ipilimumab (Yervoy)

Brand Names: Yervoy

Generic Name: ipilimumab

• What is ipilimumab (Yervoy)?
• What are the possible side effects of ipilimumab (Yervoy)?
• What is the most important information I should know about ipilimumab (Yervoy)?
• What should I discuss with my healthcare provider before receiving ipilimumab (Yervoy)?
• How is ipilimumab given (Yervoy)?
• What happens if I miss a dose (Yervoy)?
• What happens if I overdose (Yervoy)?
• What should I avoid while receiving ipilimumab (Yervoy)?
• What other drugs will affect ipilimumab (Yervoy)?
• Where can I get more information (Yervoy)?

Ipilimumab is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Ipilimumab is used to treat melanoma (skin cancer) that cannot be treated with surgery or has spread to other parts of the body. Ipilimumab is also used to prevent melanoma from coming back after surgery, including lymph node removal surgery.

Ipilimumab is also used to treat kidney cancer, sometimes given with another medicine called nivolumab (Opdivo).

Ipilimumab is also used to treat colorectal cancer that has spread to other parts of the body, that has certain specific DNA mutations, and that has not responded to chemotherapy with other medicines.

Ipilimumab may also be used for purposes not listed in this medication guide.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult 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, itchy, warm, tingly, feverish, chilled, or light-headed.

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

• stomach pain, nausea, vomiting, loss of appetite, diarrhea, bloody or tarry stools;
• dark urine, jaundice (yellowing of the skin or eyes);
• fever, neck stiffness, headache, feeling cold or tired;
• mood or behavior changes, dizziness, drowsiness, confusion, hallucinations;
• a seizure;
• memory problems, trouble with daily activities;
• muscle weakness, numbness or tingling;
• new or worsening cough, chest pain, shortness of breath;
• little or no urination, swelling in your ankles, blood in your urine; or
• eye pain or vision problems.

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

Common side effects may include:

• fever, cough;
• nausea, diarrhea, loss of appetite, weight loss;
• rash or itching;
• headache, tiredness; or
• pain in your muscles, joints, or bones.

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.

Serious and sometimes fatal reactions may occur during treatment with ipilimumab, or months after stopping. Call your doctor right away if you have symptoms such as: stomach pain, diarrhea, bloody or tarry stools, dark urine, yellowing of your skin or eyes, neck stiffness, headache, confusion, mood or behavior changes, vision problems, muscle weakness, numbness or tingling, trouble with daily activities, chest pain, cough, or shortness of breath.

You should not receive ipilimumab if you are allergic to it.

Tell your doctor if you have ever had:

• liver damage caused by disease or by using certain medicines;
• an autoimmune disorder such as lupus or sarcoidosis;
• Crohn's disease or ulcerative colitis; or
• an organ transplant.

Ipilimumab may harm an unborn baby. 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.

In animal studies, ipilimumab caused miscarriage, premature delivery, low birth weight, stillbirth, and infant death. However, it is not known whether these effects would occur in humans. Ask your doctor about your risk.

You should not breast-feed while you are receiving ipilimumab and for at least 3 months after your last dose.

Ipilimumab is not approved for use by anyone younger than 12 years old.

Ipilimumab is given as an infusion into a vein. A healthcare provider will give you this injection.

This medicine must be given slowly, and the infusion can take up to 90 minutes to complete.

Ipilimumab is usually given once every 3 weeks for up to 4 doses. Additional doses may be given once every 2 to 12 weeks. Follow your doctor's dosing instructions very carefully.

You may be given other medications to treat or prevent certain side effects.

You may need frequent medical tests to be sure this medicine is not causing harmful effects. Your cancer treatments may be delayed based on the results of these tests.

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Call your doctor for instructions if you miss an appointment for your ipilimumab injection.

Since ipilimumab is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

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

Other drugs may affect ipilimumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Your pharmacist can provide more information about ipilimumab.

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