Gemtuzumab Ozogamicin
Gemtuzumab Ozogamicin Uses, Dosage, Side Effects, Food Interaction and all others data.
Gemtuzumab Ozogamicin is a recombinant humanized IgG4 kappa antibody which is conjugated with calicheamicin derivative, a cytotoxic antitumor antibiotic isolated from fermentation of Micromonospora echinospora ssp. calichensis. Gemtuzumab Ozogamicin has approximately 50% of the antibody loaded with 4-6 moles calicheamicin per mole of antibody . The antibody is specifically directed against the CD33 antigen present on leukemic myeloblasts in most patients with acute myeloid leukemia (AML). By binding to the CD33 antigen on tumors, the cytotoxic agent blocks the growth of cancerous cells and causes cell death.
Marketing approval of gemtuzumab ozogamicin was granted on May 17, 2000 by FDA as a treatment for patients with CD33-positive AML in first relapse who are 60 years of age or older and who are not considered candidates for cytotoxic chemotherapy . However, it was voluntarily withdrawn from the market in 2010 due to safety concerns, increased patient deaths and insufficient evidence of clinical benefit during confirmatory trials . On September 1 2017, gemtuzumab ozogamicin was again approved for the treatment of adults with newly diagnosed CD33-positive acute myeloid leukemia but with a lower dosing regimen and a different schedule in combination with chemotherapy or on its own . It is also indicated for the treatment of patients aged 2 years and older with CD33-positive AML who have experienced a relapse or who have not responded to initial treatment (refractory) .
Used for the treatment of acute myeloid leukemia (AML), mylotarg binds to the CD33 antigen, which is expressed on the surface of leukemic cells in more than 80% of patients with AML. The CD33 antigen is not expressed on pluripotent hematopoietic stem cells or nonhematopoietic cells. This gives mylotarg the selectivity needed to target leukemic cells.
| Trade Name | Gemtuzumab Ozogamicin |
| Generic | Gemtuzumab ozogamicin |
| Gemtuzumab ozogamicin Other Names | Gemtuzumab ozogamicin |
| Weight | 4.5mg |
| Type | Intravenous powder for injection |
| Weight | 151500.0 Da (range) |
| Groups | Approved, Investigational |
| Therapeutic Class | |
| Manufacturer | |
| Available Country | United States |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Gemtuzumab Ozogamicin is a monoclonal anti-CD33 antibody used to treat CD33-positive acute myeloid leukemia.
Indicated for the treatment of patients with CD33 positive acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for other cytotoxic chemotherapy. Indicated for the treatment of patients aged 2 years and older with CD33-positive AML who have experienced a relapse or who have not responded to initial treatment (refractory).
Gemtuzumab Ozogamicin is also used to associated treatment for these conditions: Acute Myeloid Leukemia (AML), Refractory Acute Myelogenous Leukemia (AML), Relapsed Acute Myelogenous Leukemia (AML)
How Gemtuzumab Ozogamicin works
Mylotarg is directed against the CD33 antigen expressed by hematopoietic cells. Binding of the anti-CD33 antibody portion of Mylotarg with the CD33 antigen results in the formation of a complex that is internalized. Upon internalization, the calicheamicin derivative is released inside the lysosomes of the myeloid cell. The released calicheamicin derivative binds to DNA in the minor groove resulting in site-specific DNA double strand breaks via formation of a p-benzene diradical . Eventually, cell death is induced.
Toxicity
The most frequently reported toxicities are myelosuppression and hepatic veno-occlusive disorder.
Food Interaction
No interactions found.Volume of Distribution
The volume of distribution at steady state (Vss) was approximately 6.5 ± 5.5 L in pediatric patients receiving a dose level of 9mg/m^2 .
Elimination Route
In pediatric patients receiving a dose level of 9mg/m^2, the peak plasma concentration (Cmax) was approximately 3.47±1.04 mg/L with the AUC of 136 ±107 mg * h/L .
Half Life
In pediatric patients receiving a dose level of 9mg/m^2, the half life was approximately 64±44 h after the first dose .
Clearance
The mean clearance rate was approximately 0.12±0.15 L/h/m^2 in pediatric patients receiving a dose level of 9mg/m^2 .
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