OPDIVO®

Both OPDIVO and ipilimumab 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.

OPDIVO®(op-DEE-voh)

Active ingredient: nivolumab (nee-vol-u-mab)

---

Consumer Medicine Information (CMI)

This leaflet provides important information about using OPDIVO. 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.

Where to find information in this leaflet:

1. Why am I given OPDIVO?
2. What should I know before I am given OPDIVO?
3. What if I am taking other medicines?
4. How am I given OPDIVO?
5. What should I know while receiving OPDIVO?
6. Are there any side effects?
7. Product details

1. Why am I given OPDIVO?

OPDIVO contains the active ingredient nivolumab. OPDIVO is a protein which helps your immune system to attack and destroy cancer cells.

OPDIVO 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 blood cancer called classical Hodgkin lymphoma
• 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 and adolescents (12 years and older)

OPDIVO in combination with ipilimumab is used to treat:

• Advanced melanoma (unresectable or metastatic melanoma)
• A type of advanced kidney cancer (renal cell carcinoma)
• A type of cancer that affects the lining of the lung (Malignant pleural mesothelioma)
• A type of cancer of the food pipe (oesophageal squamous cell cancer).

OPDIVO in combination with ipilimumab and chemotherapy is used to treat:

• A type of lung cancer (non-small cell lung cancer without certain biological markers)

OPDIVO in combination with cabozantinib is used to treat:

• A type of kidney cancer (renal cell carcinoma)

OPDIVO 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)
• Lung cancer before you have surgery

2. What should I know before I am given OPDIVO?

Warnings

You should not be given OPDIVO 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 for the treatment of advanced melanoma, 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. 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.

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 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, and for at least 5 months following the last dose of 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.

Use in children or adolescents

• For treatment of adjuvant melanoma, it is recommended to use this medicine in adolescents (12 years and older).
• For all other indications, it is not recommended to use this medicine in children or an adolescent (below 18 years) until further information becomes available.

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.

3. What if I am taking other medicines?

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.

4. How am I given OPDIVO?

How is OPDIVO 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)
• Your doctor will decide how many treatments you should be given

Dosage and frequency of administration of OPDIVO

• The recommended dose (amount) and frequency (timing) of OPDIVO can be different depending on the type of cancer it is being used to treat
• Some types of cancer are treated with OPDIVO 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

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 are given too much OPDIVO

As OPDIVO 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, tell your doctor immediately.

5. What should I know while receiving OPDIVO?

Things you should do

Tell any other doctors, dentists, nurses 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.

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
• 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.

Take special care with OPDIVO

• OPDIVO 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
• 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 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 and notify your doctor if you notice any changes to your ability.

6. Are there any side effects?

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.

Serious side effects

Serious side effects

What to do

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), 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 (polyneuropathy) 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 Complications of allogeneic Haematopoietic Stem Cell Transplant (HSCT): 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. 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) 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 Infusion reactions: Allergic reaction, reaction related to the infusion of the medicine Life threatening allergic reaction

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.

Other side effects

Other side effects	What to do
The following side effects have been reported in clinical trials when OPDIVO 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	Speak to your doctor if you have any of these side effects and they worry you.
The following side effects have been reported in clinical trials when OPDIVO 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	Speak to your doctor if you have any of these side effects and they worry you.
The following side effects have been reported in clinical trials when OPDIVO has been given in combination with ipilimumab and chemotherapy Very Common side effects Decreased appetite Diarrhoea (watery, loose or soft stools), vomiting, nausea Skin rash sometimes with blisters, itching Feeling tired or weak Common side effects Conjunctivitis Serious lung infection (pneumonia), infections of the upper respiratory tract Dry eyes headache Shortness of breath (dyspnoea) Mouth ulcers and cold sores (stomatitis), inflammation of the pancreas (pancreatitis), constipation, dry mouth Dry skin, redness of the skin, unusual hair loss or thinning Pain in the joints, muscles and bones, inflammation of the joints Fever Oedema (swelling)	Speak to your doctor if you have any of these side effects and they worry you.
The following side effects have been reported in clinical trials when OPDIVO 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	Speak to your doctor if you have any of these side effects and they worry you.
The following side effects have been reported in clinical trials when OPDIVO 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) Constipation Common side effects Serious lung infection (pneumonia) 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)	Speak to your doctor if you have any of these side effects and they worry you.

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.

7. Product details

This medicine is only available with a doctor’s prescription.

What OPDIVO contains

Active ingredient (main ingredient)	nivolumab
Other ingredients (inactive ingredients)	sodium citrate dihydrate sodium chloride mannitol (E421) pentetic acid polysorbate 80 sodium hydroxide hydrochloric acid water for injections

Do not take this medicine if you are allergic to any of these ingredients.

What OPDIVO looks like

OPDIVO concentrate for solution for infusion is a clear to opalescent, colourless to pale yellow liquid that may contain light (few) particles.

OPDIVO is available in the following presentations:

• 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
• OPDIVO (nivolumab) concentrate solution for infusion 240mg in 24mL (10mg/mL) AUST R 318057 (not marketed)

Who distributes OPDIVO

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^® (nivolumab) is a registered trademark of Bristol-Myers Squibb Company

This leaflet was prepared in January 2024.