All About Opdivo

What is Opdivo’s dosage?

Your doctor will recommend the dosage of Opdivo that’s right for you. Below are commonly used dosages, but the dosage you receive will be determined by your doctor.

Form and strengths

Opdivo comes as a liquid solution in single-dose vials. You’ll receive Opdivo at your doctor’s office or a clinic as an intravenous (IV) infusion. An IV infusion is an injection into your vein given over time.

Opdivo infusions usually take about 30 minutes.

Opdivo comes in a strength of 10 milligrams (mg) per 1 milliliter (mL). The vials come in the following sizes:

• 40 mg/4 mL
• 100 mg/10 mL
• 120 mg/12 mL
• 240 mg/24 mL

Recommended dosages

Your dosage of Opdivo depends on:

• your age, weight, and overall health
• the condition being treated
• how often you’re receiving Opdivo
• other medications you may be taking with Opdivo

Opdivo may be given once every 2, 3, 4, or 6 weeks. But it’ll depend on the type of cancer being treated and whether Opdivo is given with other drugs.

Children receiving Opdivo may be given a dose once every 2, 3, or 4 weeks. This will be based on their treatment plan, body weight, and whether Opdivo is given with another drug.

Your doctor can tell you more about your dosage of Opdivo and how often you’ll receive the drug. To learn more about Opdivo’s dosage, you can also refer to this article.

Questions about receiving Opdivo

Here are answers to some common questions about Opdivo treatment.

• What if I miss a dose of Opdivo? You’ll get doses of Opdivo at your doctor’s office or a clinic. Your doctor’s office will schedule appointments for these treatments. If you miss an appointment, call your doctor’s office as soon as you remember. The office staff will help you reschedule. You might consider using a reminder tool so you don’t miss appointments. It’s important to have steady levels of Opdivo in your body so the drug can work to treat your cancer.
• Will I need to use Opdivo long term? You may receive Opdivo long term. Your doctor will discuss your treatment and they’ll recommend if you should take this treatment long term. How long you may receive Opdivo depends on:
  • the type and stage of your cancer
  • other treatment you’re getting with Opdivo
  • whether Opdivo is working to treat your cancer
  • if you’re having any serious side effects from Opdivo
• Should I take Opdivo with food? Opdivo is given by IV infusion at your doctor’s office or a clinic. The drug may cause nausea and vomiting, so ask your doctor about when you should eat or drink around receiving doses. This may help lessen these side effects of the drug.
• How long does Opdivo take to work? Opdivo starts to work soon after you receive a dose. But keep in mind, it may take several weeks to months for the drug to be effective for your type of cancer. Your doctor will order blood tests regularly to see if Opdivo is working to treat your cancer.

What are Opdivo’s side effects?

Like most drugs, Opdivo may cause mild or serious side effects. The lists below describe some of the more common side effects. These lists don’t include all possible side effects.

Keep in mind that side effects of a drug can depend on:

• your age
• other health conditions you have
• other medications you may be taking

Your doctor or pharmacist can tell you more about the potential side effects of Opdivo. They can also suggest ways to help reduce side effects.

Mild side effects

Here’s a list of some of the mild side effects that Opdivo can cause. To learn about other mild side effects, talk with your doctor or pharmacist, or read Opdivo’s prescribing information.

Mild side effects of Opdivo that have been reported include:

• constipation
• loss of appetite
• diarrhea
• fatigue (lack of energy)
• headache
• bone pain
• nausea or vomiting
• upper respiratory infection, such as the common cold
• cough
• itchy skin or rash
• joint pain, muscle pain, and back pain
• hair loss*
• mild allergic reaction†

Mild side effects of many drugs may go away within a few days or a couple of weeks. But if they become bothersome, talk with your doctor or pharmacist.

* Hair loss is a rare side effect of Opdivo. But it’s also possible to have hair loss from certain other side effects of Opdivo (such as thyroid problems) or other factors. For example, if you’re also taking chemotherapy drugs, they can commonly cause hair loss.
† To learn more about this side effect, see the “Allergic reaction” section below.

Serious side effects

Serious side effects from Opdivo can occur, but they aren’t common. If you have serious side effects from Opdivo, call your doctor right away. However, if you think you’re having a medical emergency, you should call 911 or your local emergency number.

Serious side effects of Opdivo that have been reported include:

• pneumonia
• infusion reactions, which may cause fever, dizziness, shaking, back or neck pain, itchiness, rash, shortness of breath, and chills
• serious skin reactions, such as Stevens-Johnson syndrome
• problems caused by your immune system attacking your healthy cells, such as:
  • colitis (swelling and damage in the colon)
  • blood cell disorders, such as anemia (low level of red blood cells)
  • eye problems, such as blurry vision
  • kidney damage, such as nephritis (swelling and damage in your kidneys)
  • liver damage, such as hepatitis (liver swelling and damage)
  • problems with hormone glands, such as the adrenals, pituitary, and thyroid
  • nervous system problems, such as nerve damage causing peripheral neuropathy
  • pneumonitis (swelling and damage in the lungs)
  • type 1 diabetes, which may cause diabetic ketoacidosis (a dangerous buildup of acids called ketones in your blood)
  • meningitis (swelling of the lining around the brain and spinal cord)
  • encephalitis (swelling in the brain)
• low sodium level
• high potassium level
• severe allergic reaction*

For details about Opdivo’s side effects, you can refer to this article.

