Ipilimumab Solution for injection
What is this medicine?
IPILIMUMAB (IP i LIM ue mab) is a monoclonal antibody. It is used to treat melanoma, a type of skin cancer.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
blood in your stools (black or tarry stools) or if you have blood in your vomit
eye disease, vision problems
history of pancreatitis
history of stomach bleeding
immune system problems
inflammatory bowel disease
stomach or intestine problems
tingling of the fingers or toes, or other nerve disorder
an unusual or allergic reaction to ipilimumab, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
How should I use this medicine?
This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.
A special MedGuide will be given to you before each treatment. Be sure to read this information carefully each time.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.
What may interact with this medicine?
Interactions are not expected.
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.
Do not become pregnant while taking this medicine or for 3 months after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine or for 3 months after the last dose.
Your condition will be monitored carefully while you are receiving this medicine.
You may need blood work done while you are taking this medicine.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
black, tarry stools
bloody or watery diarrhea
changes in vision
fast, irregular heartbeat
feeling faint or lightheaded, falls
pain, tingling, numbness in the hands or feet
redness, blistering, peeling or loosening of the skin, including inside the mouth
signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin
unusual bleeding or bruising
Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):
loss of appetite
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
This drug is given in a hospital or clinic and will not be stored at home.
NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
March 21, 2017
U.S. FDA-approved Package Insert