Nivolumab

Nivolumab (OPDIVO®) is an anti-cancer medication, which doesn’t allow tumor cells to escape from the survelience of immune system

What is Nivolumab?

Nivolumab (pronounced ni-VOH-loo-mab) is a type of cancer treatment known as immunotherapy. It belongs to the group of “immune checkpoint inhibitor,” and even more specifically, a “PD-1 inhibitor“.

Unlike traditional chemotherapy that directly attacks cancer cells, nivolumab works with your own immune system, essentially empowering it to recognize and fight the cancer more effectively.

Think of it as taking the brakes off your immune cells so they can do their job better against the cancer.

Nivolumab is a prescription medication given intravenously (as an infusion into a vein). Its most common brand name is OPDIVO®.

What is Nivolumab Used For?

Nivolumab is approved to treat several different types of cancer, often in advanced stages or when other treatments haven’t worked or are no longer working.

All of these cancers express ligand PDL-1 to connect to PD-1 and evade immune attack:

Skin Cancer (Melanoma)

• To treat advanced melanoma (that has spread or cannot be removed by surgery), sometimes with ipilimumab, especially if not previously treated.
• After surgery to completely remove melanoma and its metastases, to help prevent or delay the cancer from coming back (this is called adjuvant therapy).

Lung Cancer (Non-Small Cell Lung Cancer – NSCLC)

• To treat advanced NSCLC that has spread or grown after treatment with platinum-based chemotherapy. (If you have specific mutations like EGFR or ALK, you usually need to have tried targeted therapies first).
• As a first treatment for advanced NSCLC, often combined with ipilimumab (sometimes depending on PD-L1 test results).
• As a first treatment for metastatic NSCLC, combined with ipilimumab and platinum-based chemotherapy.
• Before surgery for NSCLC (neoadjuvant therapy), combined with chemotherapy.

Malignant Pleural Mesothelioma.

• For untreated mesothelioma (cancer affecting the lining of the lungs/chest wall) that cannot be removed by surgery, given in combination with ipilimumab.

Kidney Cancer (Renal Cell Carcinoma – RCC)

• To treat advanced RCC that has spread or grown after treatment with therapies that block blood vessel growth (anti-angiogenic therapies).
• As a first treatment for advanced RCC, combined with ipilimumab.
• As a first treatment for advanced RCC (that cannot be treated with radiation/surgery or is metastatic), combined with cabozantinib.

Head and Neck Cancer (Squamous Cell Carcinoma)

• To treat advanced head and neck cancer when it grows or spreads during or after treatment with platinum-based chemotherapy.

Hodgkin Lymphoma.

• For cancer that has come back or spread after an autologous stem cell transplant (using your own stem cells) and treatment with brentuximab vedotin, OR after at least 3 kinds of treatment including an autologous stem cell transplant. (Note: This use was approved under Health Canada’s NOC/c policy, meaning ongoing studies are confirming its benefit).

Colon or Rectal Cancer

• For cancer shown by tests to be microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), given in combination with ipilimumab, IF you have already tried treatment with specific chemotherapy combinations (fluoropyrimidine with oxaliplatin, or irinotecan) and the cancer has spread/grown or you can no longer tolerate that treatment.

Esophageal Cancer.

• After chemoradiation and surgery to remove the cancer (adjuvant therapy).
• For advanced esophageal squamous cell carcinoma that tests positive for PD-L1, cannot be removed surgically, and has come back or spread. Sometimes given with chemotherapy or ipilimumab as a first treatment in the metastatic setting.

Stomach Cancer (Adenocarcinoma type).

• As a first treatment when the cancer cannot be removed by surgery, given in combination with chemotherapy (fluoropyrimidine and platinum).

Bladder and Urinary Tract Cancer (Urothelial Carcinoma).

• To help prevent cancer from returning after it was removed by surgery (adjuvant therapy), particularly if you are at high risk and may have had prior platinum chemotherapy. (Note: This use was approved under Health Canada’s NOC/c policy).
• As a first treatment when the cancer has spread (metastatic) or cannot be removed by surgery, given in combination with cisplatin and gemcitabine chemotherapy.

Important Note: Nivolumab is not currently known to be safe or effective for children under 18 years of age.

How is Nivolumab Given?

