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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is an antibody-drug conjugate consisting of a humanized anti-CD33 monoclonal antibody conjugated to the cytotoxic agent calicheamicin. It targets CD33-expressing myeloid cells.
## Primary Indications
* Treatment of newly diagnosed acute myeloid leukemia (AML) in adult patients who are candidates for induction chemotherapy.
* Treatment of relapsed or refractory AML in adult patients.
## Adult Dosing
**Newly Diagnosed AML (in combination with standard induction chemotherapy):**
* **First dose:** 3 mg/kg on day 1.
* **Subsequent doses:** 3 mg/kg on day 4 and day 7, if consolidation chemotherapy is given.
**Relapsed or Refractory AML:**
* **First cycle:** 6 mg/kg on day 1. If tolerated, a second dose of 6 mg/kg can be given on day 4.
* **Maximum dose:** A maximum of two doses per cycle, not to exceed 12 mg/kg total per cycle.
## Pediatric Dosing
* Dosing for pediatric patients (less than 18 years) is not established.
## Dose Adjustments
* **Hepatic Impairment:** Use with caution. Monitor liver function tests closely. Data is limited to guide specific dose adjustments.
* **Renal Impairment:** No specific dose adjustments are recommended, but use with caution.
## Contraindications
* Hypersensitivity to gemtuzumab ozogamicin, calicheamicin, or any component of the formulation.
## Adverse Effects
**Serious/Life-threatening:**
* Hepatotoxicity, including veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS), potentially fatal. Risk factors include prior stem cell transplant, prior high-dose chemotherapy, and elevated bilirubin.
* Myelosuppression, including neutropenia, thrombocytopenia, and anemia, leading to infections and bleeding.
* Hemorrhagic events, including gastrointestinal, pulmonary, and cerebral bleeding.
* Infusion-related reactions.
* Embryo-fetal toxicity.
**Common:**
* Nausea, vomiting, diarrhea, stomatitis, constipation
* Fever, headache, fatigue
* Rash, pruritus
* Peripheral edema
* Pneumonia, febrile neutropenia
## Key Drug Interactions
* **Other myelosuppressive agents:** Increased risk of myelosuppression.
## Monitoring
* **Liver Function Tests:** Baseline and regularly throughout treatment (AST, ALT, bilirubin, alkaline phosphatase).
* **Complete Blood Counts (CBC) with differential and platelet count:** Prior to each dose and as clinically indicated.
* **Signs and symptoms of VOD/SOS:** Edema, weight gain, jaundice, hepatomegaly, ascites.
* **Signs and symptoms of bleeding:** Hemoptysis, hematemesis, melena, petechiae.
* **Signs and symptoms of infusion reactions.**
* **Pregnancy status:** Counsel patients of childbearing potential on the risks and need for contraception.
## Clinical Pearls
* Consider prophylactic antibiotics, antivirals, and antifungals for patients receiving Mylotarg due to the risk of severe myelosuppression and infection.
* Mylotarg can cause serious and potentially fatal hepatotoxicity. Early recognition and management are crucial.
* Patients with hepatic impairment may be at increased risk.
* Due to the risk of embryo-fetal toxicity, advise pregnant patients of the potential hazard to the fetus and to use effective contraception.
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*This information is intended for healthcare professionals. Always consult the current prescribing information and institutional protocols before administering any medication.*
