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OPDIVO® SC
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist. This CMI is for the subcutaneous dosage form of
OPDIVO. For information about the intravenous dosage form of OPDIVO, please refer
to the intravenous OPDIVO CMI.
OPDIVO SC contains the active ingredient nivolumab. OPDIVO SC is used to treat various
kinds of cancer.
For more information, see Section 1. Why am I given OPDIVO SC? in the full CMI.
Do not use if you have ever had an allergic reaction to OPDIVO SC or any of the ingredients
listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I am given OPDIVO SC? in the full CMI.
Some medicines may interfere with OPDIVO SC and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
OPDIVO SC will be given to you in hospital or clinic under the supervision of an experienced
doctor and/or nurse
It will be given to you as an injection under the skin (subcutaneously) of the abdomen
or thigh over a period of 3 to 5 minutes by a doctor or nurse
Your doctor will decide how many treatments you should be given
More instructions can be found in Section 4. How am I given OPDIVO SC? in the full CMI.
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Things you should do
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Tell any other doctors, dentists, nurses, and pharmacists who are treating you that
you are being given OPDIVO SC
Ensure you tell your doctor if you have autoimmune disease, any history of inflammation
of the lungs, melanoma of the eye, if you have cancer that has spread to the brain,
if you were previously given ipilimumab (another medicine used to treat various kinds
of cancer) and experienced side effects because of this medicine or if you are taking
any medicines that suppress your immune system, such as corticosteroids
OPDIVO SC acts on your immune system and may cause inflammation in parts of your body
which may be life threatening and need treatment or withdrawal of OPDIVO SC
Tell your doctor immediately if you have any signs or symptoms of possible side effects
or if they get worse despite medical care or management
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Things you should not do
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Do not try to treat your symptoms with other medicines on your own without telling
your doctor. Your doctor may give you other medicines to prevent complications or
reduce your symptoms, your doctor may withhold the next dose of OPDIVO SC, or stop
your treatment with OPDIVO SC altogether
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Driving or using machines
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OPDIVO SC is unlikely to affect your ability to drive or use machines; however, use
caution when performing these activities and notify your doctor if you notice any
changes to your ability
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For more information, see Section 5. What should I know while receiving OPDIVO SC? in the full CMI.
Like all medicines, OPDIVO SC can cause side effects. Your doctor will discuss potential
side effects with you and will explain the risks and benefits of your treatment. Some
side effects can be serious and you may require medical attention. Contact your doctor
immediately or go to the Emergency Department at your nearest hospital if you have
any signs or symptoms (changes to your normal self), particularly if they are getting
worse or do not go away. For more information, including what to do if you have any
side effects, see Section 6. Are there any side effects? in the full CMI.
OPDIVO® SC (op-DEE-voh S-C)
Active ingredient:
nivolumab (nee-vol-u-mab)
Consumer Medicine Information (CMI)
This leaflet provides important information about using OPDIVO SC. You should also speak to your doctor, nurse or pharmacist if you would like further
information or if you have any concerns or questions about using OPDIVO SC.
Where to find information in this leaflet:
OPDIVO SC contains the active ingredient nivolumab. Nivolumab is a protein which helps your immune system to attack and destroy cancer
cells.
OPDIVO SC alone is used to treat:
Advanced skin cancer (unresectable or metastatic melanoma)
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)
A type of head and neck cancer (squamous cell cancer of the head and neck)
A type of bladder cancer (urothelial carcinoma)
A type of liver cancer (hepatocellular carcinoma)
A type of food pipe cancer (oesophageal squamous cell cancer), if your cancer has
not responded, or if it has stopped responding, to earlier treatment
Cancer of the oesophagus (food pipe) or gastro-oesophageal junction (area which connects
your food pipe and stomach) after chemoradiotherapy followed by surgical removal of
the cancer
Bladder cancer (urothelial carcinoma) after surgical removal of the cancer. Treatment
after surgery is also called adjuvant therapy.
Skin cancer (melanoma) after surgical removal of the cancer in adults
OPDIVO SC alone as continuing therapy (single-agent phase) following combination therapy
of intravenous OPDIVO with ipilimumab (combination phase) is used to treat:
Advanced melanoma (unresectable or metastatic melanoma)
A type of advanced kidney cancer (renal cell carcinoma)
A type of liver cancer (unresectable or metastatic hepatocellular carcinoma)
A type of cancer of the colon or rectum, together referred to as colorectal cancer
or bowel cancer, that is shown by a laboratory test to have certain biological markers
(microsatellite instability-high [MSI-H] or mismatch repair deficient [dMMR])
OPDIVO SC in combination with cabozantinib is used to treat:
A type of kidney cancer (renal cell carcinoma)
OPDIVO SC in combination with chemotherapy is used to treat:
A type of cancer of the stomach (gastric adenocarcinoma), the connection between the
stomach and food pipe (gastro-oesophageal junction adenocarcinoma) or the food pipe
(oesophageal adenocarcinoma or oesophageal squamous cell cancer)
A type of lung cancer (non-small cell lung cancer) before you have surgery
A type of lung cancer (non-small cell lung cancer) before surgery and following surgery
(treatment before surgery is called neoadjuvant therapy; treatment after surgery is
called adjuvant therapy)
A type of bladder cancer (unresectable or metastatic urothelial carcinoma)
You should not be given OPDIVO SC if:
you are allergic to nivolumab, or any of the ingredients listed in Section 7. Product details
Always check the ingredients or talk to your doctor to make sure you can use this
medicine.
