Ipilimumab injection is used alone or in combination with nivolumab (Opdivo) to treat certain types of melanoma (a type of skin cancer) that that has spread to other parts of the body or cannot be treated with surgery. It is also used alone to prevent melanoma from returning after surgery. Ipilimumab injection is also used in combination with nivolumab to treat certain types of renal cell cancer (a type of cancer that begins in the cells of the kidneys), colorectal cancer (cancer that begins in the large intestine), hepatocellular cancer (a type of liver cancer), esophageal cancer (cancer of the tube that connects your throat to your stomach), and malignant pleural mesothelioma (a type of cancer that affects the inside lining of the lungs and chest cavity). It is also used in combination with nivolumab and other chemotherapy medications to treat a certain type of lung cancer (non-small cell lung cancer, NSCLC). Ipilimumab injection is in a class of medications called monoclonal antibodies. It works by helping the body to slow or stop the growth of cancer cells.

Your doctor will review your specific type of cancer and past treatment history and other available treatments to determine if ipilimumab is right for you.

Ipilimumab injection comes as a solution (liquid) to be injected intravenously (into a vein) by a doctor or nurse in a hospital or medical facility. When ipilimumab is given alone to help prevent the return of melanoma, it is usually given over 90 minutes once every 3 weeks for 4 doses and then once every 12 weeks as long as your doctor recommends that you receive treatment. When ipilimumab is given alone or along with nivolumab to treat melanoma, renal cell carcinoma, hepatocellular carcinoma, or colorectal cancer, it is usually given over 30 minutes once every 3 weeks for up to 4 doses. When ipilimumab is given with nivolumab to treat malignant pleural mesothelioma, esophageal cancer, or with nivolumab and other chemotherapy medications to treat NSCLC, it is usually given over 30 minutes once every 6 weeks for as long as your doctor recommends that you receive treatment.

Ipilimumab injection may cause serious or life-threatening reactions during an infusion. A doctor or nurse will watch you closely while you are receiving the infusion and shortly after the infusion to be sure you are not having a serious reaction to the medication. 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, or feeling faint.

Your doctor may slow down your infusion, delay, or stop your treatment with ipilimumab 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.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with ipilimumab and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.

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

Before receiving ipilimumab injection,

• tell your doctor and pharmacist if you are allergic to ipilimumab injection, any other medications, or any of the ingredients in ipilimumab injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• 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 received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic) 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 (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum), lupus (a condition in which the immune system attacks many tissues and organs including the skin, joints, blood, and kidneys); any condition that affects your nervous system such as myasthenia gravis (a disorder of the nervous system that causes muscle weakness) or Guillain-Barré syndrome (weakness, tingling, and possible paralysis due to sudden nerve damage); thyroid problems; 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 ipilimumab. You should use effective birth control to prevent pregnancy during your treatment with ipilimumab injection and for 3 months after your final dose. Talk to your doctor about birth control methods that will work for you. If you become pregnant while receiving ipilimumab injection, call your doctor immediately. Ipilimumab injection may harm the fetus.
• tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while receiving ipilimumab injection and for 3 months after your final dose.

Unless your doctor tells you otherwise, continue your normal diet.

Ipilimumab may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• difficulty falling asleep or staying asleep
• joint pain

Some side effects can be serious. If you experience any of the symptoms, call your doctor immediately or get emergency medical treatment.

• decreased urination, blood in urine, swelling of feet, ankles, or lower legs, or loss of appetite
• diarrhea, bloody or black, tarry, sticky stools, severe stomach pain or tenderness, or fever
• cough, chest pain, or shortness of breath
• tiredness, confusion, memory problems, hallucinations, seizures, or stiff neck
• feeling tired, increased appetite, increased thirst, increased urination, or weight loss
• rapid heartbeat, uncontrollable shaking of a part of the body or sweating
• fatigue or sluggishness, increased sensitivity to cold, constipation, muscle ache and weakness, weight gain, heavier than normal or irregular menstrual periods, thinning hair, headache, dizziness, irritability, forgetfulness, decreased sex drive, or depression
• yellowing of skin or eyes, dark (tea-colored) urine, pain in upper right part of the stomach, nausea, vomiting, or easy bruising or bleeding
• unusual weakness of legs, arms, or face; or numbness or tingling in hands or feet
• rash with or without itching, blistering or peeling skin, or mouth sores
• blurred vision, double vision, eye pain or redness, or other vision problems

Ipilimumab injection may cause other side effects. Call your doctor if you have any unusual problems while you are receiving 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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

Ask your pharmacist any questions you have about ipilimumab injection.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests before and during your treatment to see if it is safe for you to receive ipilimumab injection and to check your body’s response to ipilimumab injection.

For some conditions, your doctor will order a lab test before you begin your treatment to see whether your cancer can be treated with ipilimumab.

Ask your pharmacist any questions you have about ipilimumab injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Yervoy^®