nivolumab at a glance
Medicine class
Immune checkpoint inhibitor targeting PD-1
How it is given
By intravenous infusion or, for suitable indications, injection under the skin by a healthcare professional
Important safety point
Immune-related inflammation can affect almost any organ and may begin during treatment or months afterwards
Treatment setting
Initiated and supervised by clinicians experienced in cancer treatment
What is nivolumab used for?
The selected products license nivolumab alone or with specified anticancer treatments for these main settings:
Melanoma, including advanced disease and treatment after complete resection.
Non-small-cell lung cancer, including selected resectable disease around surgery and locally advanced or metastatic disease.
Malignant pleural mesothelioma and advanced renal cell carcinoma.
Relapsed or refractory classical Hodgkin lymphoma and recurrent or metastatic squamous head and neck cancer.
Urothelial carcinoma, including selected adjuvant and advanced settings.
Mismatch-repair-deficient or microsatellite-instability-high colorectal cancer.
Specified oesophageal, gastro-oesophageal junction and gastric cancers.
Unresectable or advanced hepatocellular carcinoma.
How does nivolumab work?
Nivolumab binds to the PD-1 receptor on T cells and blocks its interaction with PD-L1 and PD-L2. This removes an inhibitory immune signal that cancers can exploit, allowing stronger T-cell responses against tumour cells. The same immune activation can also inflame healthy tissues.
nivolumab preparations and strengths
Solution for infusion
Route: Intravenous
Strengths: 10 mg/mL
Injection
Route: Parenteral
Strengths: 600 mg
How to take nivolumab
Nivolumab is given by a trained healthcare professional in a hospital or clinic. Depending on the licensed indication and treatment plan, it is given as an intravenous infusion or as a ready-to-use injection under the skin of the abdomen or thigh. It is not taken by mouth or self-administered. Keep the patient alert card available and report new symptoms promptly.
The intravenous concentrate may be used undiluted or prepared with a compatible infusion fluid.
The subcutaneous product contains recombinant human hyaluronidase to aid dispersion and absorption.
Successive subcutaneous injections should use alternate sites and avoid tender, red, bruised or hardened skin.
nivolumab side effects
Common or expected effects
- Tiredness or weakness
- Muscle, bone or joint pain
- Diarrhoea, nausea, vomiting, abdominal discomfort or constipation
- Rash or itching
- Cough or breathlessness
- Reduced appetite
- Headache or fever
- Changes in blood-cell counts or blood glucose
- Thyroid inflammation or altered thyroid function
- Injection-site reaction with the subcutaneous formulation
Get urgent medical advice
- Inflammation of the lungs causing new cough, breathlessness or low oxygen
- Colitis causing persistent diarrhoea, abdominal pain, mucus or blood in stools
- Hepatitis causing jaundice, right-sided abdominal pain or abnormal liver tests
- Kidney inflammation causing reduced urine or increased creatinine
- Hormone-gland inflammation causing profound fatigue, headache, low blood pressure, confusion or marked thirst and urination
- Severe skin reactions with blistering, peeling or mouth, eye or genital sores
- Myocarditis, myositis or myasthenia causing chest pain, palpitations, muscle pain, weakness, swallowing difficulty or breathing problems
- Severe allergic, infusion-related or injection-related reaction
- Neurological inflammation causing severe headache, confusion, weakness, numbness, seizures or vision changes
nivolumab in pregnancy
Human pregnancy evidence remains limited. Nivolumab can cross the placenta and animal studies found embryo-fetal toxicity, so it is not recommended during pregnancy unless the expected clinical benefit outweighs the potential risk. Effective contraception is advised during treatment and for at least five months after the final administration. Pregnancy or pregnancy planning requires prompt specialist oncology and obstetric discussion.
nivolumab while breastfeeding
It is unknown whether nivolumab enters human milk, and risk to a breastfed child cannot be excluded. The oncology and maternity teams should jointly decide whether breastfeeding or nivolumab treatment should be stopped, considering the benefit of each.
nivolumab interactions
Conventional CYP-mediated pharmacokinetic interactions are not expected, but clinically important treatment interactions and combinations remain relevant.
Systemic corticosteroids or other immunosuppressants
Baseline use should generally be avoided where possible because it may interfere with nivolumab's immune effect; these medicines remain appropriate when required to treat immune-related toxicity.
Ipilimumab
Combination treatment causes immune-related adverse reactions more frequently than nivolumab alone.
Common questions about nivolumab
Answers are fully visible for fast scanning and source review.
Is nivolumab chemotherapy?
No. Nivolumab is an immune checkpoint inhibitor that strengthens T-cell responses against cancer; it may be used alone or alongside chemotherapy or other anticancer treatments.
Can nivolumab be given under the skin?
Yes. A ready-to-use subcutaneous formulation is licensed for adults in suitable indications; intravenous infusion remains another formulation.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.