MHRA publishes advice for patients taking Opdivo▼ (nivolumab): patient safety update
Opdivo▼, for Melanoma, Lung cancer (Non-Small Cell), Renal cell carcinoma, Kidney cancer, Hodgkin lymphoma, Squamous cell carcinoma, Head and neck cancer, Urothelial cancer and Bladder cancer from Bristol-Myers Squibb
- colitis is known to occur commonly in patients treated with nivolumab; advise patients to contact their healthcare professional immediately at the onset of symptoms of colitis (including diarrhoea, blood in stools, or abdominal pain)
- if patients on nivolumab present with diarrhoea or colitis, investigate possible causes, including infections; perform a stool infection work-up and screen for cytomegalovirus (CMV)
- for patients with immune-related colitis that is corticosteroid refractory, use of an additional immunosuppressive agent should only be considered if other causes are excluded using appropriate laboratory tests and additional examinations (including screening for CMV using viral PCR on biopsy, and for other viral, bacterial, and parasitic causes)
- report suspected adverse drug reactions associated with nivolumab to the Yellow Card Scheme
- melanoma, a type of skin cancer. Opdivo is used on its own or with another cancer medicine, ipilimumab, to treat adults whose cancer has spread to other parts of the body or cannot be surgically removed. It is also used on its own in patients who have had surgery for the removal of melanoma that has spread to the lymph nodes or elsewhere in the body.
- a lung cancer called non-small cell lung cancer (NSCLC) that has spread locally or to other parts of the body. Opdivo is used on its own in patients who have previously been treated with other cancer medicines (chemotherapy);
- advanced renal cell carcinoma, a kidney cancer. Opdivo is used on its own in patients who have been previously treated with other cancer medicines; it is used in combination with ipilimumab (another cancer medicine) in patients with previously untreated disease that is considered to be at moderate or high risk of worsening;
- classical Hodgkin lymphoma, a cancer of the lymphocytes (a type of white blood cell), that has not improved or has returned after an autologous stem cell transplant (a procedure where the bone marrow is replaced with the patient’s own stem cells to form new bone marrow that produces healthy blood cells). Opdivo is used on its own after treatment with brentuximab vedotin (another cancer medicine);
- squamous cell cancer of the head and neck (SCCHN) that has come back or spread to other parts of the body. Opdivo is used on its own in patients whose cancer is progressing despite treatment with platinum-based cancer medicines
- urothelial cancer, a cancer of the bladder and urinary tract, that has spread locally and cannot be surgically removed or has spread to other parts of the body. It is used on its own when treatment with platinum-based cancer medicines has not worked.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.
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