(op-DEE-voh)
Nivolumab (nee-vol-u-mab)
Consumer Medicine Information
WARNINGS AND PRECAUTIONS - COMBINATION OF OPDIVO AND YERVOY IN THE TREATMENT OF ADVANCED
MELANOMA
Both OPDIVO and Yervoy act on your immune system and may cause inflammation in parts
of your body. Inflammation may cause serious damage to your body and some inflammatory
conditions may be life-threatening.
These side effects are most likely to begin during treatment, however, side effects
can show up months after your last infusion.
IT IS IMPORTANT TO TELL YOUR DOCTOR IMMEDIATELY IF YOU HAVE, OR DEVELOP, ANY OF THE
SYMPTOMS LISTED UNDER POSSIBLE SIDE EFFECTS.
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about OPDIVO. It does not contain all of
the available information. It does not take the place of talking to your doctor or
pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you receiving
OPDIVO against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor.
You should read this leaflet carefully and keep it in a safe place to refer to it
later.
WHAT IS OPDIVO USED FOR
OPDIVO contains the active substance nivolumab, a protein which helps your immune
system to attack and destroy cancer cells.
OPDIVO is used to treat advanced melanoma (unresectable or metastatic) in adults.
OPDIVO in combination with YERVOY (ipilimumab) is used to treat advanced melanoma(defined
as M1c or elevated LDH) in adults.
OPDIVO is used in adults to treat a type of lung cancer (advanced squamous and non
squamous non-small cell lung cancer), a type of kidney cancer (clear cell renal cell
carcinoma) and a type of head and neck cancer (squamous cell cancer of the head and
neck) if your cancer has not responded, or if it has stopped responding, to earlier
treatment.
OPDIVO is also used in adults to treat a type of blood cancer called classical Hodgkin
lymphoma after relapse from previous therapies, including autologous stem-cell transplant
(a transplant of your own blood-producing cells).
This medicine is available only with a doctor's prescription.
OPDIVO will be given to you in hospital under the supervision of an experienced doctor.
Ask your doctor if you have any questions about why OPDIVO has been prescribed for
you.
Your doctor will continue giving you OPDIVO for as long as you keep benefitting from
it or until you no longer tolerate the treatment
BEFORE YOU ARE GIVEN OPDIVO
You should not be given OPDIVO
if you are allergic (hypersensitive) to nivolumab or any of the other ingredients
of OPDIVO. If you are not sure, talk to your doctor.
Check with your doctor or nurse before you are given OPDIVO if:
you have an autoimmune disease (a condition where the body attacks its own cells)
like Crohn's, ulcerative colitis or lupus;
you have any history of inflammation of the lungs
you have been told your cancer has spread to your brain
you have melanoma of the eye
you were previously given ipilimumab (YERVOY®), another medicine for the treatment of advanced melanoma, and experienced side effects
because of this medicine.
you are taking any medicines that suppress your immune system, such as corticosteroids,
since these medicines may interfere with the effect of OPDIVO. However, once you are
treated with OPDIVO, your doctor may give you corticosteroids to reduce any possible
side effects that you may have during your treatment and this will not impact the
effect of the medicine.
OPDIVO may cause:
Problems with your lungs such as breathing difficulties, or cough. These may be signs
of inflammation of the lungs (pneumonitis or interstitial lung disease).
Diarrhoea (watery, loose or soft stools) or any symptoms of inflammation of the intestines
(colitis), such as stomach pain and mucus or blood in the stool.
Inflammation of the liver (hepatitis).Signs and symptoms of hepatitis may include
abnormal liver function tests, eye or skin yellowing (jaundice), pain on the right
side of your stomach area, or tiredness.
Inflammation or problems with your kidneys. Signs and symptoms may include abnormal
kidney function tests decreased volume of urine, and kidney failure.
Problems with your hormone producing gland (including the thyroid, pituitary, and
adrenal glands) that may affect how these glands work. Signs and symptoms that your
glands are not working properly may include fatigue (extreme tiredness), weight change
or headache and visual disturbances.
