Nivorz 40mg Injection contains nivolumab and is used as part of treatment for certain cancers. In India, Nivorz has been approved by the Drugs Controller General of India (DCGI) across 12 indications covering solid tumours and haematological malignancies.

These include:

• Non-small cell lung cancer (NSCLC): Used in certain patients with metastatic disease.

• Renal cell carcinoma (RCC): Used in selected patients with kidney cancer.

• Squamous cell carcinoma of the head and neck (SCCHN): Used for certain recurrent or metastatic disease.

• Melanoma: Used in specified stages and treatment settings.

• Classical Hodgkin lymphoma (cHL): Used in eligible patients with this type of blood cancer.

• Urothelial carcinoma: Used in selected treatment settings for cancers of the urinary tract.

• Colorectal cancer (CRC): Used for specific colorectal cancers, including biomarker-defined disease.

• Oesophageal squamous cell carcinoma (ESCC): Used in specified treatment settings.

• Gastric, gastroesophageal junction and oesophageal adenocarcinoma: Used in certain treatment settings, including combination treatment.

• Resected oesophageal or gastroesophageal junction cancer: Used as adjuvant treatment in eligible patients after surgery and prior treatment.

• Malignant pleural mesothelioma: Used for certain patients with this cancer of the lining of the lungs.

• Hepatocellular carcinoma (HCC): Used in specified treatment settings for liver cancer.

The exact indication, treatment combination and stage of disease for which Nivorz is prescribed depend on the patient's cancer type and the treatment regimen recommended by the oncologist.

Nivorz contains nivolumab, which is a PD-1 immune checkpoint inhibitor.

Some cancer cells can use the PD-1 pathway to reduce the activity of T cells, allowing them to avoid immune attack. Nivolumab binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2. This can help restore T-cell activity against tumour cells.

Nivolumab does not directly destroy cancer cells. Instead, it helps the body's immune system mount an anti-tumour response.

Tell your doctor about all medicines, supplements and treatments you are receiving before starting Nivorz.

Particular attention may be needed with:

• Medicines that suppress the immune system: Immunosuppressive medicines may affect the intended immune response and may also be used to manage certain immune-related reactions caused by nivolumab.

• Other cancer treatments: Nivorz may be prescribed with other medicines as part of a specific cancer treatment regimen. The combination should only be used when recommended by the treating oncologist.

• Other prescription or non-prescription medicines: Tell your doctor about all medicines you take so potential interactions can be assessed.

Do not start, stop or change any medicine without discussing it with your doctor.

• Store Nivorz 40mg Injection in a refrigerator at 2°C to 8°C.

• Do not freeze.

• Keep the vial in its original package to protect it from light.

• Do not shake the vial.

• The prepared infusion should be handled and stored according to the instructions provided by the healthcare professional or product information.

Nivorz 40mg Injection is given by intravenous infusion by a doctor or other qualified healthcare professional.

The dose and frequency depend on the type of cancer, the treatment regimen and whether nivolumab is being used alone or with other medicines. The vial contains a concentrated solution that must be prepared for infusion according to the prescribed regimen.

Do not attempt to inject Nivorz yourself. Your healthcare team will determine the appropriate dose and infusion schedule for you.

Like other medicines, Nivorz may cause side effects. Some occur because nivolumab activates the immune system and can cause inflammation in healthy organs.

Commonly reported side effects may include:

• Tiredness

• Rash

• Itching

• Diarrhoea

• Nausea

• Reduced appetite

• Cough

• Shortness of breath

• Musculoskeletal pain

• Fever

Nivolumab can also cause serious immune-mediated adverse reactions involving organs such as the lungs, bowel, liver, kidneys, skin and endocrine glands. Seek medical attention promptly if you develop severe or persistent symptoms during treatment.

Infusion-related reactions can also occur during or after administration. Your healthcare team will monitor you during the infusion and manage any reaction according to its severity.

• Nivorz should only be used under the supervision of an oncologist experienced in cancer immunotherapy.

• Keep all scheduled appointments because your doctor may need to monitor your symptoms and blood tests during treatment.

• Report new or worsening symptoms promptly, even if they appear unrelated to your cancer.

• Do not start any new medicine, supplement or herbal product without informing your treating doctor.

• Tell your doctor about any previous autoimmune condition or treatment with medicines that suppress the immune system.

• Nivorz is administered as an intravenous infusion and should not be self-injected.

• Keep the medicine refrigerated as instructed and do not freeze or shake the vial.