FULL INDICATIONS
For certain adults with advanced
OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) as a first treatment for adults with a type of advanced stage lung cancer (called
OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) and 2 cycles of chemotherapy that contains platinum and another chemotherapy medicine, as a first treatment for adults with a type of advanced stage lung cancer (called
It is not known if OPDIVO is safe and effective in children younger than 12 years of age with melanoma or MSI-H or dMMR metastatic colorectal cancer.
It is not known if OPDIVO is safe and effective in children for the treatment of any other cancers.
OPDIVO (10 mg/mL) and YERVOY
For adults with previously treated advanced
OPDIVO® (nivolumab) is a prescription medicine used to treat adults with a type of advanced stage lung cancer (called
It is not known if OPDIVO is safe and effective in children younger than 12 years of age with melanoma or MSI-H or dMMR metastatic colorectal cancer.
It is not known if OPDIVO is safe and effective in children for the treatment of any other cancers.
For adults with early-stage
OPDIVO® (nivolumab) is a prescription medicine used in combination with chemotherapy that contains platinum and another chemotherapy medicine, before you have surgery, for adults with early-stage lung cancer (called
It is not known if OPDIVO is safe and effective in children younger than 12 years of age with melanoma or MSI-H or dMMR metastatic colorectal cancer.
It is not known if OPDIVO is safe and effective in children for the treatment of any other cancers.
For adults and children 12 years and older with advanced melanoma
OPDIVO® (nivolumab) is a prescription medicine used to treat adults and children 12 years of age and older with a type of skin cancer called melanoma that has spread or cannot be removed by surgery (advanced melanoma).
OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) to treat adults and children 12 years of age and older with a type of skin cancer called melanoma that has spread or cannot be removed by surgery (advanced melanoma).
It is not known if OPDIVO is safe and effective in children younger than 12 years of age with melanoma or MSI-H or dMMR metastatic colorectal cancer.
It is not known if OPDIVO is safe and effective in children for the treatment of any other cancers.
OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.
For adults and children 12 years and older with melanoma after it and the affected lymph nodes have been removed by surgery to prevent it from coming back
OPDIVO® (nivolumab) is a prescription medicine used to treat adults and children 12 years of age and older with a type of skin cancer called melanoma to help prevent melanoma from coming back after it and lymph nodes that contain cancer have been removed by surgery.
It is not known if OPDIVO is safe and effective in children younger than 12 years of age with melanoma or MSI-H or dMMR metastatic colorectal cancer.
It is not known if OPDIVO is safe and effective in children for the treatment of any other cancers.
For certain adults with advanced kidney cancer (renal cell carcinoma)
OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) to treat adults with kidney cancer in certain people when your cancer has spread (advanced renal cell carcinoma) and you have not already had treatment for your advanced RCC.
It is not known if OPDIVO is safe and effective in children younger than 12 years of age with melanoma or MSI-H or dMMR metastatic colorectal cancer.
It is not known if OPDIVO is safe and effective in children for the treatment of any other cancers.
OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.
For newly diagnosed adults whose kidney cancer (renal cell carcinoma) has spread
OPDIVO® (nivolumab) is a prescription medicine used in combination with cabozantinib to treat adults with kidney cancer when your cancer has spread (advanced renal cell carcinoma) and you have not already had treatment for your advanced RCC. Please read the Patient Information that comes with cabozantinib.
It is not known if OPDIVO is safe and effective in children younger than 12 years of age with melanoma or MSI-H or dMMR metastatic colorectal cancer.
It is not known if OPDIVO is safe and effective in children for the treatment of any other cancers.
For adults with previously treated advanced kidney cancer (renal cell carcinoma)
OPDIVO® (nivolumab) is a prescription medicine used to treat adults with kidney cancer (renal cell carcinoma) when your cancer has spread or grown after treatment with other cancer medications.
It is not known if OPDIVO is safe and effective in children younger than 12 years of age with melanoma or MSI-H or dMMR metastatic colorectal cancer.
It is not known if OPDIVO is safe and effective in children for the treatment of any other cancers.
