Humanized Monoclonal Antibody HU3F8-IGG1
Humanized Monoclonal Antibody HU3F8-IGG1 Uses, Dosage, Side Effects, Food Interaction and all others data.
Humanized Monoclonal Antibody HU3F8-IGG1 (humanized 3F8, hu3F8) is an IgG1 monoclonal antibody directed against the oncofetal differentiation antigen GD2 disialoganglioside. Normally expressed during fetal development and in mature neurons, pain fibers, and skin cells, GD2 constitutes a highly efficient target in the treatment of neuroblastoma - it is widely expressed across and within neuroblastomas (and other neuroectodermal tumors), and is rarely subject to antigen loss.
The first anti-GD2-monoclonal IgG antibody to be approved by the FDA for the treatment of neuroblastoma was dinutuximab under the brand name Unituxin in 2015. One stark disadvantage of this therapy is the requirement for concurrent use of granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA).
Humanized Monoclonal Antibody HU3F8-IGG1-gqgk (Danyelza) was granted accelerated approval by the FDA in November 2020 for the treatment of high-risk relapsed/refractory neuroblastoma of the bone or bone marrow. This approval requires naxitamab to be co-administered only with GM-CSF, a factor known to enhance the granulocyte-mediated antibody-dependent cytotoxicity of anti-GD2 therapies, making the administration of naxitamab therapy markedly simpler than that of its predecessor.
| Trade Name | Humanized Monoclonal Antibody HU3F8-IGG1 |
| Availability | Prescription only |
| Generic | Naxitamab |
| Naxitamab Other Names | Anti-Gd2 igg3 monoclonal antibody 3F8 humanized, Anti-Gd2 monoclonal antibody 3F8 humanized, HU3F8, Humanized 3F8, Humanized anti-Gd2 monoclonal antibody 3F8, Humanized monoclonal antibody HU3F8-IGG1, Monoclonal antibody HU3F8, Naxitamab, naxitamab-gqgk |
| Related Drugs | doxorubicin, cisplatin, vincristine, Adriamycin, Danyelza, Platinol |
| Type | |
| Weight | 144000.0 Da (non-glycosylated) |
| Groups | Approved |
| Therapeutic Class | |
| Manufacturer | |
| Available Country | |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Humanized Monoclonal Antibody HU3F8-IGG1 is a GD2-targeted IgG1 monoclonal antibody for the treatment of high-risk relapsed/refractory neuroblastoma of the bone or bone marrow.
Humanized Monoclonal Antibody HU3F8-IGG1-gqgk is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of patients 1 year of age and older with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy.
Humanized Monoclonal Antibody HU3F8-IGG1 is also used to associated treatment for these conditions: High risk, refractory Neuroblastomas of the bone or bone marrow, High risk, relapsed Neuroblastomas of the bone or bone marrow
How Humanized Monoclonal Antibody HU3F8-IGG1 works
Neuroblastomas are neuroendocrine tumors occurring in immature and developing cells of the nervous system and are the most common malignancy diagnosed in children 4 The GD2 disialoganglioside is a glycolipid found highly expressed on the surface of neuroectodermal tumors, including neuroblastomas. GD2 exhibits high density and homogeneity across neuroblastomas and a rare occurrence of antigen loss, making it a desirable target in the treatment of these cancers.
Humanized Monoclonal Antibody HU3F8-IGG1 is an IgG1 monoclonal antibody directed against GD2 disialogangliosides - it binds to GD2 on the surface of neuroblastoma cells and induces both complement-dependent cytotoxicity (CDC) and antibody-dependent cell-mediated cytotoxicity (ADCC), the latter of which is enhanced by co-administration with GM-CSF.
Toxicity
Data regarding overdose of naxitamab are unavailable. In the event of an overdose, patients should be treated with symptomatic and supportive measures.
Food Interaction
No interactions found.Humanized Monoclonal Antibody HU3F8-IGG1 Hypertension interaction
[Moderate] The use of naxitamab can cause hypertension.
Do not initiate naxitamab in patients with uncontrolled hypertension.
It is recommended to monitor blood pressure during infusion, and at least daily on Days 1 to 8 of each cycle and evaluate for complications of hypertension including reversible posterior leukoencephalopathy syndrome.
Interrupt infusion and resume at a reduced rate, or permanently discontinue naxitamab based on the severity of symptoms.
Humanized Monoclonal Antibody HU3F8-IGG1 Drug Interaction
Moderate: influenza virus vaccine, inactivatedUnknown: fluticasone / salmeterol, umeclidinium / vilanterol, aspirin, diphenhydramine, fluticasone / vilanterol, acetaminophen / chlorpheniramine, chlorpheniramine / dextromethorphan, fluticasone nasal, fluticasone, ibuprofen, ferrous sulfate, polyethylene glycol 3350, guaifenesin, dextromethorphan / guaifenesin, famotidine, acetaminophen / oxycodone, omeprazole, albuterol, beclomethasone
Humanized Monoclonal Antibody HU3F8-IGG1 Disease Interaction
Elimination Route
The mean plasma concentration of naxitamab following an intravenous infusion of 3 mg/kg over 30 minutes was 57.4 μg/mL. The AUC of naxitamab appears to correlate with body size.
Half Life
The mean terminal half-life of naxitamab is 8.2 days.
Clearance
The clearance of naxitamab appears to be correlated inversely with body weight.
Elimination Route
Monoclonal antibodies are typically eliminated via uptake into cells and subsequent catabolism via lysosomal degradation. Due to their large size, they are only eliminated renally under pathologic conditions.
Innovators Monograph
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