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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

The Medicines and Healthcare products Regulatory Agency (MHRA) have published an alert for Bristol-Myers Squibb's cancer treatment nivolumab, brand name Opdivo▼, that there have been reports of cytomegalovirus (CMV) gastrointestinal infection or reactivation in patients taking Opdivo.

Patients on nivolumab who present with diarrhoea or other symptoms of colitis, and those who do not respond to steroid treatment for immune-related colitis, should be investigated to exclude other causes, including infections such as cytomegalovirus (CMV).

You can follow developments with Opdivo by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

Advice for healthcare professionals:
  • 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
About Opdivo (source EMA)
Opdivo is a cancer medicine used to treat the following:
  • 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.
Opdivo contains the active substance nivolumab.

The active substance in Opdivo, nivolumab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a receptor (target) called PD-1 found on certain cells of the immune system called T cells. Cancer cells can produce proteins (PD-L1 and PD-L2) that attach to this receptor and switch off the activity of the T cells, preventing them from attacking the cancer. By attaching to the receptor, nivolumab prevents PD-L1 and PD-L2 from switching off the T cells, thereby increasing the ability of the immune system to kill cancer cells.

Opdivo was first made available in the EU in 2015. It is manufactured by Bristol-Myers Squibb.

Sources
European Medicines Agency website page for Opdivo
MHRA website
Accessed 21/10/19
Links available in External Resources

MHRA: Nivolumab (Opdivo): reports of cytomegalovirus (CMV) gastrointestinal infection or reactivation

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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