nivolumab and relatlimab

What is the most important information I should know about nivolumab and relatlimab?

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.

What is 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.

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

What should I discuss with my healthcare provider before receiving nivolumab and relatlimab?

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.

How is nivolumab and relatlimab given?

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.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while receiving nivolumab and relatlimab?

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

What are the possible side effects of nivolumab and relatlimab?

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.

• 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 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.

What other drugs will affect nivolumab and relatlimab?

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.

Where can I get more information?

Your doctor or pharmacist can provide more information about nivolumab and relatlimab.