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Mylotarg (gemtuzumab ozogamicin) is a targeted antibody-drug conjugate used in the treatment of acute myeloid leukemia (AML).
### Primary Indications
* Newly diagnosed CD33-positive AML in adult patients, in combination with other chemotherapy.
* Relapsed or refractory CD33-positive AML in adult patients.
### Adult Dosing
**Newly Diagnosed CD33-positive AML (in combination with chemotherapy):**
* **First cycle:** 6 mg/m² on Day 1, Day 4, and Day 7.
* **Second cycle (if completed first cycle without unacceptable toxicity):** 6 mg/m² on Day 1.
**Relapsed or Refractory CD33-positive AML:**
* **First cycle:** 3 mg/m² on Day 1, Day 4, and Day 7.
* **Second cycle (if completed first cycle without unacceptable toxicity):** 3 mg/m² on Day 1.
* **Subsequent cycles (if benefit observed and toxicity allows):** Up to 8 cycles may be considered, with subsequent cycles administered at 3 mg/m² every 2 to 4 weeks.
**Maximum dose per administration:** The dose should not exceed 4.7 mg/kg for the 3 mg/m² schedule or 9.4 mg/kg for the 6 mg/m² schedule.
### Pediatric Dosing
Mylotarg is **not recommended** for use in pediatric patients due to a lack of established efficacy and safety data.
### Dose Adjustments
* **Hepatic Impairment:** No dose adjustment. However, monitor closely for adverse events. Gemtuzumab ozogamicin exposure may be increased in patients with severe hepatic impairment.
* **Renal Impairment:** No dose adjustment. However, monitor closely for adverse events. Gemtuzumab ozogamicin exposure may be increased in patients with severe renal impairment.
Dose modifications or interruptions may be necessary due to toxicity, including but not limited to:
* **Hepatotoxicity:** Monitor liver function tests closely. Consider withholding or discontinuing treatment based on severity.
* **Myelosuppression:** Monitor complete blood counts regularly. Dose reductions or delays may be required.
* **Posterior Reversible Encephalopathy Syndrome (PRES):** Discontinue treatment immediately.
### Contraindications
* None listed.
### Adverse Effects
* **Hepatotoxicity:** Including veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS), elevated transaminases, hyperbilirubinemia. This is a significant and potentially life-threatening toxicity.
* **Myelosuppression:** Neutropenia, thrombocytopenia, anemia, febrile neutropenia.
* **Hemorrhagic events:** Gastrointestinal hemorrhage, intracranial hemorrhage.
* **Infusion-related reactions:** Pyrexia, rash, dyspnea.
* **Nausea and vomiting.**
* **Mucositis.**
* **Peripheral neuropathy.**
* **QTc prolongation.**
### Key Drug Interactions
* **Strong CYP3A4 Inhibitors:** May increase exposure to calicheamicin derivatives. Monitor for adverse effects.
* **CYP3A4 Substrates:** May potentially increase exposure to CYP3A4 substrates. Monitor for adverse effects.
### Monitoring
* **Liver Function Tests (LFTs):** Including ALT, AST, and bilirubin, prior to each dose and as clinically indicated. Monitor closely for VOD/SOS symptoms.
* **Complete Blood Counts (CBCs):** With differential and platelet count prior to each dose and as clinically indicated.
* **Hemostasis:** Monitor coagulation parameters as clinically indicated, especially before initiating treatment and if hemorrhagic events occur.
* **ECG:** To assess for QTc prolongation.
* **Neurological status:** For signs and symptoms of PRES.
### Clinical Pearls
* Mylotarg's safety profile, particularly the risk of severe hepatotoxicity (VOD/SOS), requires diligent monitoring and careful patient selection.
* Early recognition and management of VOD/SOS are crucial. Symptoms include jaundice, hepatomegaly, ascites, and weight gain.
* Consider prophylactic measures for mucositis and infection.
* Administer gemtuzumab ozogamicin as a 2-hour infusion.
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**Disclaimer:** This information is intended for healthcare professionals. Always consult the official prescribing information and relevant clinical guidelines for complete details and to confirm current recommendations before prescribing.
