Generic Name: Nivolumab

(nye VOL ue mab)

Trade name: Opdivo®

Nivolumab is the generic name for the trade drug name Opdivo®. In some cases, health care professionals may use the generic name nivolumab when referring to the trade name Opdivo®.

Nivolumab is a targeted therapy. It is a human programmed death receptor-1 (PD-1) blocking antibody. (For more detail, see "How this drugs works," below).

What This Drug Is Used For:

Treatment of patients with:

• Unresectable or metastatic melanoma
• Metastatic non-small cell lung cancer (NSCLC)
• Advanced renal cell cancer
• Classical Hodgkins lymphoma (cHL)
• Recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN)
• Locally advanced or metastatic urothelial carcinoma
• Metastatic small cell lung cancer (SCLC)
• Adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient solid tumors or colorectal cancer
• Hepatocellular cancer (HCC)
• Unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC)
• Advanced or metastatic gastric cancer, and gastroesophageal junction cancer, and esophageal adenocarcinoma

Note: if a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.

How This Drug Is Given:

• Nivolumab is administered intravenously (IV) into the vein over 60 minutes every 2 weeks.
• The amount of nivolumab that you will receive depends on many factors, your general health or other health problems, and the type of cancer or condition being treated. Higher doses do not give a better response and may cause increased toxicity. Your doctor will determine your dose and schedule.
• If you miss any appointments call your healthcare provider as soon as possible to reschedule your appointment.

Side Effects:

Things to remember about the side effects of nivolumab:

• Most people do not experience all of the side effects listed.
• Side effects are often predictable in terms of their onset and duration.
• Side effects are almost always reversible and will go away after treatment is complete.
• There are many options to help minimize or prevent side effects.
• There is no relationship between the presence or severity or side effects and the effectiveness of the medications

The following side effects are common (occurring in greater than 30%) for patients taking nivolumab:

• Fatigue
• Lymphocytopenia (low white blood cells)
• Low sodium
• Shortness of breath
• Musculoskeletal pain
• Decreased appetite
• Cough

These side effects are less common side effects (occurring in about 10-29%) of patients receiving nivolumab:

• Nausea
• Anemia
• Constipation
• Increased serum creatinine
• Colitis
• Low potassium
• Low magnesium
• High calcium
• Vomiting
• Weakness
• Diarrhea
• High potassium
• Low calcium
• Swelling
• Fever
• Rash
• Abdominal pain
• Increased serum AST
• Thrombocytopenia
• Increased serum alkaline phosphatase
• Chest pain
• Weight loss
• Joint pain
• Increased serum ALT
• Itching
• Pneumonia
• Pain

Not all side effects are listed above. Some that are rare (occurring in less than 10% of patients) are not listed here. However, you should always inform your health care provider if you experience any unusual symptoms.

A few rare but severe side effects include:

• Immune-mediated Pneumonitis
• Immune-mediated Colitis
• Immune-mediated Hepatitis
• Immune-mediated Nephritis and Renal Dysfunction
• Immune-mediated Hypothyroidism and Hyperthyroidism

When to contact your doctor or health care provider:

Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:

• Fever of 100.4° F (38° C) or higher, chills
• Signs of an allergic reaction, like rash; hives; itching; red, peeling, or blistered skin with or without fever; tightness in the chest or throat; wheezing; trouble breathing or talking; unusual hoarseness; or swelling of the lips, mouth, face, throat, or tongue.

Always inform your health care provider if you experience any unusual symptoms.

The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:

• Diarrhea should be reported to your health care provider
• Nausea (interferes with ability to eat and unrelieved with prescribed medication)
• Vomiting (vomiting more than 4-5 times in a 24 hour period)
• Unable to eat or drink for 24 hours or have signs of dehydration: tiredness, thirst, dry mouth, dark and decrease amount of urine, or dizziness
• Sudden change in eyesight
• Sudden onset of shortness of breath, accompanied by cough and/or fever
• Skin or whites of your eyes turn yellow
• Light colored stools
• Blood in stools
• Dark, tarry or sticky stools
• Urine turns dark or brown (tea color)
• Blood in urine
• Big weight gain
• Unable to pass urine or change in the amount of urine passed
• Decreased appetite
• Stomach pain or upset stomach
• Bleed or bruise more easily than normal
• Fast heartbeat
• Cough with or without mucus
• Any skin change, irritation, itching or rash
• Very bad muscle or weakness
• Very bad joint pain
• Swelling in the arms or legs
• Signs of trouble with your thyroid or pituitary gland (change in mood or the way you act, change in weight, constipation, dizziness, deeper voice, feeling cold, fainting, hair loss, feeling very tired, headache or loss of sex drive)

Always inform your health care provider if you experience any unusual symptoms.

Precautions:

• Before starting nivolumab treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.).
• Do not receive any kind of immunization or vaccination without your doctor's approval while taking nivolumab.
• Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Pregnancy category D (nivolumab may be hazardous to the fetus. Women who are pregnant or become pregnant must be advised of the potential hazard to the fetus).
• For both men and women: Do not conceive a child (get pregnant) while taking nivolumab. Barrier methods of contraception, such as condoms, are recommended while you are taking this drug and for 5 months after you stop taking it. Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.
• Do not breast feed while taking this medication.

Self-Care Tips:

• Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
• Nivolumab can cause visual changes, dizziness and tiredness. If you have any of these symptoms, use caution when driving a car, using machinery, or anything that requires you to be alert.
• Wash your hands often.
• Avoid contact sports or activities that could cause injury
• To reduce any potential nausea eat small, frequent meals. Sucking on lozenges and chewing gum may also help.
• Eat foods that may help reduce diarrhea (see managing side effects - diarrhea).
• Avoid sun exposure. Wear SPF 30 (or higher) sunblock and protective clothing.
• In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.
• Get plenty of rest.
• Maintain good nutrition. (see eating well during chemotherapy)
• If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.

Monitoring and Testing:

You will be checked regularly by your health care professional while you are taking nivolumab to monitor side effects and check your response to therapy.

How This Drug Works:

Targeted therapy is the result of about 100 years of research dedicated to understanding the difference between cancer cells and normal cells. To date, cancer treatment has focused primarily on killing rapidly dividing cells because one feature of cancer cells is that they divide rapidly. Unfortunately, some of our normal cells divide rapidly too, causing multiple side effects.

Targeted therapy is about identifying other features of cancer cells. Scientists look for specific difference in the cancer cells and the normal cells. This information is used to create a targeted therapy to attack the cancer cells without damaging the normal cells, thus leading to fewer side effects. Each type of targeted therapy works a little bit differently but all interfere with the ability of the cancer cell to grow, divide, repair and/or communicate with other cells.

There are different types of targeted therapies, defined in three broad categories. Some targeted therapies focus on the internal components and function of the cancer cell. The targeted therapies use small molecules that can get into the cell and disrupt the function of the cells, causing them to die. There are several types of targeted therapy that focus on the inner parts of the cells. Other targeted therapies target receptors that are on the outside of the cell. Therapies that target receptors are also known as monoclonal antibodies. Antiangiogenisis inhibitors target the blood vessels that supply oxygen to the cells, ultimately causing the cells to starve.

Nivolumab is a human monoclonal antibody that blocks the interaction between PD-1 and it's ligands, PD-L1 and PD-L2. Binding these ligands to the PD-1 receptor found on T cells, inhibits T cell proliferation and cytokine production. Upregulation of the PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response, resulting in decreased tumor growth.

Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.

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