Diabetes (symptoms include excessive thirst, the passing of a greatly increased amount
of urine, increase in appetite with a loss of weight, feeling tired, drowsy, weak,
depressed, irritable and generally unwell) or diabetic ketoacidosis (acid in the blood
produced from diabetes).
Inflammation of the skin that can lead to rash and itching. Severe and possibly fatal
peeling of the skin (toxic epidermal necrolysis, Steven-Johnson syndrome).
Loss of the covering around the nerves (demyelination), inflammation of the nerves
caused by the body attacking itself, causing numbness, weakness, tingling or burning
pain.
A condition in which the muscles become weak and tire easily (myasthenic syndrome).
A temporary inflammation of the nerves that causes pain, weakness and paralysis in
the extremities (Guillain-Barré syndrome).
Inflammation of the brain
Inflammation of muscles causing pain or stiffness
Inflammation of the heart (myocarditis) characterised by shortness of breath, fatigue,
palpitations or chest pain
Muscle breakdown/injury (rhabdomyolysis) characterised by muscle pain, weakness, nausea
or vomiting.
Solid organ transplant rejection.
Tell your doctor immediately if you have any signs or symptoms of the possible side
effects listed above or if your symptoms get worse.
Do not try to treat your symptoms with other medicines.
Complications of stem cell transplant that uses donor cells (allogeneic) may occur
after treatment with Opdivo.
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.
Using other medicines
Please tell your doctor if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription. Ask your doctor for advice before
taking any medicine during your treatment.
Children
It is not recommended to use this medicine in children or an adolescent (below 18
years) until further information becomes available.
Take special care with OPDIVO
OPDIVO is a medicine that influences your immune system and may cause inflammation
in parts of your body. Inflammation can cause serious damage to your body and some
inflammatory conditions may be life-threatening. Tell your doctor immediately if you
have any of the symptoms of inflammation listed in "Possible Side Effects".
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, planning to become pregnant, or if you are breast-feeding.
You must not use OPDIVO if you are pregnant unless your doctor specifically recommends
it.
The effects of OPDIVO in pregnant women are not known, but it is possible that the
active substance, nivolumab, could harm an unborn baby.
You must use effective contraception while you are being treated with OPDIVO if you
are a woman who could become pregnant.
If you become pregnant while using OPDIVO, tell your doctor.
You should stop breast-feeding if you are being treated with OPDIVO.
It is not known whether nivolumab gets into breast milk. A risk to the breast-fed
infant cannot be excluded.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed.
OPDIVO is unlikely to affect your ability to drive or use machines; however, use caution
when performing these activities until you are sure that OPDIVO does not adversely
affect you.
Important information about some of the ingredients of OPDIVO
Tell your doctor if you are on a low-sodium (low-salt) diet before you are given OPDIVO.
This medicine contains 2.5 mg sodium per mL of concentrate.
HOW OPDIVO IS GIVEN
OPDIVO will be given to you in hospital or clinic under the supervision of an experienced
doctor.
It will be given to you as an infusion (a drip) into a vein (intravenously) over a
period of 60 minutes, every 2 weeks. Your doctor will continue giving OPDIVO for as
long as you keep benefitting from it or until you no longer tolerate the treatment.
OPDIVO is a concentrate solution for infusion. The amount of OPDIVO you will be given
will be calculated based on your body weight. Depending on your dose, some or all
of the content of the OPDIVO vial may be diluted with saline or glucose solution before
use. More than one vial may be necessary to obtain the required dose.
Dosage and frequency of administration
The recommended dose is 3 mg of OPDIVO per kilogram of your body weight for the treatment
of metastatic melanoma, squamous and non squamous non small cell lung cancer, clear
cell renal cell carcinoma, classical Hodgkin lymphoma and patients with advanced cancer
of the head and neck.
If you have advanced melanoma your doctor may decide to give you OPDIVO in combination
with YERVOY.
When OPDIVO is given in combination with YERVOY, you will first be given OPDIVO followed
by YERVOY.
When OPDIVO is given in combination with YERVOY the recommended dose of OPDIVO is
1mg of OPDIVO per kilogram of your body weight for the first 4 doses (combination
phase). Thereafter the recommended dose of OPDIVO is 3mg of OPDIVO per kilogram of
your body weight (single-agent phase).
