Ipilimumab

Ipilimumab is a prescription medication used to treat melanoma (a type of skin cancer). Ipilimumab belongs to a group of drugs called monoclonal antibodies, which help slow or stop the growth of cancer cells.

This medication comes in an injectable form to be given directly into a vein (IV) by a healthcare provider, once every 3 weeks for up to 4 doses.

Common side effects include tiredness, diarrhea, and itching.

Ipilimumab is a prescription medicine used to treat adults and pediatric patients (12 years and older) with melanoma (a kind of skin cancer) that has spread or cannot be removed by surgery.

It is also approved to help prevent melanoma from returning after it and lymph nodes that contain cancer have been removed by surgery. 

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

Ipilimumab may be found in some form under the following brand names:

• Yervoy

Ipilimumab can cause serious side effects. See “Ipilimumab Precautions."

The most common side effects of ipilimumab include:

• tiredness
• diarrhea
• itching
• rash

These are not all of the possible side effects of ipilimumab. For more information, ask your healthcare provider.

Call your healthcare provider for medical advice about side effects.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you are taking medications that suppress your immune system, including oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), prednisone (Deltasone), and prednisolone (Prelone).

This is not a complete list of ipilimumab drug interactions. Ask your doctor or pharmacist for more information.

Ipilimumab can cause serious side effects in many parts of your body which can lead to death. These side effects are most likely to begin during treatment; however, side effects can show up months after your last infusion.

These side effects may include:

1. Inflammation of the intestines (colitis) that can cause tears or holes (perforation) in the intestines. Signs and symptoms of colitis may include:
   • diarrhea (loose stools) or more bowel movements than usual
   • blood in your stools or dark, tarry, sticky stools
   • stomach pain (abdominal pain) or tenderness
2. Inflammation of the liver (hepatitis) that can lead to liver failure. Signs and symptoms of hepatitis may include:
   • yellowing of your skin or the whites of your eyes
   • dark urine (tea colored)
   • nausea or vomiting
   • pain on the right side of your stomach
   • bleeding or bruise more easily than normal
3. Inflammation of the skin that can lead to a severe skin reaction (toxic epidermal necrolysis). Signs and symptoms of severe skin reactions may include:
   • skin rash with or without itching
   • sores in your mouth
   • your skin blisters and/or peels
4. Inflammation of the nerves that can lead to paralysis. Symptoms of nerve problems may include:
   • an unusual weakness of legs, arms, or face
   • numbness or tingling in hands or feet
5. Inflammation of hormone glands (especially the pituitary, adrenal, and thyroid glands) that may affect how these glands work. Signs and symptoms that your glands are not working properly may include:
   • persistent or unusual headaches
   • unusual sluggishness, feeling cold all the time, or weight gain
   • changes in mood or behavior such as decreased sex drive, irritability, or forgetfulness
   • dizziness or fainting
6. Inflammation of the eyes. Symptoms may include:
   • blurry vision, double vision, or other vision problems
   • eye pain or redness

Call your healthcare provider if you have any of these signs or symptoms or they get worse. Do not try to treat symptoms yourself.

Getting medical treatment right away may keep the problem from becoming more serious. Your oncologist may decide to delay or stop ipilimumab.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of ipilimumab, there are no specific foods that you must exclude from your diet when receiving this medication.

Before you are given ipilimumab, tell your healthcare provider about all your health problems if you:

• have an active condition where your immune system attacks your body (autoimmune disease), such as ulcerative colitis, Crohn’s disease, lupus, or sarcoidosis
• had an organ transplant, such as a kidney transplant
• have liver damage from diseases or drugs
• have any other medical conditions
• are pregnant or plan to become pregnant. Ipilimumab may cause stillbirth, premature delivery, and/or death of your unborn baby
• are breastfeeding

Tell your healthcare provider about all the medicines you take, including all prescription and non-prescription medicines, steroids or other medicines that lower your immune response, vitamins, and herbal supplements.

Know the medicines you take. Keep a list to show your doctors and pharmacists each time you get a new medicine.

You should not start a new medicine before you talk with the healthcare provider who prescribes you ipilimumab.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Ipilimumab falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

It is not known if ipilimumab crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using ipilimumab.

You will get ipilimumab through an intravenous line in your vein (infusion). It takes about 90 minutes to get a full dose.

• Ipilimumab is usually given every 3 weeks for up to 4 doses. 
• When used to help prevent melanoma from coming back, ipilimumab is usually given every 3 weeks for 4 doses, followed by every 12 weeks for up to 3 years. 
• Your healthcare provider may change how often you receive ipilimumab or how long the infusion may take.
• Your healthcare provider should perform blood tests before starting and during treatment with ipilimumab.

It is important for you to keep all appointments with your healthcare provider. Call your healthcare provider if you miss an appointment. There may be special instructions for you.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.
The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your age

The recommended dose of ipilimumab is 3 mg/kg administered intravenously over 90 minutes every 3 weeks for a total of four doses.

The recommended dose of ipilimumab to help prevent melanoma from coming back is 10 mg/kg. It is administered into the vein (intravenously) over 90 minutes every 3 weeks for 4 doses, followed by 10 mg/kg every 12 weeks for up to 3 years. 

Ipilimumab is usually administered by a healthcare provider in a medical setting making it unlikely for an overdose to occur. However, if an overdose is suspected, seek emergency medical attention.

WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS

Ipilimumab can result in severe and fatal immune-mediated adverse reactions due to T-cell activation and proliferation. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of ipilimumab.

Permanently discontinue ipilimumab and initiate systemic high-dose corticosteroid therapy for severe immune-mediated reactions.

Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including liver function tests and thyroid function tests at baseline and before each dose.