Nivorz 100mg 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, a PD-1 immune checkpoint inhibitor.

PD-1 is a receptor found on T cells. Some cancer cells can exploit the PD-1 pathway to reduce T-cell activity and avoid immune attack. Nivolumab binds to PD-1 and prevents its interaction with PD-L1 and PD-L2.

This can help restore T-cell activity and allow the immune system to recognise and attack cancer cells. Nivolumab therefore works by modifying the body's immune response rather than directly destroying tumour cells.

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: These may affect the immune response associated with treatment and may also be used to manage immune-related reactions.

• Other cancer medicines: Nivorz may be prescribed with other medicines as part of a specific cancer treatment regimen.

• Prescription and non-prescription medicines: Tell your doctor about everything you take so potential interactions can be assessed.

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

• Store Nivorz 100mg 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 according to the instructions provided by the healthcare professional and the applicable product information.

Nivorz 100mg Injection is administered by intravenous infusion by a doctor or qualified healthcare professional.

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

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

Nivorz may cause side effects. Some of these 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 reactions involving organs such as the lungs, bowel, liver, kidneys, skin and endocrine glands. Promptly report new, persistent or worsening symptoms to your healthcare team.

Infusion-related reactions may 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 be administered under the supervision of an oncologist or qualified healthcare professional.

• Keep all scheduled appointments for treatment and monitoring.

• Report new or worsening symptoms promptly, even if they do not appear to be related to your cancer.

• Tell your doctor about all medicines, supplements and herbal products you use.

• Inform your doctor if you have an autoimmune condition or have previously received medicines that suppress the immune system.

• Do not self-administer Nivorz. It is given by intravenous infusion.

• Store the vial as instructed and do not freeze or shake it.