Instructions for Naxitamab Injection (Naxitamab)

1. Name: Naxitamab Injection, Naxitamab, Naxitamab, naxitamab-gqgk, Danyelza

2. Indications:

Naxitamab injection (Naxitamab) is indicated for use in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of pediatric patients 1 year of age and older and adult patients with high-risk neuroblastoma that is relapsed or refractory in the bone or bone marrow and who have demonstrated partial response, minor response, or stable disease to prior therapy.

3. Usage and dosage:

1. Preoperative medication and prevention:

(1) Begin a 12-day course of preventive medication for neuropathic pain (eg, gabapentin) 5 days before the first infusion of each cycle (days 4-7), and an oral opioid 45-60 minutes before the start of each infusion.

(2) During the infusion, intravenous opioids are administered as needed to relieve pain; if pain persists with opioid analgesics, consider using ketamine.

(3) Give intravenous methylprednisolone 2 mg/kg (maximum dose 80 mg) or equivalent intravenous corticosteroid 30 minutes to 2 hours before the first infusion to minimize the risk of infusion-related reactions. If a patient has had a severe infusion reaction during a previous infusion or treatment cycle, continue corticosteroids with subsequent infusions.

(4) Administer a premedication regimen consisting of an antihistamine, H2 antagonist, acetaminophen, and antiemetics 30 minutes before each infusion to reduce the risk of infusion-related reactions and nausea/vomiting.

2. Recommended dosage: On the 1st, 3rd and 5th days of each treatment cycle, the recommended dosage of nocetuzumab injection is 3mg/kg/day (up to 150mg/day), which should be diluted and administered subcutaneously in combination with GM-CSF. Treatment cycles are repeated every 4 weeks until complete or partial remission, followed by 5 additional cycles every 4 weeks. Subsequent cycles can be repeated every 8 weeks. For disease progression or unacceptable toxicity, discontinue use of nacertuzumab injectionandGM-CSF.

Begin 5 days before the infusion of nosituzumab injectionAdminister by subcutaneous injectionGM-CSF 250g/m2/day; Administer at least 1 hour before the infusion of nosituximab injection on days1, 3 and 5, subcutaneous injectionGM-CSF 500g/m2/day; Days 1, 3, and 5: Give by intravenous infusion3 mg/kg/day (up to 150 mg/day) of noxituzumab injection.

3. Missed dose: If you miss a dose of Nasiltuzumab Injection , take the missed dose on the 10th day of the following week. GM-CSF 500g/m2/day was administered on the first day of the infusion of Nasiltuzumab injection and on the day before and on the second and third infusions (i.e., 500g/m2/day for a total of 5 days).

4. Adverse reactions:

In clinical studies of nocetuzumab injection , the most common adverse reactions (≥25% in both studies) were infusion-related reactions, pain, tachycardia, vomiting, cough, nausea, diarrhea, decreased appetite, hypertension, fatigue, erythema multiforme, peripheral neuropathy, urticaria, pyrexia, headache, injection site reactions, edema, anxiety, local edema, and irritability. The most common grade 3 or 4 laboratory abnormalities (≥5% in any study) were lymphopenia, neutropenia, hemoglobin decrease, platelet count decrease, potassium decrease, alanine aminotransferase increase, glucose decrease, calcium decrease, albumin decrease, sodium decrease, and phosphate decrease.

5. Storage:

Nocertuzumab injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow intravenous infusion solution. It is provided in carton packaging and needs to be refrigerated in an outer carton at 2°C to 8°C (36°F to 46°F) and protected from light until use. If not for immediate use, store diluted narcistumumab injection at room temperature (15°C to 25°C [59°F to 77°F]) for 8 hours or refrigerated (2°C to 8°C [36°F to 46°F]) for 24 hours. After removing from the refrigerator, start the infusion within 8 hours.

6. Taboo:

Naxituzumab injection is contraindicated in patients with a history of severe allergic reactions to naxitamab-gqgk, including anaphylaxis.

7. Mechanism of action:

Naxitamab-gqgkin naxitamab injection combines with glycolipidGD2. GD2 is a disialoganglioside overexpressed on neuroblastoma cells and other cells of neuroectodermal origin, including the central nervous system and peripheral nerves. In vitro, nasitomab is able to bind to cell surface GD2 and induce complement-dependent cytotoxicity (CDC) and antibody-dependent cell-mediated cytotoxicity (ADCC).

8. Special groups:

1. Women: According to the mechanism of action of nositumumab, the use of nositumumab injection by pregnant women may cause harm to the fetus. It is recommended that women should not breastfeed during treatment and within 2 months after the last dose of nositumumab injection; women of reproductive potential should use effective contraceptive measures during treatment and within 2 months after the last dose of nositumumab injection.

2. Pediatric patients: The safety and effectiveness of nacituzumab injection combined with GM-CSF in the treatment of relapsed or refractory high-risk neuroblastoma in bone or bone marrow has been confirmed in pediatric patients 1 year old and above who have shown partial response, mild response or stable disease after previous treatment. The safety and effectiveness of this product in pediatric patients under 1 year of age have not been determined.

3. Use in the elderly: Neuroblastoma is mainly a disease of pediatric and young adult patients. Clinical studies of nasitumumab InjectionGM-CSF do not include patients aged 65 and above.

It is understood that noxituzumab injection has been approved in China, but it has not been included in medical insurance. Its price is still unclear and the purchase method is difficult. The original drug of Naxituzumab injection marketed overseas is very expensive, and the price may fluctuate due to exchange rates. For more drug information and specific prices, please consult a medical consultant.