For adults with previously treated squamous cell carcinoma of the head and neck
OPDIVO® (nivolumab) is a prescription medicine used to treat adults with head and neck cancer (squamous cell carcinoma) that has come back or spread and you have tried chemotherapy that contains platinum and it did not work or is no longer working.
It is not known if OPDIVO is safe and effective in children younger than 12 years of age with melanoma or MSI-H or dMMR metastatic colorectal cancer.
It is not known if OPDIVO is safe and effective in children for the treatment of any other cancers.
For adults with liver cancer (hepatocellular carcinoma) who have received treatment with sorafenib
OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) to treat adults with liver cancer (hepatocellular carcinoma) if you have previously received treatment with sorafenib. OPDIVO in combination with YERVOY was approved based on response rate and how long patients’ responses lasted. There is ongoing evaluation of clinical benefit of OPDIVO in combination with YERVOY for this use.
It is not known if OPDIVO is safe and effective in children younger than 12 years of age with melanoma or MSI-H or dMMR metastatic colorectal cancer.
It is not known if OPDIVO is safe and effective in children for the treatment of any other cancers.
OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.
For adults with previously treated advanced cancer in the bladder or urinary tract (urothelial carcinoma)
OPDIVO® (nivolumab) is a prescription medicine used to treat adults with cancer of the lining of the urinary tract (including the bladder, urethra, ureters, or renal pelvis) [urothelial carcinoma] when it has spread or grown (locally advanced or metastatic) and you have tried chemotherapy that contains platinum, and it did not work or is no longer working or your cancer worsened within 12 months of treatment with chemotherapy that contains platinum, either before or after surgery to remove your cancer.
It is not known if OPDIVO is safe and effective in children younger than 12 years of age with melanoma or MSI-H or dMMR metastatic colorectal cancer.
It is not known if OPDIVO is safe and effective in children for the treatment of any other cancers.
For adults with a type of bladder or urinary tract cancer (urothelial carcinoma) to help prevent it from coming back after it was removed by surgery
OPDIVO® (nivolumab) is a prescription medicine used to treat adults with cancer of the lining of the urinary tract (including the bladder, ureters, or renal pelvis) [urothelial carcinoma] to help prevent cancer of the urinary tract from coming back after it was removed by surgery.
It is not known if OPDIVO is safe and effective in children younger than 12 years of age with melanoma or MSI-H or dMMR metastatic colorectal cancer.
It is not known if OPDIVO is safe and effective in children for the treatment of any other cancers.
For people 12 years of age and older whose CRC has spread to other parts of the body (metastatic); has progressed after treatment with a fluoropyrimidine, oxaliplatin, and irinotecan; and is MSI-H or dMMR
OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) to treat adults and children 12 years of age and older, with a type of colon or rectal cancer (colorectal cancer) that has spread to other parts of the body (metastatic), is microsatellite instability-high
OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.
OPDIVO® (nivolumab) is a prescription medicine used to treat adults and children 12 years of age and older with a type of colon or rectal cancer (colorectal cancer) that has spread to other parts of the body (metastatic), is microsatellite instability-high
It is not known if OPDIVO is safe and effective in children younger than 12 years of age with melanoma or MSI-H or dMMR metastatic colorectal cancer.
It is not known if OPDIVO is safe and effective in children for the treatment of any other cancers.
For adults with previously treated classical Hodgkin lymphoma including an autologous stem cell transplant whose cancer has come back or spread
OPDIVO® (nivolumab) is a prescription medicine used to treat adults with a type of blood cancer called classical Hodgkin lymphoma 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 medicine brentuximab vedotin before or after your stem cell transplant, or if you received at least 3 kinds of treatment including an autologous stem cell transplant. OPDIVO was approved based on response rate. There is ongoing evaluation of clinical benefit of OPDIVO for this use.
It is not known if OPDIVO is safe and effective in children younger than 12 years of age with melanoma or MSI-H or dMMR metastatic colorectal cancer.
It is not known if OPDIVO is safe and effective in children for the treatment of any other cancers.
For adults with previously treated advanced esophageal squamous cell cancer
OPDIVO® (nivolumab) is a prescription medicine used to treat adults with cancer of the tube that connects your throat to your stomach (esophageal cancer) if your esophageal cancer is a type called squamous cell carcinoma, and cannot be removed with surgery, and has come back or spread to other parts of the body after you have received chemotherapy that contains fluoropyrimidine and platinum.
