Full Indication

Opdualag is a prescription medication used to treat both adults and children [12 years of age or older who weigh at least 88 pounds (40 kg)] 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 in children 12 years and older weighing less than 88 pounds (40 kg) or for the treatment of any other cancers.

Full Indication

Opdualag is a prescription medication used to treat both adults and children [12 years of age or older who weigh at least 88 pounds (40 kg)] 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 in children 12 years and older weighing less than 88 pounds (40 kg) or for the treatment of any other cancers.
Prescribing Information
Medication Guide
For Healthcare Professionals

Actor portrayals.

Helpful tips and resources for patients and caregivers

There’s no one-size-fits-all plan. Talk with your loved one and healthcare team to create a plan that works for you. And of course, be flexible and adjust along the way.

Support for patients

You’re not alone—create a support team. Your team can be:

Family and friends who provide emotional support and help with
day-to-day tasks
Your healthcare team, which is your most important source of information and support
Advocacy and support groups for sharing experiences with others
and finding resources

Support for caregivers

You can play an important role, both early on and throughout treatment:

Help your loved one learn more about treatment
Go with your loved one to appointments to take notes and ask questions
Help your loved one become aware of and monitor potential side effects of treatment with the guidance of your healthcare team
Keep a calendar with your loved one to keep track of appointments

Don’t forget, as a caregiver, it’s important to take care of yourself, too. Here are some ideas:

Keep up with your own medical needs, including checkups, medications, and other medical necessities
Make sure you get enough sleep and maintain a healthy diet
Do exercises you enjoy under the advice of your doctor
Make time for yourself. Stretch, read, watch television, or talk on the phone—whatever helps you unwind

Patient & caregiver support materials

Download useful resources below to help you or a loved one better navigate treatment.

THERE’S NO
ONE-SIZE-FITS-ALL PLAN

Talk with your loved one and healthcare team to create a plan that works for you.
And of course, be flexible and adjust along the way.

Doctor Discussion Guide
Download PDF
Infusion Guide
Download PDF
Side Effects
Tracker
Download PDF
Caregiver Brochure
Download PDF
Medication Guide
Download PDF

Please talk to your doctor if you have any questions regarding the Prescribing Information or Medication Guide for Opdualag.

Patient & caregiver resources*

Below are resources that you and your loved one may find helpful.

AIM at Melanoma

aimatmelanoma.org

This organization is globally engaged and locally invested in advancing the battle against melanoma through innovative research, legislative reform, education, and patient and caregiver support.

American Cancer Society

cancer.org

The American Cancer Society’s mission is to save lives, celebrate lives, and lead the fight for a world without cancer.

CancerCare

cancercare.org

The mission of CancerCare is to provide free, professional support services to anyone affected by cancer.

Cancer Research Institute

cancerresearch.org

Cancer Research Institute (CRI) is dedicated to pursuing research in and advancing awareness of immunotherapy for cancer.

Cancer Support Community

cancersupportcommunity.org

This group is an internal nonprofit dedicated to providing support, education, and hope to people affected by cancer and their loved ones.

Melanoma Research Alliance

curemelanoma.org

The mission of the MRA is to end suffering and death due to melanoma by collaborating with all stakeholders to accelerate powerful research, advance cures for all patients, and prevent more melanomas.

Melanoma Research Foundation

melanoma.org

The MRF supports medical research for finding effective treatments and eventually a cure for melanoma; educates patients, physicians, and the public about the prevention, diagnosis, and treatment of melanoma; and acts as an advocate for the melanoma community to raise awareness of this disease and the need for a cure.

Bristol Myers Squibb does not endorse these organizations. The information/links provided by Bristol Myers Squibb are meant for informational purposes only and are not meant to replace a physician’s medical advice.

Opdualag with You Means Just That

We’re here to help you better understand Opdualag, whether you or a loved one are already receiving Opdualag. This program includes helpful information and details about support and advocacy groups.

Call 1-855-OPDUALAG or click to sign up.

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.

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Helpful information
to remember

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:

new or worsening cough

shortness of breath

chest pain

Intestinal problems — Things to look out for may include:

diarrhea (loose stools) or more frequent
bowel movements than usual

stools that are black, tarry, sticky, or have
blood or mucus

severe stomach-area (abdominal) pain or tenderness

Liver problems — Things to look out for may include:

yellowing of your skin or the whites of
your eyes
severe nausea or vomiting

pain on the right side of your stomach
area (abdomen)
dark urine (tea colored)

bleeding or bruising more easily than normal

Hormone gland problems — Things to look out for may include:

headaches that will not go away or
unusual headaches
eye sensitivity to light
eye problems
rapid heartbeat
increased sweating
extreme tiredness

weight gain or weight loss
feeling more hungry or thirsty than usual
urinating more often than usual
hair loss
feeling cold

constipation
your voice gets deeper
dizziness or fainting
changes in mood or behavior, such as
decreased sex drive, irritability, or
forgetfulness

Kidney problems — Things to look out for may include:

decrease in the amount of urine

blood in your urine
swelling in your ankles

loss of appetite

Skin problems — Things to look out for may include:

rash
itching

skin blistering or peeling

painful sores or ulcers in the mouth or nose, throat, or genital area

Heart problems — Things to look out for may include:

new or worse chest pain
irregular heartbeat or feel like
your heart is racing

shortness of breath
tiredness

swelling in your ankles

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:

confusion
sleepiness
memory problems

changes in mood or behavior
stiff neck
balance problems

tingling or numbness of the arms or legs

Eye or vision problems — Things to look out for may include:

double vision
blurry vision

sensitivity to light
eye pain

changes in eyesight

Muscle problems — Things to look out for may include:

persistent or severe muscle pain or weakness

muscle cramps

Blood problems — Things to look out for may include:

low red blood cells

bruising

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:

chills or shaking
itching or rash
flushing

shortness of breath
dizziness
feel like passing out

fever
back or neck pain

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:

muscle and bone pain
tiredness
decreased red blood cell and white blood cell counts

increased liver function test results
rash
itching

diarrhea
decreased salt (sodium) in your blood

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:

have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
have had an organ transplant
have had or plan to have a stem cell transplant that uses donor stem cells (allogeneic)
have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome

Tell your healthcare team about all the medicines you take, including:

prescription medicines

over-the-counter medicines

vitamins

herbal supplements

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.

For more information, please see U.S. Full Prescribing Information and Medication Guide for Opdualag, or talk to your healthcare team.

Information on this website is not a substitute for talking with your healthcare professional.
Your healthcare professional is the best source of information about your disease.

All individuals depicted are models used for illustrative purposes only.

Prescribing Information Medication Guide

Important Facts About Opdualag^™ (nivolumab and relatlimab-rmbw)

Opdualag can cause problems that can sometimes become serious or life-threatening and can lead to death. Serious side effects may include: lung problems; intestinal problems; liver problems; hormone gland problems; kidney problems; skin problems; heart problems; problems in other organs and tissues; severe infusion reactions; complications of stem cell transplant, including graft-versus-host disease (GVHD), that uses donor stem cells (allogeneic). Call or see your healthcare provider right away for any new or worsening signs or symptoms.

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EDUCATION & SUPPORT

Helpful tips and resources for patients and caregivers