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Opdivo (nivolumab) – Package leaflet - L01XC

Updated on site: 09-Oct-2017

Medication nameOpdivo
ATC CodeL01XC
Substancenivolumab
ManufacturerBristol-Myers Squibb Pharma EEIG

Package leaflet: Information for the user

OPDIVO 10 mg/mL concentrate for solution for infusion nivolumab

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-It is important that you keep the Alert Card with you during treatment.

-If you have any further questions, ask your doctor.

-If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What OPDIVO is and what it is used for

2.What you need to know before you use OPDIVO

3.How to use OPDIVO

4.Possible side effects

5.How to store OPDIVO

6.Contents of the pack and other information

1.What OPDIVO is and what it is used for

OPDIVO is a medicine used to treat:

advanced melanoma (a type of skin cancer) in adults

advanced non-small cell lung cancer (a type of lung cancer) in adults

advanced renal cell carcinoma (advanced kidney cancer) in adults

classical Hodgkin lymphoma that has come back after or has not responded to previous therapies, including an autologous stem-cell transplant (a transplant of your own blood-producing cells) in adults

advanced cancer of the head and neck in adults

advanced urothelial carcinoma (bladder and urinary tract cancer) in adults.

It contains the active substance nivolumab, which is a monoclonal antibody, a type of protein designed to recognise and attach to a specific target substance in the body.

Nivolumab attaches to a target protein called programmed death-1 receptor (PD-1) that can switch off the activity of T cells (a type of white blood cell that forms part of the immune system, the body’s natural defences). By attaching to PD-1, nivolumab blocks its action and prevents it from switching off your T cells. This helps increase their activity against the melanoma, lung, kidney, lymphoid, head and neck or bladder cancer cells.

OPDIVO may be given in combination with ipilimumab. It is important that you also read the package leaflet for this medicine. If you have any questions about ipilimumab, please ask your doctor.

2. What you need to know before you use OPDIVO

You should not be given OPDIVO

if you are allergic to nivolumab or any of the other ingredients of this medicine (listed in section 6 "Contents of the pack and other information"). Talk to your doctor if you are not sure.

Warnings and precautions

Talk to your doctor before using OPDIVO as it 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 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, or decreased volume of urine.

Problems with your hormone producing glands (including the pituitary, the thyroid and adrenal glands) that may affect how these glands work. Signs and symptoms that these 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 severe skin reaction (known as toxic epidermal necrolysis and Stevens-Johnson syndrome). Signs and symptoms of severe skin reaction may include rash, itching, and peeling of the skin (possibly fatal).

Inflammation of the muscles such as myocarditis (inflammation of the heart muscle), myositis (inflammation of the muscles) and rhabdomyolysis (stiffness in muscles and joints, muscle spasm). Signs and symptoms may include muscle pain, stiffness, weakness, chest pain, or severe fatigue.

Solid organ transplant rejection.

Tell your doctor immediately if you have any of these signs or symptoms or if they get worse. Do not try to treat your symptoms with other medicines on your own. 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 your treatment.

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);

you have melanoma of the eye;

you were previously given ipilimumab, another medicine for treating melanoma, and experienced serious side effects because of that medicine;

you have been told that your cancer has spread to your brain;

you have any history of inflammation of the lungs;

you have been taken medicines to suppress your immune system.

Complications of stem cell transplant that uses donor stem cells (allogeneic) 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.

Children and adolescents

OPDIVO should not be used in children and adolescents below 18 years of age.

Other medicines and OPDIVO

Before you are given OPDIVO, tell your doctor if 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.

Tell your doctor if you are taking or have recently taken any other medicines. Do not take any other medicines during your treatment without talking to your doctor first.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant or think you might be, if you are planning to become pregnant, or if you are breast-feeding.

Do not use OPDIVO if you are pregnant unless your doctor specifically tells you to. 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.

It is not known whether nivolumab gets into breast milk. A risk to the breast-fed infant cannot be excluded. Ask your doctor if you can breast-feed during or after treatment with OPDIVO.

Driving and using machines

Nivolumab is unlikely to affect your ability to drive or use machines; however, use caution when performing these activities until you are sure that nivolumab does not adversely affect you.

OPDIVO contains sodium

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.

You will also find this information in the Patient Alert Card you have been given by your doctor. It is important that you keep this Alert Card and show it to your partner or caregivers.

3.How to use OPDIVO

How much OPDIVO is given

The amount of OPDIVO you will be given will be calculated based on your body weight. The recommended dose is 3 mg of nivolumab per kilogram of your body weight.