It is not known if OPDIVO is safe and effective in children younger than 12 years of age with melanoma or MSI-H or dMMR metastatic colorectal cancer.
It is not known if OPDIVO is safe and effective in children for the treatment of any other cancers.
For adults newly diagnosed with malignant pleural mesothelioma (MPM)
OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) as a first treatment for adults with a type of cancer that affects the lining of the lungs and chest wall called malignant pleural mesothelioma which cannot be removed by surgery.
It is not known if OPDIVO is safe and effective in children younger than 12 years of age with melanoma or MSI-H or dMMR metastatic colorectal cancer.
It is not known if OPDIVO is safe and effective in children for the treatment of any other cancers.
OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.
For adults with esophageal or gastroesophageal junction (GEJ) cancer who have been treated with chemoradiation followed by surgery to help prevent it from coming back
OPDIVO® (nivolumab) is a prescription medicine that may be used in adults to help prevent cancer of the tube that connects your throat to your stomach (esophageal cancer) or cancer where the esophagus joins the stomach (gastroesophageal junction cancer) from coming back after it has been treated with chemoradiation followed by surgery to remove the cancer, but some cancer cells were still present in the removed tumor or lymph nodes.
It is not known if OPDIVO is safe and effective in children younger than 12 years of age with melanoma or MSI-H or dMMR metastatic colorectal cancer.
It is not known if OPDIVO is safe and effective in children for the treatment of any other cancers.
For adults with advanced gastric cancer, gastroesophageal junction (GEJ) cancer, and esophageal adenocarcinoma (EAC)
OPDIVO® (nivolumab) is a prescription medicine used in combination with chemotherapy that contains fluoropyrimidine and platinum to treat adults with cancer of the tube that connects your throat to your stomach (esophageal cancer) when your cancer is a type called squamous cell carcinoma and cannot be removed with surgery (advanced) or has spread to other parts of the body (metastatic) and you have not already had treatment for your advanced or metastatic esophageal cancer.
OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) to treat adults with cancer of the tube that connects your throat to your stomach (esophageal cancer) when your cancer is a type called squamous cell carcinoma and cannot be removed with surgery (advanced) or has spread to other parts of the body (metastatic), and you have not already had treatment for your advanced or metastatic esophageal cancer.
OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.
OPDIVO® (nivolumab) is a prescription medicine used in combination with chemotherapy that contains fluoropyrimidine and platinum to treat adults with cancer of the stomach (gastric), junction between the stomach and esophagus (gastroesophagael junction), and esophagus that is a type called adenocarcinoma and cannot be removed with surgery or has spread to other parts of the body.
It is not known if OPDIVO is safe and effective in children younger than 12 years of age with melanoma or MSI-H or dMMR metastatic colorectal cancer.
It is not known if OPDIVO is safe and effective in children for the treatment of any other cancers.
Important Facts About OPDIVO® (nivolumab) and OPDIVO + YERVOY® (ipilimumab)
This is a summary of important information that you need to know about OPDIVO and OPDIVO + YERVOY. Your healthcare team can work with you to help answer any questions you may have about these medications. Keep this information in a safe place so you can refer to it before and during your treatment.
Look out for the following icons as you read:
What is the most important information I should know about OPDIVO + YERVOY?
OPDIVO and YERVOY are medicines that may treat certain cancers by working with your immune system. OPDIVO and YERVOY can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. Some of these problems may happen more often when OPDIVO is used in combination with another therapy.
Get medical help immediately if you develop any of these signs or symptoms or they get worse. It may keep these problems from becoming more serious. Your healthcare team will check you for these problems during treatment and may treat you with corticosteroid or hormone replacement medicines. If you have severe side effects, your healthcare team may also need to delay or completely stop your treatment.
What are the serious side effects of OPDIVO and OPDIVO + YERVOY?
A serious side effect is a side effect that can sometimes become severe or life-threatening and can lead to death. They may happen anytime during treatment or even after your treatment has ended. You may have more than one of these problems at the same time.
