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Nivolumab: Mechanism, Uses & Side Effects

Nivolumab is a monoclonal antibody used in cancer treatment that activates the immune system to fight tumor cells. It belongs to the class of immune checkpoint inhibitors.

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Things worth knowing about "Nivolumab"

Nivolumab is a monoclonal antibody used in cancer treatment that activates the immune system to fight tumor cells. It belongs to the class of immune checkpoint inhibitors.

What is Nivolumab?

Nivolumab is a monoclonal antibody used in oncology – the medical specialty focused on cancer. It belongs to a class of drugs called immune checkpoint inhibitors and is marketed under the brand name Opdivo®. The medication was developed by Bristol-Myers Squibb and Ono Pharmaceutical and is approved in the European Union, the United States, and many other countries worldwide.

Mechanism of Action

The human immune system has checkpoint proteins that normally prevent immune cells from attacking the body's own healthy tissue. Cancer cells exploit this mechanism by displaying the protein PD-L1 (Programmed Death-Ligand 1) on their surface. This protein binds to the receptor PD-1 (Programmed Cell Death Protein 1) on T-cells – specialized immune cells – effectively switching them off and allowing tumor cells to evade immune destruction.

Nivolumab works by specifically blocking the PD-1 receptor on T-cells. This removes the inhibitory signal sent by tumor cells, allowing T-cells to recognize and attack cancer cells again. This treatment approach is called immunotherapy.

Indications

Nivolumab is approved for a wide range of cancers, including:

Non-small cell lung cancer (NSCLC)
Malignant melanoma (skin cancer)
Renal cell carcinoma (kidney cancer)
Hodgkin lymphoma
Squamous cell carcinoma of the head and neck
Urothelial carcinoma (bladder cancer)
Colorectal cancer with mismatch repair deficiency
Hepatocellular carcinoma (liver cancer)
Esophageal carcinoma
Gastric cancer and gastroesophageal junction adenocarcinoma

Nivolumab may be used as a monotherapy or in combination with other agents such as ipilimumab (another checkpoint inhibitor) or platinum-based chemotherapy regimens.

Dosage and Administration

Nivolumab is administered exclusively as an intravenous infusion in a clinical or hospital setting. The exact dose depends on the patient's body weight or is given as a flat dose. Common dosing schedules include:

240 mg every 2 weeks
480 mg every 4 weeks

Each infusion typically takes approximately 30 minutes. Treatment continues for as long as the patient benefits from it or until unacceptable side effects occur.

Side Effects

Because nivolumab activates the immune system, it can cause immune-related adverse events (irAEs) that may affect almost any organ. Common side effects include:

Fatigue and general weakness
Skin rash and itching
Diarrhea and bowel inflammation (colitis)
Lung inflammation (pneumonitis)
Thyroid disorders (hypothyroidism or hyperthyroidism)
Elevated liver enzymes (hepatitis)
Kidney inflammation (nephritis)

Severe immune-related side effects can be life-threatening and require prompt medical management, often with corticosteroids. Patients should immediately inform their treating physician if new or worsening symptoms develop.

Contraindications and Interactions

Nivolumab must not be used in patients with known hypersensitivity to the active substance. Special caution is required in patients with pre-existing autoimmune diseases, as nivolumab may exacerbate these conditions. The use of nivolumab during pregnancy and breastfeeding is not recommended due to potential harm to the unborn child or infant.

Drug interactions should always be discussed with the treating physician. In particular, the concomitant use of systemic corticosteroids or other immunosuppressive agents at the start of treatment may interfere with the effectiveness of nivolumab.

References

European Medicines Agency (EMA): Opdivo (Nivolumab) – Summary of Product Characteristics. URL: https://www.ema.europa.eu/en/medicines/human/EPAR/opdivo (accessed 2024)
Brahmer J et al. – Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer. New England Journal of Medicine, 2015; 373(2): 123-135.
Robert C et al. – Nivolumab in Previously Untreated Melanoma without BRAF Mutation. New England Journal of Medicine, 2015; 372(4): 320-330.

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