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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is a CD33-directed antibody and an antineoplastic agent. It is an anti-CD33 monoclonal antibody linked to a cytotoxic agent.
## Primary Indications
* Treatment of newly diagnosed adult patients with acute myeloid leukemia (AML) in remission that is de novo, or secondary to other myeloid malignancies with myeloid or lymphoid blasts, or with myelodysplastic syndrome-related changes, who are fit for intensive chemotherapy.
* Treatment of adult patients with relapsed or refractory AML.
## Adult Dosing
Dosing depends on the indication and treatment cycle. It is crucial to follow specific institutional protocols for administration.
**For newly diagnosed adult AML (in combination with chemotherapy):**
* Administer as a 3 mg/kg intravenous (IV) infusion over 2 hours on days 4, 7, and 10 of induction chemotherapy, and on day 4 of consolidation chemotherapy, if consolidation is given. A maximum of 5 cycles can be administered over approximately 4 months.
**For relapsed or refractory AML:**
* Administer as a 6 mg/kg IV infusion over 2 hours on day 1 of the first cycle, and 3 mg/kg IV infusion over 2 hours on day 1 of the second cycle, if a second cycle is administered.
* Cycles should be separated by at least 14 days.
* A second cycle should only be administered if the patient is in remission and their performance status, organ function, and bone marrow recovery are adequate.
## Pediatric Dosing
The safety and efficacy of Mylotarg in pediatric patients have not been established.
## Dose Adjustments
Dose modifications are generally not prescribed but rather treatment interruptions or discontinuations based on toxicity.
## Contraindications
* Known severe hypersensitivity to gemtuzumab ozogamicin or any of its components.
## Adverse Effects
* **Hepatotoxicity:** This is a serious and potentially fatal adverse effect, including sinusoidal obstruction syndrome (SOS)/vessel obliteration. Risk factors include prior stem cell transplant, prior treatment with gemtuzumab ozogamicin, and elevated bilirubin or AST.
* **Myelosuppression:** Including neutropenia, thrombocytopenia, anemia, and febrile neutropenia.
* **Infections:** Including sepsis, pneumonia, and fungemia.
* **Infusion-related reactions:** Including fever, chills, rash, and dyspnea.
* **Hemorrhage:** Especially in patients with severe thrombocytopenia.
* **Thrombocytopenia:**
* **Nausea and Vomiting:**
* **Diarrhea:**
* **Fatigue:**
* **Stomatitis:**
## Key Drug Interactions
* **Chemotherapy Agents:** Concurrent administration with other cytotoxic agents can increase the risk and severity of myelosuppression and other toxicities.
* **Hepatotoxic Agents:** Concomitant use of drugs with known hepatotoxicity may increase the risk of liver damage.
## Monitoring
* **Liver Function Tests (LFTs):** Including bilirubin, AST, ALT, and alkaline phosphatase, at baseline and regularly during treatment, especially before each dose. Be vigilant for signs and symptoms of SOS/vessel obliteration.
* **Complete Blood Count (CBC) with differential and platelet count:** At baseline and regularly during treatment, including frequent monitoring during periods of myelosuppression.
* **Signs and symptoms of infection:**
* **Signs and symptoms of bleeding/hemorrhage:**
* **Infusion-related reactions:** Monitor closely during and after infusion.
## Clinical Pearls
* Due to the risk of hepatotoxicity, especially SOS, careful monitoring of LFTs and prompt recognition of symptoms are critical. Pre-treatment evaluation for risk factors like prior stem cell transplant is important.
* Consider prophylactic use of antiemetics and corticosteroids to manage infusion-related reactions.
* Manage myelosuppression and infections aggressively with supportive care, including transfusions and antibiotics/antifungals.
* The recommended dose and schedule can vary based on the specific treatment regimen and patient response. Always refer to the most current prescribing information and institutional protocols.
***
*This information is intended for healthcare professionals and does not substitute for professional medical advice. Always consult the most current prescribing information and relevant clinical guidelines before making any treatment decisions.*
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