What is OPDIVO (Nivolumab)?
OPDIVO is a prescription medicine used to treat:
- People with a type of skin cancer called melanoma: OPDIVO may be used alone or in combination with ipilimumab to treat melanoma that has spread or cannot be removed by surgery (advanced melanoma), or OPDIVO may be used alone to help prevent melanoma from coming back after it and lymph nodes that contain cancer have been removed by surgery.
- People with a type of advanced stage lung cancer (called non-small cell lung cancer).
- OPDIVO may be used when your lung cancer : has spread or grown, and you have tried chemotherapy that contains platinum, and it did not work or is no longer working.
- People with a type of lung cancer called small cell lung cancer.
- OPDIVO may be used when your lung cancer: has spread or grown, and you have tried at least two different types of chemotherapy, including one that contains platinum, and it did not work or is no longer working.
- People with kidney cancer (renal cell carcinoma). OPDIVO may be used alone when your cancer has spread or grown after treatment with other cancer medicines. OPDIVO may be used in combination with ipilimumab in certain people when their cancer has spread.
- Adults with a type of blood cancer called classical Hodgkin lymphoma
- OPDIVO may be used if: Your cancer has come back or spread after a type of stem cell transplant that uses your own stem cells (autologous), and You used the drug brentuximab vedotin before or after your stem cell transplant, or You received at least 3 kinds of treatment including a stem cell transplant that uses your own stem cells (autologous).
- People with head and neck cancer (squamous cell carcinoma)
- OPDIVO may be used when your head and neck cancer: Has come back or spread, and You have tried chemotherapy that contains platinum and it did not work or is no longer working.
- People with bladder cancer (urothelial carcinoma).
- OPDIVO may be used when your bladder cancer: Has spread or grown, and You have tried chemotherapy that contains platinum, and it did not work or is no longer working.
- OPDIVO may be used alone or in combination with ipilimumab when your colon or rectal cancer: Has spread to other parts of the body (metastatic), Is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and You have tried treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, and it did not work or is no longer working.
- People with liver cancer (hepatocellular carcinoma) : OPDIVO may be used alone or in combination with ipilimumab if you have previously received treatment with sorafenib.
It is not known if OPDIVO is safe and effective when used alone: In children younger than 12 years of age with MSI-H or dMMR metastatic colorectal cancer, any other cancers
What is the most important information I should know about OPDIVO?
OPDIVO can cause serious side effects. These serious side effects include:
- OPDIVO is a medicine that may treat certain cancers by working with your immune system. OPDIVO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended. Some of these problems may happen more often when OPDIVO is used in combination with ipilimumab
- Lung problems (pneumonitis)
- Intestinal problems (colitis) that can lead to tears or holes in your intestine
- Liver problems (hepatitis)
- Hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas)
- Kidney problems, including nephritis and kidney failure.
- Skin Problems
- Inflammation of the brain (encephalitis)
- Problems in other organs
- Severe infusion reactions. Tell your doctor or nurse right away if you get these symptoms during an infusion of OPDIVO:
- Chills or shaking
- Itching or rash
- Flushing
- Difficulty breathing
- Dizziness
- Fever
- Feeling like passing out
- Complications of stem cell transplant that uses donor stem cells (allogeneic). These complications can be severe and can lead to death. Your healthcare provider will monitor you for signs of complications if you have an allogeneic stem cell transplant.
- The most common side effects of OPDIVO when used alone include:
- Feeling tired
- Rash
- Pain in muscles, bones, and joints
- Itchy skin
- Diarrhea
- Nausea
- Weakness
- Ccugh
- Vomiting
- Shortness of breath
- Constipation
- Decreased appetite
- Back pain
- Upper respiratory tract infection
- Fever
- Headache
- Abdominal pain
- The most common side effects of OPDIVO when used in combination with ipilimumab include:
- Feeling tired
- Diarrhea
- Rash
- Itching
- Nausea
- Pain in muscles, bones, and joints
- Fever
- Cough
- Decreased appetite
- Vomiting
- Abdominal pain
- Shortness of breath
- Upper respiratory tract infection
- Headache
- Low thyroid hormone levels (hypothyroidism)
- Decreased weight
- Dizziness
How should I take OPDIVO?
- Your healthcare provider will give you OPDIVO into your vein through an intravenous (IV) line over 30 minutes.
- OPDIVO is usually given every 2 weeks or 4 weeks depending on the dose you are receiving.
- When used in combination with ipilimumab, OPDIVO is usually given every 3 weeks, for a total of 4 doses. Ipilimumab will be given on the same day. After that, OPDIVO will be given alone every 2 weeks or 4 weeks depending on the dose you are receiving.
- Your healthcare provider will decide how many treatments you need.
- Your healthcare provider will do blood tests to check you for side effects.
- If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.
Important Safety Information
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- You should use an effective method of birth control during and for at least 5 months after the last dose of OPDIVO. Talk to your healthcare provider about birth control methods that you can use during this time.
- It is not known if OPDIVO passes into your breast milk. Do not breastfeed during treatment with OPDIVO..
- If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.
Ask your healthcare provider if you do not know.
What should I tell my healthcare provider before taking OPDIVO?
Before you receive OPDIVO, tell your healthcare provider if you:
- Have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
- Have had an organ transplant
- Have lung or breathing problems
- Have liver problems
- Have any other medical conditions
- Are pregnant or plan to become pregnant. OPDIVO can harm your unborn baby.
- Are breastfeeding or plan to breastfeed. It is not known if OPDIVO passes into your breast milk. Do not breastfeed during treatment with OPDIVO
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements.
General information about OPDIVO
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you would like more
information about OPDIVO, talk with your healthcare provider. You can ask your healthcare provider for information
about OPDIVO that is written for health professionals.
What are the ingredients in OPDIVO?
Active ingredient: Nivolumab
Other ingredient: Mannitol, pentetic acid, polysorbate 80, sodium chloride, sodium citrate dihydrate, and Water for
Injection. May contain hydrochloric acid and/or sodium hydroxide.