OPDIVO- nivolumab injection 
E.R. Squibb & Sons, L.L.C.

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MEDICATION GUIDE

OPDIVO® (op-DEE-voh)
(nivolumab)
Injection

Read this Medication Guide before you start receiving OPDIVO and before each infusion. There may be new information. If your healthcare provider prescribes OPDIVO in combination with ipilimumab (YERVOY®), also read the Medication Guide that comes with ipilimumab. 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 OPDIVO?

OPDIVO is a medicine that may treat certain cancers by working with your immune system. OPDIVO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended. Some of these problems may happen more often when OPDIVO is used in combination with ipilimumab.

Call or see your healthcare provider right away if you develop any symptoms of the following problems or these symptoms get worse:

Lung problems (pneumonitis). Symptoms of pneumonitis may include:

new or worsening cough
chest pain
shortness of breath

Intestinal problems (colitis) that can lead to tears or holes in your intestine. 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
severe stomach-area (abdomen) pain or tenderness

Liver problems (hepatitis). Signs and symptoms of hepatitis 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)
drowsiness
dark urine (tea colored)
bleeding or bruising more easily than normal
feeling less hungry than usual
decreased energy

Hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas). Signs and symptoms that your hormone glands are not working properly may include:

headaches that will not go away or unusual headaches
extreme tiredness
weight gain or weight loss
dizziness or fainting
changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
hair loss
feeling cold
constipation
voice gets deeper
excessive thirst or lots of urine

Kidney problems, including nephritis and kidney failure. Signs of kidney problems may include:

decrease in the amount of urine
blood in your urine
swelling in your ankles
loss of appetite

Skin Problems. Signs of these problems may include:

rash
itching
skin blistering
ulcers in mouth or other mucous membranes

Inflammation of the brain (encephalitis). Signs and symptoms of encephalitis may include:

headache
fever
tiredness or weakness
confusion
memory problems
sleepiness
seeing or hearing things that are not really there (hallucinations)
seizures
stiff neck

Problems in other organs. Signs of these problems may include:

changes in eyesight
severe or persistent muscle or joint pains
severe muscle weakness
chest pain

Getting medical treatment right away may keep these problems from becoming more serious.

Your healthcare provider will check you for these problems during treatment with OPDIVO. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with OPDIVO, if you have severe side effects.

What is OPDIVO?

OPDIVO is a prescription medicine used to treat:

people with a type of skin cancer called melanoma:
o
OPDIVO may be used alone or in combination with ipilimumab to treat melanoma that has spread or cannot be removed by surgery (advanced melanoma), or
o
OPDIVO may be used alone to help prevent melanoma from coming back after it and lymph nodes that contain cancer have been removed by surgery.
people with a type of advanced stage lung cancer (called non-small cell lung cancer).
OPDIVO may be used when your lung cancer:
o
has spread or grown, and
o
you have tried chemotherapy that contains platinum, and it did not work or is no longer working.
 
If your tumor has an abnormal EGFR or ALK gene, you should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working.
people with a type of lung cancer called small cell lung cancer.
OPDIVO may be used when your lung cancer:
o
has spread or grown, and
o
you have tried at least two different types of chemotherapy, including one that contains platinum, and it did not work or is no longer working.
people with kidney cancer (renal cell carcinoma).
o
OPDIVO may be used alone when your cancer has spread or grown after treatment with other cancer medicines.
o
OPDIVO may be used in combination with ipilimumab in certain people when their cancer has spread.
adults with a type of blood cancer called classical Hodgkin lymphoma.
OPDIVO may be used if:
o
your cancer has come back or spread after a type of stem cell transplant that uses your own stem cells (autologous), and
o
you used the drug brentuximab vedotin before or after your stem cell transplant, or
o
you received at least 3 kinds of treatment including a stem cell transplant that uses your own stem cells (autologous).
people with head and neck cancer (squamous cell carcinoma)
OPDIVO may be used when your head and neck cancer:
o
has come back or spread, and
o
you have tried chemotherapy that contains platinum and it did not work or is no longer working.
people with bladder cancer (urothelial carcinoma).
OPDIVO may be used when your bladder cancer:
o
has spread or grown, and
o
you have tried chemotherapy that contains platinum, and it did not work or is no longer working.
adults and children 12 years of age and older, with a type of colon or rectal cancer (colorectal cancer)
OPDIVO may be used alone or in combination with ipilimumab when your colon or rectal cancer:
o
has spread to other parts of the body (metastatic),
o
is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and
o
you have tried treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, and it did not work or is no longer working.
people with liver cancer (hepatocellular carcinoma)
o
OPDIVO may be used alone or in combination with ipilimumab if you have previously received treatment with sorafenib.

