Nivolumab

Nivolumab is a prescription medication used to treat certain types of skin, lung, kidney, bladder, head and neck cancers, and colorectal cancer. Nivolumab also treats Hodgkin lymphoma. In addition, nivolumab treats liver cancer (hepatocellular carcinoma) in patients who have been previously treated with sorafenib. 

Nivolumab belongs to a group of drugs called PD-1 inhibitors. These work by giving the immune system the opportunity to attack cancer cells.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects of nivolumab include rash, itching, cough, upper respiratory tract infections, and fluid retention.

Nivolumab is a prescription medication used to treat patients with:

• skin cancer that has spread or cannot be removed by surgery
• advanced non-small cell lung cancer (NSCLC) 
• advanced kidney cancer that has spread or grown after treatment with other cancer medicines)
• a type of blood cancer called Hodgkin lymphoma that has returned or has worsened
• recurrent or advanced cancer of the head and neck 
• advanced bladder cancer 
• colon or rectal cancer (adults and children 12 years of age and older) that has spread to other parts of the body
• liver cancer 

It is not known if this medication is safe and effective:

• in children less than 12 years of age with MSI-H or dMMR metastatic colorectal cancer, or
• in children less than 18 years of age for the treatment of any other cancers.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Nivolumab may be found in some form under the following brand names:

• Opdivo

Serious side effects have been reported with nivolumab. See the “Drug Precautions” section.

Common side effects of nivolumab include the following:

• Rash
• Itching
• Cough
• Upper respiratory tract infection
• Fluid retention
• Liver injury
• High levels of potassium in the body
• Low levels of sodium (salt) in the body
• Unusual weakness
• Diarrhea
• Constipation
• Decreased appetite
• Back pain
• Joint pain

This is not a complete list of side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been studied by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with nivolumab including the following:

• Lung Problems (pneumonitis). This is a condition where lung tissues become inflamed or swollen. Tell your healthcare provider right away if you have some or all of the following symptoms:
  • Shortness of breath
  • Cough
  • Tiredness or fatigue
  • Loss of appetite
  • Losing weight unintentionally
• Intestinal Problems (colitis) that can lead to tears or holes in your intestine. This is a condition where the intestines and the colon become inflamed or swollen. Tell your healthcare provider right away if you have some or all of the following symptoms:
  • Diarrhea, which can have blood or pus
  • Stomach pain or cramps
  • Pain in the rectum or anus
  • Bleeding from the rectum or anus
  • Having trouble defecating (going to the restroom) even though you feel the need to
  • Losing weight unintentionally
  • Fever
  • Tiredness or fatigue
• Liver problems (hepatitis). This is a condition where the liver becomes inflamed or swollen, causing damage to the liver. Tell your healthcare provider right away if you have some or all of the following symptoms:
  • Loss of appetite
  • Tiredness or fatigue
  • Nausea or vomiting
  • Stomach pain or discomfort, especially on your right side below the ribs
  • Fever
  • Muscle pain or joint pain
  • Headaches
  • Yellowing of the eyes or skin (jaundice)
• Kidney problems including nephritis and kidney failure. This is a condition where the kidneys become inflamed or swollen, causing damage to the kidneys. Tell your healthcare provider right away if you have some or all of the following symptoms:
  • Pain in the very bottom of your stomach (pelvis)
  • Blood in the urine (pee)
  • Pain in the lower back
  • Increases in blood pressure
  • Nausea and vomiting
  • Fever
  • Fluid retention and swelling in the body
• Hormone gland problems (especially the thyroid, pituitary, and glands). Tell your healthcare provider right away if you have some or all of the following symptoms:
  • headaches that will not go away or unusual headaches
  • extreme tiredness
  • changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
  • dizziness or fainting
  • hair loss
  • feeling cold
  • constipation
  • voice gets deeper 
• Inflammation of the brain (encephalitis). Tell your healthcare provider right away if you have some or all of the following symptoms: 

  • headache
  • fever
  • tiredness or weakness
  • confusion
  • memory problems
  • sleepiness
  • seeing or hearing things that are not really there (hallucinations)
  • seizures
  • stiff neck
• Skin problems such as rash, itching, or ulcers in mouth or other mucous membranes
• Severe infusion reactions. Tell your doctor or nurse right away if you get these symptoms during an infusion of nivolumab:
  • chills or shaking
  • dizziness
  • itching or rash
  • fever
  • flushing
  • feeling like passing out
  • difficulty breathing
• Problems in other organs. Tell your healthcare provider right away if you have some or all of the following symptoms:
  • rash
  • itching
  • skin blistering
  • ulcers in mouth or other mucous membranes
  • change in eyesight
  • severe or persistent muscle or joint pains
  • severe muscle weakness
• There is a chance for complications with stem cell transplant that uses donor stem cells (allogeneic) after treatment with this medication. These complications can be very serious. Your healthcare provider will monitor you for signs of complications after you receive a stem cell transplant.
• Harm to your unborn baby. Effective forms of contraception is recommended. 

Do not take nivolumab if you are allergic to nivolumab or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of nivolumab, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking nivolumab, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to nivolumab or to any of its ingredients
• have or have had intestinal problems, including colitis
• have liver problems
• have kidney problems
• have lung problems or trouble breathing
• have thyroid problems
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. 

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Nivolumab can cross the placenta. Nivolumab is expected to cause harm to the fetus if it is used during pregnancy. 

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if nivolumab crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with the use of this medication, it is advised for women to stop breastfeeding during treatment with nivolumab.

Receive nivolumab exactly as prescribed.

Nivolumab comes in an injection and is given directly into a vein (IV) by a healthcare professional is administered every 2 weeks or every 4 weeks. 

When used in combination with ipilimumab, nivolumab is usually given every 3 weeks, for a total of 4 doses. (Ipilimumab will be given on the same day). Then Opdivo will be given alone every 2 weeks or every 4 weeks. 

Your healthcare provider will decide how many treatments you need.

Your healthcare provider will do blood tests to check you for side effects.

If you miss any appointments call your healthcare provider as soon as possible to reschedule your appointment.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight

The recommended dose of Opdivo (nivolumab) for skin cancer, non-small cell lung cancer, advanced kidney cancer, advanced bladder cancer, classical Hodgkin lymphoma, cancer of the head and neck, and liver cancer (hepatocellular carcinoma) is 240 mg every two weeks or 480 mg every 4 weeks. 

• When Opdivo (nivolumab) is given with ipilimumab to treat advanced skin cancer, the dose of Opdivo (nivolumab) is 1 mg/kg, (ipilimumab will be given on the same day) every 3 weeks for 4 doses. Followed by Opdivo (nivolumab) (alone) 240 mg every 2 weeks or 480 mg every 4 weeks. 
• When Opdivo (nivolumab) is given with ipilimumab to treat advanced kidney cancer, the dose of Opdivo (nivolumab) is 3 mg/kg (ipilimumab will be given on the same day) 1 mg/kg on the same day every 3 weeks for 4 doses. Followed by Opdivo (nivolumab) (alone) 240 mg every 2 weeks or 480 mg every 4 weeks. 

The recommended dose of Opdivo (nivolumab) for advanced colorectal cancer is 240 mg every two weeks

If nivolumab is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if an overdose is suspected, seek emergency medical attention.