Nivolumab is administered via intravenous (IV) infusion. Patient receive the drip in the specilized clinic under supervision of health professional.

Here some key

• Duration. A standard infusion typically takes about 30 minutes.
• Frequency. Depending on your specific cancer, the dose being used, and whether you’re receiving it alone or with other treatments, you’ll likely receive nivolumab every 2, 3, or 4 weeks. Your doctor will determine the exact schedule for you.
• Combination Therapy Order. If you receive nivolumab with chemotherapy or ipilimumab, nivolumab is usually given first, followed by the other medication(s). If combined with cabozantinib (a pill), you’ll receive the nivolumab infusion first.
• Appointments are Key: It’s very important to keep all your scheduled appointments for treatment. If you have to miss an appointment, contact your healthcare team immediately to reschedule.

How Does Nivolumab Work?

Your immune system has cells called T-cells that are designed to find and destroy threats like infections and cancer cells. However, cancer cells can be sneaky. They sometimes develop ways to “hide” from the immune system. One way they do this is by displaying a protein called PD-L1 on their surface.

When PD-L1 on a cancer cell connects with a protein called PD-1 on your T-cells, it acts like a switch, telling the T-cell to turn off or leave the cancer cell alone. This is called an “immune checkpoint.”

Nivolumab is designed to block the PD-1 protein on your T-cells. By blocking PD-1, nivolumab prevents the cancer cell’s PD-L1 from delivering that “off” signal. This action “releases the brakes” on the T-cells, allowing them to recognize the cancer cells as harmful and attack them.

Read more about how does it work in our article “nivolumab mechanism of action“.

Side Effects of Nivolumab

Because nivolumab works by stimulating your immune system, its side effects are often related to inflammation caused by the immune system becoming overactive and potentially affecting healthy organs. These are sometimes called immune-related adverse events (irAEs).

It’s crucial to remember that these side effects can occur during treatment and sometimes weeks or even months after your last dose.

When to Call your Medical Team Immediately ?

While many side effects are manageable, some can be serious or even life-threatening if not addressed promptly. Contact your healthcare team right away if you experience any of the following symptoms.

Nivolumab and serious inflammation of other organs

• Pneumonia.  New or worsening cough, chest pain, shortness of breath, difficulty breathing might be signs of inflamation developing inside your lungs.
• Inflammation of the large intestine (Colitis). Diarrhea (watery, loose, or more frequent than usual), blood or mucus in your stool, black/tarry stools, severe stomach pain or tenderness. Do not self-meidicate, tell your doctor about problems with the loose or watery stool.
• Liver inflammation (Hepatitis). Yellowing of the skin or whites of the eyes (jaundice), severe nausea or vomiting, pain on the right side of your stomach area, dark urine (tea-colored), unusual tiredness, bruising or bleeding easily.
• Kidney Problems (Nephritis). When urine saddenly changes the color, becoming much darker, your face and hands are swollen, and you have a dull pain in your lower back, it might be signs of nephritis. Call your medical team immediately.
• Brain and problems with nervous symptoms. Headache that doesn’t go away, coupled with fever, or a neural deficit (confusion, palsy, memory loss or coordination problems) are signs you have some neural side effects.
• Heart Problems. Most common side efefct is an inflammation of heart muscles, called myocarditis. Common signs are chest pain, irregular heartbeat, shortness of breath, fatigue, swelling in the legs.

Nivolumab and serious endocrine events

• Hormone imbalances. 
  • Thyroid problems. Whe the thyroid is affected and stop profucing suffcient levels of hormones, you might expirience extreme tiredness or sleepiness, weight gain or loss, changes in mood or behavior (irritability, forgetfulness, depression, low sex drive).
  • Diabetes. Frequent urination, feeling thirsty, and muscle wasting are common symptoms of diabetes.
  • Pituitary gland. A small gland in your brain, that produces bunch of important hormones controlling how other glands in your body are working. A person might expirirence symptoms ranging from low sex drive (decreased libido) and infertility to weight gain, frequent urination or headaches.