Depending on your dose, the appropriate amount of OPDIVO will be diluted with sodium chloride 9 mg/mL (0.9%) solution for injection or glucose 50 mg/mL (5%) solution for injection before use. More than one vial of OPDIVO may be necessary to obtain the required dose.

When OPDIVO is given in combination with ipilimumab the recommended dose of OPDIVO is 1 mg of nivolumab per kilogram of your body weight for the first 4 doses (combination phase). Thereafter the recommended dose of OPDIVO is 3 mg of nivolumab per kilogram of your body weight (single- agent phase).

How OPDIVO is given

You will receive treatment with OPDIVO in a hospital or clinic, under the supervision of an experienced doctor.

OPDIVO 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 you OPDIVO for as long as you keep benefitting from it or until you no longer tolerate the treatment.

When OPDIVO is given in combination with ipilimumab, you will be given an infusion over a period of 60 minutes, every 3 weeks for the first 4 doses (combination phase). Thereafter it will be given as an infusion over a period of 60 minutes, every 2 weeks (single-agent phase).

If you miss a dose of OPDIVO

It is very important for you to keep all your 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 on the use of this medicine, ask your doctor.

When OPDIVO is given in combination with ipilimumab, you will first be given OPDIVO followed by ipilimumab.

Please refer to the package leaflet of ipilimumab in order to understand the use of this medicine. If you have questions about this medicine, please ask your doctor.

4.Possible side effects

Like all medicines, this medicine 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 nivolumab.

The following side effects have been reported in clinical trials with nivolumab alone:

Very common (may affect more than 1 in 10 people)

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

Allergic reaction, reactions related to the infusion of the medicine

Underactive thyroid gland (which can cause tiredness or weight gain), overactive thyroid gland (which can cause rapid heart rate, sweating and weight loss)

High sugar levels in the blood (hyperglycaemia)

Decreased appetite

Inflammation of the nerves (causing numbness, weakness, tingling or burning pain of the arms and legs), headache, dizziness

High blood pressure (hypertension)

Inflammation of the lungs (pneumonitis, characterised by coughing and difficulty breathing), shortness of breath (dyspnoea), cough

Mouth ulcers and cold sores (stomatitis), vomiting, stomach pain, constipation, dry mouth

Skin colour change in patches (vitiligo), dry skin, redness of the skin, unusual hair loss or thinning

Pain in the muscles, bones (musculoskeletal pain) and joints (arthralgia)

Fever, oedema (swelling)

Uncommon (may affect up to 1 in 100 people)

Serious lung infection (pneumonia), bronchitis

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, swelling of the thyroid gland

Dehydration, increased acid levels in the blood

Inflammation of the liver (hepatitis)

Damage to nerves causing numbness and weakness (polyneuropathy)

Inflammation of the eye (which causes pain and redness), blurred vision, dry eyes

Fast heart rate

Fluid around the lungs

Inflammation of the intestines (colitis), inflammation of the pancreas

Severe condition of the skin that causes red, often itchy spots, similar to the 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 with silvery scales (psoriasis), skin condition of the face where the nose and cheeks are unusually red (rosacea), hives (itchy, bumpy rash)

Inflammation of the muscles causing pain or stiffness (polymyalgia rheumatica), inflammation of the joints (arthritis)

Inflammation of the kidney, kidney failure

Pain, chest pain

Rare (may affect up to 1 in 1000 people)

A disease causing the inflammation or enlargement of a lymph node (Kikuchi lymphadenitis)

Life-threatening allergic reaction

Diabetes, acid in the blood produced from diabetes (diabetic ketoacidosis)

Blockage of bile ducts

A temporary inflammation of the nerves that causes pain, weakness, and paralysis in the extremities (Guillain- Barré syndrome); loss of the protective sheath around nerves (demyelination); a condition in which the muscles become weak and tire easily (myasthenic syndrome), inflammation of the nerves caused by the body attacking itself, causing numbness, weakness, tingling or burning pain

Inflammation of the brain

Changes in the rhythm or rate of the heartbeat, abnormal heart rhythm, inflammation of the heart muscle

Inflammatory disease of blood vessels

Fluid in the lungs

Gastritis (inflammation of the stomach), ulcer of the small intestines

Severe and possibly fatal peeling of the skin (toxic epidermal necrolysis or Stevens-Johnson syndrome)

Myopathy (aching muscles, muscle tenderness or weakness, not caused by exercise), myositis (inflammation of the muscles), rhabdomyolysis (stiffness in muscles and joints, muscle spasm)

Tell your doctor immediately if you get any of the side effects listed above. Do not try to treat your symptoms with other medicines on your own.

