Nivolumab and relatlimab-rmbw

Nivolumab and relatlimab is used to treat certain types of melanoma (a type of skin cancer). 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 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 while you are receiving an infusion. 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.

You will be given the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm to obtain the Medication Guide.

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

Before taking nivolumab and relatlimab,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• 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; constipation; deepening of voice or hoarseness; rapid heartbeat; increased sweating; increased urination, changes in weight (gain or loss); changes in mood or behavior (decreased sex drive, irritability, or forgetfulness); headaches, including those that are unusual or will not go away; dizziness or fainting; hair loss
• confusion; pain, burning, tingling, or numbness in the hands or feet
• fever; itching, rash, hives, or blisters on your skin
• drowsiness
• yellowing of skin or eyes, dark-colored urine, nausea, vomiting, bleeding or bruising more easily than normal, loss of appetite, decreased energy, or pain on right side of stomach area
• increased thirst; decreased urination; swelling of face, arms, legs, feet or ankles; blood in urine
• changes in vision, including sensitivity to light
• 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 (https://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.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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