Nivolumab and relatlimab is used to treat certain types of melanoma (a type of skin cancer) that has spread to other parts of the body or cannot be removed by surgery in adults and children 12 years of age or older who weigh at least 40 kg. Nivolumab and relatlimab are in a class of medications called monoclonal antibodies. They work by helping your immune system to slow or stop the growth of cancer cells.

Nivolumab and relatlimab comes as a solution (liquid) to be given intravenously (into a vein) over 30 minutes by a doctor or nurse in a hospital or medical facility. It is usually given every 4 weeks for as long as your doctor recommends that you receive treatment.

Nivolumab and relatlimab may cause serious or life-threatening reactions during an infusion. A doctor or nurse will watch you closely while you are receiving the infusion and shortly after the infusion to be sure you are not having a serious reaction to the medication. Tell your doctor or nurse immediately if you experience any of the following symptoms that may occur during the infusion: chills or shaking, itching, rash, flushing, difficulty breathing, dizziness, fever, and feeling faint.

Your doctor may slow down your infusion, delay it, or stop your treatment with nivolumab and relatlimab injection, or treat you with additional medications depending on your response to the medication and any side effects that you experience. Talk to your doctor about how you are feeling during your treatment.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking nivolumab and relatlimab,

• tell your doctor and pharmacist if you are allergic to nivolumab, relatlimab, any other medications, or any of the ingredients in nivolumab and relatlimab. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had an organ transplant. Also tell your doctor if you have or have ever had an autoimmune disease (condition in which the immune system attacks a healthy part of the body) such as Crohn’s disease (condition in which the immune system attacks the lining of the digestive tract causing pain, diarrhea, weight loss, and fever), ulcerative colitis (condition that causes swelling and sores in the lining of the colon [large intestine] and rectum), or lupus (condition in which the immune system attacks many tissues and organs including the skin, joints, blood, and kidneys); any type of lung disease or breathing problems; or thyroid, kidney or liver disease.
• tell your doctor if you are pregnant or plan to become pregnant. You will need to take a pregnancy test before you receive nivolumab and relatlimab. You should not become pregnant while you are receiving nivolumab and relatlimab injection. You should use effective birth control to prevent pregnancy during your treatment with nivolumab and relatlimab injection and for at least 5 months after your final dose. Talk to your doctor about birth control methods that will work for you. If you become pregnant while receiving nivolumab and relatlimab injection, call your doctor immediately. Nivolumab and relatlimab injection may harm the fetus.
• tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while receiving nivolumab and relatlimab injection and for 5 months after your final dose.

Unless your doctor tells you otherwise, continue your normal diet.

Nivolumab and relatlimab may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• muscle pain or weakness
• headache
• reduced appetite

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• shortness of breath
• new or worsening cough
• coughing up blood
• chest pain
• diarrhea
• stomach area pain or tenderness
• stools that are black, tarry, sticky, or contain blood
• tiredness or weakness
• feeling cold
• deepening of voice or hoarseness
• rapid heartbeat
• increased sweating
• changes in weight (gain or loss)
• changes in mood or behavior (decreased sex drive, irritability, or forgetfulness)
• pain, burning, tingling, or numbness in the hands or feet
• headaches, including those that are unusual or will not go away
• confusion
• fever
• hair loss
• itching, rash, hives, or blisters on your skin
• constipation
• nausea
• vomiting
• drowsiness
• dizziness or fainting
• yellowing of skin or eyes, dark-colored urine, bleeding or bruising more easily than normal, loss of appetite, decreased energy, or pain on right side of stomach area
• increased thirst
• decreased or increased urination
• swelling of face, arms, legs, feet or ankles
• blood in urine
• changes in vision, including sensitivity to light
• breath that smells fruity
• painful sores in mouth, nose, throat, or genital area

Nivolumab and relatlimab may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body’s response to nivolumab and relatlimab.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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