It is not known if OPDIVO is safe and effective when used alone:

in children younger than 12 years of age with MSI-H or dMMR metastatic colorectal cancer, or
in children younger than 18 years of age for the treatment of any other cancers.

What should I tell my healthcare provider before receiving OPDIVO?

Before you receive OPDIVO, tell your healthcare provider if you:

have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
have had an organ transplant
have lung or breathing problems
have liver problems
have any other medical conditions
are pregnant or plan to become pregnant. OPDIVO can harm your unborn baby.
 
Females who are able to become pregnant:
 
Your healthcare provider should do a pregnancy test before you start receiving OPDIVO.
o
You should use an effective method of birth control during and for at least 5 months after the last dose of OPDIVO. Talk to your healthcare provider about birth control methods that you can use during this time.
o
Tell your healthcare provider right away if you become pregnant during treatment with OPDIVO.
are breastfeeding or plan to breastfeed. It is not known if OPDIVO passes into your breast milk. Do not breastfeed during treatment with OPDIVO.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your healthcare providers and pharmacist when you get a new medicine.

How will I receive OPDIVO?

Your healthcare provider will give you OPDIVO into your vein through an intravenous (IV) line over 30 minutes.
OPDIVO is usually given every 2 weeks or 4 weeks depending on the dose you are receiving.
When used in combination with ipilimumab, OPDIVO is usually given every 3 weeks, for a total of 4 doses. Ipilimumab will be given on the same day. After that, OPDIVO will be given alone every 2 weeks or 4 weeks depending on the dose you are receiving.
Your healthcare provider will decide how many treatments you need.
Your healthcare provider will do blood tests to check you for side effects.
If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

What are the possible side effects of OPDIVO?

OPDIVO can cause serious side effects, including:

See “What is the most important information I should know about OPDIVO?”
Severe infusion reactions. Tell your doctor or nurse right away if you get these symptoms during an infusion of OPDIVO:
 
o
chills or shaking
o
itching or rash
o
flushing
o
difficulty breathing
 
o
dizziness
o
fever
o
feeling like passing out
Complications of stem cell transplant that uses donor stem cells (allogeneic). These complications can be severe and can lead to death. Your healthcare provider will monitor you for signs of complications if you have an allogeneic stem cell transplant.

The most common side effects of OPDIVO when used alone include:

feeling tired
rash
pain in muscles, bones, and joints
itchy skin
diarrhea
nausea
weakness
cough
vomiting
shortness of breath
constipation
decreased appetite
back pain
upper respiratory tract infection
fever
headache
abdominal pain

The most common side effects of OPDIVO when used in combination with ipilimumab include:

feeling tired
diarrhea
rash
itching
nausea
pain in muscles, bones, and joints
fever
cough
decreased appetite
vomiting
abdominal pain
shortness of breath
upper respiratory tract infection
headache
low thyroid hormone levels (hypothyroidism)
decreased weight
dizziness

These are not all the possible side effects of OPDIVO.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of OPDIVO.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you would like more information about OPDIVO, talk with your healthcare provider. You can ask your healthcare provider for information about OPDIVO that is written for health professionals.

What are the ingredients in OPDIVO?

Active ingredient: nivolumab

Inactive ingredients: mannitol, pentetic acid, polysorbate 80, sodium chloride, sodium citrate dihydrate, and Water for Injection. May contain hydrochloric acid and/or sodium hydroxide.

Manufactured by: Bristol-Myers Squibb Company, Princeton, NJ 08543 USA U.S. License No. 1713

OPDIVO® and YERVOY® are trademarks of Bristol-Myers Squibb Company. Other brands listed are the trademarks of their respective owners.

For more information, call 1-855-673-4861 or go to www.OPDIVO.com.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: March 2020

Revised: 3/2020
E.R. Squibb & Sons, L.L.C.