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Mylotarg (gemtuzumab ozogamicin) is a CD33-directed antibody-drug conjugate.
## Overview
Gemtuzumab ozogamicin is an antineoplastic agent. It is composed of a humanized anti-CD33 monoclonal antibody conjugated to the cytotoxic agent calicheamicin. The antibody binds to CD33-expressing cells, leading to internalization of the conjugate and release of calicheamicin, which causes DNA damage and cell death.
## Primary Indications
* Acute Myeloid Leukemia (AML) in adults who are newly diagnosed and ineligible for intensive induction chemotherapy.
* AML in adults who have relapsed or are refractory to prior therapy.
## Adult Dosing
**For newly diagnosed AML in patients ineligible for intensive induction chemotherapy:**
* **First course:** 3 mg/kg on days 1, 4, and 7.
* **Second course (if residual disease is present):** 3 mg/kg on days 1 and 4.
**For relapsed or refractory AML:**
* **First course:** 6 mg/kg on day 1.
* **Second course (if residual disease is present):** 3 mg/kg on days 1, 4, and 7.
**Maximum cumulative dose:** 33 mg/kg over the lifetime of the patient.
## Pediatric Dosing
Dosing for pediatric patients is not established.
## Dose Adjustments
* **Hepatic Impairment:** No specific dose adjustment is recommended. However, caution is advised due to the potential for increased exposure to calicheamicin.
* **Renal Impairment:** No specific dose adjustment is recommended. However, caution is advised due to the potential for increased exposure to calicheamicin.
## Contraindications
* Hypersensitivity to gemtuzumab ozogamicin, calicheamicin, or any component of the formulation.
## Adverse Effects
* **Hepatotoxicity:** Including severe and potentially fatal veno-occlusive liver disease (VOD)/sinusoidal obstruction syndrome (SOS).
* **Myelosuppression:** Including neutropenia, thrombocytopenia, and anemia.
* **Infusion-related reactions:** Fever, chills, rash, dyspnea.
* **Bleeding events.**
* **Infections.**
* **Gastrointestinal toxicity:** Nausea, vomiting, diarrhea, stomatitis.
* **Fatigue.**
* **Headache.**
## Key Drug Interactions
No significant drug interactions are expected due to the cytotoxic component being released intracellularly. However, monitor for additive myelosuppression with other myelosuppressive agents.
## Monitoring
* **Liver function tests (LFTs):** Baseline and regularly during treatment, particularly for signs of VOD/SOS (e.g., hyperbilirubinemia, hepatomegaly, ascites).
* **Complete blood counts (CBCs):** With differential and platelet counts, frequently during treatment.
* **Signs and symptoms of infusion-related reactions.**
* **Signs and symptoms of bleeding.**
* **Signs and symptoms of infection.**
## Clinical Pearls
* **Veno-Oclusive Liver Disease (VOD/SOS):** This is a serious and potentially fatal toxicity. Early recognition and management are crucial. Monitor liver function closely.
* **Infusion Reactions:** Premedication with an antihistamine, antipyretic, and corticosteroid may help reduce the incidence and severity of infusion-related reactions.
* **Pregnancy Prevention:** Gemtuzumab ozogamicin can cause fetal harm. Females of reproductive potential should use effective contraception during treatment and for at least 6 months after the last dose. Males with female partners of reproductive potential should use effective contraception during treatment and for at least 3 months after the last dose.
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**Disclaimer:** This information is intended for healthcare professionals and is not exhaustive. Always consult the official prescribing information and current clinical guidelines for the most up-to-date and complete details regarding drug use.
