naxitamab

Action and Spectrum

Actions and Spectrum: 

Actions: 

naxitamab (also known as naxitamab-gqgk) is a monoclonal antibody used to treat certain types of cancer. It specifically targets the GD2 antigen, expressed on the surface of various neuroblastoma and melanoma cells. 

Spectrum: 

naxitamab is primarily used to treat high-risk neuroblastoma, cancer commonly affecting children. Neuroblastoma cancer originates in the nerve tissue and is often found in the adrenal glands, which are located above the kidneys.

naxitamab is specifically indicated for treating relapsed or refractory high-risk neuroblastoma in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF). 

Drug Interaction

Adverse Reaction

Frequency defined 

>10% 

Infusion-related reaction (94-100%) 

Pain (94-100%) 

Tachycardia (44-84%) 

Decreased lymphocytes (74-79%) 

Decreased hemoglobin (48-76%) 

Increased glucose (74%) 

Decreased albumin (50-68%) 

Decreased calcium (64%) 

Decreased neutrophils (61-72%) 

Decreased platelets (65-71%) 

Decreased potassium (47-63%) 

Nausea (56-57%) 

Diarrhea (50-56%) 

Vomiting (60-63%) 

Cough (57-60%) 

Increased ALT (42-55%) 

Decreased magnesium (54%) 

Rhinovirus infection (12-14%) 

Enterovirus infection (13%) 

Upper respiratory tract infection (12%) 

Weight decreased (12%) 

Anaphylactic reaction (12%) 

Influenza (12%) 

Erythema (11%) 

1-10% 

Increased ALT (8-9%) 

Decreased calcium (8%) 

Decreased albumin (7%) 

Decreased glucose (8%) 

Diarrhea (4.2-8%) 

Headache (8%) 

Hypertension (4-7%) 

Decreased sodium (6%) 

Vomiting (2.8-4%) 

Urticaria (4%) 

Tachycardia (1.4-4%) 

Decreased phosphate (5%) 

Decreased appetite (4.2%) 

Increased AST (4%) 

Nausea (1.4%) 

Black Box Warning

Black Box Warning: 

The usage of drugs can lead to severe reactions through infusion, like anaphylaxis, cardiac arrest, hypotension, stridor, and bronchospasm. 

Severe neurotoxicity is also reported, which includes transverse myelitis, neuropathic pain, and RPLS. One may discontinue the medication permanently based on severity and adverse reactions. 

Contraindication / Caution

Contraindication/Caution: 

Contraindications 

• Hypersensitivity 

Cautions 

• Infusion reactions 
• Capillary leak syndrome 
• Interactions with vaccines 
• Pregnancy 
• Breastfeeding 

Pregnancy / Lactation

Pregnancy consideration:  

No data is available regarding the risk due to drugs in pregnant females. Though administering the drug may cause harm to the fetus as per the mechanism of action. 

Breastfeeding warnings:  

No data is available regarding the excretion of drugs in breast milk. Also, human milk contains IgG. 

Pregnancy category: 

Category A: well-controlled and satisfactory studies show no risk to the fetus in the first or later trimester. 

Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women. 

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.    

Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.    

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.    

Category N: No data is available for the drug under this category. 

Pharmacology

Pharmacology: 

naxitamab specifically binds to the GD2 antigen expressed on the surface of neuroblastoma and melanoma cells. By binding to GD2, naxitamab triggers an immune response, leading to antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). These immune mechanisms help in the destruction of cancer cells. 

Pharmacodynamics: 

• Target Specificity: naxitamab targets the GD2 antigen, expressed on the surface of specific cancer cells, particularly neuroblastoma and melanoma cells. By binding to GD2, naxitamab triggers immune responses against these cancer cells. 
• Immune Activation: naxitamab is immunotherapy by stimulating the body’s immune system. When naxitamab binds to GD2 on cancer cells, it activates immune effector cells, such as natural killer (NK) cells, macrophages, and granulocytes. This activation leads to antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC), mechanisms through which the immune cells recognize and kill the GD2-expressing cancer cells. 
• Cytotoxic Effects: The immune effector cells activated by naxitamab release cytotoxic substances, such as perforin and granzymes, that directly induce cell death in the targeted cancer cells. This cytotoxic effect contributes to the destruction of GD2-expressing cancer cells. 

Pharmacokinetics: 

Absorption 

naxitamab is administered intravenously, ensuring the drug’s complete and immediate bioavailability.  

The peak plasma concentration is 57.4mcg/ml 

Distribution 

The distribution of naxitamab is expected to be similar to other monoclonal antibodies. It will likely have a large distribution volume, meaning it distributes extensively into the tissues. 

Metabolism 

The drug is metabolized in the liver 

Elimination and Excretion 

The elimination half-life is 8.2 days 

Adminstartion

Administration: 

naxitamab is available as a concentrated solution for infusion. The healthcare professional will prepare the medication according to the manufacturer’s instructions, ensuring proper handling and adherence to aseptic techniques. The infusion time for naxitamab may vary but typically ranges from one to two hours. 

Pre-medication with certain medications, such as antihistamines and corticosteroids, may be given before naxitamab infusion to help mitigate potential infusion-related reactions or hypersensitivity responses. The decision to administer pre-medication will be made by the healthcare provider based on the patient’s individual needs and clinical judgment. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: naxitamab 

Pronounced: nax-IT-a-mab 

Why do we use naxitamab? 

naxitamab is mainly used in treating high-risk neuroblastoma, which refers to cases with a higher chance of recurrence or poorer prognosis. High-risk neuroblastoma often requires intensive and aggressive treatment strategies, and naxitamab is used as part of a comprehensive treatment plan to improve outcomes. 

naxitamab is specifically indicated for the treatment of relapsed or refractory high-risk neuroblastoma. It is used when the cancer has returned (relapsed) or has not responded to previous treatments (refractory). naxitamab offers a potential treatment option for patients with limited or no response to other therapies. naxitamab effectively reduces tumor size, slows disease progression, and increases the likelihood of long-term survival.