Call or see your healthcare provider right away if you develop any new or worse signs or symptoms, including:
Lung problems – Things to look out for may include:
Intestinal problems – Things to look out for may include:
Liver problems – Things to look out for may include:
Hormone gland problems – Things to look out for may include:
Kidney problems – Things to look out for may include:
Skin problems – Things to look out for may include:
Eye problems – Things to look out for may include:
Problems can also happen in other organs and tissues. These are not all the signs and symptoms of immune system problems that can happen with OPDIVO and YERVOY. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include:
What are the possible side effects of OPDIVO + YERVOY?
OPDIVO and OPDIVO + YERVOY can cause serious side effects, including:
See the previous section, “What is the most important information I should know about OPDIVO + YERVOY?”
Severe infusion reactions – Things to look out for may include:
Tell your healthcare team right away if you get these symptoms during an infusion of OPDIVO or YERVOY.
Complications, including graft-versus-host disease (GVHD), of bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be severe and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with OPDIVO or YERVOY. Your healthcare provider will monitor you for these complications.
What are the most common side effects?
The most common side effects of OPDIVO when used alone include:
The most common side effects of OPDIVO when used in combination with YERVOY include:
The most common side effects of OPDIVO when used in combination with YERVOY and chemotherapy include:
The most common side effects of OPDIVO when used in combination with chemotherapy include:
The most common side effects of OPDIVO when used in combination with cabozantinib include:
The most common side effects of OPDIVO when used in combination with fluoropyrimidine and platinum-containing chemotherapy include:
These are not all the possible side effects. Talk to your healthcare team or pharmacist for more information. You are encouraged to report side effects of prescription drugs to the FDA. Call 1-800-FDA-1088.
What should I discuss with my healthcare team before receiving OPDIVO or YERVOY?
Tell your healthcare provider about all your medical conditions, including if you:
Females who are able to become pregnant:
Your healthcare provider should do a pregnancy test before you start receiving OPDIVO or YERVOY.
Tell your healthcare provider about all the medicines you take, including:
For more information, please see U.S. Full Prescribing Information and Medication Guide for OPDIVO and U.S. Full Prescribing Information and Medication Guide for YERVOY, or talk to your healthcare team.
Information provided in this website is not a substitute for talking with your healthcare professional. Your healthcare professional is the best source of information about your disease.
FULL INDICATION
For people with advanced melanoma
Opdualag™ (nivolumab and relatlimab-rmbw) is a prescription medicine used to treat adults and children 12 years of age or older with a type of skin cancer called melanoma that has spread or cannot be removed by surgery (advanced melanoma). It is not known if Opdualag is safe and effective when used in children younger than 12 years of age or older who weigh less than 88 pounds (40 kg), or in children younger than 12 years of age.
Opdualag, 80 mg relatlimab and 240 mg nivolumab/20 mL (4 mg and 12 mg/mL), is an injection in a single-dose vial for intravenous (IV) use.
Important Facts About Opdualag™ (nivolumab and relatlimab-rmbw)
This is a summary of important information that you need to know about Opdualag. Your healthcare team can work with you to help answer any questions you may have about this medication. Keep this information in a safe place so you can refer to it before and during your treatment.
Look out for the following icons as you read:
What is Opdualag?
Opdualag is a premixed combination of nivolumab and relatlimab that is prepared and given through intravenous (IV) infusions. Opdualag is a prescription medicine used to treat:
Adults who have a type of skin cancer called melanoma that has spread or cannot be removed by surgery (advanced melanoma).
Children who are 12 years of age and older, who have melanoma that has spread or cannot be removed by surgery (advanced melanoma).
It is not known if Opdualag is safe and effective when used in children younger than 12 years of age or in children 12 years and older weighing less than 88 pounds (40 kg) or for the treatment of any other cancers.
An IV infusion is when medicine is given directly into the bloodstream through a needle placed in a vein by a healthcare professional – usually in the arm or hand.
What is the most important information I should know about Opdualag?
Opdualag can cause serious side effects any time during and after treatment. A serious side effect is a side effect that can sometimes become life-threatening and can lead to death. Serious side effects may happen anytime during treatment or even after your treatment has ended. You may experience more than one side effect at the same time.
