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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is a CD33-directed antibody-drug conjugate used in the treatment of certain types of acute myeloid leukemia (AML).
## Primary Indications
* Newly diagnosed acute myeloid leukemia (AML) in adult patients who are not candidates for intensive induction chemotherapy.
* Relapsed or refractory AML in adult patients.
## Adult Dosing
**For newly diagnosed AML unfit for intensive induction chemotherapy:**
* 6 mg/m² on day 1, day 4, and day 7 of the first cycle.
* If continued, 3 mg/m² on day 1 of subsequent cycles.
* Maximum of 4 cycles.
**For relapsed or refractory AML:**
* 6 mg/m² on day 1.
* If continued, 3 mg/m² on day 4.
* If continued, 3 mg/m² on day 7.
* Maximum of 2 cycles.
## Pediatric Dosing
There is no established pediatric dosing for Mylotarg.
## Dose Adjustments
* **Hepatic Impairment:** No dose adjustment specified. Use with caution and monitor liver function closely.
* **Renal Impairment:** No dose adjustment specified. Use with caution and monitor renal function closely.
* **Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS):** Discontinue treatment.
## Contraindications
* None listed.
## Adverse Effects
**Most common adverse reactions (may occur in >30% of patients):**
* Infections (including febrile neutropenia)
* Thrombocytopenia
* Anemia
* Leukopenia
* Nausea
* Vomiting
* Diarrhea
* Constipation
* Fatigue
* Hemorrhage
* Headache
* Fever
* Rash
* Musculoskeletal pain
**Serious adverse reactions include:**
* Hepatotoxicity (including VOD/SOS)
* Myelosuppression
* Infusion-related reactions
* Hypersensitivity reactions
## Key Drug Interactions
* No significant drug interactions have been identified. Consider potential additive myelosuppressive effects with other medications that cause bone marrow suppression.
## Monitoring
* **Complete Blood Counts (CBC) with differential and platelet count:** Frequently during treatment and until recovery.
* **Liver Function Tests (LFTs):** Before treatment and regularly during treatment.
* **Renal Function Tests:** Before treatment and regularly during treatment.
* **Signs and Symptoms of Infusion Reactions:** During and after infusion.
* **Signs and Symptoms of Hepatotoxicity:** Including abdominal pain, jaundice, ascites.
## Clinical Pearls
* **Infusion-related reactions:** Administer as a 2-hour intravenous infusion. Premedication with an antihistamine and corticosteroid may be considered.
* **Hepatotoxicity:** Monitor liver function closely, especially in patients with pre-existing liver disease or those who have received prior hepatic radiation. VOD/SOS is a serious and potentially fatal adverse event.
* **Hemorrhage:** Monitor for signs of bleeding and manage promptly.
* **Pregnancy:** Gemtuzumab ozogamicin can cause fetal harm. Advise patients of reproductive potential to use effective contraception.
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*This information is intended as a quick reference. Always consult the current prescribing information and your institution's protocols for complete and up-to-date guidance.*
