ipilimumab

What is the most important information I should know about ipilimumab?

Before you receive ipilimumab, tell your doctor if you have liver damage, an autoimmune disorder such as lupus or sarcoidosis, Crohn's disease, ulcerative colitis, or if you have received an organ transplant.

Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

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

• diarrhea, increased bowel movements, black or bloody stools, stomach tenderness;
• pain in your upper stomach, dark urine, jaundice (yellowing of the skin or eyes), easy bruising or bleeding;
• unusual muscle weakness, numbness or tingling in your hands or feet;
• unusual headaches, feeling cold or tired, weight gain, dizzy spells, mood changes, irritability, confusion;
• mouth sores, skin rash with or without itching, blistering or peeling, skin sores with bleeding; or
• eye pain, or vision problems.

What is ipilimumab?

Ipilimumab is a cancer medication 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 and has not spread to other parts of the body.

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

What should I discuss with my healthcare provider before receiving ipilimumab?

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

To make sure you can safely receive ipilimumab, tell your doctor if you have any of these other conditions:

• liver damage (caused by disease or by using certain medicines);
• an autoimmune disorder such as systemic lupus erythematosus (SLE) or sarcoidosis;
• Crohn's disease or ulcerative colitis; or
• if you have received an organ transplant.

FDA pregnancy category C. It is not known whether ipilimumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

In animal studies, ipilimumab caused stillbirth, premature delivery, low birth weight, miscarriage in the third trimester, and infant death. However, very high doses are used in animal studies. It is not known whether these effects would occur in people using doses recommended for human use. Ask your doctor about your individual risk.

It is not known whether ipilimumab passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are receiving ipilimumab.

How is ipilimumab given?

Ipilimumab is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Ipilimumab must be given slowly, and the IV infusion can take about 90 minutes to complete.

Ipilimumab is usually given every 3 weeks for up to 4 doses. Follow your doctor's instructions.

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

To make sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests. Do not miss any follow-up visits to your doctor.

What happens if I miss a dose?

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

What happens if I overdose?

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

What should I avoid while receiving ipilimumab?

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

What are the possible side effects of ipilimumab?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

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

• diarrhea, increased bowel movements, black or bloody stools, stomach tenderness;
• pain in your upper stomach, dark urine, jaundice (yellowing of the skin or eyes), easy bruising or bleeding;
• unusual muscle weakness, numbness or tingling in your hands or feet;
• unusual headaches, feeling cold or tired, weight gain, dizzy spells, mood changes, irritability, confusion;
• mouth sores, skin rash with or without itching, blistering or peeling, skin sores with bleeding; or
• eye pain, or vision problems.

Call your doctor at once if you have any of these other serious side effects:

• severe stomach pain, bloating, constipation, or vomiting;
• having several more bowel movements per day than before you started receiving ipilimumab;
• loss of bowel control;
• trouble with daily activities;
• feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;
• urinating less than usual or not at all;
• severe upper stomach pain spreading to your back, nausea and vomiting, fast heart rate;
• fever, cough, trouble breathing; or
• chest pain, feeling short of breath (even with mild exertion), swelling, rapid weight gain.

Less serious side effects may include:

• feeling tired;
• mild diarrhea; or
• mild skin rash or itching.

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 ipilimumab?

There may be other drugs that can interact with ipilimumab. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about ipilimumab.