Opdivo™

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Melanoma,OPDIVO, as monotherapy, is indicated for the adjuvant treatment of adults and adolescent patients 12 years and older with completely resected Stage IIB, IIC, III or IV melanoma. 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 platinum-doublet chemotherapy, is indicated for the neoadjuvant treatment of patients with resectable non-small cell lung cancer (NSCLC). OPDIVO, in combination with platinum-doublet chemotherapy, is indicated for the neoadjuvant treatment of adult patients with resectable (tumours equal to or greater than 4cm or node positive) non-small cell lung cancer and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, followed by OPDIVO as a single agent in the adjuvant setting after surgical resection. 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.,Malignant Pleural Mesothelioma (MPM),OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of patients with unresectable malignant pleural mesothelioma.,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, in combination with cabozantinib, is indicated for the first-line treatment of patients with 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 adjuvant treatment of patients with muscle invasive urothelial carcinoma (MIUC) who are at high risk of recurrence after undergoing radical resection of MIUC. OPDIVO, in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of patients with unresectable or metastatic urothelial carcinoma. 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, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma. 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 in combination with ipilimumab is indicated for the first-line treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression equal to or greater than 1% as determined by a validated test. OPDIVO in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression equal to or greater than 1% as determined by a validated test. 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.,Adjuvant Oesophageal Cancer (OC) or Gastro-Oesophageal Junction Cancer (GOJC),OPDIVO, as monotherapy, is indicated for the adjuvant treatment of resected oesophageal or gastro-oesophageal junction cancer in patients who have received neoadjuvant chemoradiotherapy.,Gastric Cancer (GC), Gastro-oesophageal Junction Cancer (GOJC), or Oesophageal Adenocarcinoma (OAC),OPDIVO, in combination with fluoropyrimidine- and platinum-based combination chemotherapy, is indicated for the first-line treatment of patients with HER2 negative advanced or metastatic gastric or gastro-oesophageal junction or oesophageal adenocarcinoma.,Microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) Colorectal Cancer (CRC),OPDIVO in combination with ipilimumab is indicated for the treatment of adult patients with unresectable or metastatic colorectal cancer (CRC) that is MSI-H or dMMR as determined by a validated test.

Source: ARTG

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

Source: ARTG

Non-composite pack

This medicine contains one component only.

Component

• Injection, concentrated
• Intravenous Infusion
• A clear to opalescent, colorless to pale yellow liquid which may contain light (few) particulates.

Source: ARTG

These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4: Prescription Only Medicine.?What is the medicines and poisons schedule?

All medicines and poisons in Australia are categorised by how they are made available to the public. Medicines with a low safety risk are usually less tightly controlled than medicines with a higher safety risk. This system is called ‘scheduling’. You can read more about the scheduling of medicines as well as the different scheduling categories on our Scheduling of medicines and poisons information page.

• 1 vial per pack

Source: ARTG

This medicine was verified as available on the Pharmaceutical Benefits Scheme (PBS) on 1 August 2026, under the following PBS item codes:

• 14231B (Opens in new tab)
• 11900H (Opens in new tab)
• 13246E (Opens in new tab)
• 14233D (Opens in new tab)
• 14232C (Opens in new tab)
• 13240W (Opens in new tab)
• 11906P (Opens in new tab)
• 14260M (Opens in new tab)
• 15224G (Opens in new tab)
• 15238B (Opens in new tab)

Ask your pharmacist or doctor about your eligibility

Source: PBS

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.

Source: AHT

If you experience a side effect from this medicine, tell your doctor or pharmacist. Or report it directly to the TGA (Therapeutic Goods Administration).

You can report side effects to your doctor, or directly at Report an adverse event or safety problem (Opens in new tab)

Source: ARTG

Healthdirect medicines information is not intended for use in an emergency. If you are suffering an acute illness, overdose, or emergency condition, call triple zero (000) and ask for an ambulance.

Reasonable care has been taken to provide accurate information at the time of creation. This information is not intended to substitute medical advice, diagnosis or treatment and should not be exclusively relied on to manage or diagnose a medical condition. Please refer to our terms and conditions (Opens in new tab).