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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is an antibody-drug conjugate that targets CD33-expressing cells. It consists of a humanized anti-CD33 monoclonal antibody linked to the cytotoxic agent calicheamicin.
## Primary Indications
* Acute Myeloid Leukemia (AML) in adults:
* Newly diagnosed, in combination with induction and ---consolidation chemotherapy.
* Relapsed or refractory.
* Pediatric and young adult patients aged 1 month and older with newly diagnosed AML in remission who are candidates to receiveopoietic stem cell transplantation (HSCT) in the first or second complete remission.
## Adult Dosing
* **Newly diagnosed AML (combination therapy):**
* Day 1: 3 mg/m² IV infusion over 2-2.5 hours.
* Day 4: 3 mg/m² IV infusion over 2-2.5 hours.
* Day 7: 2 mg/m² IV infusion over 2-2.5 hours.
* Subsequent cycles, if administered: 3 mg/m² every 2-4 weeks.
* **Relapsed or refractory AML:**
* 2 doses: 3 mg/m² IV infusion over 2-2.5 hours on Day 1 and Day 4, with at least 7 days between doses.
* Alternatively, a single dose of 6 mg/m² IV infusion over 2-2.5 hours. No more than two courses of treatment.
## Pediatric Dosing
* **Newly diagnosed AML in remission (HSCT candidates):**
* 6 mg/m² IV infusion over 2-2.5 hours for a maximum of 2 doses, given approximately 14 to 21 days apart.
## Dose Adjustments
* **Hepatotoxicity:** Dose interruption or discontinuation may be necessary. Consult prescribing information for specific guidance based on AST/ALT levels and total bilirubin.
* **Thrombocytopenia:** Dose interruption or discontinuation may be necessary, especially if occurring early in treatment.
* **Infusion Reaction:** Slow infusion rate, pause infusion, or discontinue based on severity.
## Contraindications
* None listed in current prescribing information. Close monitoring for adverse events is critical.
## Adverse Effects
* **Hepatotoxicity:** Including Veno-Occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS), characterized by hyperbilirubinemia, hepatomegaly, and ascites. This is a potentially fatal toxicity.
* **Hematologic Toxicity:** Thrombocytopenia, neutropenia, anemia.
* **Infusion Reactions:** Fever, chills, rash, dyspnea, hypertension.
* **Bleeding:** Hemorrhage, particularly intracranial and gastrointestinal.
* **Infections:** Sepsis, pneumonia.
* **Nausea, vomiting, diarrhea, stomatitis, fatigue.**
## Key Drug Interactions
* **Hepatotoxic agents:** Concomitant use with other drugs known to cause hepatotoxicity may increase the risk and severity of liver injury. Exercise caution and monitor liver function closely. There are no specific pharmacokinetic interactions listed, but additive toxicity is a concern.
## Monitoring
* **Liver Function Tests (LFTs):** Baseline and regularly throughout treatment (e.g., ALT, AST, bilirubin). Monitor closely for signs of VOD/SOS.
* **Complete Blood Count (CBC):** Including differential and platelet counts, throughout treatment.
* **Coagulation Parameters:** PT/INR, PTT, especially if concomitant bleeding risk factors are present.
* **Signs and Symptoms of Infusion Reaction:** Monitor during and after infusion.
* **Signs and Symptoms of Bleeding:** Monitor closely.
* **Signs and Symptoms of Infection:** Monitor closely.
## Clinical Pearls
* Administer as a slow IV infusion over 2-2.5 hours to mitigate infusion reaction risk.
* Premedication with antipyretics, antihistamines, and corticosteroids may be considered to prevent or minimize infusion reactions (consult local protocol).
* Close monitoring for hepatotoxicity, especially VOD/SOS, is paramount. Assess liver function frequently and be prepared to manage based on severity.
* Manage thrombocytopenia and bleeding risk proactively. Consider platelet transfusions as clinically indicated.
* The risk of severe myelosuppression should be anticipated.
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**Disclaimer:** This information is intended for healthcare professionals and is not a substitute for clinical judgment. Always refer to the most current prescribing information and institutional protocols for definitive guidance.