Skin, eye problem and infusion reactions

• Skin Problems. Itchy skin is quite common in immunotherapy. Sometimes you might experience more disturbing skin side effects like blistering or peeling skin, painful sores or ulcers in the mouth, nose, throat, or genital area.
• Severe Infusion Reactions. Some people might react on a drip. Chills or shaking, itching or rash, flushing, difficulty breathing, dizziness, fever, feeling like you might pass out during or shortly after the infusion.
• Eye Problems. Blurry vision, sadden changes in clarity of your vision are two serius, but rare side effects. More benign changes, like “red eyes” or an itchy eye

It is vital to report ANY new or worsening symptoms to your healthcare team promptly. Early detection and management are key to preventing serious complications.

Common Side Effects

These side effects are seen more frequently but are often less severe. They can vary depending on whether you receive nivolumab alone or in combination.

• You take only Nivolumab: 
  • Fatigue (feeling tired or weak);
  • skin rash or itchy skin;
  • decreased appetite;
  • nausea, diarrhea;
  • joint pain.
• Nivolumab with other medicines.:
  • fatigue;
  • skin rash or itching;
  • diarrhea, nausea or a vomiting, decreased appetite,
  • thyroid problems,
  • headache;
  • shortness of breath;
  • fever;
  • low white blood count;
  • muscle/bone/joint pain.

Less Common or Rare Side Effects

Besides the serious conditions listed under “When to Seek Medical Attention,” other less common but potentially serious side effects include:

• Inflammation of muscles (myositis) or muscle breakdown (rhabdomyolysis).
• Inflammation of the pancreas (pancreatitis).
• Blood sugar problems (diabetes or ketoacidosis).
• Changes in blood levels of calcium, potassium, magnesium, or sodium.
• Rare blood conditions where the immune system attacks blood cells (autoimmune hemolytic anemia, aplastic anemia) or causes widespread inflammation (haemophagocytic lymphohistiocytosis).
• Complications if you have an allogeneic stem cell transplant (using donor cells) after receiving nivolumab – these can be severe or fatal. Inform your transplant team if you’ve had nivolumab.

This is not an exhaustive list of potential side effect, so you feel something is wrong, do not hesitate to talk with your medical team.

Before Taking Nivolumab

To ensure nivolumab is as safe and effective as possible for you, it’s crucial to have an open discussion with your healthcare team about your health history before you start treatment. Be sure to tell them if you:

• Have any allergies, especially if you’ve ever had a reaction to nivolumab or any of its ingredients.
• Tall about all medications you are taking
• Have any autoimmune diseases (like Crohn’s disease, ulcerative colitis, lupus, rheumatoid arthritis, etc.), where the body’s immune system attacks itself.
• If you expirience any problems with your lungs, liver, kidneys, or hormone glands (thyroid, pituitary, adrenals, pancreas).
• Have melanoma of the eye.
• If you have had an organ transplant, including a stem cell transplant using donor cells (allogeneic).
• Have cancer that has spread to your brain.
• Are taking any medications that suppress your immune system, such as steroids (like prednisone).
• Have experienced serious side effects from other immunotherapies (like ipilimumab).

Nivolumab and pregnancy

Nivolumab can harm your unborn baby. Women who could become pregnant must use effective birth control during treatment and for at least 5 months after the last dose.
Do not become pregnant while taking nivolumab.

Nivolumab and breast-feeding

Breast-feeding: It’s not known if nivolumab passes into breast milk, but due to the potential for serious side effects in the baby, you should not breast-feed during treatment.

What Should I Avoid While Receiving Nivolumab?

• Pregnancy and breast-feeding;
• Self-treating side effects;
• Stopping treatment abruptly or not missing a drip;
• Driving/Operating machinery.

Brand Names for Nivolumab

The brand name for nivolumab is OPDIVO®.

Similar Medications

Nivolumab belongs to a class of drugs called immune checkpoint inhibitors. Other medications work in similar ways by targeting PD-1, PD-L1, or CTLA-4 to help the immune system fight cancer. These include:

• Other PD-1 Inhibitors: Pembrolizumab (Keytruda®), Cemiplimab (Libtayo®)
• PD-L1 Inhibitors: Atezolizumab (Tecentriq®), Durvalumab (Imfinzi®), Avelumab (Bavencio®)
• CTLA-4 Inhibitors: Ipilimumab (Yervoy®) – often used in combination with nivolumab.

While these drugs have similar mechanisms, they may be used for different types of cancer or have slightly different side effect profiles.