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Nivolumab BMS
nivolumab

Package leaflet: Information for the user


Nivolumab BMS 10 mg/mL concentrate for solution for infusion

nivolumab


imageThis 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 Nivolumab BMS is and what it is used for

  2. What you need to know before you use Nivolumab BMS

  3. How to use Nivolumab BMS

  4. Possible side effects

  5. How to store Nivolumab BMS

  6. Contents of the pack and other information


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  1. What Nivolumab BMS is and what it is used for


    Nivolumab BMS is a medicine used to treat advanced non-small cell lung cancer (a type of lung 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 lung cancer cells.


  2. What you need to know before you use Nivolumab BMS You should not be given Nivolumab BMS

    • 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 Nivolumab BMS 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 rash and itching.


      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 Nivolumab BMS,

    • or stop your treatment with Nivolumab BMS 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 Nivolumab BMS if:

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

    • you have an autoimmune disease (a condition where the body attacks its own cells);

    • you have any history of inflammation of the lungs;

    • you have been taken medicines to suppress your immune system.


      Children and adolescents

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


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      Other medicines and Nivolumab BMS

      Before you are given Nivolumab BMS, 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 Nivolumab BMS. However, once you are treated with Nivolumab BMS, 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 Nivolumab BMS if you are pregnant unless your doctor specifically tells you to. The effects of Nivolumab BMS 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 Nivolumab BMS and for at least 5 months following the last dose of Nivolumab BMS, if you are a woman who could

      become pregnant.

    • If you become pregnant while using Nivolumab BMS 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 Nivolumab BMS.


      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.

      Nivolumab BMS contains sodium

      Tell your doctor if you are on a low-sodium (low-salt) diet before you are given Nivolumab BMS. 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 Nivolumab BMS How much Nivolumab BMS is given

    The amount of Nivolumab BMS 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 Nivolumab BMS 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 Nivolumab BMS may be necessary to obtain the required dose.


    How Nivolumab BMS is given

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


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


    If you miss a dose of Nivolumab BMS

    It is very important for you to keep all your appointments to receive Nivolumab BMS. If you miss an

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    appointment, ask your doctor when to schedule your next dose.


    If you stop using Nivolumab BMS

    Stopping your treatment may stop the effect of the medicine. Do not stop treatment with Nivolumab BMS 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.


  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. Nivolumab BMS 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:


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

    • Decreased appetite

    • Nausea

    • Feeling tired or weak


      Common (may affect up to 1 in 10 people)

    • Underactive thyroid gland which can cause tiredness or weight gain

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

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

    • Diarrhoea (watery, loose or soft stools), mouth ulcers and cold sores (stomatitis), vomiting,

      stomach pain, constipation, dry mouth

    • Skin rash, itching

    • Pain in the muscles, bones and joints

    • Fever, oedema (swelling)


      Uncommon (may affect up to 1 in 100 people)

    • Bronchitis, infections of the upper respiratory tract

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

    • Allergic reaction, reactions related to the administration of the medicine

    • Adrenal glands not working properly, inflammation of the thyroid gland

    • A condition in which the muscles become weak and tire easily (myasthenic syndrome), damage to the nerves in different parts of the body that can cause decreased feeling or affect movement

    • Fast heart rate

    • Inflammation of blood vessels

    • Fluid in the lungs

    • Inflammation of the intestines (colitis), ulcer of the small intestines

    • Hives (itchy, bumpy rash)

    • Inflammation of muscles causing pain or stiffness

    • Kidney disease, kidney failure.


      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

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      Nivolumab BMS may cause changes in the results of tests carried out by your doctor. These include:

    • 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)

    • Abnormal liver function tests (increased amounts of the liver enzymes aspartate

      aminotransferase, alanine aminotransferase or alkaline phosphatase in your blood, higher blood levels of bilirubin)

    • Abnormal kidney function tests (increased amounts of creatinine in your blood)

    • Abnormal levels of calcium, potassium, magnesium, or sodium in your blood

    • An increased level of the enzyme that breaks down lipids and of the enzyme that breaks down starch.


      Reporting of side effects

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      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 Nivolumab BMS


    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 Nivolumab BMS contains


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

Nivolumab BMS 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. Nivolumab BMS should not be frozen.


Do not use Nivolumab BMS 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.


Nivolumab BMS infusion

Nivolumab BMS 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 4 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

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material should be disposed of in accordance with local requirements.