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Opdivo

Pronunciation: op-DEE-voh
Generic name: nivolumab
Dosage form: injection for intravenous use
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 Opdivo?

Opdivo (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.

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

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

Opdivo 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.

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

Opdivo 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.

Opdivo was first FDA-approved on December 22, 2014.

Warnings

Opdivo 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 Opdivo.

Opdivo 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 Opdivo.

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

Before taking this medicine

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

Pregnancy

Opdivo 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 Opdivo 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 Opdivo passes into your breast milk. Do not breastfeed while using this medicine, and for at least 5 months after your last dose.

How is Opdivo administered?

Opdivo 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.

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 Opdivo?

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

What are the side effects of Opdivo?

Opdivo can cause serious side effects, including:

Get emergency medical help if you have signs of an allergic reaction to Opdivo (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:

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

Common Opdivo side effects may include:

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 Opdivo?

Other drugs may interact with Opdivo, 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.

Popular FAQ

Opdivo (nivolumab) is an immunotherapy used to treat a wide variety of cancer types. How long treatment with this monoclonal antibody prolongs or extends life depends on the type and stage of cancer it is used to treat and other factors. Continue reading

Monoclonal antibodies (mAbs) are man-made proteins that mimic the natural antibodies produced by our immune systems. Monoclonal antibodies can be formulated into medicines to treat various types of illnesses, such as cancer, rheumatoid arthritis or psoriasis. Continue reading

Results from clinical trial indicate that it can take about 2 months to see a response to treatment with Opdivo, but some patients will respond more quickly and others will take longer.

Your doctor will order periodic tests, such as CT (computed tomography) and PET (positron emission tomography) scans and MRI (magnetic resonance imaging) to see if you are responding to treatment. Continue reading

Opdivo (nivolumab) and Keytruda (pembrolizumab) are two immunotherapy drugs for various cancers. Both are monoclonal antibodies, known as PD1 inhibitors, first approved in 2014. Opdivo is from Bristol Myers Squibb, and Keytruda is from Merck & Co. The main differences lie in dosing, combination therapies, and approved cancer types. Continue reading

Opdivo stays in your system for a very long time, up to 3 to 4 months (100 to 125 days). This is based on the half-life of Opdivo, which is 25 days. The half-life is the time it takes for half of a drug to be removed from the body, and experts have agreed it takes 4 to 5 half-lives for a drug to be completely removed from the body. This calculates out to 100 to 125 days for Opdivo. This means that side effects can still occur because of Opdivo a few months after you stop taking the drug. Continue reading

Opdivo (nivolumab) is an immunotherapy used to treat a variety of cancer types, including melanoma. Durable responses to treatment have been observed following discontinuation of Opdivo therapy. Continue reading

Opdivo is an immunotherapy treatment. It 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. Continue reading

Opdivo and Yervoy are administered by slow intravenous infusion over at least 30 minutes – this is when a bag containing the medicine is hung from a stand, and the medicine runs through a piece of tubing called an intravenous line into your vein. This needs to be done in your doctor’s office, an infusion center, or a hospital. Continue reading

Opdivo is approved to treat advanced or metastatic urothelial cancer, the most common type of bladder cancer, in adults whose disease has progressed during, following, or within 12 months of first-line or adjuvant platinum-containing chemotherapy. Approximately 50% of patients with bladder cancer do not respond to their first course of chemotherapy, and only 10 to 15% of those respond to second-line chemotherapy, and Opdivo represents another treatment option for these people. Opdivo may also be used to treat adults with urothelial carcinoma that has a high risk of returning despite surgery. Continue reading

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.