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 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

Increased or decreased amount of calcium or potassium

Increased or decreased blood levels of magnesium or sodium

Decrease in body weight

The following side effects have been reported in clinical trials with nivolumab in combination with ipilimumab:

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 sometimes with blisters, itching

Pain in the joints (arthralgia)

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

Allergic reaction, reactions related to the infusion of the medicine

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; swelling of the thyroid gland, high sugar levels in the blood (hyperglycaemia)

Dehydration

Inflammation of the liver

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, vision problems or blurred vision

Fast heart rate

High blood pressure (hypertension)

Inflammation of the lungs (pneumonitis), characterised by coughing and difficulty breathing, blood clots, shortness of breath (dyspnoea), cough

Mouth ulcers and cold sores (stomatitis), gastritis (inflammation of the stomach), 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 (musculoskeletal pain)

Kidney failure

Oedema (swelling), pain

Uncommon (may affect up to 1 in 100 people)

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

Inflammation of the brain

Changes in the rhythm or rate of the heartbeat, abnormal heart rhythm, inflammation of the heart muscle

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 the joints (arthritis), myopathy (aching muscles, muscle tenderness of weakness, not caused by exercise), myositis (inflammation of the muscles), rhabdomyolysis (stiffness in muscles and joints, muscle spasm)

Inflammation of the kidney

Chest pain

Rare (may affect up to 1 in 1000 people)

Severe and possibly fatal peeling of the skin (toxic epidermal necrolysis or Stevens-Johnson syndrome)

Tell your doctor immediately if you get any of the side effects listed above. Do not try to treat your symptoms with other medicines on your own.

Changes in test results

OPDIVO in combination with ipilimumab 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.

Increased or decreased amount of calcium or potassium

Increased or decreased blood levels of magnesium or sodium

Decrease in body weight

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.How to store OPDIVO

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the vial label 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.

Do not store any unused portion of the infusion solution for reuse. Any unused medicine or waste material should be disposed of in accordance with local requirements.

6.Contents of the pack and other information

What OPDIVO contains

The active substance is nivolumab.

Each mL of concentrate for solution for infusion contains 10 mg of nivolumab. Each vial contains either 40 mg (in 4 mL) or 100 mg (in 10 mL) of nivolumab.

The other ingredients are sodium citrate dihydrate, sodium chloride (see section 2 "OPDIVO contains sodium"), mannitol (E421), pentetic acid, polysorbate 80, sodium hydroxide, hydrochloric acid and water for injections.

What OPDIVO looks like and contents of the pack

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

It is available in packs containing either 1 vial of 4 mL or 1 vial of 10 mL.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

United Kingdom

Manufacturer

Bristol-Myers Squibb S.r.l. Loc. Fontana del Ceraso 03012 Anagni (FR)

Italy

Swords Laboratories t/a Bristol-Myers Squibb Cruiserath Biologics

Cruiserath Road, Mulhuddart

Dublin 15

Ireland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Belgique/België/Belgien

Lietuva

N.V. Bristol-Myers Squibb Belgium S.A.

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft.

Tél/Tel: + 32 2 352 76 11

Tel: +370 52 369140

България

Luxembourg/Luxemburg

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. N.V. Bristol-Myers Squibb Belgium S.A.

Teл.: + 359 800 12 400

Tél/Tel: + 32 2 352 76 11

Česká republika

Magyarország

Bristol-Myers Squibb spol. s r.o.

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft.

Tel: + 420 221 016 111

Tel.: + 36 1 301 9700

Danmark

Malta

Bristol-Myers Squibb

Bristol-Myers Squibb S.r.l.

Tlf: + 45 45 93 05 06

Tel: + 39 06 50 39 61

Deutschland

Nederland

Bristol-Myers Squibb GmbH & Co. KGaA

Bristol-Myers Squibb B.V.

Tel: + 31 (0)30 300 2222

Eesti

Norge

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. Bristol-Myers Squibb Norway Ltd

Tel: +372 640 1030

Tlf: + 47 67 55 53 50

Ελλάδα

Österreich

Bristol-Myers Squibb A.E.

Bristol-Myers Squibb GesmbH

Τηλ: + 30 210 6074300

Tel: + 43 1 60 14 30

España

Polska

Bristol-Myers Squibb, S.A.

Bristol-Myers Squibb Polska Sp. z o.o.

Tel: + 34 91 456 53 00

Tel.: + 48 22 5796666

France

Portugal

Bristol-Myers Squibb SARL

Bristol-Myers Squibb Farmacêutica Portuguesa,

Tél: + 33 (0)1 58 83 84 96

S.A.