Please refer to the package leaflet of YERVOY in order to understand the use of this
medicine. If you have questions about this medicine, please ask your doctor.
If you miss a dose of OPDIVO
It is very important for you to keep all appointments to receive OPDIVO. If you miss
an appointment, ask your doctor when to schedule your next dose.
If you stop using OPDIVO
Stopping your treatment may stop the effect of the medicine. Do not stop treatment
with OPDIVO unless you have discussed this with your doctor.
If you have any further questions about your treatment or the use of this medicine,
ask your doctor.
WHILE YOU ARE BEING TREATED WITH OPDIVO
Things you must do
Tell your doctor immediately if you have any signs or symptoms of possible adverse
effects or if they get worse. See Possible Side Effects.
Do not try to treat your symptoms with other medicines on your own. You doctor may
Give you other medicines in order to prevent complications and reduce your symptoms
Withhold the next dose of OPDIVO
Or stop your treatment with OPDIVO altogether.
Please note that these signs and symptoms are sometimes delayed, and may develop weeks
or months after your last dose. Before treatment, your doctor will check your general
health. You will also have blood tests during treatment.
Tell any other doctors, dentists, and pharmacists who are treating you that you are
being given OPDIVO.
If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist
that you are being given OPDIVO.
Tell your doctor immediately if you develop symptoms of an allergic reaction.
These symptoms may be:
shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
POSSIBLE SIDE EFFECTS
Like all medicines, OPDIVO can cause side effects, although not everybody gets them.
Your doctor will discuss these with you and will explain the risks and benefits of
your treatment.
Be aware of important symptoms of inflammation. OPDIVO acts on your immune system
and may cause inflammation in parts of your body. Inflammation may cause serious damage
to your body and some inflammatory conditions may be life-threatening and need treatment
or withdrawal of OPDIVO.
Do not try to treat your symptoms with other medicines.
Do not be alarmed by possible side effects.
You may not experience any of them.
Ask your doctor to answer any questions you may have.
The following side effects have been reported in clinical trials when OPDIVO has been
given alone:
Very common (may affect more than 1 in 10 people)
Diarrhoea (watery, loose or soft stools), nausea
Skin rash, itching
Feeling tired or weak
Common (may affect up to 1 in 10 people)
Infections of the upper respiratory tract
Underactive thyroid gland, which can cause tiredness or weight gain, overactive thyroid
gland, which can cause rapid heart rate, sweating and weight loss
Decreased appetite
Inflammation of the nerves causing numbness, weakness, tingling or burning pain of
the arms and legs, headaches, dizziness
Inflammation of the lungs (pneumonitis), characterised by coughing and difficulty
breathing
coughing, shortness of breath (dyspnoea)
Inflammation of the intestines (colitis)
Stomach pain, constipation
Mouth ulcers and cold sores (stomatitis), vomiting, dry mouth
Skin colour changes in patches (vitiligo), dry skin, redness of the skin, hair loss
or thinning
Pain in the muscles, bones and joints
Fever, oedema (swelling)
Allergic reaction, reaction related to the infusion of the medicine
High blood pressure (hypertension)
Uncommon (may affect up to 1 in 100 people)
Serious lung infection (pneumonia), bronchitis
Decreased secretion of hormones produced by adrenal glands (glands situated above
the kidneys), underactive function (hypopituitarism) or inflammation (hypophysitis)
of the pituitary gland situated at the base of the brain, swelling of the thyroid
gland, diabetes
Inflammation of the pancreas, inflammation of the stomach (gastritis)
Dehydration
Increased acid level in the blood
Increase in some white blood cells
Inflammation of the eye, which causes pain and redness, blurred vision, dry eyes
Inflammation in the kidney, kidney failure
Fast heart rate
Arthritis
Damage to nerves causing numbness and weakness (polyneuropathy),inflammation of the