Check with your doctor if you:
have an autoimmune disease (a condition where the body attacks its own cells) like
Crohn's, ulcerative colitis or lupus
have any history of inflammation of the lungs
have been told your cancer has spread to your brain
have melanoma of the eye
were previously given ipilimumab (another medicine used to treat various kinds of
cancer) and experienced side effects because of this medicine.
are taking any medicines that suppress your immune system, such as corticosteroids,
since these medicines may interfere with the effect of OPDIVO SC. However, once you
are treated with OPDIVO SC, 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.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant, intend to become pregnant, or if you are
breast-feeding.
You must not use OPDIVO SC if you are pregnant unless your doctor specifically recommends
it.
The effects of OPDIVO SC 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 SC, and
for at least 5 months following the last dose of OPDIVO SC, if you are a woman who
could become pregnant
If you become pregnant while using OPDIVO SC, tell your doctor
You should stop breast-feeding if you are being treated with OPDIVO SC.
It is not known whether nivolumab gets into breast milk. A risk to the breast-fed
infant cannot be excluded.
Use in children or adolescents
It is not recommended to use this medicine in children or an adolescent (below 18
years).
Tell your doctor, nurse or pharmacist if you are taking any other medicines, including
any medicines, vitamins or supplements that you buy without a prescription (over the
counter) from your pharmacy, supermarket or health food shop.
Ask your doctor for advice before taking any medicine or dietary supplement/vitamin
during your treatment.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect OPDIVO SC.
How is OPDIVO SC given
OPDIVO SC will be given to you in hospital or clinic under the supervision of an experienced
doctor
It will be given to you as an injection under the skin (subcutaneously) of the abdomen
or thigh over a period of 3 to 5 minutes by a doctor or nurse
Your doctor will decide how many treatments you should be given
Dosage and frequency of administration of OPDIVO SC
The recommended dose (amount) and frequency (timing) of OPDIVO SC can be different
depending on the type of cancer it is being used to treat
Some types of cancer are treated with OPDIVO SC in combination with other prescription
anti-cancer medicines
Your doctor will advise you which treatments you will be given and will tell you about
the dose and frequency of these treatments
Please refer to the Consumer Medicine Information of the other prescription anti-cancer
medicines in order to understand the use of these other prescription anti-cancer medicines.
If you have questions about these medicines, please ask your doctor
If you miss a dose of OPDIVO SC
It is very important for you to keep all appointments to receive OPDIVO SC. If you
miss an appointment, ask your doctor when to schedule your next dose.
If you are given too much OPDIVO SC
As OPDIVO SC is given to you under the supervision of your doctor, it is unlikely
that you will be given too much. However, if you experience any side effects after
being given OPDIVO SC, tell your doctor immediately.
Things you should do
Tell any other doctors, dentists, nurses and pharmacists who are treating you that
you are being given OPDIVO SC.
If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist
that you are being given OPDIVO SC.
Call your doctor straight away if you:
Have any signs or symptoms of possible side effects or if they get worse. See Section
6. Are there any side effects?
Develop symptoms of an allergic reaction. These symptoms may include 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.
Things you should not do
Do not try to treat your symptoms with other medicines on your own without telling
your doctor.
Your doctor may:
Give you other medicines in order to prevent complications and reduce your symptoms
Withhold the next dose of OPDIVO SC
Or stop your treatment with OPDIVO SC 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.
Take special care with OPDIVO SC
OPDIVO SC is a medicine that influences 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 SC
Tell your doctor immediately if you have any of the symptoms of inflammation listed
in Section 6. Are there any side effects?
Driving or using machines
No studies on the effects of OPDIVO SC on the ability to drive and use machines have
been performed.
OPDIVO SC is unlikely to affect your ability to drive or use machines; however, use
caution when performing these activities until you are sure that OPDIVO SC does not
adversely affect you and notify your doctor if you notice any changes to your ability.
