Why would this drug be used?
This drug is used to treat melanoma that can't be removed with surgery or has spread to other parts of the body. It is also being studied for use in earlier stages of melanoma and in other types of cancer.
How does this drug work?
Ipilimumab is a type of immunotherapy known as a monoclonal antibody. A monoclonal antibody is a man-made version of an immune system protein that fits like a lock and key with a certain protein in the body.
Ipilimumab is designed to seek out and lock onto CTLA-4, a protein that normally helps keep immune system cells called T cells in check. By blocking the action of CTLA-4, ipilimumab is thought to boost the immune response against melanoma cells in the body.
Before taking this medicine
Tell your doctor…
- If you are allergic to anything, including medicines, dyes, additives, or foods.
- If you have any condition where your immune system attacks your body (an autoimmune disease), such as ulcerative colitis, Crohn's disease, lupus, or sarcoidosis. This drug could make these conditions worse.
- If you have any type of liver disease, such as hepatitis or cirrhosis. This drug may cause the immune system to attack the liver, which could make any existing liver disease worse.
- If you have had an organ transplant, such as a kidney transplant. By boosting your body's immune system, this drug might increase the chance that your body could reject the transplanted organ.
- If you have any other medical conditions such as kidney disease, heart disease, congestive heart failure, diabetes, gout, or infections. Your doctor may need to monitor you more closely during treatment.
- If you are pregnant, trying to get pregnant, or if there is any chance of pregnancy. It is not known if this drug might cause problems if either the male or female is taking it at the time of conception or during pregnancy. Animal studies (monkeys) had more infant deaths and low birth weight offspring when the drug was given to pregnant females. Men and women who will be taking this drug should talk with their doctor about birth control, including what kinds of birth control can be used with this medicine. This drug should be used during pregnancy only if the potential benefit is thought to justify the potential risk to the fetus.
- If you are breast-feeding. Studies in animals suggest that this drug may pass into breast milk and affect the baby.
- If you think you might want to have children in the future. It is not known whether or not this drug can affect fertility. Talk with your doctor about the possible risk with this drug and the options that may preserve your ability to have children.
- About any other prescription or over-the-counter medicines you are taking, including vitamins and herbs. In fact, keeping a written list of each of these medicines (including the doses of each and when you take them) with you in case of emergency may help prevent complications if you get sick.
Interactions with other drugs
No serious interactions with other drugs are known at this time, but this does not necessarily mean that none exist. Check with your doctor, nurse, or pharmacist about your other medicines, herbs, and supplements, and whether alcohol can cause problems with this medicine.
Interactions with foods
No serious interactions with food are known at this time. Check with your doctor, nurse, or pharmacist about whether some foods may be a problem.
Tell all the doctors, dentists, nurses, and pharmacists you visit that you are taking this drug.
How is this drug taken or given?
Ipilimumab is given as an infusion into a vein (IV), usually over about 90 minutes. It is given once every 3 weeks for a total of 4 doses. The dose given is based on your body weight.
The next dose may need to be delayed if you have minor immune-related side effects, or the drug may need to be stopped permanently if you have more serious side effects.
This drug works by basically taking the brakes off the body's immune system. This can lead to serious side effects if the immune system starts to attack other parts of the body. In some people these side effects have been fatal. They most often occur during treatment, but some have been reported up to a few months after treatment has finished. If they do occur, treatment may need to be stopped and you may get high doses of corticosteroids to suppress your immune system.
This drug may cause inflammation of the intestines (known as colitis), which can lead to tears or holes in the intestines. Tell your doctor or nurse right away if you start to have abdominal (belly) pain, fever, diarrhea, blood in your stools, or dark colored stools.
This drug may cause inflammation in the liver, which in some cases may lead to liver failure. Your doctor will order blood tests to make sure your liver is working well and will check you for signs of liver problems before each treatment. Tell your doctor or nurse right away if you have yellowing of the skin or the whites of your eyes (jaundice), dark urine, nausea or vomiting, pain on the right side of your belly, or any abnormal bruising or bleeding.
This drug may cause severe skin reactions, which in some cases may be life-threatening. Your doctor will check you for signs of rash or itching. Tell your doctor or nurse right away if you notice a new skin rash, itching, sores in your mouth, or if your skin blisters or peels.
This drug may cause inflammation of the nerves, which in severe cases may cause paralysis. Your doctor will check you for any signs of muscle weakness or changes in sensation. Tell your doctor or nurse right away if you notice any unusual weakness in your face, arms, or legs, or if you have numbness or tingling in your hands or feet.
This drug may affect certain hormone-making glands, such as the thyroid, pituitary, or adrenal glands. This could lead to low levels of important hormones in the body. Your doctor will order blood tests to check your thyroid and other organs before each treatment and will check you for signs of hormone problems. Tell your doctor or nurse right away if you have constant or unusual headaches, feel tired or cold all the time, if you gain weight unexpectedly, if you notice changes in your mood or ability to concentrate, if you have a change in the pattern of your bowel movements, or if you feel dizzy or faint.
This drug may cause inflammation of the eyes. Tell your doctor or nurse right away if you start to have vision problems or have pain or redness in the eyes.
In rare cases this drug may cause the immune system to affect other parts of the body, such as the heart, brain, lungs, kidneys, pancreas, blood vessels, or joints. Be sure to tell your doctor or nurse right away about any new symptoms you are having.
In rare cases, this drug may cause allergic reactions in some people while the drug is being given. Mild reactions usually consist of fever and chills. More serious reactions happen rarely, but can be dangerous. Symptoms can include feeling lightheaded or dizzy (due to low blood pressure), fainting, headache, feeling warm or flushed, fever or chills, hives, itching, shortness of breath, changes in heart rate, pain the back or abdomen, or swelling of the face, tongue, or throat. Tell your doctor or nurse right away if you notice any of these symptoms during or after being given the drug.
Do not get any immunizations (vaccinations), either during or after treatment with this drug, without your doctor's OK.
Possible side effects
Most of the following side effects probably will not occur. Your doctor or nurse will want to discuss specific care instructions with you. They can help you understand these side effects and help you deal with them.
- Feeling tired
- Skin rash
- Inflammation of the intestines (colitis)*
- Inflammation of the liver*
- Severe skin reactions*
- Inflammation of the nerves*
- Low levels of important hormones*
- Inflammation of the eyes*
- Inflammation of the heart, blood vessels, lungs, or other organs*
- Allergic reaction during the infusion*
- Death due to the immune system attacking part of the body*
*See the Precautions section for more detailed information.
There are other side effects not listed above that can also occur in some patients. Tell your doctor or nurse if you develop these or any other problems.
Yes – first approved in 2011
Disclaimer: This information may not cover all possible uses, actions, precautions, side effects, or interactions. It is not intended as medical advice, and should not be relied upon as a substitute for talking with your doctor, who is familiar with your medical needs.
Last Revised: 11/20/2012