Nivolumab BMS
nivolumab
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.
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 Nivolumab BMS is and what it is used for
What you need to know before you use Nivolumab BMS
How to use Nivolumab BMS
Possible side effects
How to store Nivolumab BMS
Contents of the pack and other information
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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.
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.
Talk to your doctor before using Nivolumab BMS as it may cause:
(colitis), such as stomach pain and mucus or blood in stool.
area, or tiredness.
generally unwell) or diabetic ketoacidosis (acid in the blood produced from diabetes).
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
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.
Nivolumab BMS should not be used in children and adolescents below 18 years of age.
Medicinal product no longer authorised
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.
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.
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.
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.
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.
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.
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.
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.
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.
The following side effects have been reported in clinical trials with nivolumab:
Decreased appetite
Nausea
Feeling tired or weak
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)
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.
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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.
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.
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.
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 " Nivolumab BMS contains sodium"), mannitol (E421), pentetic acid, polysorbate 80, sodium hydroxide, hydrochloric acid and water for injections.
Nivolumab BMS 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.
Medicinal product no longer authorised
Sanderson Road Uxbridge UB8 1DH
United Kingdom
Bristol-Myers Squibb S.r.l.
Loc. Fontana del Ceraso 03012 Anagni (FR) Italy
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
N.V. Bristol-Myers Squibb Belgium S.A. Tél/Tel: + 32 2 352 76 11
Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. Tel: + 370 5 2790 762
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
Bristol-Myers Squibb spol. s r.o. Tel: + 420 221 016 111
Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. Tel.: + 36 1 301 9700
Bristol-Myers Squibb
Tlf: + 45 45 93 05 06
BRISTOL-MYERS SQUIBB S.R.L.
Tel: + 39 06 50 39 61
Bristol-Myers Squibb GmbH & Co. KGaA Tel: + 49 89 121 42-0
Bristol-Myers Squibb B.V. Tel: + 31 (0)30 300 2222
Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. Bristol-Myers Squibb Norway Ltd
Tel: + 372 6827 400
Tlf: + 47 67 55 53 50
BRISTOL-MYERS SQUIBB A.E.
Τηλ: + 30 210 6074300
Bristol-Myers Squibb GesmbH
Tel: + 43 1 60 14 30
BRISTOL-MYERS SQUIBB, S.A. Tel: + 34 91 456 53 00
BRISTOL-MYERS SQUIBB POLSKA SP. Z O.O. Tel.: + 48 22 5796666
Bristol-Myers Squibb SARL Tél: + 33 (0)810 410 500
Bristol-Myers Squibb Farmacêutica Portuguesa, S.A.
Tel: + 351 21 440 70 00
Bristol-Myers Squibb spol. s r.o. TEL: +385 (1) 6311-833
Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. Tel: + 40 (0)21 272 16 00
Bristol-Myers Squibb Pharmaceuticals Ltd
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Tel: + 353 (1 800) 749 749
Bristol-Myers Squibb spol. s r.o.
Tel: + 386 1 236 47 00
Vistor hf.
Sími: + 354 535 7000
Bristol-Myers Squibb spol. s r.o.
Tel: + 421 2 59298411
BRISTOL-MYERS SQUIBB S.R.L. Tel: + 39 06 50 39 61
Oy Bristol-Myers Squibb (Finland) Ab Puh/Tel: + 358 9 251 21 230
BRISTOL-MYERS SQUIBB A.E.
Τηλ: + 357 800 92666
Bristol-Myers Squibb AB
Tel: + 46 8 704 71 00
Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. Bristol-Myers Squibb Pharmaceuticals Ltd
Tel: + 371 67 50 21 85
Tel: + 44 (0800) 731 1736
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Preparation should be performed by trained personnel in accordance with good practices rules, especially with respect to asepsis.
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 Nivolumab BMS 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 Nivolumab BMS concentrate to prepare the dose (mL) = the total dose in mg, divided by 10 (the Nivolumab BMS concentrate strength is 10 mg/mL).
prepared in a laminar flow hood or safety cabinet using standard precautions for the safe handling of intravenous agents.
Nivolumab BMS can be used for intravenous administration either:
range between 1 and 10 mg/mL. Nivolumab BMS concentrate may be diluted with either:
sodium chloride 9 mg/mL (0.9%) solution for injection; or
Medicinal product no longer authorised
50 mg/mL (5%) glucose solution for injection.
Inspect the Nivolumab BMS concentrate for particulate matter or discoloration. Do not shake the vial. Nivolumab BMS concentrate is a clear to opalescent, colourless to pale yellow liquid
that may contain few light particles.
Withdraw the required volume of Nivolumab BMS concentrate using an appropriate sterile syringe.
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. Gently mix the infusion by manual rotation. Do not shake.
Nivolumab BMS infusion must not be administered as an intravenous push or bolus injection.
Administer the Nivolumab BMS infusion intravenously over a period of 60 minutes.
Nivolumab BMS 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).
Nivolumab BMS 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.
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.
Do not store any unused portion of the infusion solution for reuse. Any unused medicine or waste
Medicinal product no longer authorised
material should be disposed of in accordance with local requirements.