nerves caused by the body attacking itself, causing numbness, weakness, tingling and
burning pain
Inflammation of the liver (hepatitis)
Fluid around the lungs
Severe condition of the skin that causes red, often itchy spots, similar to rash of
measles, which starts on the limbs and sometimes on the face and the rest of the body
(erythema multiforme), skin disease with thickened patches of red skin, often silvery
scales (psoriasis), skin conditions of the face where the nose and cheeks are unusually
red (rosacea), hives (itchy, bumpy rash)
Pain, chest pain
Rare (may affect up to 1 in 1000 people)
Life threatening allergic reaction
Severe and possibly fatal peeling of the skin (toxic epidermal necrolysis, Steven-Johnson
syndrome)
Loss of the covering around the nerves (demyelination) pain
A condition in which the muscles become weak and tire easily (myasthenic syndrome)
A temporary inflammation of the nerves that causes pain, weakness and paralysis in
the extremities (Guillain-Barré syndrome)
Inflammation of the brain
Ulcer of the small intestine
Blockage of the bile ducts
Fluid in lungs
, acid in the blood produced from diabetes (diabetic ketoacidosis)
A disease causing inflammation or enlargement of a lymph node (Kikuchi lymphadenitis)
Changes in the rhythm or rate of the heart, abnormal heart rhythm
Inflammation of the heart (myocarditis) characterised by shortness of breath, fatigue,
palpitations or chest pain
Inflammation of muscles causing pain or stiffness
Muscle breakdown/injury (rhabdomyolysis) characterised by muscle pain, weakness, nausea
or vomiting.
Myopathy (aching muscles, muscle tenderness or weakness, not caused by exercise)
Inflammatory disease of blood vessels
Disease in which the
immune system attacks the glands that make moisture for the body, such as tears and
saliva (Sjogren's syndrome)
Changes in test results
OPDIVO may cause changes in the results of tests carried out by your doctor. These
include:
Abnormal liver function tests (increased amounts of the liver enzyme aspartate aminotransferase,
alanine aminotransferase or alkaline phosphatase in your blood, higher blood levels
or bilirubin)
Abnormal kidney function tests (increased amounts of creatinine in your blood)
A decreased number of red blood cells (which carry oxygen), white blood cells (which
are important in fighting infection) or platelets (cells which help the blood clot)
Abnormal levels of calcium, potassium, magnesium or sodium in your blood
Decrease in body weight
Higher levels of sugar in your blood (hyperglycaemia)
The following side effects have been reported in clinical trials when OPDIVO has been
given in combination with YERVOY:
Very common (may affect more than 1 in 10 people)
Underactive thyroid gland, which can cause tiredness or weight gain
Decreased appetite
Headache
Inflammation of the intestines (colitis), diarrhoea (watery, loose or soft stools),
vomiting, nausea, stomach pain
Skin rash, itching
Pain in the joints
Feeling tired or weak, fever
Common (may affect up to 1 in 10 people)
Infections of the upper respiratory tract, serious lung infection (pneumonia)
Increase in some white blood cells
Decreased secretion of hormones produced by adrenal glands (glands situated above
the kidneys); underactive function (hypopituitarism) or inflammation (hypophysitis)
of the pituitary gland situated at the base of the brain; overactive thyroid gland,
which can cause rapid heart rate, sweating and weight loss; inflammation of the thyroid
gland (hyperthyroidism); swelling of the thyroid gland
Dehydration
Inflammation of the nerves causing numbness, weakness, tingling or burning pain of
the arms and legs; dizziness
Inflammation of the eye, which causes pain and redness, blurred vision
Fast heart rate
High blood pressure (hypertension)
Inflammation of the lungs (pneumonitis), characterised by coughing and difficulty
breathing
Coughing, shortness of breath (dyspnoea)
Mouth ulcers and cold sores (stomatitis), gastritis (inflammation of the stomach),
constipation, dry mouth
Inflammation of the liver
Skin colour change in patches (vitiligo), dry skin, redness of the skin, unusual hair
loss or thinning, hives (itchy rash)
Pain in the muscles and bones
Kidney failure