 

Tel: + 351 21 440 70 00

Hrvatska

România

Bristol-Myers Squibb spol. s r.o.

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft.

TEL: +385 1 2078 508

Tel: + 40 (0)21 272 16 00

Ireland

Slovenija

Bristol-Myers Squibb Pharmaceuticals

Bristol-Myers Squibb spol. s r.o.

Tel: + 353 (1 800) 749 749

Tel: +386 1 2355 100

Ísland

Slovenská republika

Vistor hf.

Bristol-Myers Squibb spol. s r.o.

Sími: + 354 535 7000

Tel: + 421 2 59298411

Italia

Suomi/Finland

Bristol-Myers Squibb S.r.l.

Oy Bristol-Myers Squibb (Finland) Ab

Tel: + 39 06 50 39 61

Puh/Tel: + 358 9 251 21 230

Κύπρος

Sverige

Bristol-Myers Squibb A.E.

Bristol-Myers Squibb AB

Τηλ: + 357 800 92666

Tel: + 46 8 704 71 00

Latvija

United Kingdom

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. Bristol-Myers Squibb Pharmaceuticals Ltd

Tel: +371 67708347

Tel: + 44 (0800) 731 1736

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu

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The following information is intended for healthcare professionals only:

Preparation and administration of OPDIVO

Preparation should be performed by trained personnel in accordance with good practices rules, especially with respect to asepsis.

Calculating the dose

The prescribed dose for the patient is given in mg/kg. Based on this prescribed dose, calculate the total dose to be given. More than one vial of OPDIVO concentrate may be needed to give the total dose for the patient.

The total nivolumab dose in mg = the patient’s weight in kg × the prescribed dose in mg/kg.

The volume of OPDIVO concentrate to prepare the dose (mL) = the total dose in mg, divided by 10 (the OPDIVO concentrate strength is 10 mg/mL).

Preparing the infusion

Take care to ensure aseptic handling when you prepare the infusion.

OPDIVO can be used for intravenous administration either:

without dilution, after transfer to an infusion container using an appropriate sterile syringe;

or

after diluting to concentrations as low as 1 mg/mL. The final infusion concentration should range between 1 and 10 mg/mL. OPDIVO concentrate may be diluted with either:

sodium chloride 9 mg/mL (0.9%) solution for injection; or

50 mg/mL (5%) glucose solution for injection.

STEP 1

Inspect the OPDIVO concentrate for particulate matter or discoloration. Do not shake the vial. OPDIVO concentrate is a clear to opalescent, colourless to pale yellow liquid. Discard the vial if the solution is cloudy, is discoloured, or contains particulate matter other than a few translucent- to-white particles.

Withdraw the required volume of OPDIVO concentrate using an appropriate sterile syringe.

STEP 2

Transfer the concentrate into a sterile, evacuated glass bottle or intravenous container (PVC or polyolefin).

If applicable, dilute with the required volume of sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL (5%) glucose solution for injection. For ease of preparation, the concentrate can be transferred directly into a pre-filled bag containing the appropriate volume of sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL (5%) glucose solution for injection.

Gently mix the infusion by manual rotation. Do not shake.

Administration

OPDIVO infusion must not be administered as an intravenous push or bolus injection. Administer the OPDIVO infusion intravenously over a period of 60 minutes.

OPDIVO infusion should not be infused at the same time in the same intravenous line with other agents. Use a separate infusion line for the infusion.

Use an infusion set and an in-line, sterile, non-pyrogenic, low protein binding filter (pore size of 0.2 μm to 1.2 μm).

OPDIVO infusion is compatible with:

PVC containers

Polyolefin containers

Glass bottles

PVC infusion sets

In-line filters with polyethersulfone membranes with pore sizes of 0.2 µm to 1.2 µm.

After administration of the nivolumab dose, flush the line with sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL (5%) glucose solution for injection.

Storage conditions and shelf life

Unopened vial

OPDIVO must be stored in a refrigerator (2°C to 8°C). The vials must be kept in the original package in order to protect from light. OPDIVO should not be frozen.

Do not use OPDIVO after the expiry date which is stated on the carton and on the vial label after EXP. The expiry date refers to the last day of that month.

OPDIVO infusion

OPDIVO infusion must be completed within 24 hours of preparation. If not used immediately, the solution may be stored under refrigeration conditions (2°C-8°C) and protected from light for up

to 24 hours [a maximum of 8 hours of the total 24 hours can be at room temperature (20°C-25°C) and room light]. Other in-use storage time and conditions are the responsibility of the user.

Disposal

Do not store any unused portion of the infusion solution for reuse. Any unused medicine or waste material should be disposed of in accordance with local requirements.

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