Patient Card
You will also find key messages from this CMI in the Patient Card you have been given
by your doctor. It is important that you keep this Patient Card with you and show
it to your partner, caregivers and Healthcare Professionals.
Looking after your medicine
OPDIVO SC is administered in a hospital or clinic by a Healthcare Professional (e.g.
nurse) under the supervision of an experienced doctor. There is no need to store this
medicine at home.
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
OPDIVO SC alone or in combination may cause changes in the results of tests carried
out by your doctor.
Serious side effects
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Serious side effects
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What to do
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Lung problems:
Problems with your lungs such as breathing difficulties, shortness of breath, or cough.
These may be signs of inflammation of the lungs (pneumonitis or interstitial lung
disease)
Stomach and Intestinal problems:
Inflammation of the intestines (colitis, enterocolitis, coeliac disease, pancreatic
exocrine insufficiency), stomach (gastritis) and duodenum (duodenitis) which can worsen
to bleeding or bowel perforation
Symptoms may include diarrhoea (watery, loose or soft stools), an increased number
of bowel movements (an increase by two or more per day), constipation, vomiting, nausea,
mucus and blood in your stools, or darker-coloured stools, stomach pain or tenderness
in your stomach area
Liver problems:
Inflammation of the liver (hepatitis) and Inflammation of the bile duct system (cholangitis).
Symptoms may include yellowing of the eyes or skin (jaundice), pain on the right side
of your stomach area, tiredness, nausea or vomiting, fever or chills
Kidney problems:
Inflammation in the kidney (nephritis)
Signs and symptoms may include abnormal kidney function tests, decreased volume of
urine and kidney failure (including abrupt loss of kidney function)
Hormone gland problems:
Underactive thyroid gland, which can cause tiredness or weight gain
Overactive thyroid gland, which can cause rapid heart rate, sweating and weight loss
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
Decrease in parathyroid hormone
Acid in the blood produced by diabetes (diabetic ketoacidosis)
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 (diabetes)
Skin problems:
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)
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), hives (itchy, bumpy rash)
Brain and nervous system problems:
Damage to nerves causing numbness and weakness, including in the extremities like
hands or feet (polyneuropathy, peripheral neuropathy)
Inflammation of the brain (encephalitis)
A condition in which the muscles become weak and tire easily (myasthenic syndrome)
Inflammation of the nerves causing numbness, weakness, tingling or burning pain of
the arms and legs, headaches, dizziness (autoimmune neuropathy)
Loss of the covering around the nerves (demyelination) pain
A temporary inflammation of the nerves that causes pain, weakness and paralysis in
the extremities (Guillain-Barré syndrome)
Sensations like numbness and tingling (paraesthesia), dizziness
Inflammation of the spinal cord (myelitis) causing back and neck pain, weakness in
the arms or legs, loss of bladder or bowel control
Inflammation of the tissue around the brain and spinal cord (aseptic meningitis) causing
headache, neck stiffness (with or without fever), light sensitivity, muscle pain and
altered levels of consciousness
Complications of allogeneic Haematopoietic Stem Cell Transplant (HSCT):
Complications of stem cell transplant that uses donor cells (allogeneic) may occur
after treatment with OPDIVO SC.
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.
Problems in other organs:
Inflammation of the heart (myocarditis). Symptoms may include shortness of breath,
fatigue, palpitations or chest pain
Changes in the rhythm or rate of the heart, abnormal heart rhythm
Inflammation of muscles (myositis). Symptoms may include muscle pain, stiffness, weakness,
chest pain or severe fatigue
Muscle breakdown/injury (rhabdomyolysis). Symptoms may include muscle pain, weakness,
nausea or vomiting.
Inflammation of the eye, which causes pain and redness, blurred vision
Solid organ transplant rejection
A condition where the immune system mistakenly destroys red blood cells (oxygen carrying
cells) and results in decreased number of red blood cells (autoimmune haemolytic anaemia)
A condition where the bone marrow fails to produce enough new blood cells (aplastic
anaemia) which can result in anaemia (decreased red blood cells), and susceptibility
to infection or bruising
Inflammation throughout the body (systemic inflammatory response syndrome) leading
to redness and swelling (oedema) in the affected parts, intense pain, fatigue, fast
heart rate, abnormal breathing, fever or chills
Reactions to administration of medication:
Allergic reaction, reaction related to the administration of the medicine
Life threatening allergic reaction
Hypovolaemic shock, causing rapid heart rate, shallow breathing, cool, clammy skin,
confusion or dizziness
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Other side effects
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Other side effects
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What to do
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The following side effects have been reported in clinical trials when nivolumab has
been given alone:
Very Common side effects
Diarrhoea (watery, loose or soft stools), nausea
Skin rash sometimes with blisters, itching
Feeling tired or weak
Common side effects
Infections of the upper respiratory tract
Decreased appetite
Coughing, shortness of breath (dyspnoea)
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)
High blood pressure (hypertension)
Dry eye
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Speak to your doctor if you have any of these side effects and they worry you.
