d 1.5% (95% CI: 0.2%, 5.2%) in the gp100 arm. The median duration of response was 11.5 months in the YERVOY+gp100 arm and has not been reached in the YERVOY or gp100 arm.
16 HOW SUPPLIED/STORAGE AND HANDLING
YERVOY is available as follows:
Carton Contents NDC
One 50 mg vial (5 mg/mL), single-use vial NDC 0003-2327-11
One 200 mg vial (5 mg/mL), single-use vial NDC 0003-2328-22
Store YERVOY under refrigeration at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect vials from light.
17 PATIENT COUNSELING INFORMATION
See MEDICATION GUIDE.
Inform patients of the potential risk of immune-mediated adverse reactions.
Advise patients to read the YERVOY Medication Guide before each YERVOY infusion.
Advise women that YERVOY may cause fetal harm.
Advise nursing mothers not to breast-feed while taking YERVOY.
Manufactured by:Bristol-Myers Squibb Company
Princeton, NJ 08543 USA
U.S. License No. 1713
MEDICATION GUIDE
YERVOYTM (yur-voi)
(ipilimumab)
Read this Medication Guide before you start receiving YERVOY and before each infusion. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or your treatment.
What is the most important information I should know about YERVOY?
YERVOY 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:
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
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
Inflammation of the skin that can lead to 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
Inflammation of the nerves that can lead to paralysis. Symptoms of nerve problems may include:
unusual weakness of legs, arms, or face
numbness or tingling in hands or feet
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
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 YERVOY.
What is YERVO
