Nivolumab and relatlimab is used to treat people 12 years or older who weigh at least 88 lbs (40 kg) with a type of skin cancer called melanoma that has spread or cannot be removed by surgery.

Nivolumab and relatlimab may also be used for purposes not listed in this medication guide.

Call your doctor at once if you have: new or worsening cough, shortness of breath, diarrhea or more frequent bowel movements than usual, severe abdominal pain or tenderness, severe nausea or vomiting, pain on the right side of your stomach area.

Also call your doctor at once if you have: extreme tiredness, weight gain or loss, decrease in the amount of urine, blood in your urine, rash, itching, irregular heartbeat, new or worse chest pain, memory problems, changes in mood or behavior, severe muscle pain or weakness, bruising.

Follow all directions on your prescription label and read all medication guides or instruction sheets.

Nivolumab and relatlimab is injected into a vein by a healthcare provider over 30 minutes.

Nivolumab and relatlimab is usually given every 4 weeks and your healthcare provider will tell you how many treatments you need.

Your treatment with nivolumab and relatlimab may be delayed or permanently discontinued if you have certain side effects.

You will need frequent blood tests to check for side effects.

Usual Adult Dose for Malignant Melanoma:

Recommended dose: 480 mg nivolumab and 160 mg relatlimab IV every 4 hours

Duration of therapy: Until disease progression or unacceptable toxicity occurs

Use: Unresectable or metastatic melanoma

Usual Pediatric Dose for Malignant Melanoma:

Recommended dose: 480 mg nivolumab and 160 mg relatlimab IV every 4 hours in pediatric patients 12 years of age or older who weight at least 40 kg

Duration of therapy: Until disease progression or unacceptable toxicity occurs

Use: Unresectable or metastatic melanoma

Tell your doctor if you have ever had:

• a nervous system problem, such as myasthenia gravis or Guillain-Barré syndrome;

• a immune system problem, such as Crohn's disease, ulcerative colitis, or lupus;

• received or plan to receive a stem cell transplant that uses donor stem cells; or

• received an organ transplant.

May harm an unborn baby. You may need a pregnancy test to make sure you are not pregnant. Use effective birth control while using nivolumab and relatlimab and for at least 5 months after your last dose. Tell your doctor if you become pregnant.

Do not breastfeed while using nivolumab and relatlimab, and for at least 5 months after your last dose.

Call your doctor for instructions if you miss an appointment for your nivolumab and relatlimab injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Nivolumab and relatlimab may cause serious side effects. Call your doctor at once if you have:

• double or blurry vision;

• severe muscle pain, cramps, or weakness;

• confusion, sleep or memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness in your extremities;

• lung problems--new or worsening cough, shortness of breath, or chest pain;

• intestinal problems--diarrhea or more frequent bowel movements than usual, bloody or tarry stools, severe stomach pain or tenderness;

• liver problems--swelling around your midsection, right-sided upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• hormonal problems--headaches that will not go away or unusual headaches, sensitivity to light, eye problems, rapid heartbeat, increased sweating, extreme tiredness, weight gain or loss, feeling more hungry or thirsty than usual, urinating more often than usual, hair loss, feeling cold, constipation, deepened voice, dizziness, fainting, changes in mood or behavior;

• kidney problems--swelling in your ankles, loss of appetite, urinating less, blood in your urine;

• skin problems--rash, itching, skin blistering or peeling, sore or ulcers in mouth, nose, throat, or genital area;

• heart problems--new or worse chest pain, irregular heartbeat, shortness of breath, tiredness, swelling in your ankles; or

• low red blood cells (anemia)--pale skin, feeling light-headed or short of breath, cold hands and feet.

Common side effects of nivolumab and relatlimab may include:

• muscle and bone pain;

• rash, itching;

• diarrhea;

• tiredness; or

• abnormal blood test results.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect nivolumab and relatlimab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.