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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is an antibody-drug conjugate (ADC) targeting CD33, a protein found on most myeloid leukemia cells. It delivers a cytotoxic agent (ozogamicin) directly to CD33-expressing cells.
## Primary Indications
* Acute Myeloid Leukemia (AML):
* Newly diagnosed AML in adult patients aged 75 years or older who are unfit to receive intensive induction chemotherapy.
* Relapsed or refractory AML in adult patients.
## Adult Dosing
* **Newly diagnosed AML (in patients unfit for intensive induction):**
* **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.
* **Cycle 2:** 3 mg/m² IV infusion over 2 hours on Day 1, repeated every 2 weeks for up to 4 cycles.
* *Note:* Do not administer if total bilirubin > 2 times the upper limit of normal (ULN) or if AST/ALT > 3 times ULN.
* **Relapsed or refractory AML:**
* **Cycle 1:** 6 mg/m² IV infusion over 2 hours on Day 1. If tolerated, Day 4: 3 mg/m² IV infusion over 2 hours.
* **Cycle 2:** 3 mg/m² IV infusion over 2 hours on Day 1, repeated every 2 weeks for up to 4 cycles.
* *Note:* Do not administer if total bilirubin > 2 times ULN or if AST/ALT > 3 times ULN.
## Pediatric Dosing
The safety and efficacy of Mylotarg in pediatric patients have not been established.
## Dose Adjustments
* **Hepatotoxicity:** Dose interruption or discontinuation may be necessary. Consult prescribing information for specific guidelines based on bilirubin and transaminase levels.
* **Infusion Reactions:** Slow infusion rate or interrupt infusion. Discontinue if severe.
* **Thrombocytopenia:** Monitor platelet counts closely. Dose interruption or discontinuation may be necessary.
## Contraindications
* None listed.
## Adverse Effects
* **Common:** Febrile neutropenia, anemia, thrombocytopenia, nausea, vomiting, diarrhea, stomatitis, fatigue, headache, rash, pyrexia, elevated liver enzymes (AST, ALT, bilirubin).
* **Serious:** Hepatotoxicity (including VOD/SOS), infusion reactions, myelosuppression, tumor lysis syndrome, embryo-fetal toxicity.
## Key Drug Interactions
* No significant drug interactions have been identified in clinical trials. However, caution may be advised with concomitant medications affecting liver function or causing myelosuppression.
## Monitoring
* **Baseline and ongoing:** Complete blood counts (CBC) with differential and platelet count, liver function tests (bilirubin, AST, ALT).
* **Monitor for:** Signs and symptoms of hepatotoxicity (jaundice, abdominal pain, ascites, edema), infusion reactions, and myelosuppression.
* **Pregnancy testing:** For females of reproductive potential.
## Clinical Pearls
* Hepatotoxicity, particularly veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS), is a significant risk. Early recognition and management are crucial.
* Thrombocytopenia is common and expected; close monitoring and management are essential.
* Administer all doses via IV infusion; do not administer as a rapid infusion or IV push.
* Consider prophylaxis for tumor lysis syndrome in patients with a high tumor burden.
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*Disclaimer: This information is intended for clinical use by healthcare professionals. It is not exhaustive and does not replace the need for clinical judgment. Always refer to the most current official prescribing information and relevant guidelines for complete details.*
