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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is an antibody-drug conjugate that targets CD33, a protein found on the surface of myeloid leukemia cells. It delivers a cytotoxic agent (calicheamicin) directly to these cells.
## Primary Indications
* Relapsed or refractory acute myeloid leukemia (AML) in adults.
* Newly diagnosed AML in adults who are 75 years or older, or who are unable to tolerate intensive induction chemotherapy.
## Adult Dosing
* **Newly Diagnosed AML:** 6 mg/m² on days 1, 4, and 7. If the patient achieves a complete remission, a second course of 3 mg/m² can be given on day 1 of cycle 2.
* **Relapsed or Refractory AML:** 6 mg/m² on day 1. If the patient achieves a complete remission, a second course of 3 mg/m² can be given on day 1 of cycle 2.
* Maximum dose per administration is 9 mg.
## Pediatric Dosing
Safety and efficacy in pediatric patients have not been established.
## Dose Adjustments
* **Hepatic Impairment:** Use with caution. Consider dose reduction or interruption based on bilirubin levels.
* Bilirubin 1.5 to 3 times the upper limit of normal (ULN): Reduce dose by 50%.
* Bilirubin > 3 times ULN: Withhold treatment.
* **Renal Impairment:** Use with caution. No specific dose adjustments are recommended, but monitor renal function closely.
## Contraindications
* None specific to the drug itself, but consider patient's overall health and comorbidities.
## Adverse Effects
* **Most Common:** Myelosuppression (thrombocytopenia, neutropenia, anemia), nausea, vomiting, diarrhea, mucositis, liver toxicity (hyperbilirubinemia, elevated AST/ALT), infusion-related reactions, fatigue, headache, fever, rash.
* **Serious:** Hepatotoxicity (especially VOD/SOS), severe myelosuppression leading to infections and bleeding, hypersensitivity reactions.
## Key Drug Interactions
* No significant drug interactions have been identified with gemtuzumab ozogamicin itself due to its targeted delivery and mechanism of action. However, concurrent use of other myelosuppressive agents can increase the risk of severe myelosuppression.
## Monitoring
* **Prior to and during treatment:**
* Complete blood counts (CBC) with differential and platelet count (at least weekly).
* Liver function tests (LFTs), including bilirubin and transaminases (at least weekly).
* Renal function tests (BUN, creatinine).
* Monitor for signs and symptoms of VOD/SOS (e.g., jaundice, right upper quadrant pain, ascites, weight gain, hepatomegaly).
* Monitor for signs and symptoms of infusion-related reactions.
## Clinical Pearls
* Mylotarg carries a boxed warning for hepatotoxicity, particularly VOD/SOS. Patients with a history of VOD/SOS or risk factors for it should be monitored very closely.
* Dosing frequency and duration should adhere strictly to the approved labeling or local institutional protocols.
* Infusion reactions can occur, and patients should be monitored during and after infusion.
* Due to the risk of severe myelosuppression, close monitoring of blood counts and prompt management of infections and bleeding are critical.
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*This information is intended for clinical use and does not replace the official prescribing information. Always consult the current drug monograph and institutional guidelines before administering any medication.*
