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# Mylotarg (gemtuzumab ozogamicin)
## Overview
CD33-directed antibody-drug conjugate (calicheamicin toxin). Used in acute myeloid leukemia (AML).
## Primary Indications
- Newly diagnosed CD33+ AML in adults (in combination with daunorubicin/cytarabine)
- Relapsed/refractory CD33+ AML in adults and pediatric patients ≥1 year
## Adult Dosing
Dosing is regimen-dependent and per local protocol. Common examples:
- **Frontline (combination):** 3 mg/m² (max 4.5 mg) IV on Day 1, 4, and 7 of induction; 3 mg/m² on Day 1 of consolidation (if used).
- **Relapsed/refractory monotherapy:** 3 mg/m² IV on Days 1, 4, and 7 (one cycle); or 6 mg/m² on Day 1, then 3 mg/m² on Day 8 (per historical regimen; less common now).
## Pediatric Dosing
Approved ≥1 year (with cytarabine for relapsed/refractory):
- **3 mg/m²/dose (max 4.5 mg)** IV on Days 1, 4, 7.
Exact dose/cycle may vary by clinical trial or protocol.
## Dose Adjustments
- **Hepatic impairment:** Avoid use in moderate-severe (bilirubin >2x ULN, AST/ALT >2.5x ULN). Dose reduction if hepatotoxicity develops.
- **Hematologic toxicity:** Delay or reduce per protocol; hold for persistent cytopenias.
## Contraindications
- Hypersensitivity to gemtuzumab ozogamicin or any component
- Active severe hepatic impairment (e.g., veno-occlusive disease/sinusoidal obstruction syndrome history)
## Adverse Effects
- **Hepatotoxicity:** Veno-occlusive disease (SOS; black box warning), ↑ transaminases, bilirubin
- **Myelosuppression:** Severe neutropenia, thrombocytopenia, anemia
- **Infusion reactions:** Fever, chills, hypotension, dyspnea (premedicate)
- **Infections:** Increased risk due to neutropenia
## Key Drug Interactions
- **Hepatotoxic agents (e.g., azoles, MTX):** Increased SOS risk; avoid or monitor closely.
- **Immunosuppressants:** May exacerbate myelosuppression/infections.
## Monitoring
- **Pre-infusion:** CBC, LFTs (bilirubin, AST/ALT), vital signs
- **During infusion:** Monitor for infusion reactions (have resuscitation equipment)
- **Post-infusion:** CBC weekly, LFTs at least every 2 weeks; monitor for SOS (weight gain, ascites, RUQ pain)
## Clinical Pearls
- Premedicate with corticosteroids, antihistamines, acetaminophen 30–60 min prior.
- Dose based on actual BSA, cap at 4.5 mg/dose.
- Prophylaxis for tumor lysis syndrome may be needed.
- SOS risk is dose-dependent; cumulative exposure increases risk.
**Disclaimer:** This information is for educational purposes and is not a substitute for the full prescribing information or individualized clinical judgment. Always verify current dosing, protocols, and safety updates from the manufacturer and institutional guidelines.
