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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is an antibody-drug conjugate consisting of a humanized anti-CD33 monoclonal antibody linked to the cytotoxic agent calicheamicin. It targets CD33-expressing myeloid leukemia cells.
## Primary Indications
* Acute Myeloid Leukemia (AML):
* Newly diagnosed CD33-positive AML in adult patients in combination with induction and consolidation chemotherapy.
* Relapsed or refractory CD33-positive AML in adult patients.
## Adult Dosing
**Newly Diagnosed CD33-Positive AML (in combination with chemotherapy):**
* **Induction Cycle 1:** 3 mg/m² on Day 1, 6 mg/m² on Day 4, and 6 mg/m² on Day 7.
* **Induction Cycle 2 (if needed):** 3 mg/m² on Day 1.
* **Consolidation:** 3 mg/m² on Day 1 of each consolidation cycle, up to 4 cycles.
**Relapsed or Refractory CD33-Positive AML:**
* **First cycle:** 3 mg/m² on Day 1, 6 mg/m² on Day 4, and 6 mg/m² on Day 7.
* **Subsequent cycles (if needed):** 3 mg/m² on Day 1.
* **Maximum cumulative dose:** 33.8 mg/m² over the course of therapy.
## Pediatric Dosing
Mylotarg is not approved for use in pediatric patients.
## Dose Adjustments
* **Hepatic Impairment:** Use with caution. No specific dose adjustment is recommended by the manufacturer, but close monitoring for toxicity is advised.
* **Renal Impairment:** Use with caution. No specific dose adjustment is recommended by the manufacturer, but close monitoring for toxicity is advised.
* **Hepatotoxicity:** Management of hepatotoxicity may require dose interruption, reduction, or discontinuation. Refer to specific protocols for detailed guidance on dose adjustments based on liver function test abnormalities (e.g., AST, ALT, bilirubin).
* **Thrombocytopenia:** Management of thrombocytopenia may require dose interruption or discontinuation. Refer to specific protocols for detailed guidance.
## Contraindications
* None listed by the manufacturer.
## Adverse Effects
**Serious:**
* Hepatotoxicity (including VOD/SOS)
* Myelosuppression (neutropenia, thrombocytopenia, anemia)
* Infusion-related reactions
* Hemorrhage
* Embryo-fetal toxicity
**Common:**
* Nausea, vomiting, diarrhea
* Stomatitis
* Headache
* Fever
* Fatigue
* Rash
* Peripheral edema
* Elevated liver enzymes
## Key Drug Interactions
* **Other myelosuppressive agents:** Increased risk of myelosuppression. Mylotarg should be administered after or on separate days from other cytotoxic agents when used in combination chemotherapy.
* **Hepatotoxic agents:** Concomitant use with other drugs known to cause liver toxicity may increase the risk of hepatotoxicity.
## Monitoring
* **Liver Function Tests (LFTs):** Monitor bilirubin, AST, ALT, and alkaline phosphatase before and regularly during treatment. Assess for signs and symptoms of VOD/SOS.
* **Complete Blood Counts (CBCs):** Monitor closely for myelosuppression (neutropenia, thrombocytopenia, anemia) before and regularly during treatment.
* **Signs and Symptoms of Infusion-Related Reactions:** Monitor during and after infusion.
* **Signs and Symptoms of Hemorrhage:** Monitor closely, especially in patients with thrombocytopenia.
* **Pregnancy Status:** Advise patients of reproductive potential to use effective contraception.
## Clinical Pearls
* Mylotarg administration requires careful dose calculation based on body surface area (BSA).
* Veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS) is a serious potential toxicity. Risk factors include prior stem cell transplant, prior chemotherapy, and liver dysfunction.
* Mylotarg carries a boxed warning for hepatotoxicity, especially VOD/SOS, and for risk of bleeding.
* Infusion reactions can occur; premedication with corticosteroids, antihistamines, and antipyretics may be considered per institutional protocol.
* Refer to the full Prescribing Information for detailed guidance on dose modifications and management of adverse reactions.
***
**Disclaimer:** This information is intended for healthcare professionals and is based on available prescribing information. It is essential to consult the most current official prescribing information and relevant clinical guidelines before prescribing or administering any medication. Dosing and management may vary based on individual patient factors and local institutional protocols.
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