Please check your internet connection and try again.
```markdown
# Mylotarg (gemtuzumab ozogamicin)
## Overview
Gemtuzumab ozogamicin is an antibody-drug conjugate consisting of a humanized anti-CD33 monoclonal antibody linked to the cytotoxic agent calicheamicin. It targets CD33-expressing myeloid cells.
## Primary Indications
* Acute Myeloid Leukemia (AML): Relapsed or refractory CD33-positive AML in adults.
* AML: Newly diagnosed CD33-positive AML in adult patients in combination with chemotherapy.
## Adult Dosing
**Relapsed or Refractory CD33-positive AML:**
* **Cycle 1:** 3 mg/kg on Day 1, 6 mg/kg on Day 4, and 3 mg/kg on Day 7.
* **Cycle 2 (if needed):** 3 mg/kg on Day 1. A second cycle may be administered if there is evidence of disease control and the patient has recovered from the toxicities of the first cycle. A minimum of 14 days should elapse between cycles.
* **Maximum cumulative dose:** 27 mg/kg.
**Newly Diagnosed CD33-positive AML (in combination with chemotherapy):**
* The specific dosing schedule within combination regimens varies. Consult specific institutional protocols or approved prescribing information for detailed regimens (e.g., CALGB 10603/ALLIANCE).
## Pediatric Dosing
Gemtuzumab ozogamicin is not approved for use in pediatric patients. Data is limited.
## Dose Adjustments
* **Hepatic Impairment:** Use with caution. If bilirubin > 2.5 mg/dL or AST > 5 times upper limit of normal, consider delaying or not administering the dose.
* **Veno-occlusive Disease (VOD) / Sinusoidal Obstruction Syndrome (SOS):** Discontinue treatment.
## Contraindications
* None listed.
## Adverse Effects
* **Hepatotoxicity:** Including severe VOD/SOS, particularly in patients with hepatic impairment or receiving other hepatotoxic agents (e.g., stem cell transplant conditioning regimens).
* **Myelosuppression:** Neutropenia, thrombocytopenia, anemia, leukopenia.
* **Hemorrhage/Bleeding Events:** Particularly in patients with severe thrombocytopenia.
* **Infusion-Related Reactions:** Fever, chills, rash, dyspnea.
* **Gastrointestinal:** Nausea, vomiting, diarrhea, mucositis.
* **Infections:** Sepsis, pneumonia.
## Key Drug Interactions
* **Hepatotoxic Agents:** Concomitant use with other drugs known to cause liver injury (e.g., certain chemotherapy agents, anti-infectives) may increase the risk of severe hepatotoxicity. Monitor liver function closely.
## Monitoring
* **Complete Blood Counts (CBC) with differential:** Regularly, especially prior to each dose and as clinically indicated.
* **Liver Function Tests (LFTs):** Including bilirubin and AST, regularly, especially prior to each dose and as clinically indicated.
* **Signs and symptoms of VOD/SOS:** Daily monitoring during treatment and for at least 30 days after the last dose.
* **Signs and symptoms of infusion-related reactions:** During and after infusion.
## Clinical Pearls
* Gemtuzumab ozogamicin should be administered by or under the supervision of a physician experienced in the use of anticancer and other adjuvant therapies.
* Premedication for infusion-related reactions (e.g., antihistamines, antipyretics, corticosteroids) may be considered.
* Patient education regarding signs/symptoms of VOD/SOS and bleeding is crucial.
***
*Disclaimer: This information is intended for healthcare professionals and is not a substitute for professional medical advice. Always consult the official prescribing information and relevant clinical guidelines for the most up-to-date and comprehensive drug details. Dosing and management may vary based on individual patient factors and institutional protocols.*
```
