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Brand name: Opdivo TM

Listen to the Pronunciation:

Active ingredients: nivolumab

What it is used for

Melanoma,OPDIVO, as monotherapy, is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. OPDIVO, as monotherapy, is indicated for the treatment of patients with unresectable or metastatic melanoma. OPDIVO, in combination with ipilimumab, is indicated for the treatment of patients with unresectable or metastatic melanoma. The approval of this indication is based on a pre-specified comparison to ipilimumab monotherapy. All analyses comparing nivolumab monotherapy with the nivolumab/ipilimumab combination are descriptive.,Non-Small Cell Lung Cancer (NSCLC),OPDIVO, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumour aberrations. OPDIVO, as monotherapy, is indicated for the treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after prior chemotherapy. OPDIVO, as monotherapy, is indicated for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with progression on or after prior chemotherapy. In patients with tumour EGFR or ALK genomic aberrations, OPDIVO should be used after progression on or after targeted therapy.,Renal Cell Carcinoma (RCC),OPDIVO, in combination with ipilimumab, is indicated for the treatment of patients with intermediate/poor-risk, previously untreated advanced renal cell carcinoma. OPDIVO, as monotherapy, is indicated for the treatment of patients with advanced clear cell renal cell carcinoma after prior anti-angiogenic therapy.,Classical Hodgkin Lymphoma (cHL),OPDIVO, as monotherapy, is indicated for the treatment of patients with relapsed or refractory classical Hodgkin lymphoma (cHL) after autologous stem cell transplant and treatment with brentuximab vedotin. The approval of this indication is based on objective response rate in a single arm study.,Squamous Cell Carcinoma of the Head and Neck (SCCHN),OPDIVO, as monotherapy, is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in patients progressing on or after platinum based therapy. Urothelial Carcinoma (UC) OPDIVO, as monotherapy, is indicated for the treatment of patients with locally advanced unresectable or metastatic urothelial carcinoma after prior platinum-containing therapy. The approval of this indication is based on objective response rate and duration of response in a single arm study.,Hepatocellular Carcinoma (HCC),OPDIVO, as monotherapy, is indicated for the treatment of patients with hepatocellular carcinoma after prior sorafenib therapy. This indication is approved based on objective response rate and duration of response in a single arm study. An improvement in survival or disease-related symptoms has not been established.,Oesophageal Squamous Cell Carcinoma (OSCC),OPDIVO, as monotherapy, is indicated for the treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine and platinum based chemotherapy.

How to take it

The way to take this medicine is: Intravenous Infusion.

  • Store at 2 to 8 degrees Celsius
  • Refrigerate
  • Do not Freeze
  • Protect from Light
  • Reconstituted Solution see label for shelf life
  • Shelf lifetime is 3 Years.

You should seek medical advice in relation to medicines and use only as directed by a healthcare professional.

Always read the label. If symptoms persist see your healthcare professional.

Visual appearance

A clear to opalescent, colorless to pale yellow liquid which may contain light (few) particulates.

Do I need a prescription?

This medicine is available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.

Pregnant or planning a pregnancy?

For the active ingredient nivolumab

You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.

Consumer Medicines Information (CMI)

For side effects, taking other medicines and more

Print the CMI.


Reporting side effects

You can help ensure medicines are safe by reporting the side effects you experience.

You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems

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