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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is a targeted therapy, specifically an antibody-drug conjugate, used in the treatment of acute myeloid leukemia (AML). It consists of an anti-CD33 antibody linked to a cytotoxic agent, calicheamicin.
## Primary Indications
* Treatment of newly diagnosed adult patients with acute myeloid leukemia (AML) who are ineligible for intensive induction chemotherapy.
* Treatment of adult patients with relapsed or refractory AML.
## Adult Dosing
**Newly Diagnosed AML (in combination with other agents):**
* Day 1: 3 mg/m² IV infusion over 2 hours.
* Day 4: 3 mg/m² IV infusion over 2 hours.
* Day 7: 2 mg/m² IV infusion over 2 hours.
**Relapsed or Refractory AML:**
* First cycle: 6 mg/m² IV infusion over 2 hours.
* If tolerated, second cycle (given within 2-4 weeks): 6 mg/m² IV infusion over 2 hours.
**Maximum cumulative dose:** 21.1 mg/m² over the course of therapy.
## Pediatric Dosing
* **Newly Diagnosed AML (in combination with other agents):**
* Ages 1 to <17 years: 3 mg/m² IV on days 1, 4, and 7.
* **Relapsed or Refractory AML:**
* Ages 1 to <17 years: 4.5 mg/m² IV on days 1 and 4.
* **Note:** Dosing for pediatric patients should be managed by a clinician experienced in pediatric hematology/oncology.
## Dose Adjustments
* **Hepatic Impairment:** Use with caution. If bilirubin > 1.5 mg/dL or AST > 3 times the upper limit of normal, consider delaying or reducing the dose. Consult prescribing information for specific recommendations.
* **Renal Impairment:** Use with caution. No dose adjustment is recommended for mild to moderate renal impairment. Data in severe renal impairment is limited.
* **Hepatotoxicity:** If veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS) is suspected or confirmed, permanently discontinue Mylotarg. If AST or ALT increases to > 5 times the upper limit of normal, withhold Mylotarg. Resume at a reduced dose if liver function improves. If bilirubin increases to > 2 times the upper limit of normal, withhold Mylotarg. Resume at a reduced dose if bilirubin falls to ≤ 2 times the upper limit of normal.
## Contraindications
* None listed in standard prescribing information.
## Adverse Effects
The most common adverse reactions (≥30%) include:
* Febrile neutropenia
* Thrombocytopenia
* Nausea
* Vomiting
* Mucositis
* Diarrhea
* Anemia
* Fatigue
* Constipation
* Rash
* Pyrexia
* Headache
* Pneumonia
* Hypokalemia
* Abdominal pain
* Musculoskeletal pain
* Stomatitis
* Hypophosphatemia
* Increased gamma-glutamyl transferase
**Serious adverse reactions** include:
* Hepatotoxicity, including VOD/SOS
* Hemorrhage
* Myelosuppression
* Infusion-related reactions
* Embryo-fetal toxicity
## Key Drug Interactions
* **Hepatotoxic agents:** Concomitant use with other agents known to cause hepatotoxicity may increase the risk of liver injury. Monitor liver function closely.
## Monitoring
* **Liver Function Tests (LFTs):** Monitor bilirubin and transaminases regularly, especially before and during treatment, and particularly in patients with hepatic impairment.
* **Complete Blood Counts (CBCs):** Monitor regularly for myelosuppression.
* **Signs and Symptoms of VOD/SOS:** Monitor closely.
* **Signs and Symptoms of Hemorrhage:** Monitor closely, especially in patients with thrombocytopenia.
* **Infusion-related reactions:** Monitor during and after infusion.
## Clinical Pearls
* Mylotarg carries a boxed warning for hepatotoxicity, including VOD/SOS, and embryo-fetal toxicity.
* VOD/SOS can be fatal. Risk factors include pre-existing liver disease, prior stem cell transplant, and prior chemotherapy.
* Hemorrhage can be severe and life-threatening.
* Prior to initiating treatment, ensure adequate contraception for both males and females.
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**Disclaimer:** This information is intended for clinical decision-making and does not replace comprehensive drug information resources. Always consult the most current prescribing information and relevant clinical guidelines before initiating or modifying therapy. Dosing and management may vary based on individual patient factors and institutional protocols.
