Nivolumab and relatlimab

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.

Your doctor will confirm that you have the right type of tumor to be treated with nivolumab and relatlimab.

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

Nivolumab and relatlimab is given as an infusion into a vein by a healthcare provider. This medicine must be given slowly, and the infusion can take 30 minutes to complete.

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

You will need frequent medical tests, and your next dose may be delayed based on the results.

Nivolumab and relatlimab can cause side effects in many different parts of your body. You may be given medication to prevent certain side effects.

Call your doctor right away if you have: a new or worsening cough, trouble breathing, diarrhea or more frequent bowel movements than usual, severe pain or tenderness in your abdomen, severe nausea or vomiting, or pain on the right side of your stomach.

Also call your doctor right away if you have: extreme tiredness, weight gain or loss, less urine than usual, blood in your urine, a rash, itching, an irregular heartbeat, new or worse chest pain, problems with memory, changes in mood or behavior, severe muscle pain or weakness, or bruising.

Tell your doctor if you have or have ever had:

• received a medication similar to nivolumab and relatlimab;
• chemotherapy or radiation treatment;
• a nervous system disorder such as myasthenia gravis or Guillain-Barré syndrome;
• an autoimmune disorder (lupus, Crohn's disease, ulcerative colitis);
• an organ transplant, or a stem cell transplant from a donor; 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 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.

Get emergency medical help if you have signs of an allergic reaction (hives, trouble breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Some side effects may happen during the injection. Tell your caregiver immediately if you feel dizzy, light-headed, like you might faint, short of breath, itchy, or tingly, or if you have a fever, chills, back pain, or neck pain.

Nivolumab and relatlimab may cause serious side effects. Call your doctor right away 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 arms or legs;
• 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, pain in the upper right stomach, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• hormonal problems—headaches that do not go away or unusual headaches, sensitivity to light, eye problems, rapid heartbeat, increased sweating, extreme tiredness, weight gain or loss, feeling hungrier or thirstier 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, sores 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.

Your cancer treatments may be delayed or stopped permanently if you have certain side effects.

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.

Usual Adult Dose for Malignant Melanoma:

Recommended dose: 480 mg nivolumab and 160 mg relatlimab intravenously every 4 weeksDuration of therapy: Until disease progression or unacceptable toxicity occursUse: For the treatment of patients with unresectable or metastatic melanoma

Usual Pediatric Dose for Malignant Melanoma:

Recommended dose: 480 mg nivolumab and 160 mg relatlimab intravenously every 4 weeks in pediatric patients 12 years of age or older who weigh at least 40 kgDuration of therapy: Until disease progression or unacceptable toxicity occursComments:-No dosage recommendation has been established for pediatric patients 12 years and older weighing less than 40 kg. Use: For the treatment of patients with unresectable or metastatic melanoma

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.

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.