* For more information about this side effect, see the “Allergic reaction” section below.

Allergic reaction

Some people may have an allergic reaction to Opdivo.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing (temporary warmth, redness, or deepening of skin color)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include swelling under your skin, typically in your eyelids, lips, hands, or feet. They can also include swelling of your tongue, mouth, or throat, which can cause trouble breathing.

Call your doctor right away if you have an allergic reaction to Opdivo. But if you think you’re having a medical emergency, call 911 or your local emergency number.

What does Opdivo cost?

Whether you have health insurance or not, cost may be a factor when you’re considering Opdivo. What you’ll pay for Opdivo may depend on several things, such as your treatment plan and the pharmacy you use.

If you have questions about how to pay for your prescription, talk with your doctor or pharmacist. A copay assistance program and other resources may also be available on Opdivo’s manufacturer’s website.

For details about Opdivo’s cost, you can refer to this article. There’s also this overview of Opdivo and Medicare. And you can check out this article to learn more about saving money on prescriptions.

What are some frequently asked questions about Opdivo?

Below are answers to some commonly asked questions about Opdivo.

How does Opdivo work?

Opdivo is an immunotherapy drug, which means it works with your immune system to fight off cancer cells.

It belongs to a group of drugs called programmed death receptor-1 (PD-1) inhibitors. PD-1 inhibitors are called immune checkpoint inhibitors. They work with your immune system to inhibit (block) PD-1 proteins.

This helps your immune system recognize cancer cells and stop the cancer cells from growing or spreading. This is Opdivo’s mechanism of action (how the drug works).

Is Opdivo used for pancreatic, ovarian, prostate, or breast cancer? And does it treat brain metastasis?

No, Opdivo isn’t approved to treat these types of cancer. But your doctor may prescribe Opdivo off-label for them. With off-label use, a doctor prescribes a drug for conditions other than its approved uses.

Research is underway to learn about Opdivo’s effectiveness for these types of cancers. For example:

• For pancreatic cancer, several studies are ongoing to see the effectiveness of nivolumab (the active drug in Opdivo), either alone or with other treatments. A 2020 study showed that treatment with immunotherapy and another type of therapy improved people’s overall survival. (Opdivo is a type of immunotherapy.)
• For ovarian cancer, a 2020 study looked at using nivolumab, either alone or with ipilimumab (Yervoy). This study found that the two drugs together had a better outcome than nivolumab alone. But more research is needed to know if Opdivo is effective for ovarian cancer.
• For prostate cancer, a recent study showed that nivolumab was effective. But more research is needed to learn about Opdivo’s effectiveness for this type of cancer.
• For breast cancer, studies have shown immunotherapy drugs may be effective in certain situations. More research is ongoing to learn about the drugs’ effectiveness for breast cancer.
• For brain metastasis, a small study found that nivolumab may help in people who have brain metastasis related to non-squamous non-small cell lung cancer (NSCLC). (Brain metastasis refers to cancer that’s spread from one area of the body to the brain.) Brain metastasis is a common complication of NSCLC and is difficult to treat. More research is needed to learn about the effectiveness of immunotherapy for brain metastases.

Your doctor can provide more information about using Opdivo for these forms of cancer. Your recommended treatment will depend on the specific type and stage of your cancer and your overall health.

What is Opdivo used for?

Opdivo is used to treat the following types of cancer in adults, in certain situations.

