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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is an antibody-drug conjugate consisting of a humanized anti-CD33 monoclonal antibody linked to calicheamicin. It is indicated for the treatment of certain types of acute myeloid leukemia (AML).
## Primary Indications
* Newly diagnosed CD33-positive AML in adult patients in combination with cytarabine and daunorubicin.
* Relapsed or refractory CD33-positive AML in adult patients.
## Adult Dosing
* **Newly Diagnosed AML (combination therapy):**
* Day 1: 3 mg/m² intravenous (IV) infusion over 2 hours.
* Day 4: 3 mg/m² IV infusion over 2 hours.
* Day 7: 2 mg/m² IV infusion over 2 hours.
* Subsequent cycles (if needed) are based on physician discretion and patient response, with a target dose of 3 mg/m² every 2 weeks.
* **Relapsed or Refractory AML:**
* Cycle 1: 6 mg/m² IV infusion over 2 hours on day 1. If tolerated, a second dose of 3 mg/m² IV infusion over 2 hours on day 4.
* Subsequent cycles (if needed): 3 mg/m² IV infusion over 2 hours every 2 weeks.
## Pediatric Dosing
The safety and efficacy of Mylotarg have not been established in pediatric patients.
## Dose Adjustments
* **Hepatotoxicity:** Dose interruptions or reductions may be necessary. See full prescribing information for detailed guidance.
* **Cytopenias:** Dose delays or reductions may be required based on nadir counts and recovery.
## Contraindications
* Known hypersensitivity to gemtuzumab ozogamicin, calicheamicin, or any component of the formulation.
## Adverse Effects
* **Common:** Febrile neutropenia, nausea, vomiting, diarrhea, mucositis, headache, pyrexia, rash, stomatitis, hypokalemia, elevated transaminases, anemia, thrombocytopenia.
* **Serious:** Hepatotoxicity (including VOD/SOS), myelosuppression, infusion-related reactions, tumor lysis syndrome, embryo-fetal toxicity.
## Key Drug Interactions
* **CYP3A4 inhibitors/inducers:** Gemtuzumab ozogamicin is metabolized by CYP3A4. Concomitant use with strong CYP3A4 inhibitors or inducers may alter exposure.
* **Other myelosuppressive agents:** Increased risk of myelosuppression.
## Monitoring
* Complete blood counts (CBC) with differential and platelet count before and regularly during treatment.
* Liver function tests (LFTs) including bilirubin and transaminases.
* Signs and symptoms of infusion-related reactions.
* Signs and symptoms of hepatotoxicity (e.g., jaundice, ascites, hepatomegaly).
* Renal function.
* Pregnancy testing for females of reproductive potential.
## Clinical Pearls
* Veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS) is a serious and potentially fatal adverse event. Risk factors include prior stem cell transplant and high-dose chemotherapy.
* Due to the risk of hepatotoxicity, especially in patients with pre-existing liver impairment or those undergoing stem cell transplantation, close monitoring of liver function is crucial.
* Infusion-related reactions can occur. Premedication with an antihistamine and corticosteroid may be considered.
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*This information is intended for healthcare professionals. Always consult the official prescribing information and relevant clinical guidelines for the most current and complete drug information. Local protocols may dictate specific dosing adjustments or monitoring parameters.*
