Can Nivolumab (Opdivo) cause gastroenteritis?

From the Guidelines

Yes, Nivolumab (Opdivo) can cause gastroenteritis as a side effect. Nivolumab is an immune checkpoint inhibitor that works by enhancing the immune system's ability to fight cancer, but this immune activation can sometimes lead to inflammation in various organs, including the gastrointestinal tract. Gastroenteritis, characterized by inflammation of the stomach and intestines, may present with symptoms such as diarrhea, abdominal pain, nausea, vomiting, and in some cases, blood in stool. These symptoms can range from mild to severe and typically appear within the first few months of treatment, though they can occur at any time.

Key Points to Consider

• If you experience these symptoms while on Nivolumab, it's essential to contact your healthcare provider immediately, as severe cases may require treatment interruption, corticosteroids, or other immunosuppressive medications 1.
• Your doctor will need to rule out other causes of gastroenteritis, such as infections, before attributing symptoms to Nivolumab.
• Staying hydrated and reporting symptoms promptly can help manage this potential side effect effectively.
• The management of immune-related adverse events (irAEs) like gastroenteritis is crucial for the continuation of Nivolumab treatment and the patient's overall well-being 1.
• According to recent guidelines, the incidence of GI irAEs, including gastroenteritis, is higher with combination ipilimumab plus nivolumab than with either ipilimumab or anti-PD-1 monotherapy 1.
• Corticosteroids are typically the first line of treatment for GI irAEs, but in cases of steroid-refractory colitis, infliximab or vedolizumab may be considered as second-line immunosuppressants 1.

From the FDA Drug Label

Adverse Reaction ... c Includes colitis, enterocolitis, and gastroenteritis The most frequent serious adverse reactions in at least 2% of patients were: ... diarrhea

• Gastroenteritis is listed as an adverse reaction in the context of colitis, enterocolitis, and gastroenteritis.
• Diarrhea is also reported as one of the most frequent serious adverse reactions. The FDA drug label indicates that nivolumab can cause gastroenteritis as it is included in the list of adverse reactions 2.

From the Research

Nivolumab and Gastroenteritis

• Nivolumab, also known as Opdivo, is a medication used to treat various types of cancer, including lung cancer and melanoma.
• It works by stimulating the immune system to attack cancer cells, but it can also cause immune-related adverse events, including gastrointestinal problems.
• Gastroenteritis, which is an inflammation of the stomach and intestines, can be a potential side effect of nivolumab treatment.

Immune-Mediated Colitis

• Studies have shown that nivolumab can cause immune-mediated colitis, which is a type of colitis that is triggered by the immune system 3, 4.
• This condition can present with symptoms such as diarrhea, abdominal pain, and weight loss, and can be difficult to distinguish from other types of colitis, such as ulcerative colitis.
• Treatment for immune-mediated colitis typically involves the use of corticosteroids, such as prednisolone, to reduce inflammation and suppress the immune system 5.

Severity and Treatment of Nivolumab-Induced Gastrointestinal Side Effects

• Nivolumab-induced gastrointestinal side effects can range from mild to severe, and can include conditions such as colitis, enterocolitis, and gastritis 6, 7.
• In some cases, these side effects can be refractory to conventional treatment with corticosteroids, and may require the use of additional medications, such as infliximab, to manage symptoms.
• It is essential for healthcare providers to be aware of the potential for nivolumab to cause gastrointestinal side effects, and to monitor patients closely for signs of these conditions.

Gastroenteritis as a Potential Side Effect

• While the studies do not specifically mention gastroenteritis as a side effect of nivolumab, they do report on various gastrointestinal immune-related adverse events, including colitis and enterocolitis 3, 4, 5, 6, 7.
• These conditions can be related to gastroenteritis, and it is possible that nivolumab could contribute to the development of gastroenteritis in some patients.