• Non-small cell lung cancer (NSCLC). This is cancer that affects certain cells in your lungs. Opdivo is used for NSCLC that is able to be removed surgically, as well as for NSCLC that has spread from the lung to other areas of the body. You can learn more about Opdivo’s use for NSCLC in this article.
• Melanoma. This is a form of skin cancer that affects skin cells that make melanin (the pigment that gives your skin its color). Opdivo can be used for melanoma that has spread from where it started or can’t be removed by surgery. Opdivo can also be used to help prevent melanoma from coming back after it’s been surgically removed. For this type of cancer, Opdivo can also be used in children ages 12 years and older.
• Renal cell carcinoma (RCC). RCC is a type of kidney cancer. Opdivo is used for RCC that has spread to other areas of the body.
• Esophageal cancer. Esophageal cancer affects the esophagus (a muscular tube that connects your mouth to your stomach). Opdivo can be used for cancer in the esophagus or the area where the stomach and esophagus meet, after the cancer has been removed with surgery. It can also be used for certain esophageal cancers that can’t be removed by surgery and have spread to other parts of the body. It’s also used for cancer affecting squamous cells in the esophagus.
• Bladder cancer.* Bladder cancer affects the bladder (the organ where the body holds urine). Opdivo is used to treat a type of bladder cancer called urothelial carcinoma that has spread near the bladder or to other areas of the body. For details about Opdivo’s use for bladder cancer, see this article.
• Liver cancer.* Liver cancer affects cells in the liver. Opdivo is used in adults with liver cancer that has been treated in the past with sorafenib (Nexavar).
• Gastric cancer. Gastric cancer affects the stomach lining. Opdivo is used to treat gastric cancer that includes cancer affecting the area where the stomach and esophagus meet, and esophageal adenocarcinoma (cancer in certain glandular cells in the esophagus).
• Classic Hodgkin’s lymphoma.* Classic Hodgkin’s lymphoma is a type of cancer that starts in the lymphatic system, which helps the immune system fight off infections. Opdivo is used when cancer has come back or gotten worse after certain treatments.
• Colorectal cancer.* Colorectal cancer affects the colon or rectum. Opdivo is used for colorectal cancer with certain gene mutations (atypical changes) that has spread to other areas of the body. And the cancer has worsened after treatment with certain chemotherapy drugs. For colorectal cancer, Opdivo can also be used in children ages 12 years and older.
• Malignant pleural mesothelioma. Malignant pleural mesothelioma is a type of lung cancer that affects the pleura (outer lining of the lungs). It’s mainly caused by exposure to asbestos. Opdivo is used when this cancer can’t be treated with surgery.
• Squamous cell carcinoma of the head and neck (SCCHN). This is a type of head and neck cancer that starts in squamous cells. It affects the eyes, skin, and other organs. Opdivo is used to treat SCCHN that has come back after past treatment or has spread to other areas of the body. It can be used for SCCHN that worsened during or after treatment with certain chemotherapy drugs.

Opdivo is used in certain situations. Your doctor will determine whether your type of cancer meets the criteria for Opdivo treatment. Opdivo may be prescribed with another drug or other treatments in some cases (see below).

* For this use, Opdivo received accelerated approval from the Food and Drug Administration (FDA). This means its approval is based on information from early studies. The FDA will decide about full approval after more studies are completed.

Receiving Opdivo with other drugs

Opdivo may be used alone or with other medications or treatments for cancer. This will depend on the type and stage of the cancer.

Some other drugs or treatments that may be given with Opdivo include:

• immunotherapy drugs, such as ipilimumab (Yervoy); see just below for more details
• chemotherapy drugs, such as fluorouracil, leucovorin, and oxaliplatin
• radiation therapy

Opdivo and Yervoy

Opdivo may be used with Yervoy to treat certain types of cancer in adults. These cancers include NSCLC, melanoma, liver cancer, and RCC, among others. Also, Opdivo may be given with Yervoy to adults and children ages 12 years and older for a type of colorectal cancer and a type of melanoma.

You’ll likely receive doses of both Opdivo and Yervoy on the same days. They’re both given by intravenous (IV) infusion.

What should be considered before taking Opdivo?

Below is important information you should consider before receiving Opdivo treatment.

Interactions

Taking a medication with certain vaccines, foods, and other things can affect how the drug works. These effects are called interactions.

Opdivo is not known to interact with other medications, herbs, supplements, or foods.

Before starting Opdivo, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, talk with your doctor or pharmacist.

Opdivo and alcohol

There aren’t any known interactions between alcohol and Opdivo. But Opdivo may cause certain liver-related side effects, such as hepatitis. And drinking a lot of alcohol can also cause liver damage.

If you drink alcohol, ask your doctor whether it’s safe for you to consume alcohol with Opdivo. They can let you know how much is safe to drink during treatment.

Pregnancy and breastfeeding

Opdivo is not safe to use during pregnancy. The drug may cause pregnancy loss or harm to a fetus.

If needed, your doctor will have you take a pregnancy test before starting treatment with Opdivo. To help prevent pregnancy, people who can become pregnant should use an effective type of birth control while taking Opdivo. And they should continue using it for 5 months after their last dose of the drug.

It’s not known whether Opdivo passes into breast milk. But Opdivo has serious side effects, which could possibly affect a child who’s breastfed. You should not breastfeed while taking Opdivo and for at least 5 months after your last dose of the drug. Ask your doctor about other ways to feed your child.

Your doctor can give you more information about the risks of Opdivo use during pregnancy and while breastfeeding.

Warnings

Opdivo may not be right for you if you have certain medical conditions or other factors that affect your health. Talk with your doctor about your health history before you take Opdivo. Factors to consider include those in the list below.

• autoimmune disorders, such as inflammatory bowel disease, lupus, and multiple sclerosis
• lung problems
• chest radiation treatment
• organ transplant
• allogenic hematopoietic stem cell transplant
• nervous system disorder, such as Guillain-Barré syndrome or myasthenia gravis
• previous allergic reaction to Opdivo
• pregnancy
• breastfeeding

Similar drugs

Other drugs are available that can treat your condition. If you’d like to explore an alternative to Opdivo, talk with your doctor. They can tell you about other medications that might work well for you.

The following drugs are similar to Opdivo:

• pembrolizumab (Keytruda)
• cemiplimab (Libtayo)
• atezolizumab (Tecentriq)
• durvalumab (Imfinzi)