(i pi lim′ ue mab)

Trade name : Yervoy

Ipilimumab is the generic name for the trade drug name Yervoy®. In some cases, health care professionals may use the generic name ipilimumab when referring to the trade drug name Yervoy®.

Drug type : Ipilimumab is a monoclonal antibody- (For more detail, see "How this drug works," below).

What Ipilimumab Is Used For:

• For the treatment of melanoma.
• For treatment of patients with metastatic non-small cell lung cancer whose tumors express PD-L1, with no EGFR or ALK genomic tumor abnormalities. Given in combination with nivolumab.
• For treatment of patients with renal cell cancer who have had no prior treatment. Given in combination with nivolumab.

Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.

How Ipilimumab Is Given:

• Ipilimumab is given as an intravenous injection through a vein (IV).
• You may receive medications before the infusion to reduce allergic reactions.
• The amount of ipilimumab that you will receive depends on many factors, including your weight, your general health or other health problems, and the type of cancer or condition being treated. Your doctor will determine your dose and schedule.

Side Effects:

Important things to remember about the side effects of Ipilimumab:

• Most people do not experience all of the side effects listed.
• Side effects are often predictable in terms of their onset and duration.
• A few side effects can occur weeks or months after discontinuation of treatment.
• There are many options to help manage and prevent worsening of side effects.
• There is no relationship between the presence or severity of side effects and the effectiveness of the medication.

The following side effects are common (occurring in greater than 30%) for patients taking ipilimumab:

• Fatigue
• Diarrhea
• Itching
• Rash
• Nausea/vomiting

These side effects are less common side effects (occurring in about 10-29%) of patients receiving ipilimumab:

• Decreased appetite
• Constipation
• Cough
• Headache
• Abdominal pain
• Shortness of breath
• Anemia
• Fever

A serious, but uncommon side effect of ipilimumab may be an immune-mediated reaction. When this side effect occurs, it affects primarily the bowels, liver, skin, nerves and the endocrine system. This immune reaction can occur during treatment but can also be seen weeks or months after discontinuation of treatment. Symptoms of this reaction will be monitored throughout treatment (diarrhea, rash, and neuropathy). Lab work will check for elevated liver enzymes and thyroid function.

Contact your health care provider right away if you have any new or worsening symptoms.

Not all side effects are listed above. Some that are rare (occurring in less than 10% of patients) are not listed here. However, you should always inform your health care provider if you experience any unusual symptoms.

When to contact your doctor or health care provider:

Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:

• Fever of 100.4° F (38° or higher)
• Chills
• Signs of reaction to the drug (wheezing, chest tightness, itching, bad cough, swelling of the face, lips, tongue or throat).
• Always inform your health care provider if you experience any unusual symptoms.
• Diarrhea
• Blood in your stools or dark, tarry, sticky stools
• Stomach pain or tenderness, especially right side
• Nausea (interferes with ability to eat and unrelieved with prescribed medication)
• Vomiting (vomiting more than 4-5 times in a 24 hour period)
• Unable to eat or drink for 24 hours or have signs of dehydration: tiredness, thirst, dry mouth, dark and decrease amount of urine, or dizziness
• Skin or the whites of your eyes turn yellow
• Urine turns dark or brown (tea color)
• Decreased appetite
• Bleed or bruise more easily than normal
• Skin rash with or without itching
• Sores in the mouth
• Skin blisters and/or peels
• Unusual weakness of legs, arms or face
• Numbness or tingling in hands or feet
• 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
• Blurry vision, double vision or other vision problems
• Eye pain or redness

Always inform your health care provider if you experience any unusual symptoms.

Precautions:

• Before starting ipilimumab treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.).
• Do not receive any kind of immunization or vaccination without your doctor's approval while taking ipilimumab.
• Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Pregnancy category C (ipilimumab may be hazardous to the fetus. Women who are pregnant or become pregnant must be advised of the potential hazard to the fetus.)
• For both men and women: Do not conceive a child (get pregnant) while taking ipilimumab. Barrier methods of contraception, such as condoms, are recommended. Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.
• Do not breast feed while taking this medication.

Self-Care Tips:

• Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
• If you should experience nausea, take anti-nausea medications as prescribed by your doctor, and eat small frequent meals. Sucking on lozenges and chewing gum may also help.
• Avoid sun exposure. Wear SPF 15 (or higher) sun block and protective clothing.
• In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.
• Get plenty of rest.
• Maintain good nutrition.
• Wash your hands often
• You may be at risk for infection, report fever or any other signs of infection immediately to your healthcare provider
• Discuss with your health care provider before taking any other medications including over the counter and herbal preparations.
• To help prevent mouth sores use a soft toothbrush, and rinse three times a day with ½ to 1 teaspoon of baking soda and/or ½ to 1 teaspoon of salt mixed with 8 ounces of water
• If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.

Monitoring and Testing:

You will be checked regularly by your health care professional while you are taking ipilimumab, to monitor side effects and check your response to therapy.

How Ipilimumab Works:

Ipilimumab is classified as a monoclonal antibody. Monoclonal antibodies are a relatively new type of “targeted” cancer therapy.

Antibodies are an integral part of the body’s immune system. Normally, the body creates antibodies in response to an antigen (such as a protein in a germ) that has entered the body. The antibodies attach to the antigen in order to mark it for destruction by the immune system.

To make anti-cancer monoclonal antibodies in the laboratory, scientists analyze specific antigens on the surface of cancer cells (the targets). Then, using animal and human proteins, they create a specific antibody that will attach to the target antigen on the cancer cells. When given to the patient, these monoclonal antibodies will attach to matching antigens like a key fits a lock.

Since monoclonal antibodies target only specific cells, they may cause less toxicity to healthy cells. Monoclonal antibody therapy is usually only given for cancers in which antigens (and the respective antibodies) have been identified already.

Ipilimumab works by targeting the CTLA-4 antigen on normal and malignant T-cells. Ipilimumab binds to the CTLA-4 which augments T-cell activation and proliferation. The mechanism of action of ipilimumab’s effect in patients with melanoma is indirect, possibly through T-cell mediated anti-tumor immune responses.

Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.

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