Nivolumab BMS
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
14-01-2016
Charakterystyka produktu
(SPC)
14-01-2016
Sprawozdanie z oceny publicznego
(PAR)
14-01-2016
Składnik aktywny:
nivolumab
Dostępny od:
Bristol-Myers Squibb Pharma EEIG
Kod ATC:
L01XC17
INN (International Nazwa):
nivolumab
Grupa terapeutyczna:
Antineoplastic and immunomodulating agents, Monoclonal antibodies
Dziedzina terapeutyczna:
Carcinoma, Non-Small-Cell Lung
Wskazania:
Nivolumab BMS is indicated for the treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after prior chemotherapy in adults.
Status autoryzacji:
Withdrawn
Data autoryzacji:
2015-07-20
Ulotka dla pacjenta
28
B. PACKAGE LEAFLET
Medicinal product no longer authorised
29
PACKAGE LEAFLET: INFORMATION FOR THE USER
NIVOLUMAB BMS 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 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
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 i
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Charakterystyka produktu
1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Nivolumab BMS 10 mg/mL concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of concentrate contains 10 mg of nivolumab.
One vial of 4 mL contains 40 mg of nivolumab.
One vial of 10 mL contains 100 mg of nivolumab.
Nivolumab is produced in Chinese hamster ovary cells by recombinant
DNA technology.
Each mL of concentrate contains 0.1 mmol (or 2.5 mg) sodium.
Excipient with known effect
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Clear to opalescent, colourless to pale yellow liquid that may contain
few light particles. The solution
has a pH of approximately 6.0 and an osmolality of approximately 340
mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nivolumab BMS is indicated for the treatment of locally advanced or
metastatic squamous non-small
cell lung cancer (NSCLC) after prior chemotherapy in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment must be initiated and supervised by physicians experienced
in the treatment of cancer.
The recommended dose of Nivolumab BMS is 3 mg/kg administered
intravenously over 60 minutes
every 2 weeks. Treatment should be continued as long as clinical
benefit is observed or until treatment
is no longer tolerated by the patient.
Posology
Dose escalation or reduction is not recommended. Dosing delay or
discontinuation may be required
based on individual safety and tolerability. Guidelines for permanent
discontinuation or withholding of
doses are described in Table 1. Detailed guidelines for the management
of immune-related adverse
reactions are described in section 4
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