The immune system works by creating antibodies, which are proteins that attach to antigens found on the surface of a cell. The antibody “calls” the immune system to attack the cell it is attached to, causing the immune system to kill the cell. Monoclonal antibodies are created in a lab to attach to the antigens found on specific types of cancer cells. These antibodies can work in different ways, including stimulating the immune system to kill the cell, blocking cell growth, or other functions necessary for cell growth.

Nivolumab is a type of monoclonal antibody therapy that works to stimulate the immune system to kill cancer cells. T-cells are a type of white blood cell that are important to the normal functioning of the immune system. Nivolumab works as a form of immunotherapy by binding to the "programmed death receptor" (PD1) found on T-cells to stimulate your immune system to find and kill cancer cells.

Hyaluronidase is an endoglycosidase that helps your body absorb (take in) nivolumab.

How to Take Nivolumab and hyalyronidase-nvhy

Nivolumab and hyaluronidase-nvhy is given as a subcutaneous (SubQ, under the skin) injection in your thigh or abdomen (belly) over about 3 to 5 minutes. Each subsequent injection will alternate between different injection sites. This medication is given by a healthcare professional, often in a clinic or provider’s office.

Make sure your care team is aware of all medications (including prescription and over-the-counter), supplements, and vitamins you are taking. Steroids should be avoided while on immunotherapy unless directed by your care team.

Tell your care team if you have had or are planning to have an organ or stem cell transplant, or if you have had radiation therapy to your chest in the past.

Tell your care team about all your medical conditions, including those that are autoimmune (Crohn’s disease, lupus, rheumatoid arthritis, etc.), as these can get worse with immunotherapy. You should also notify your provider if you have had or plan on having an allogeneic stem cell transplant, as this medication can worsen a side effect of the transplant called graft-versus-host disease.

Possible Side Effects of Nivolumab

There are many things you can do to manage the side effects of nivolumab. Talk to your care team about these recommendations. They can help you decide what will work best for you. These are some of the most common or important side effects:

Immune Reactions

This medication stimulates your immune system. Your immune system can attack normal organs and tissues in your body, leading to serious or life-threatening complications. It is important to notify your healthcare provider right away if you develop any of the following symptoms:

Diarrhea / Intestinal problems (colitis, inflammation of the bowel): Abdominal pain, diarrhea, cramping, mucus or blood in the stool, dark or tar-like stools, fever. Diarrhea means different things to different people. Any increase in your normal bowel patterns can be defined as diarrhea and should be reported to your healthcare team.
Skin reactions: Report rash, with or without itching (pruritis), sores in your mouth, blistering or peeling skin, as these can become severe and require treatment with corticosteroids.
Lung problems (pneumonitis, inflammation of the lung): New or worsening cough, shortness of breath, trouble breathing, or chest pain.
Liver problems (hepatitis, inflammation of the liver): Yellowing of the skin or eyes, your urine appears dark or brown, pain in your abdomen, bleeding or bruising more easily than normal, or severe nausea and vomiting.
Brain and/or nerve problems: Report any headache, drooping of eyelids, double vision, trouble swallowing, weakness of arms, legs, or face, or numbness or tingling in the hands or feet to your healthcare team.
Hormone abnormalities: Immune reactions can affect the pituitary, thyroid, pancreas, and adrenal glands, resulting in inflammation of these glands, which can affect their production of certain hormones. Some hormone levels can be monitored with blood work. It is important that you report any changes in how you are feeling to your care team. Symptoms of these hormonal changes can include: headaches, nausea, vomiting, constipation, rapid heart rate, increased sweating, extreme fatigue, weakness, changes in your voice, changes in memory and concentration, increased hunger or thirst, increased urination, weight gain, hair loss, dizziness, feeling cold all the time, and changes in mood or behavior (including irritability, forgetfulness, and decreased sex drive).
Eye problems: Report any changes in vision, blurry or double vision, and eye pain or redness to your healthcare team.
Kidney problems (kidney inflammation or failure): Decreased urine output, blood in the urine, swelling in the ankles, loss of appetite.
Heart problems: Inflammation in the heart muscle can happen in rare cases. If you develop any of these symptoms, report them to your provider right away: chest pain, shortness of breath, trouble breathing when lying down or waking up gasping for air, heart palpitations (feeling like your heart is racing), swelling in your feet or legs, lightheadedness, or fainting.

Electrolyte Abnormalities

This medication can affect the normal levels of electrolytes (sodium, potassium, calcium, etc.) in your body. Your levels will be monitored with blood tests. If your levels become too low, your care team may prescribe certain electrolytes to be given by IV or taken by mouth. Do not take any supplements without first talking with your care team.

Muscle or Joint Pain/Aches

Your healthcare provider can recommend medications and other strategies to help relieve pain.

Fatigue

Fatigue is very common during cancer treatment and is an overwhelming feeling of exhaustion that is not usually relieved by rest. While on cancer treatment, and for a period after, you may need to adjust your schedule to manage fatigue. Plan times to rest during the day and conserve energy for more important activities. Exercise can help combat fatigue; a simple daily walk with a friend can help. Talk to your healthcare team for helpful tips on dealing with this side effect.

Reproductive Concerns

Exposure of an unborn child to this medication could cause birth defects, so you should not become pregnant or father a child while on this medication. For women, effective birth control is necessary during treatment and for at least 5 months after your last dose. Men should talk with their provider about the use of birth control during and after treatment. Even if your menstrual cycle stops or you believe you are not producing sperm, you could still be fertile and conceive. You should not breastfeed while taking this medication or for 5 months after your last dose.

Nivolumab and hyaluronidase-nvhy (Opdivo Qvantig™)