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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is a targeted immunotherapy, specifically a CD33-expressing antibody-drug conjugate, used in the treatment of acute myeloid leukemia (AML).
## Primary Indications
* Newly diagnosed AML in adult patients who are ineligible for intensive induction chemotherapy.
* Relapsed or refractory AML in adult patients.
## Adult Dosing
* **For patients eligible for intensive induction chemotherapy:**
* Day 1: 3 mg/m² as a single IV infusion.
* Day 4: 3 mg/m² as a single IV infusion.
* Day 7: 2 mg/m² as a single IV infusion.
* **For patients ineligible for intensive induction chemotherapy, or for relapsed/refractory AML:**
* Cycle 1: 6 mg/m² as a single IV infusion on Day 1. If tolerated, administer 3 mg/m² as a single IV infusion on Day 4 and Day 7.
* Subsequent cycles (up to 2 additional cycles): 3 mg/m² as a single IV infusion every 2 to 4 weeks.
* Maximum cumulative dose: 18 mg/m².
## Pediatric Dosing
Dosing in pediatric patients has not been established.
## Dose Adjustments
* **Hepatotoxicity:** Treatment interruption and dose reduction may be necessary based on the severity of veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS) or elevated transaminases/bilirubin.
* **Myelosuppression:** Dose delays or reductions may be required in the event of prolonged severe neutropenia or thrombocytopenia. Specific dose adjustments depend on local protocol and patient response.
## Contraindications
* None listed for the drug itself, but use with caution in patients with severe hepatic impairment or active VOD/SOS.
## Adverse Effects
* **Common:** Febrile neutropenia, nausea, vomiting, diarrhea, mucositis, headache, pyrexia, rash, increased transaminases.
* **Serious:** Hepatotoxicity (including VOD/SOS), myelosuppression (neutropenia, thrombocytopenia, anemia), bleeding events, infusion-related reactions, tumor lysis syndrome.
## Key Drug Interactions
* No specific drug interactions have been identified. However, caution is advised when co-administering with other agents that cause myelosuppression or hepatotoxicity.
## Monitoring
* **Baseline and regular monitoring:** Complete blood counts (CBC) with differential and platelet count, liver function tests (LFTs), bilirubin, electrolytes.
* **Monitor for:** Signs and symptoms of hepatotoxicity (jaundice, abdominal pain, ascites), myelosuppression, bleeding, and infusion-related reactions.
## Clinical Pearls
* Mylotarg is administered as a slow IV infusion over 2 hours.
* Premedication with corticosteroids, antihistamines, and antipyretics may be considered to mitigate infusion-related reactions.
* Close monitoring for hepatotoxicity, especially VOD/SOS, is critical. Patients with pre-existing liver disease or receiving concurrent hepatotoxic agents are at increased risk.
* Consider the cumulative dose limit of 18 mg/m² to minimize the risk of severe hepatotoxicity.
***
**Disclaimer:** This information is intended for healthcare professionals and does not replace comprehensive prescribing information. Always consult the most current product monograph and institutional guidelines before prescribing or administering any medication.
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