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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is an antibody-drug conjugate that targets CD33-expressing cancer cells. It consists of a humanized anti-CD33 antibody linked to a cytotoxic agent, calicheamicin.
## Primary Indications
* Acute Myeloid Leukemia (AML) in adults who have relapsed or are refractory to prior therapy.
* Newly diagnosed AML in adults who are 75 years of age or older and are not candidates for intensive induction chemotherapy.
## Adult Dosing
* **For patients with relapsed or refractory AML:**
* Day 1: 3 mg/kg intravenously.
* Day 4: 3 mg/kg intravenously.
* Day 7: 2 mg/kg intravenously.
* *Maximum cumulative dose:* 10 mg/kg.
* **For newly diagnosed AML in elderly patients (75 years or older):**
* 6 mg/kg intravenously on Day 1.
* Repeat on Day 4 (3 mg/kg IV) and Day 7 (3 mg/kg IV) if there is no unacceptable toxicity.
* *Maximum cumulative dose:* 10 mg/kg.
## Pediatric Dosing
There is no established pediatric dosing.
## Dose Adjustments
* **Hepatotoxicity:** Discontinue if AST/ALT > 3 times ULN or Bilirubin > 2 times ULN. Dose may be resumed at a reduced dose (2 mg/kg or 1.5 mg/kg) upon resolution of toxicity.
* **Thrombocytopenia:** Hold dose if platelet count is < 50,000/µL. Dose may be resumed when platelets recover to ≥ 50,000/µL.
* **Febrile Neutropenia:** Hold dose. Resume when ANC is ≥ 1,000/µL and fever is resolved.
## Contraindications
* Known hypersensitivity to gemtuzumab ozogamicin or any of its components.
## Adverse Effects
* **Most common:** Thrombocytopenia, leukopenia, neutropenia, febrile neutropenia, anemia, nausea, vomiting, diarrhea, mucositis, fatigue, headache, pyrexia, rash, and liver abnormalities (e.g., elevated transaminases, hyperbilirubinemia).
* **Serious:** Hepatotoxicity (including VOD/SOS), severe myelosuppression, infusion-related reactions, tumor lysis syndrome, and posterior reversible encephalopathy syndrome (PRES).
## Key Drug Interactions
* No specific drug interactions identified in prescribing information. However, due to myelosuppressive effects, caution is advised with other myelosuppressive agents.
## Monitoring
* Complete blood counts (CBC) with differential and platelet count frequently during treatment and for at least 30 days after the last dose.
* Liver function tests (LFTs), including AST, ALT, and bilirubin, regularly.
* Signs and symptoms of infusion-related reactions, VOD/SOS, and PRES.
* Monitor for signs of infection.
## Clinical Pearls
* The risk of hepatotoxicity, particularly VOD/SOS, is increased in patients with impaired liver function or those who have undergone stem cell transplantation.
* Thrombocytopenia is a common and expected adverse effect; monitor closely and manage proactively.
* Infusion-related reactions can occur, especially with the first dose. Administer as a 2-hour infusion.
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**Disclaimer:** This information is intended for healthcare professionals. Always consult the most current prescribing information and institutional protocols for definitive guidance.
