CD33-expressing cells, leading to DNA strand breaks and cell death.
## Primary Indications
* Relapsed or refractory acute myeloid leukemia (AML) in adults.
* Newly diagnosed AML in adults who are 75 years of age or older.
## Adult Dosing
**For newly diagnosed AML in patients 75 years or older:**
* **Day 1:** 3 mg/kg
* **Day 4:** 3 mg/kg
* **Day 7:** 2 mg/kg
**For relapsed or refractory AML:**
* **Cycle 1:** 3 mg/kg on Day 1
* **Cycle 2:** 3 mg/kg on Day 1 (if needed, no sooner than 14 days after first dose)
A maximum dose of 3 mg/kg per infusion is recommended.
## Pediatric Dosing
The safety and efficacy of Mylotarg in pediatric patients have not been established.
## Dose Adjustments
* **Hepatotoxicity:** Dose reduction or interruption may be necessary. See specific guidelines for management of transaminase elevations and hyperbilirubinemia.
* **Thrombocytopenia:** Monitor platelet counts closely. Dose interruption or reduction may be considered.
## Contraindications
* None listed in current prescribing information. However, patients with severe hypersensitivity to gemtuzumab ozogamicin or any component of the formulation should not receive the drug.
## Adverse Effects
* **Common:** Febrile neutropenia, nausea, vomiting, diarrhea, mucositis, headache, pyrexia, rash, fatigue, hemorrhage, hypokalemia, elevated transaminases, elevated bilirubin.
* **Serious:** Hepatotoxicity (including sinusoidal obstruction syndrome/veno-occlusive disease), severe infusion reactions, myelosuppression (including thrombocytopenia and neutropenia), bleeding events, tumor lysis syndrome.
## Key Drug Interactions
* **Hepatotoxic agents:** Use with caution. Concurrent use with other hepatotoxic medications may increase the risk of liver injury.
* **Anticoagulants/Antiplatelets:** Increased risk of bleeding. Monitor closely.
## Monitoring
* **Hepatotoxicity:** Baseline liver function tests (ALT, AST, bilirubin) and monitoring at least weekly during treatment and for 30 days after the last dose.
* **Complete Blood Counts (CBC):** Monitor CBC with differential regularly (e.g., twice weekly) during treatment cycles and for at least 30 days after the last dose.
* **Infusion Reactions:** Monitor vital signs during and after infusion.
* **Bleeding:** Monitor for signs and symptoms of bleeding.
## Clinical Pearls
* Mylotarg administration requires a dedicated infusion line and should not be mixed or infused with other medications.
* Premedication with an antihistamine and antipyretic may be considered prior to infusion.
* Patients should be advised to report any signs of liver problems (e.g., jaundice, abdominal pain, dark urine) or bleeding immediately.
* Due to the risk of hepatotoxicity, especially sinusoidal obstruction syndrome (SOS), careful monitoring and dose modifications are crucial.
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**Disclaimer:** This information is intended for healthcare professionals. Always consult the most current official prescribing information and institutional protocols for definitive guidance.
