Ipilimumab injection may cause severe or life-threatening side effects. This includes inflammation of the intestine, which may cause tears in its walls; inflammation of the liver, which may cause severe liver damage; inflammation of the skin, which may cause a serious skin reaction; inflammation of the nerves, which may cause paralysis (loss of ability to move all or part of the body); inflammation of certain glands, which may affect how the glands work; or inflammation of the eyes. You may develop these symptoms during your treatment or during the first few weeks or months after you finish your treatment. If you experience any of the following symptoms, call your doctor immediately: diarrhea or frequent bowel movements; bloody or black, tarry, sticky stools; stomach pain or tenderness; yellowing of the skin or eyes; dark (tea-colored) urine; pain in the upper right part of the stomach; nausea or vomiting; easy bruising or bleeding; rash that may or may not be itchy; blistering or peeling skin; sores in the mouth; unusual weakness of the legs, arms, or face; numbness or tingling in the hands or feet; headaches that are unusual or that don't go away; sluggishness; feeling cold all the time; weight gain; decreased sex drive; irritability; forgetfulness; dizziness; changes in mood or behavior; fainting; blurred vision; double vision; other vision problems; or eye pain or redness. Call your doctor even if you feel that the symptoms you are experiencing are mild and do not try to treat your symptoms yourself. You may be able to prevent these side effects from becoming serious or life-threatening if you get treatment right away.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests before and during your treatment to see if it is safe for you to receive ipilimumab injection and to check your body's response to ipilimumab injection.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with ipilimumab injection and each time you receive a dose of the medication. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website ( Web Site) or the manufacturer's website to obtain the Medication Guide.
Talk to your doctor about the risks of receiving ipilimumab injection.
WHY is this medicine prescribed?
Ipilimumab injection is used to treat melanoma (a type of skin cancer) in adults and children 12 years of age and older that cannot be treated with surgery or that has spread to other parts of the body. It is also used to help prevent melanoma from coming back after surgery to remove it and any affected lymph nodes. Ipilimumab injection is used in combination with nivolumab (Opdivo) to treat advanced renal cell carcinoma (RCC; a type of cancer that begins in the cells of the kidneys). It is also used in combination with nivolumab (Opdivo) to treat certain types of colorectal cancer (cancer that begins in the large intestine) in adults and children 12 years of age and older that has spread to other parts of the body and has worsened after treatment with other chemotherapy medications. Ipilimumab injection is in a class of medications called monoclonal antibodies. It works by helping the body to slow or stop the growth of cancer cells.
HOW should this medicine be used?
Ipilimumab injection comes as a solution (liquid) to be injected intravenously (into a vein) by a doctor or nurse in a hospital or medical facility. When ipilimumab is given to treat melanoma, it is usually given over 90 minutes once every 3 weeks for as long as your doctor recommends that you receive treatment. When ipilimumab is given with nivolumab to treat renal cell carcinoma or colorectal cancer, it is usually given over 30 minutes once every 3 weeks for up to 4 doses.
Ipilimumab injection may cause serious or life-threatening reactions during an infusion. A doctor or nurse will watch you closely while you are receiving the infusion and shortly after the infusion to be sure you are not having a serious reaction to the medication. Tell your doctor or nurse immediately if you experience any of the following symptoms that may occur during the infusion: chills or shaking, itching, rash, flushing, difficulty breathing, dizziness, fever, or feeling faint.
Your doctor may slow down your infusion, delay, or stop your treatment with ipilimumab injection, or treat you with additional medications depending on your response to the medication and any side effects that you experience. Talk to your doctor about how you are feeling during your treatment.
Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before receiving ipilimumab injection,
tell your doctor and pharmacist if you are allergic to ipilimumab injection, any other medications, or any of the ingredients in ipilimumab injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor if you have ever had an organ transplant or if your liver has been damaged by a medication or an illness. Also, tell your doctor if you have or have ever had an autoimmune disease (condition in which the immune system attacks a healthy part of the body) such as Crohn's disease (condition in which the immune system attacks the lining of the digestive tract causing pain, diarrhea, weight loss, and fever), ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum), lupus (a condition in which the immune system attacks many tissues and organs including the skin, joints, blood, and kidneys), or sarcoidosis (condition in which clumps of abnormal cells grow in various parts of the body including the lungs, skin, and eyes),
tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are receiving ipilimumab injection. You should use effective birth control to prevent pregnancy during your treatment with ipilimumab injection and for 3 months after your final dose. Talk to your doctor about birth control methods that will work for you. If you become pregnant while receiving ipilimumab injection, call your doctor immediately. Ipilimumab injection may harm the fetus.
tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while receiving ipilimumab injection and for 3 months after your final dose.
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What SIDE EFFECTS can this medicine cause?
Ipilimumab may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
difficulty falling asleep or staying asleep
Some side effects can be serious. If you experience any of the symptoms listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment.
decreased urination, blood in urine, swelling of feet, ankles, or lower legs, or loss of appetite
cough, chest pain, or shortness of breath
tiredness, confusion, memory problems, hallucinations, seizures, or stiff neck
feeling tired, increased appetite, increased thirst, increased urination, or weight loss
rapid heartbeat, uncontrollable shaking of a part of the body, increased appetite, or sweating
fatigue, increased sensitivity to cold, constipation, muscle ache and weakness, heavier than normal or irregular menstrual periods, thinning hair, or depression
Ipilimumab injection may cause other side effects. Call your doctor if you have any unusual problems while you are receiving this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( Web Site ) or by phone (1-800-332-1088).
What should I do in case of OVERDOSE?
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at Web Site. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
What OTHER INFORMATION should I know?
Ask your pharmacist any questions you have about ipilimumab injection.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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