NAXITAMAB

Other

Brand names: DANYELZA

Intravenous

Mechanism of Action

12.1 Mechanism of Action Naxitamab-gqgk binds to the glycolipid GD2. GD2 is a disialoganglioside that is overexpressed on neuroblastoma cells and other cells of neuroectodermal origin, including the central nervous system and peripheral nerves. In vitro, naxitamab-gqgk was able to bind to cell surface GD2 and induce complement dependent cytotoxicity (CDC) and antibody dependent cell-mediated cytotoxicity (ADCC).

Indications

1 INDICATIONS AND USAGE DANYELZA is indicated

in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF)

minor response

in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF)

minor response

FDA Warnings

5 WARNINGS AND PRECAUTIONS Neurotoxicity: Peripheral neuropathy, neurological disorders of the eye, and prolonged urinary retention have also occurred
Advise females of reproductive potential of potential risk to a fetus and to use effective contraception
1 Serious Infusion-Related Reactions DANYELZA can cause serious infusion reactions requiring urgent intervention including fluid resuscitation, administration of bronchodilators and corticosteroids, intensive care unit admission, infusion rate reduction or interruption of DANYELZA infusion
Serious infusion-related reactions occurred in 4% of patients in Study 201 and in 18% of patients in Study 12-230

Known Side Effects

8 documented side effects by frequency

Low Blood Pressure

>10%

High Blood Pressure

1-10%

Rash

1-10%

Fever

1-10%

Rapid Heart Rate

0.1-1%

Abdominal Pain

0.1-1%

Vomiting

0.1-1%

Cough

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Intravenous