OPDIVO 240 MG / 24 ML ( NIVOLUMAB 10 MG / ML ) FOR INTRAVENOUS INFUSION USE 24 ML VIAL
OPDIVO 240 MG / 24 ML ( NIVOLUMAB 10 MG / ML ) FOR INTRAVENOUS INFUSION USE 24 ML VIAL
Giving you a choice and a chance against cancer
OPDIVO is a proven immunotherapy to help your body fight against cancer. Alone or in combination with other therapies, OPDIVO is approved by the FDA to be a first treatment option for many types of cancer. Talk to your healthcare provider to find out if OPDIVO or an OPDIVO‑based combination is right for you.
Summary of Warnings and Precautions
OPDIVO QvantigTM, OPDIVO®, and YERVOY® (ipilimumab) can cause problems that can sometimes become serious or life-threatening and can lead to death. Serious side effects may include lung problems; intestinal problems; liver problems; hormone gland problems; kidney problems; skin problems; eye problems; problems in other organs and tissues; and complications of stem cell transplant, including graft-versus-host disease (GVHD), that uses donor stem cells (allogeneic). Call or see your healthcare provider right away for any new or worsening signs or symptoms. OPDIVO is associated with severe infusion reactions. See full ISI for OPDIVO and OPDIVO Qvantig below.
Important Facts About OPDIVO® (nivolumab) and OPDIVO + YERVOY® (ipilimumab)
This is a summary of important information that you need to know about OPDIVO and OPDIVO + YERVOY. Your healthcare team can work with you to help answer any questions you may have about these medications. Keep this information in a safe place so you can refer to it before and during your treatment.
What is the most important information I should know about OPDIVO + YERVOY?
OPDIVO and YERVOY are medicines that may treat certain cancers by working with your immune system. OPDIVO and YERVOY can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. Some of these problems may happen more often when OPDIVO is used in combination with another therapy.
Get medical help immediately if you develop any of these signs or symptoms or they get worse. It may keep these problems from becoming more serious. Your healthcare team will check you for these problems during treatment and may treat you with corticosteroid or hormone replacement medicines. If you have severe side effects, your healthcare team may also need to delay or completely stop your treatment.
What are the serious side effects of OPDIVO and OPDIVO + YERVOY?
A serious side effect is a side effect that can sometimes become severe or life-threatening, and can lead to death. They may happen anytime during treatment or even after your treatment has ended. You may have more than one of these problems at the same time.
Call or see your healthcare provider right away if you develop any new or worse signs or symptoms, including:
Lung problems — Things to look out for may include:
cough
shortness of breath
chest pain
Intestinal problems — Things to look out for may include:
diarrhea (loose stools) or more frequent bowel movements than usual
stools that are black, tarry, sticky, or have blood or mucus
severe stomach-area (abdominal) pain or tenderness
Liver problems — Things to look out for may include:
yellowing of your skin or the whites of your eyes
severe nausea or vomiting
pain on the right side of your stomach area (abdomen)
dark urine (tea colored)
bleeding or bruising more easily than normal
Hormone gland problems — Things to look out for may include:
headaches that will not go away or unusual headaches
eye sensitivity to light
eye problems
rapid heartbeat
increased sweating
extreme tiredness
weight gain or weight loss
feeling more hungry or thirsty than usual
urinating more often than usual
hair loss
feeling cold
constipation
your voice gets deeper
dizziness or fainting
changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
Kidney problems — Things to look out for may include:
decrease in your amount of urine
blood in your urine
swelling of your ankles
loss of appetite
Skin problems — Things to look out for may include:
rash
itching
skin blistering or peeling
swollen lymph nodes
painful sores or ulcers in the mouth or nose, throat, or genital area
fever or flu-like symptoms
Eye problems — Things to look out for may include:
blurry vision, double vision, or other vision problems
eye pain or redness
The most common side effects of OPDIVO when used in combination with cabozantinib include:
diarrhea
feeling tired or weak
liver problems
rash, redness, pain, swelling, or blisters on the palms of your hands or soles of your feet
mouth sores
rash
high blood pressure
low thyroid hormone levels
pain in muscles, bones, and joints
decreased appetite
nausea
change in the sense of taste
stomach-area (abdominal) pain
cough
upper respiratory tract infection
The most common side effects of OPDIVO when used in combination with fluoropyrimidine- and platinum-containing chemotherapy include:
nausea
numbness, pain, tingling, or burning in your hands or feet
decreased appetite
feeling tired
constipation
mouth sores
diarrhea
vomiting
stomach-area (abdominal) pain
pain in muscles, bones, and joints
These are not all the possible side effects. Talk to your healthcare team or pharmacist for more information. You are encouraged to report side effects of prescription drugs to the FDA. Call 1-800-FDA-1088.
What should I discuss with my healthcare team before receiving OPDIVO or YERVOY?
Tell your healthcare provider about all your medical conditions, including if you:
have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
have received an organ transplant, including corneal transplant
have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
have received radiation treatment to your chest area in the past and have received other medicines that are like OPDIVO
have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
are pregnant or plan to become pregnant. OPDIVO and YERVOY can harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if OPDIVO or YERVOY passes into your breast milk. Do not breastfeed during treatment and for 5 months after your last dose of OPDIVO or YERVOY.
Females who are able to become pregnant:
Your healthcare provider should do a pregnancy test before you start receiving OPDIVO or YERVOY.
You should use an effective method of birth control during your treatment and for 5 months after the last dose of OPDIVO or YERVOY. Talk to your healthcare provider about birth control methods that you can use during this time.
Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with OPDIVO or YERVOY. You or your healthcare provider should contact Uk-online-pharmacy as soon as you become aware of a pregnancy.
Tell your healthcare provider about all the medicines you take, including:
prescription medicines
over-the-counter medicines
vitamins
herbal supplements