Ipilimumab (Yervoy) is an immunotherapy used to treat specific cancers, including melanoma, non-small cell lung cancer (NSCLC), pleural mesothelioma, esophageal cancer, kidney cancer (RCC), liver cancer, or colorectal cancer. Ipilimumab can be used alone or combined with another cancer medicine such as Opdivo (nivolumab).

Ipilimumab is a monoclonal antibody that blocks a protein (antigen) that can stop your immune system from working properly and attacking cancer cells. When ipilimumab has blocked the protein (CTLA-4) the immune system is able to find and kill the cancer cells.

Ipilimumab is from the class of medicines called immune checkpoint inhibitors, and because it blocks the T-lymphocyte antigen 4 (CTLA-4), it is called a CTLA-4 inhibitor.

Ipilimumab will be given to you as an infusion in your arm every 3 to 6 weeks, depending on your treatment plan.

Ipilimumab is a medicine that may treat certain cancers by working with your immune system. Ipilimumab can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You may have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended. Some of these problems may happen more often when ipilimumab is used in combination with nivolumab.

Call your doctor at once if you have: chest pain, cough, shortness of breath, vision changes, severe muscle pain or weakness, diarrhea and severe stomach pain, blood in your stools, little or no urinating, swelling, bruising, or bleeding, dark urine, yellowing of the skin or eyes, confusion, hallucinations, a seizure, skin blistering, or a hormonal disorder (frequent headaches, feeling light-headed, increased thirst or urination, feeling cold, weight gain or loss).

Ipilimumab is given as an infusion into a vein by your doctor or nurse. The medicine is given slowly and will take between 30 to 90 minutes. Different cancers have different dosing schedules, so depending on your cancer, it could be one dose of ipilimumab every 3 weeks or up to every 6 weeks. Your healthcare provider will work out the ideal dose, dosing schedule, and how long you will be treated with this medicine.

You may be given ipilimumab as a single cancer treatment, or it may be used in combination with other treatments. When having cancer treatment, you are often given other medications to treat or prevent any side effects.

You may be given frequent medical tests to check that your medicine is not causing harmful side effects. Your cancer treatments may be delayed based on the results.

You should not receive this medicine if you are allergic to the active ingredient ipilimumab or any of the inactive ingredients.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• liver problems;
• an autoimmune disorder (lupus, sarcoidosis, Crohn's disease, ulcerative colitis);
• an organ transplant or stem cell transplant; or
• a nerve-muscle disorder, such as myasthenia gravis, or Guillain-Barre syndrome.

Ipilimumab is not approved for use by anyone younger than 12 years old, and for some types of cancer, it is used only in adults.

Pregnancy

Ipilimumab may harm an unborn baby.

You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 3 months after your last dose. Tell your doctor if you become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of ipilimumab on the baby.

Breastfeeding

Do not breastfeed while using this medicine and for at least 3 months after your last dose.

Common ipilimumab side effects

The most common side effects include:

• fever, cough, shortness of breath;
• nausea, vomiting, stomach pain, loss of appetite;
• diarrhea, constipation;
• weight loss;
• hormonal problems;
• rash or itching;
• headache, dizziness, tiredness;
• sleep problems (insomnia); or
• pain in your muscles, joints, or bones.

Serious ipilimumab side effects

Get emergency medical help if you have signs of an allergic reaction to this medicine (hives, difficulty 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 occur during the injection. Tell your caregiver if you feel dizzy, light-headed, short of breath, itchy, tingly, chilled, or feverish.

Serious and sometimes fatal reactions may occur during treatment with this medicine or months after your last dose. Call your doctor right away if you have symptoms such as:

• severe or ongoing diarrhea, severe stomach pain, bloody or tarry stools;
• fever, swollen glands, body aches;
• new or worsening skin rash, itching, or blistering;
• painful sores in mouth or nose, throat, or genital area;
• chest pain, irregular heartbeats;
• severe muscle weakness, ongoing pain in your muscles or joints;
• numbness or tingling in your hands or feet;
• vision problems, eye pain or redness;
• lung problems - new or worsening cough, chest pain, feeling short of breath;
• kidney problems - little or no urination, swelling in your feet or ankles, blood in your urine;
• liver problems - right-sided upper stomach pain, tiredness, bruising or bleeding, dark urine, yellowing of your skin or eyes;
• signs of a hormonal disorder - frequent or unusual headaches, lack of energy, dizziness, fainting, mood or behavior changes, increased thirst or urination, feeling cold, weight gain, or weight loss; or
• symptoms of brain swelling - confusion, headache, memory problems, hallucinations, neck stiffness, drowsiness, seizure (convulsions).

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

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 the FDA at 1-800-FDA-1088.

Some medications interact with ipilimumab, so it is important to tell your doctor about any medicines that you are currently taking, or if you start or stop any medicine while you are having cancer treatment. Also, tell your doctor about any over-the-counter medicines, vitamins, minerals, or herbal products that you take.