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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is an antibody-drug conjugate consisting of a humanized anti-CD33 monoclonal antibody linked to a cytotoxic agent, calicheamicin. It targets CD33-expressing myeloid leukemia cells.
## Primary Indications
* Treatment of adults with newly diagnosed acute myeloid leukemia (AML) who are age 75 years or older.
* Treatment of adults with relapsed or refractory AML.
## Adult Dosing
**Newly Diagnosed AML (age ≥ 75 years), in combination with other chemotherapy:**
* Day 1: 3 mg/kg IV infusion
* Day 4: 3 mg/kg IV infusion
* Day 7: 2 mg/kg IV infusion
* Subsequent cycles: 2 mg/kg IV infusion every 2 weeks.
**Relapsed or Refractory AML:**
* Cycle 1: 3 mg/kg IV infusion on Day 1, Day 4, and Day 7.
* Cycle 2 onwards (if disease has not progressed and patient is eligible): 3 mg/kg IV infusion every 2 to 4 weeks.
**Maximum dose:** 3 mg/kg per infusion.
## Pediatric Dosing
Dosing for pediatric patients is not established.
## Dose Adjustments
* **Hepatotoxicity:** Dose interruption and/or reduction is recommended based on the severity of transaminase elevations and bilirubin levels. Management details are specific and require careful assessment.
* **Hyperbilirubinemia:** Dose interruption and/or reduction is recommended.
* **Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS):** Discontinue Mylotarg.
## Contraindications
* None listed in standard prescribing information. However, due to the risk of severe hepatotoxicity, Mylotarg should be used with caution in patients with pre-existing hepatic impairment.
## Adverse Effects
* **Hepatotoxicity:** Including hyperbilirubinemia, elevated AST/ALT, and VOD/SOS. This is a significant and potentially life-threatening adverse effect.
* Myelosuppression (neutropenia, thrombocytopenia, anemia).
* Infections.
* Bleeding events.
* Infusion-related reactions.
* Nausea, vomiting, diarrhea, mucositis, stomatitis.
* Fatigue, headache, fever.
## Key Drug Interactions
No significant drug interactions are specifically listed in standard prescribing information. However, co-administration with other myelosuppressive agents may increase the risk of myelosuppression and infections. Concomitant use with hepatotoxic agents may increase the risk of hepatotoxicity.
## Monitoring
* **Liver Function Tests (LFTs):** Baseline and regular monitoring of bilirubin and transaminases (AST, ALT) is crucial, particularly before each dose.
* **Complete Blood Counts (CBCs):** With differential and platelet count before each dose.
* **Signs and symptoms of bleeding and infection.**
* **Signs and symptoms of VOD/SOS:** Including jaundice, hepatomegaly, ascites, and abdominal pain.
## Clinical Pearls
* Mylotarg carries a black box warning for severe and potentially fatal hepatotoxicity, including VOD/SOS.
* Careful patient selection and close monitoring for hepatotoxicity are paramount.
* Prophylaxis for VOD/SOS is not recommended.
* It is essential to administer Mylotarg as an IV infusion only and over the specified infusion time.
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*This information is intended for healthcare professionals. Always consult the most current prescribing information and relevant clinical guidelines before making any treatment decisions.*