Oedema (swelling), pain
Allergic reaction, reactions related to the infusion of the medicine
Uncommon (may affect up to 1 in 100 people)
Inflammation of the brain
Bronchitis
Chronic diseases associated with a build-up of inflammatory cells in various organs
and tissues, most commonly the lungs (sarcoidosis)
Acid in the blood produced from diabetes (diabetic ketoacidosis), diabetes
A temporary inflammation of the nerves that causes pain, weakness and paralysis in
the extremities (Guillain-Barré syndrome); damage to nerves causing numbness and weakness
(polyneuropathy); inflammation of the nerves; foot drop (peroneal nerve palsy); inflammation
of the nerves caused by the body attacking itself, causing numbness, weakness, tingling
or burning pain
Changes in the rhythm or rate of the heart beat, abnormal heart rhythm
Fluid around the lungs
Inflammation of the pancreas, intestinal perforation, inflammation of the duodenum
Skin disease with thickened patches of red skin, often with silvery scales (psoriasis)
Chronic disease of joints (spondyloarthropathy)
Disease in which the
immune system attacks the glands that make moisture for the body, such as tears and
saliva (Sjogren's syndrome)
Inflammation of muscles causing pain or stiffness
Inflammation of the kidney
Chest pain
Inflammation of the heart (myocarditis) characterised by shortness of breath, fatigue,
palpitations or chest pain.
Muscle breakdown/injury (rhabdomyolysis) characterised by muscle pain, weakness, nausea
or vomiting.
Rare (may affect up to 1 in 1000 people)
Severe and possibly fatal peeling of the skin (toxic epidermal necrolysis, Steven-Johnson
syndrome)
Changes in test results
OPDIVO in combination with YERVOY may cause changes in the results of tests carried
out by your doctor. These include:
Abnormal liver function tests (increased amounts of the liver enzymes aspartate aminotransferase,
alanine aminotransferase or alkaline phosphatase in your blood, higher blood levels
of the waste product bilirubin)
Abnormal kidney function tests (increased amounts of creatinine in your blood)
A decreased number of red blood cells (which carry oxygen), white blood cells (which
are important in fighting infection) or platelets (cells which help the blood to clot)
An increased level of the enzyme that breaks down fats and of the enzyme that breaks
down starch.
Abnormal levels of calcium, potassium, magnesium or sodium in your blood
Higher blood levels of bilirubin
Decrease in body weight
Higher levels of sugar in your blood (hyperglycaemia)
FURTHER INFORMATION
What OPDIVO contains
The active substance is nivolumab.
Each vial contains either 40 mg (in 4mL) or 100 mg (in 10mL) of nivolumab.
Before dilution, each one mL of sterile concentrate contains 10 mg of nivolumab.
The other ingredients are sodium citrate, sodium chloride, mannitol (E421), pentetic
acid, polysorbate 80, sodium hydroxide, hydrochloric acid and water for injection.
What OPDIVO looks like and contents of the pack
OPDIVO concentrate for solution for infusion is a clear to opalescent, colourless
to pale yellow liquid that may contain light (few) particles.
It is available in packs containing either 1 vial of 40 mg in 4 mL or 1 vial of 100
mg in 10 mL.
HOW TO STORE OPDIVO
It is unlikely that you will be asked to store OPDIVO yourself. It will be stored
in the hospital or clinic where it is given to you.
Keep OPDIVO out of the reach and sight of children.
Do not use OPDIVO after the expiry date which is stated on the label and carton after
EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C to 8°C).
Do not freeze.
Store in the original package in order to protect from light.
From a microbiological point of view, once opened, the medicinal product should be
infused or diluted immediately.
Sponsored by
Bristol-Myers Squibb Australia Pty Ltd
4 Nexus Court, Mulgrave
Victoria 3170, Australia,
Registration Numbers:
OPDIVO (nivolumab) concentrate solution for infusion 40mg in 4mL (10mg/mL) AUST R
231867
OPDIVO (nivolumab) concentrate solution for infusion 100mg in 10mL (10mg/mL) AUST
R 231868
Date of preparation:
15 September 2017
OPDIVO® (nivolumab) and YERVOY® (ipilimumab) are registered trademarks of Bristol-Myers Squibb Company