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## Mylotarg (gemtuzumab ozogamicin)
### Overview
Mylotarg is a humanized anti-CD33 monoclonal antibody conjugated to an anti-tumor antibiotic, calicheamicin. It is an antineoplastic agent used in the treatment of acute myeloid leukemia (AML).
### Primary Indications
* Acute myeloid leukemia (AML) in adults who are newly diagnosed and ineligible for intensive induction chemotherapy.
* Relapsed or refractory AML in adults.
### Adult Dosing
The dosing regimen for Mylotarg can vary based on the specific indication and treatment cycle. It is typically administered intravenously.
* **Newly diagnosed AML (ineligible for intensive induction chemotherapy):**
* A total dose of 6 mg/m² on Day 1 and 6 mg/m² on Day 4, followed by 3 mg/m² on Day 7, if bone marrow blast results warrant.
* An alternative regimen is 3 mg/m² on Day 1, 3 mg/m² on Day 4, and 3 mg/m² on Day 7.
* **Relapsed or refractory AML:**
* A total dose of 3 mg/m² on Day 1 and 3 mg/m² on Day 4, followed by 3 mg/m² on Day 7, if bone marrow blast results warrant.
**Maximum dose per administration:** Generally, the maximum dose per administration should not exceed 4.8 mg (which corresponds to a typical dose for a patient with a body surface area of approximately 1.6 m² at 3 mg/m²). However, dosing is weight-based.
### Pediatric Dosing
Mylotarg is not typically recommended for pediatric patients less than 1 year of age due to potential increased toxicity. Safety and efficacy have not been established in pediatric patients for all indications. Limited data exists for use in pediatric AML; specific dosing should be determined by specialized pediatric oncology protocols and may involve different regimens.
*(Note: Consult pediatric oncology specialty guidelines for specific pediatric dosing information.)*
### Dose Adjustments
* **Hepatic Impairment:** No specific dose adjustment is recommended. However, patients with severe hepatic impairment may be at increased risk of toxicity.
* **Renal Impairment:** No specific dose adjustment is recommended. Patients with severe renal impairment may be at increased risk of toxicity.
* **Concurrent Medications:** Monitor for drug interactions (see below).
* **Adverse Reactions:** Dose interruption or discontinuation may be necessary based on the severity of adverse events, particularly veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS) and myelosuppression.
### Contraindications
* Hypersensitivity to gemtuzumab ozogamicin or any component of the formulation.
### Adverse Effects
* **Hepatotoxicity:** Including Veno-Occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) is a serious and potentially fatal adverse reaction. Risk factors include prior stem cell transplant, antecedent liver disease, and high bilirubin.
* **Myelosuppression:** Severe neutropenia, thrombocytopenia, anemia, and febrile neutropenia are common and expected.
* **Hemorrhage:** Increased risk, especially in patients with severe thrombocytopenia.
* **Infusion-Related Reactions:** Fever, chills, rash, pruritus, dyspnea.
* **Gastrointestinal:** Nausea, vomiting, diarrhea, mucositis.
* **Other:** Fatigue, headache, hypokalemia, elevated liver enzymes.
### Key Drug Interactions
* Other myelosuppressive agents: May potentiate myelosuppression.
* Vaccines: Live vaccines should be avoided during and after treatment due to the risk of disseminated infection.
### Monitoring
* **Liver Function Tests (LFTs):** Including bilirubin, AST, ALT, alkaline phosphatase, particularly before and during treatment, and more frequently in patients with risk factors for VOD/SOS.
* **Complete Blood Count (CBC) with differential and platelet count:** Frequently monitor for myelosuppression.
* **Signs and symptoms of VOD/SOS:** Monitor closely, especially in patients with risk factors.
* **Signs and symptoms of bleeding:** Monitor for any signs of hemorrhage.
* **Infusion-related reactions:** Monitor during and after infusion.
### Clinical Pearls
* Premedication with an antihistamine, antipyretic, and corticosteroid may be considered to mitigate infusion-related reactions.
* Dosing should be calculated based on body surface area (m²).
* VOD/SOS is a serious risk; careful patient selection and monitoring are crucial. Prior to re-treatment, assess for signs of VOD/SOS.
* Patients should be advised to avoid live vaccines.
***
**Disclaimer:** This information is intended for healthcare professionals and is not a substitute for professional medical advice. Always consult the most current prescribing information and relevant guidelines for complete details on indications, contraindications, warnings, precautions, adverse reactions, drug interactions, and dosage adjustments before prescribing or administering Mylotarg.
