Why is Ipilimumab prescribed?

Ipilimumab is used:

• to treat melanoma (a type of skin cancer) in adults and children 12 years of age and older that cannot be treated with surgery or that has spread to other parts of the body.
• to help prevent melanoma from coming back after surgery to remove it and any affected lymph nodes.
• in combination with nivolumab (Opdivo) to treat advanced renal cell carcinoma (RCC; a type of cancer that begins in the cells of the kidneys).
• in combination with nivolumab to treat certain types of colorectal cancer (cancer that begins in the large intestine) in adults and children 12 years of age and older that has spread to other parts of the body and has worsened after treatment with other chemotherapy medications.
• in combination with nivolumab to treat hepatocellular carcinoma (HCC; a type of liver cancer) in people who were previously treated with sorafenib (Nexafar).
• in combination with nivolumab to a certain type of lung cancer (non-small cell lung cancer; NSCLC) in adults that has spread to other parts of the body.
• in combination with nivolumab and platinum chemotherapy to treat NSCLC in adults that has returned or has spread to other parts of the body.
• in combination with nivolumab to treat malignant pleural mesothelioma (a type of cancer that affects the inside lining of the lungs and chest cavity) in adults that cannot be removed by surgery.

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.

How should ipilimumab medicine be used?

Ipilimumab injection comes as a liquid to be injected into a vein by a doctor or nurse in a hospital or medical facility.

• For melanoma, it is usually given over 90 minutes once every 3 weeks for as long as your doctor recommends that you receive treatment
• When given with nivolumab to treat renal cell carcinoma (kidney cancer), hepatocellular carcinoma (liver cancer), or colorectal cancer, it is usually given over 30 minutes once every 3 weeks for up to 4 doses.
• If given with nivolumab or with nivolumab and platinum chemotherapy to treat NSCLC (lung cancer), it is usually given over 30 minutes once every 6 weeks for as long as your doctor recommends that you receive treatment.
• When given with nivolumab to treat malignant pleural mesothelioma, 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 side effects. 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.

Other uses for Ipilimumab

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

What special precautions should I follow with Ipilimumab?

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.
• 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.
• if you have ever had an organ transplant, liver disease, or if your liver has been damaged by a medication or an illness. 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), or sarcoidosis (condition in which clumps of abnormal cells grow in various parts of the body including the lungs, skin, and eyes).
• 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.
• if you are breastfeeding or plan to breastfeed. You should not breastfeed while receiving ipilimumab injection and for 3 months after your final dose.

What special dietary instructions should I follow?

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

What side effects can Ipilimumab cause?

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

Serious side effects

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, increased appetite, 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 (Emesis), 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 emergency/overdose

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.

What other information should I know?

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 an 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.

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.

Brand names

• Yervoy^®

Last Revised – 11/15/2020