Get medical help right away if you develop any new symptoms or if they get worse. It may keep these problems from becoming more serious. Your healthcare team will check you for side effects during treatment, and may treat you with corticosteroid or hormone replacement medicines. If you have severe side effects, your healthcare team may need to delay or completely stop your treatment.
Immune system-related side effects
Opdualag is a medicine that may treat melanoma that has spread or cannot be removed by surgery by working with your immune system. Opdualag can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. Some of these problems can sometimes become severe and can lead to death.
This is a list of some possible immune system-related side effects of Opdualag. You may experience other side effects that are not listed. You may experience side effects anytime during treatment or even after treatment has ended.
Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including:
Lung problems – Things to look out for may include:
Intestinal problems – Things to look out for may include:
Liver problems – Things to look out for may include:
Hormone gland problems – Things to look out for may include:
Kidney problems – Things to look out for may include:
Skin problems – Things to look out for may include:
Heart problems – Things to look out for may include:
Immune system-related side effects can also happen in other organs and tissues with Opdualag™ (nivolumab and relatlimab-rmbw), including:
Brain and nerve problems – Things to look out for may include:
Eye or vision problems – Things to look out for may include:
Muscle problems – Things to look out for may include:
Blood problems – Things to look out for may include:
Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms.
What are some other serious side effects of Opdualag?
Severe Infusion Reactions
Opdualag™ (nivolumab and relatlimab-rmbw) is given through intravenous (IV) infusions. The medicine is put directly into your bloodstream through a needle that a healthcare professional places in a vein, usually in your arm or hand.
Things to look out for during an infusion of Opdualag may include:
Tell your healthcare team right away if you get these symptoms during or after an infusion of Opdualag.
Stem Cell Transplant Complications
You may experience complications if you receive donor stem cells (allogeneic stem cell transplant) before or after treatment with Opdualag. These complications can be severe and can lead to death. Your healthcare team will monitor you for signs of complications if you have an allogeneic stem cell transplant.
What are the most common side effects?
The most common side effects of Opdualag include:
These are not all the possible side effects.
Talk to your healthcare team for more information. You are encouraged to report side effects of prescription drugs to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.
What should I discuss with my healthcare team about pregnancy, birth control, and breastfeeding?
Talk to your healthcare team if:
You are pregnant or plan to become pregnant – Opdualag can harm your unborn baby
If you are able to become pregnant, your healthcare team should do a pregnancy test before you start receiving Opdualag. You should use an effective method of birth control during treatment and for at least 5 months after your last dose of Opdualag.
Talk to your healthcare team about birth control methods that you can use during this time.
Tell your healthcare team right away if you become pregnant or think you are pregnant during treatment with Opdualag.
You are breastfeeding or plan to breastfeed
It is not known if Opdualag passes into your breast milk. Do not breastfeed during treatment with Opdualag and for 5 months after the last dose of Opdualag.
What should I discuss with my healthcare team before starting treatment?
Talk to your healthcare team about all your health problems or concerns, including if you:
Tell your healthcare team about all the medicines you take, including:
These are not all the topics you should discuss with your healthcare team. Ask your healthcare team about anything you may be unsure about before starting treatment.
How will I receive Opdualag?
Opdualag is a premixed prescription medication (12 mg/mL nivolumab and 4 mg/mL relatlimab) that is prepared and given as intravenous (IV) infusions by your healthcare team.
An IV infusion is when medicine is given directly into the bloodstream through a needle placed in a vein by a healthcare professional – usually in the arm or hand.
Dosage:
Talk to your healthcare team to learn more about the dosing for Opdualag.
Receiving Opdualag:
IV infusion time is about 30 minutes, though actual time in clinic or place of infusion may vary.
Opdualag is usually given every 4 weeks. Your healthcare provider will decide how many treatments you will receive and do blood tests to monitor your health and check for side effects.
Call your healthcare team as soon as possible to reschedule if you miss any of your appointments.
For more information, please see U.S. Full Prescribing Information and Medication Guide for Opdualag.
Talk to your healthcare team for more information about this medication.