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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg (gemtuzumab ozogamicin) is a CD33-directed antibody-drug conjugate. It binds to CD33-expressing myeloid cells, including leukemic blasts, and is then internalized, leading to release of the cytotoxic agent calicheamicin, which induces DNA damage and cell death.
## Primary Indications
* Treatment of newly diagnosed acute myeloid leukemia (AML) in adults, in combination with induction and consolidation chemotherapy, and as a single agent for consolidation.
* Treatment of relapsed or refractory AML in adults.
## Adult Dosing
**Newly Diagnosed AML (in combination with chemotherapy):**
* **Induction:** 3 mg/m² as a single dose on day 4 of induction chemotherapy.
* **Consolidation (if AML persists after induction):** 3 mg/m² on day 4 of each consolidation cycle.
* **Consolidation (if in remission after induction):** 3 mg/m² on day 4 of each consolidation cycle.
* **Single Agent Consolidation (if no chemotherapy):** 3 mg/m² every 2 weeks for up to 4 cycles.
**Relapsed or Refractory AML:**
* **First Cycle:** 6 mg/m² as a single dose.
* **Second Cycle (if tolerated):** 6 mg/m² as a single dose, administered 2-3 weeks after the first dose.
**Maximum cumulative dose:** 18 mg/m² over the course of therapy.
## Pediatric Dosing
Dosing for pediatric patients is not established. Gemtuzumab ozogamicin is not recommended for use in pediatric patients.
## Dose Adjustments
* **Hepatotoxicity:** Dose interruptions or discontinuations may be necessary based on the severity of liver enzyme elevations or bilirubin.
* **Thrombocytopenia:** Dose interruptions or discontinuations may be necessary based on the severity of thrombocytopenia.
## Contraindications
* None listed in product labeling.
## Adverse Effects
**Black Box Warnings:**
* **Hepatotoxicity:** Severe, potentially fatal liver toxicity, including hepatic veno-occlusive disease (Veno-Occlusive Liver Disease/Sinusoidal Obstruction Syndrome, VOD/SOS), has been reported. Risk factors include prior stem cell transplant, other prior hepatotoxic treatments, and severe liver disease.
**Common Adverse Effects (may vary by indication and combination therapy):**
* Fever, headache, nausea, vomiting, diarrhea, stomatitis, constipation, rash, fatigue, muscle pain, abdominal pain, hypokalemia, hypophosphatemia, elevated liver enzymes (AST, ALT, bilirubin), thrombocytopenia, neutropenia, anemia.
* Infusion-related reactions, including fever, chills, rash, shortness of breath.
* Bleeding events.
## Key Drug Interactions
* **Hepatotoxic agents:** Concomitant use with other potentially hepatotoxic medications may increase the risk of liver toxicity. Closely monitor liver function.
## Monitoring
* **Liver Function Tests:** Regularly monitor ALT, AST, alkaline phosphatase, and bilirubin before, during, and after treatment.
* **Complete Blood Counts (CBC) with differential:** Monitor frequently to assess for myelosuppression and bleeding risk.
* **Signs and Symptoms of VOD/SOS:** Monitor for clinical signs such as hyperbilirubinemia, jaundice, fluid retention (ascites, edema), hepatomegaly, abdominal pain, ascites, and thrombocytopenia in patients with risk factors.
* **Infusion-Related Reactions:** Monitor patients during infusion for signs and symptoms of hypersensitivity or other infusion reactions.
## Clinical Pearls
* Administer pre-medications to reduce the risk of infusion-related reactions.
* Slow infusion rate if infusion-related reactions occur.
* Patients with baseline elevated bilirubin (>2.5 times the upper limit of normal) or AST/ALT (>5 times the upper limit of normal) should not receive gemtuzumab ozogamicin.
* Consider prophylactic antibiotics and antivirals due to increased risk of infection from myelosuppression.
* The maximum cumulative dose is 18 mg/m².
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**Disclaimer:** This information is intended for healthcare professionals and is not a substitute for professional medical advice. Always refer to the most current prescribing information and consult with a qualified healthcare provider for any questions regarding drug therapy.