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The following side effects have been reported in clinical trials when nivolumab has
been given in combination with ipilimumab:
Very Common side effects
Decreased appetite
Headache
Shortness of breath (dyspnoea)
Skin rash sometimes with blisters, itching
Pain in the joints, muscles and bones
Feeling tired or weak
Fever
Common side effects
Serious lung infection (pneumonia), infections of the upper respiratory tract
Dehydration
Inflammation of the eye, which causes pain and redness, blurred vision
Fast heart rate
High blood pressure (hypertension)
Mouth ulcers and cold sores (stomatitis), inflammation of the pancreas (pancreatitis),
constipation, dry mouth
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
Inflammation of the joints (arthritis)
Oedema (swelling), pain
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Speak to your doctor if you have any of these side effects and they worry you.
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The following side effects have been reported in clinical trials when nivolumab has
been given in combination with cabozantinib
Very Common side effects
Decreased appetite, altered sense of taste
High blood pressure (hypertension)
Hoarseness
Diarrhoea, nausea, mouth ulcers and cold sores (stomatitism), vomiting, abdominal
pain, indigestion
Blisters, pain of the hands or soles of the feet, rash or redness of the skin, rash,
itching
Feeling tired or weak
Common side effects
Infections of the upper respiratory tract
Dehydration
Headache, dizziness, inflammation of the nerves causing numbness or burning pain of
the arms and legs
Dry eye
Blood clots
Dry mouth, constipation, inflammation of the stomach (gastritis), oral pain
Dry skin, unusual hair loss or thinning, redness of the skin, hair colour change
Pain in the joints, muscle spasm, pain in the muscles or bones, pains, inflammation
in the joints
Oedema (swelling), fever, pain
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Speak to your doctor if you have any of these side effects and they worry you.
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The following side effects have been reported in clinical trials when nivolumab has
been given in combination with chemotherapy
Very Common side effects
Decreased appetite
Constipation
Diarrhoea (watery, loose or soft stools), vomiting, nausea
Mouth ulcers and cold sores (stomatitis)
Feeling tired or weak
Skin rash sometimes with blisters, itching, tingling and tenderness developing to
symmetrical redness, swelling and pain primarily on the palm of the hand and sole
of the foot (palmar-plantar erythrodysaesthaesia syndrome)
Common side effects
Serious lung infection (pneumonia), infections of the upper respiratory tract
Headache
Dry eyes
Blurred vision
Shortness of breath (dyspnoea)
Blood clots, low blood pressure (hypotension)
Dry mouth
Abdominal pain
Dry skin, redness of the skin, unusual hair loss or thinning, skin colour change in
patches, hives (itchy rash)
Pain in the joints, muscles and bones, inflammation of the joints, muscle weakness
Fever
Oedema (swelling)
Inflammation of the blood vessels (vasculitis)
High blood pressure (hypertension)
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Speak to your doctor if you have any of these side effects and they worry you.
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The following side effects have been reported in a clinical trial with OPDIVO SC
Injection site reactions (redness, swelling, or itching)
Pain in muscles, bones, and joints
Feeling tired
Rash
Low thyroid hormone levels
Diarrhoea (watery, loose or soft stools)
Cough
Stomach (abdominal) pain
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Speak to your doctor if you have any of these side effects and they worry you.
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Tell your doctor, nurse or pharmacist if you notice anything else that may be making
you feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems.
By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
This medicine is only available with a doctor's prescription.
What OPDIVO SC contains
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Active ingredient
(main ingredient)
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nivolumab
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Other ingredients
(inactive ingredients)
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Vorhyaluronidase alfa
Histidine
Histidine hydrochloride monohydrate
Sucrose
Pentetic acid
Polysorbate 80
Methionine
Water for injections
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Do not take this medicine if you are allergic to any of these ingredients.
What OPDIVO SC looks like
OPDIVO SC solution for injection is a clear to opalescent, colourless to pale yellow
liquid that may contain a few light particles.
OPDIVO SC is available in the following presentation:
OPDIVO SC (nivolumab) solution for injection 600 mg in 5 mL (120 mg/mL) AUST R 462669
Who distributes OPDIVO SC
Bristol-Myers Squibb Australia Pty Ltd
Level 2, 4 Nexus Court
Mulgrave VIC 3170 Australia.
Toll free number: 1800 067 567
Email: MedInfo.Australia@bms.com
OPDIVO® SC is a registered trademark of Bristol-Myers Squibb Company
This leaflet was prepared in December 2025.
