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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is an antibody-drug conjugate consisting of a humanized anti-CD33 monoclonal antibody linked to the cytotoxic agent ozogamicin. It targets cancer cells expressing the CD33 antigen.
## Primary Indications
* Relapsed or refractory acute myeloid leukemia (AML) in adults.
* Newly diagnosed AML in adults who are older than 75 years or who are unable to tolerate intensive induction chemotherapy.
## Adult Dosing
* **For newly diagnosed AML:**
* **Induction:** 3 mg/m² on days 1, 4, and 7. If consolidation is given, 3 mg/m² on day 1 of each cycle.
* Maximum cumulative dose is 18 mg/m².
* **For relapsed or refractory AML:**
* **First relapse:** 3 mg/m² on day 1.
* **Second or subsequent relapse:** 3 mg/m² on day 1.
* Repeat cycle can be given after 2-4 weeks if signs of recovery and no unacceptable toxicity.
* Maximum cumulative dose is 18 mg/m².
## Pediatric Dosing
Dosing in pediatric patients is not established.
## Dose Adjustments
* **Hepatic Impairment:** Data is limited. Use with caution. Consider dose reduction or interruption based on bilirubin levels.
* Bilirubin 1.5-3 times ULN: Consider holding therapy.
* Bilirubin >3 times ULN: Do not administer.
* **Renal Impairment:** Data is limited. Use with caution.
## Contraindications
* None listed.
## Adverse Effects
* **Common:** Nausea, vomiting, diarrhea, stomatitis, constipation, headache, fever, rash, fatigue, edema, peripheral neuropathy, cough, pneumonia, upper respiratory tract infections, and myelosuppression (thrombocytopenia, anemia, neutropenia).
* **Serious:** Hepatotoxicity (VOD/SOS), hypersensitivity reactions, infusion-related reactions, bleeding events, QT prolongation, and embryo-fetal toxicity.
* **Hepatotoxicity (VOD/SOS):** Signs and symptoms include hyperbilirubinemia, hepatomegaly, ascites, thrombocytopenia, and weight gain. This is a potentially fatal adverse reaction.
## Key Drug Interactions
* **Strong CYP3A4 Inhibitors/Inducers:** Potential for altered gemtuzumab ozogamicin exposure. Monitor closely.
* **Other Hepatotoxic Agents:** Concomitant use may increase the risk of hepatotoxicity.
## Monitoring
* **Complete Blood Counts (CBC) with differential and platelets:** Before each dose and regularly thereafter.
* **Liver Function Tests (LFTs):** Including bilirubin, AST, ALT, and alkaline phosphatase, before each dose and regularly thereafter.
* **Renal function:** Before each dose and regularly thereafter.
* **Signs and symptoms of VOD/SOS:** Daily for patients at risk during induction and consolidation.
* **Signs and symptoms of hypersensitivity and infusion reactions:** During and after infusion.
* **Pregnancy testing:** For females of reproductive potential.
## Clinical Pearls
* Mylotarg carries a Black Box Warning for hepatotoxicity, specifically veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS), which can be fatal.
* Due to the risk of VOD/SOS, careful patient selection and monitoring are crucial, especially in patients with pre-existing liver disease or those receiving other hepatotoxic agents.
* Infusion-related reactions can occur; premedication with an antihistamine and corticosteroid may be considered.
* Gemtuzumab ozogamicin has a boxed warning for toxicity and a REMS program is required for its distribution and use.
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*This information is intended for healthcare professionals. It is essential to consult the most current prescribing information and institutional protocols for complete details before prescribing or administering this medication.*
