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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is an antibody-drug conjugate that targets CD33, a protein found on the surface of most acute myeloid leukemia (AML) cells. It delivers a cytotoxic agent (calicheamicin) directly to cancer cells.
## Primary Indications
* Relapsed or refractory CD33-positive acute myeloid leukemia (AML) in adults.
* Newly diagnosed CD33-positive AML in adults in combination with chemotherapy.
## Adult Dosing
Dosing varies significantly based on indication (newly diagnosed vs. relapsed/refractory) and whether it's used as monotherapy or in combination. Always consult the specific prescribing information for the regimen being used.
**Example regimen for relapsed/refractory AML (monotherapy):**
* First cycle: 3 mg/m² on days 1, 4, and 7.
* Second cycle (if applicable): 3 mg/m² on day 1.
* Maximum cumulative dose: 18 mg/m².
**Example regimen for newly diagnosed AML (combination):**
* 3 mg/m² on days 1, 4, and 7, followed by chemotherapy.
* Subsequent cycles may involve 3 mg/m² on day 1.
* Consult specific combination therapy protocols for detailed schedules and dose adjustments.
## Pediatric Dosing
Mylotarg is not approved for use in pediatric patients.
## Dose Adjustments
* **Hepatic Impairment:** Use with caution. Data is limited. Monitor liver function closely. Dose reduction may be necessary based on ALT/AST elevations.
* **Renal Impairment:** Use with caution. Data is limited. Monitor renal function. Dose reduction may be necessary based on creatinine clearance.
* **Hematologic Toxicity:** Dose interruption or reduction may be required based on the severity of myelosuppression.
* **Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS):** If VOD/SOS occurs, Mylotarg should be permanently discontinued.
## Contraindications
* None listed in standard prescribing information.
## Adverse Effects
* **Common:** Myelosuppression (neutropenia, thrombocytopenia, anemia), nausea, vomiting, diarrhea, stomatitis, mucositis, rash, fatigue, fever, headache, increased liver enzymes, hyperbilirubinemia.
* **Serious:** Veno-occlusive disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) (potentially fatal), hemorrhagic events, infusion-related reactions, tumor lysis syndrome, hypersensitivity reactions.
## Key Drug Interactions
* No significant drug interactions have been identified in clinical trials. However, concomitant use of other agents that cause myelosuppression may increase the risk of hematologic toxicity.
## Monitoring
* **Complete Blood Counts (CBC) with differential and platelet count:** Frequently, especially prior to each dose and as clinically indicated.
* **Liver Function Tests (LFTs):** Including ALT, AST, alkaline phosphatase, and bilirubin, prior to each dose and as clinically indicated.
* **Renal Function Tests:** Including BUN and creatinine, as clinically indicated.
* **Signs and symptoms of VOD/SOS:** Monitor closely.
* **Signs and symptoms of bleeding:** Monitor closely.
## Clinical Pearls
* Mylotarg carries a Black Box Warning for hepatotoxicity, particularly VOD/SOS, and hemorrhage.
* Premedication with antipyretics, antihistamines, and corticosteroids may be considered for infusion-related reactions, although specific protocols vary.
* Rapid infusion can increase the risk of infusion-related reactions.
* Careful patient selection is crucial, especially those with pre-existing liver dysfunction.
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*This information is intended for clinical professionals. Always verify current prescribing information and consult with relevant resources before making clinical decisions.*
