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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is an antibody-drug conjugate targeting CD33, an antigen expressed on myeloid leukemia cells.
## Primary Indications
Treatment of newly diagnosed acute myeloid leukemia (AML) in adults in combination with induction and consolidation chemotherapy. Treatment of patients aged 1 year and older with relapsed or refractory AML that expresses CD33.
## Adult Dosing
**Newly Diagnosed AML (in combination with chemotherapy):**
* **Induction:** 3 mg/m² on Day 1, Day 4, and Day 7 of induction chemotherapy.
* **Consolidation:** 3 mg/m² on Day 1 of each consolidation chemotherapy cycle, up to 4 cycles.
**Relapsed/Refractory AML:**
* **First Relapse:** 3 mg/m² on Day 1, Day 4, and Day 7. A second course may be administered if achieving hematologic remission and platelet count is less than 50,000/microL.
* **Subsequent Relapses or Refractory Disease:** 3 mg/m² on Day 1. A second course may be administered 2-3 weeks after the first course if tolerated and not achieving complete remission.
**Maximum cumulative dose:** Generally not to exceed 3 courses (approximately 30 mg/m²).
## Pediatric Dosing
**Relapsed or refractory AML (1 year and older):**
* **First Relapse:** 3 mg/m² on Day 1, Day 4, and Day 7. A second course may be administered if achieving hematologic remission and platelet count is less than 50,000/microL.
* **Subsequent Relapses or Refractory Disease:** 3 mg/m² on Day 1. A second course may be administered 2-3 weeks after the first course if tolerated and not achieving complete remission.
**Note:** Dosing in pediatric patients should be carefully considered by a pediatric hematologist/oncologist.
## Dose Adjustments
* **Hepatic Impairment:**
* Bilirubin 1.5 to 3 times the upper limit of normal (ULN): Reduce dose by 50%.
* Bilirubin > 3 times ULN: Contraindicated.
* **Renal Impairment:** No dose adjustment recommended for mild to moderate renal impairment. Data for severe renal impairment is limited.
## Contraindications
* Hypersensitivity to gemtuzumab ozogamicin or any of its components.
* Active bleeding.
* Active, clinically significant infections.
* Concurrent use of other daunorubicin, doxorubicin, or other anthracycline-based therapy.
* Hepatic impairment with bilirubin > 3 times ULN.
## Adverse Effects
**Common:** Febrile neutropenia, nausea, vomiting, diarrhea, stomatitis, headache, pyrexia, hypokalemia, elevated liver enzymes, thrombocytopenia, anemia, neutropenia.
**Serious:** Hepatotoxicity (including VOD/SOS), myelosuppression, hypersensitivity reactions, infusion-related reactions, bleeding events, tumor lysis syndrome.
## Key Drug Interactions
* **Myelosuppressive agents:** Increased risk of myelosuppression.
* **CYP3A4 inhibitors/inducers:** May affect exposure of calicheamicin (cytotoxic component).
## Monitoring
* **Hepatotoxicity:** Monitor liver function tests (AST, ALT, bilirubin) regularly.
* **Myelosuppression:** Monitor complete blood counts (CBC) with differential and platelet count regularly.
* **Infusion-related reactions:** Monitor vital signs during and after infusion.
* **Bleeding:** Monitor for signs and symptoms of bleeding.
* **VOD/SOS:** Monitor for signs and symptoms (jaundice, hepatomegaly, ascites, weight gain, abdominal pain).
## Clinical Pearls
* Administer prophylactic antiemetics, antidiarrheals, and agents to manage potential mucositis.
* Consider pre-medication with corticosteroids, antihistamines, and antipyretics for infusion-related reactions.
* Monitor closely for signs of VOD/SOS, especially in patients with pre-existing hepatic impairment or those receiving other treatments that can cause VOD/SOS.
* Discontinue therapy and manage symptomatically if severe VOD/SOS or significant bleeding occurs.
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*This information is intended for clinical decision-making and does not replace professional medical judgment. Always verify current prescribing information with the official product labeling and relevant clinical guidelines.*
