Detailed Chinese instructions for nivolumab

[Drug Name]: Nivolumab Injection

[Common name]: nivolumab

[Ingredients]: Each ml contains nivolumab100mg or 40mg

[Indications]:

1.Advanced non-small cell lung cancer (NSCLC): As first-line treatment for patients whose disease has progressed after platinum-based chemotherapy.

2.Melanoma: used to treat advanced melanoma.

3.Renal cell carcinoma: used to treat advanced renal cell carcinoma.

4.Hodgkin lymphoma: used to treat relapsed or refractory Hodgkin lymphoma after treatment.

[Dosage form and specification]: Colorless transparent injection, each containing 100mg or 40mg nivolumab.

[Usage and Dosage]:

Usually given once every 2 weeks.

Dosing speed: per minute 30 minutes to complete the injection.

Dose: Adjust individually according to the patient's weight and severity of the condition. It is generally recommended to take 240 mg per dose.

[Adverse reactions]:

1.Immune system related: including rash, itching, fatigue, fever, joint pain, etc.

2.Digestive system related: including nausea, vomiting, diarrhea, loss of appetite, etc.

3.Respiratory system related: Symptoms such as coughing and shortness of breath may occur.

4.Others: headache, dizziness, infection, etc.

[Contraindications]:

1.Those who are allergic to the ingredients of this product.

2.Patients with active severe infection.

[Notes]:

1.Please read the instructions carefully before use and use it under the guidance of a doctor.

2.The patient’s liver and kidney function, blood routine and other indicators should be checked before injection.

3.Monitor the patient's vital signs and adverse reactions regularly during use.

4.Live vaccines should be avoided during treatment.

5.Pregnant women should use with caution, and lactating women should stop breastfeeding during treatment.

6.Caution should be used when combined with other immunomodulatory drugs.

7.Avoid exposure to sunlight during use to avoid aggravating skin reactions.

【Pediatric Medication】: The safety and effectiveness of children's medication have not been determined, so use with caution.

【Drug use in the elderly】: Elderly patients should pay attention to monitoring liver and kidney function when using this product.

[Drug Interaction]:

1.The risk of adverse reactions may increase when used in combination with other immunomodulatory drugs.

2.Combined use with immunosuppressants (such as prednisone) may reduce the therapeutic effect.

[Pharmacological effects]: Nivolumab is a PD-1 inhibitor that can inhibit the binding of PD-1 and its ligand PD-L1, thereby activating T cells and enhancing the immune system's ability to attack cancer cells.

[Storage Conditions]: Protect from light, sealed, moisture-proof, and stored at room temperature (15-30℃).

[Packaging]: Each tube contains 100 mg or 40 mg.

[Manufacturer]:Bristol-Myers Squibb of the United StatesPharmaceutical Company

[Approval number]: National drug approval numberSJ20180015/National drug approval numberSJ20180014