Opdivo

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NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

(op-DEE-voh)

Nivolumab (nee-vol-u-mab)

Consumer Medicine Information

WARNINGS AND PRECAUTIONS - COMBINATION OF OPDIVO AND YERVOY

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.

Treatment with OPDIVO

OPDIVO is used to treat advanced skin cancer (unresectable or metastatic melanoma). OPDIVO is also used to treat skin cancer (melanoma) after surgical removal of the cancer.

OPDIVO is used 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) , 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) and a type of liver cancer (hepatocellulcar carcinoma) if your cancer has not responded, or if it has stopped responding, to earlier treatment.

Treatment with OPDIVO in combination with YERVOY

OPDIVO in combination with YERVOY (ipilimumab) is used to treat advanced melanoma in adults and a type of advanced kidney cancer (renal cell carcinoma).

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.

Patients receiving OPDIVO after surgical removal of melanoma may require treatment for no longer than one year.

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 glands (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. 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 "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).

Your doctor will decide how many treatments you need.

Dosage and frequency of administration

The recommended dose and frequency 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 YERVOY.

Your doctor will advise you if you will be given both treatments and will tell you about the dose and frequency of these treatments.

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 side 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.

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)

Decrease in some white blood cells

Diarrhoea (watery, loose or soft stools), nausea

Skin rash sometimes with blisters, 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

Abnormal kidney function tests

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)

Overactive thyroid gland, which can cause rapid heart rate, sweating and weight loss

Underactive thyroid gland, which can cause tiredness or weight gain

Decreased appetite

Headache

Shortness of breath (dyspnoea)

Inflammation of the intestines (colitis), diarrhoea (watery, loose or soft stools), vomiting, nausea, stomach pain

Skin rash sometimes with blisters, itching

Pain in the joints, muscles and bones

Feeling tired or weak

Fever

Common (may affect up to 1 in 10 people)

Serious lung infection (pneumonia), infections of the upper respiratory tract

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, blood clots, cough

Mouth ulcers and cold sores (stomatitis), inflammation of the pancreas (pancreatitis), 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 (including abrupt loss of kidney function)

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 (autoimmune neuropathy)

Changes in the rhythm or rate of the heart beat, abnormal heart rhythm

Fluid around the lungs

Intestinal perforation, inflammation of the stomach (gastritis), inflammation of the duodenum (duodenitis)

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 the joints (arthritis)

Inflammation of muscles (myositis) causing pain or stiffness

Inflammation of the kidney (nephritis)

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

Abnormal kidney function tests

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 (hyperglycaemia) or lower (hypoglycaemia) levels of sugar in your blood

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.

The other ingredients are sodium citrate dihydrate, sodium chloride, mannitol (E421), pentetic acid, polysorbate 80, sodium hydroxide, hydrochloric acid and water for injection.