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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is an antibody-drug conjugate targeting CD33, an antigen expressed on myeloid blasts and myeloid cells. It is indicated for the treatment of certain types of acute myeloid leukemia (AML).
## Primary Indications
* Treatment of newly diagnosed adult patients with acute myeloid leukemia (AML) who are less than 60 years of age.
* Treatment of relapsed or refractory CD33-positive AML in adult patients.
## Adult Dosing
The dosing regimen can vary based on the indication and whether it's used in combination or as monotherapy.
**For newly diagnosed AML in patients < 60 years of age (in combination with chemotherapy):**
* Day 1: 3 mg/kg intravenously (IV) infusion over 2 hours.
* Day 4: 3 mg/kg IV infusion over 2 hours.
* Day 7: 3 mg/kg IV infusion over 2 hours.
* Subsequent cycles (if applicable): 3 mg/kg IV infusion over 2 hours on days 1, 4, and 7 of each cycle.
**For relapsed or refractory CD33-positive AML (as monotherapy):**
* Day 1: 3 mg/kg IV infusion over 2 hours.
* Day 4: 3 mg/kg IV infusion over 2 hours.
* Day 7: 3 mg/kg IV infusion over 2 hours.
* Cycle 2 (if applicable and if no unacceptable toxicity): 3 mg/kg IV infusion over 2 hours on Day 1.
**Note:** Dosing may be adjusted based on local protocol and patient response/toxicity.
## Pediatric Dosing
Mylotarg is not approved for pediatric patients. Efficacy and safety have not been established.
## Dose Adjustments
* **Hepatotoxicity:** If ALT or AST > 5 times the upper limit of normal (ULN), or total bilirubin > 2 times ULN, delay treatment until these laboratory values improve.
* **Thrombocytopenia:** If platelet count is < 50,000/mcL, delay treatment.
* **Infusion Reactions:** Manage as clinically indicated. Slowing the infusion rate or interrupting the infusion may be necessary.
## Contraindications
* Known history of severe hypersensitivity to gemtuzumab ozogamicin or any of its components.
## Adverse Effects
* **Hepatotoxicity:** Including veno-occlusive liver disease (VOD)/sinusoidal obstruction syndrome (SOS).
* **Myelosuppression:** Including thrombocytopenia, neutropenia, leukopenia, and anemia.
* **Infusion-related reactions:** Fever, chills, rash, dyspnea.
* **Hemorrhage:** Especially in patients with severe thrombocytopenia.
* **Gastrointestinal:** Nausea, vomiting, diarrhea, stomatitis.
* **Infections:** Including sepsis.
## Key Drug Interactions
No specific drug interactions are listed in the prescribing information. However, concurrent use with other myelosuppressive agents may increase the risk of myelosuppression.
## Monitoring
* **Liver Function Tests (LFTs):** Including ALT, AST, and bilirubin, prior to each dose and as clinically indicated.
* **Complete Blood Count (CBC) with differential:** Prior to each dose and as clinically indicated. Monitor closely for myelosuppression and thrombocytopenia.
* **Signs and symptoms of VOD/SOS:** Monitor for jaundice, ascites, hepatomegaly, and abdominal pain.
* **Signs and symptoms of infusion reactions:** Monitor during and after infusion.
* **Signs and symptoms of hemorrhage:** Monitor closely, especially in patients with thrombocytopenia.
## Clinical Pearls
* Pre-medication for infusion reactions is not routinely recommended but should be available.
* Consider co-administration of prophylactic antibiotics, antivirals, and antifungals due to the risk of infection.
* Close monitoring for VOD/SOS is crucial, especially in patients receiving other potentially hepatotoxic agents or those with pre-existing liver disease.
* Ensure adequate contraception in patients of reproductive potential.
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*This information is intended for healthcare professionals. Always consult the most current prescribing information and institutional protocols for complete details and to ensure patient safety.*
