Pronunciation: nye-VOL-ue-mab
Generic name: nivolumab
Brand name: Opdivo
Dosage form: intravenous solution (10 mg/mL)
Drug class: Anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint inhibitors)

Medically reviewed by Carmen Pope, BPharm. Last updated on Mar 13, 2024.

What is nivolumab?

Nivolumab is a cancer medicine that is given intravenously (into a vein) that works with your immune system to interfere with the growth and spread of cancer cells in the body.

Nivolumab is used alone or in combination with other medicines to treat adults with:

• advanced melanoma (a type of skin cancer);
• advanced non-small cell lung cancer (NSCLC);
• pleural mesothelioma (cancer that affects the lining of the lungs and chest wall);
• kidney cancer (renal cell carcinoma);
• classical Hodgkin lymphoma (cHL);
• squamous cell cancer of the esophagus or head and neck;
• bladder cancer (urothelial carcinoma);
• liver cancer;
• colorectal cancer; or
• cancer of the stomach and esophagus.

For some cancers, such as melanoma and colorectal cancer, nivolumab is also approved for children aged 12 years and older. See the prescribing information for a full list of indications and eligibility criteria.

Nivolumab is often given when the cancer has spread to other parts of the body (metastatic), cannot be surgically removed, or has come back after prior treatment.

Nivolumab is sometimes given only if laboratory testing shows specific genetic markers or DNA mutations associated with your cancer.

Nivolumab belongs to the class of medicines known as checkpoint inhibitors and works by blocking the PD-1 (programmed death receptor-1) pathway to help prevent cancer cells from hiding from the immune system, boosting the immune system's response against cancer.

Nivolumab was first FDA-approved on December 22, 2014, under the brand name Opdivo. It is currently only available as Opdivo, there are no biosimilars.

Warnings

Nivolumab can cause serious, sometimes life-threatening, side effects in many different parts of your body. Some side effects may need to be treated with other medicines, and your cancer treatments may be delayed.

Call your doctor at once if you have a cough, shortness of breath or other lung problems, vision changes, muscle pain or weakness, stomach pain, diarrhea, blood in your stools, little or no urinating, bruising or bleeding, dark urine (tea colored), yellowing of your skin or eyes, severe nausea or vomiting, frequent headaches, dizziness, confusion, increased thirst or urination, skin problems, numbness or tingling, feeling cold, changes in mood or behavior, decreased sex drive, increased sweating, sensitivity to light or other eye problems, skin problems, bruising, or weight gain or loss.

Problems can also happen in other organs and tissues. These are not all signs and symptoms of immune system problems that can happen with Nivolumab.

• Your healthcare provider will conduct regular laboratory tests throughout your treatment.

Nivolumab can cause severe infusion-related reactions. Tell your healthcare provider right away if you experience chest tightness, wheezing, shortness of breath, facial flushing, itching, hives, swelling, or any other allergic reaction.

Life-threatening and other serious complications can occur in people who have received an allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody, such as Nivolumab.

May cause harm to an unborn baby. Females who can get pregnant should use an adequate form of contraception while being treated with nivolumab.

Before taking this medicine

To make sure Nivolumab is safe for you, tell your doctor if you:

• have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
• have received an organ transplant
• have liver disease
• have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
• have received radiation treatment to your chest area in the past and have received other medicines that are similar to nivolumab
• have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Pregnancy

Nivolumab may harm an unborn baby. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while receiving nivolumab and for at least 5 months after your last dose. Tell your doctor right away if you become pregnant.

Breastfeeding

It is not known if nivolumab passes into your breast milk. Do not breastfeed while using this medicine, and for at least 5 months after your last dose.

How is nivolumab administered?

Nivolumab is given as an infusion into a vein by a healthcare provider. This medicine must be given slowly and can take 30 to 90 minutes.

• Nivolumab is usually given once every 2 to 4 weeks. Your other cancer medicines may be given on different schedules. Your doctor will determine how long to treat you with all medicines.
• You will need frequent medical tests to help your doctor determine if it is safe for you to keep receiving nivolumab.
• Nivolumab can cause side effects in many different parts of your body. You may be given medication to prevent certain side effects, and your cancer treatments may be delayed if you need treatment for a side effect.

What happens if I miss a dose?

Call your doctor for instructions if you miss a chemotherapy appointment.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving nivolumab?

Follow your doctor's instructions about restricting food, beverages, or activity.

What are the side effects of nivolumab?

Nivolumab can cause serious side effects, including:

• Serious, life-threatening immune system and other reactions (see warnings above)
• Severe infusion reactions. Tell your healthcare provider or nurse right away if you get these symptoms during an infusion of nivolumab:
• chills or shaking
• dizziness
• itching or rash
• feeling like you might pass out
• flushing
• fever
• shortness of breath or wheezing
• back or neck pain.

Get emergency medical help if you have signs of an allergic reaction to nivolumab (hives, difficulty breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

• severe or ongoing diarrhea, severe stomach pain, bloody or tarry stools;
• eye pain, vision changes, sensitivity to light;
• severe muscle pain or weakness;
• confusion, memory problems, neck stiffness, drowsiness, balance problems;
• numbness or tingling in your arms or legs;
• kidney problems - little or no urination, swelling in your feet or ankles, blood in your urine;
• liver problems - severe nausea or vomiting, right-sided upper stomach pain, easy bruising or bleeding, dark urine, jaundice (yellowing of the skin or eyes);
• lung problems - new or worsening cough, chest pain, feeling short of breath;
• skin problems - rash, itching, redness, swelling, pain, sores, blisters, sores in your mouth or nose or on your genitals;
• signs of a hormonal disorder - frequent or unusual headaches, vision problems, fast heartbeats, dizziness, fainting, tiredness, mood or behavior changes, hunger, increased thirst or urination, constipation, hair loss, hoarse or deepened voice, sweating, feeling cold, weight gain or loss; or
• (if you have had a stem cell transplant) feeling sick or uneasy, with pain or swelling near your transplanted organ.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common nivolumab side effects may include:

• nausea, vomiting, stomach pain, loss of appetite, diarrhea, constipation;
• mouth sores, altered sense of taste;
• itching, rash, redness, or blisters on your hands or feet;
• hormonal problems;
• liver problems;
• numbness, tingling, or burning pain in your hands or feet;
• fever, body aches;
• feeling weak, tired, or short of breath;
• cold symptoms such as runny or stuffy nose, cough, sore throat;
• headache, dizziness, increased blood pressure; or
• weight loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What other drugs will affect nivolumab?

Other drugs may interact with nivolumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Should not be given to patients with multiple myeloma who also take thalidomide medication in combination with dexamethasone unless they are part of a controlled clinical trial.

Storage

Keep refrigerated at 2°C to 8°C (36°F to 46°F). Protect from light by storing in the original package until the time of use.

Do not freeze or shake.

Ingredients

Active ingredient: nivolumab

Inactive ingredients: mannitol, pentetic acid, polysorbate 80, sodium chloride, sodium citrate dihydrate, and Water for Injection. May contain hydrochloric acid and/or sodium hydroxide.

Manufacturer

Bristol-Myers Squibb Company.

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