NIVOLUMAB

Nivolumab is an active pharmaceutical substance indicated for the treatment of cancers affecting the skin, lungs, kidney, lymph nodes, bladder, oesophagus, and urinary tract. This medicine is used when cancer has recurred following prior treatment with medicines, surgery, and radiation.

Nivolumab functions as an immunotherapy agent that enhances the immune system's capacity to combat cancer. It works by targeting and blocking specific molecules that ordinarily suppress or diminish the immune system's ability to recognise and attack cancer cells. By inhibiting these molecules, nivolumab strengthens immune response against cancer and may reduce or slow tumour growth.

Immunotherapy agents including nivolumab offer a distinct clinical advantage: they can produce sustained responses in certain patients, persisting even after treatment completion. This contrasts with conventional chemotherapy and radiation therapy, which typically deliver temporary benefit and carry substantial side effect burdens.

Nivolumab received its initial approval from the United States Food and Drug Administration on 22 December 2014 for treatment of unresectable or metastatic melanoma. Subsequent approvals have extended its use to additional cancer types.

Nivolumab is primarily used to treat several types of cancer, including Hodgkin's lymphoma, non-Hodgkin's lymphoma, squamous cell carcinoma, and testicular cancer. It is also used off-label for treating other types of cancers, such as cervical cancer and melanoma. As part of a chemotherapy regimen, it is often used with other drugs to increase its effectiveness. In some cases, it may also be used as a single agent for treating certain cancers. It is particularly effective in the treatment of testicular cancer.

Nivolumab is a medication a healthcare professional administers, typically in a hospital or clinic setting. The medication is given as an intravenous (IV) injection by healthcare professional. The infusion typically takes several hours. You will be closely monitored during and after the infusion to ensure the medication works effectively and to watch for any side effects. The dosage and frequency of administration will depend on the condition being treated and your circumstances. Your healthcare provider will determine the appropriate dosage and schedule for you.

Nivolumab can cause a range of side effects, which can vary in severity. Common side effects of nivolumab include fatigue, nausea, skin rash, itching, loss of appetite, diarrhea, constipation, joint pain, and headache. More serious side effects can also occur due to the effects of nivolumab on the immune system, which can cause inflammation in different organs of the body. These side effects are known as immune-related adverse events (irAEs) and can include pneumonitis, colitis, hepatitis, thyroid disorders, and adrenal insufficiency. Other rare but serious side effects of nivolumab may include severe allergic reactions, infusion-related reactions, neurological side effects, and eye disorders.

Nivolumab can cause immune-mediated adverse reactions, which can affect various organs in the body. These reactions can be serious or even life-threatening. It can cause infusion-related reactions, including fever, chills, or low blood pressure. It can cause fetal harm if administered to a pregnant woman. It also increases the risk of infections, including bacterial, viral, and fungal infections. It can increase the risk of developing secondary malignancies, including non-melanoma skin cancers and melanoma.

Patients receiving nivolumab should be monitored closely for any signs of immune-related adverse reactions, which can occur during or after treatment. Patients should report any new or worsening symptoms to their healthcare provider promptly, as some side effects can be serious and require medical attention. Women of childbearing potential should use effective contraception during treatment with nivolumab and for at least 5 months after the last dose. Patients should be monitored for any signs of infection, including fever, chills, or other symptoms. Patients should avoid prolonged sun exposure and use appropriate sun protection measures, such as wearing protective clothing and sunscreen, as nivolumab can increase the risk of skin cancer.

Discuss the potential risks and benefits of nivolumab 100mg injection with your healthcare provider before starting treatment. Follow all safety precautions and guidelines provided by your healthcare provider to minimise potential risks associated with treatment. Report any new or worsening symptoms to your healthcare provider promptly, as some side effects can be serious and require immediate medical attention. Women of reproductive age should use effective contraception during and for at least 5 months after the last dose to avoid potential harm to a developing fetus. Maintain self-care during treatment, including eating a healthy diet, getting adequate rest, and seeking support from family members or support groups.

Harrison's Principles of Internal Medicine. 20th edition, 2018, 929-932 Bristol-Myers Squibb, U.S. Food and Drug Administration, Nivolumab, [ Last updated, 4 April 2023]. [ Accessed on 4 April] https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125554s114lbl.pdf . Goodman & Gilman's The Pharmacological Basis of Therapeutics. 12th edition, 2011,1655-1660 Takeda UK Ltd, Electronic Medicines Compendium (emc), Opdivo 10 mg/mL concentrate for solution for infusion, [Last updated: 30 October 2020], [Accessed on 4 April 2023], https://www.medicines.org.uk/emc/product/6154/smpc