Opdivo 100mg10ml concentrate for solution for infusion vials

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Nivolumab

Tillgänglig från:

Bristol-Myers Squibb Pharmaceuticals Ltd

ATC-kod:

L01XC17

INN (International namn):

Nivolumab

Dos:

10mg/1ml

Läkemedelsform:

Solution for infusion

Administreringssätt:

Intravenous

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 08010500; GTIN: 5012712004349

Bipacksedel

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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 bloc

Produktens egenskaper

OBJECT 1
OPDIVO 10 MG/ML CONCENTRATE FOR SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 24-May-2018 | Bristol-Myers
Squibb Pharmaceuticals
limited
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
OPDIVO 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.
One vial of 24 mL contains 240 mg of nivolumab.
Nivolumab is produced in Chinese hamster ovary cells by recombinant
DNA technology.
Excipient with known effect
Each mL of concentrate contains 0.1 mmol (or 2.5 mg) sodium.
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
Melanoma
OPDIVO as monotherapy or in combination with ipilimumab is indicated
for the treatment of advanced
(unresectable or metastatic) melanoma in adults.
Relative to nivolumab monotherapy, an increase in progression-free
survival (PFS) and overall survival
(OS) for the combination of nivolumab with ipilimumab is established
only in patients with low tumour
PD-L1 expression (see sections 4.4 and 5.1).
Non-Small Cell Lung Cancer (NSCLC)
OPDIVO as monotherapy is indicated for the treatment of locally
advanced or metastatic non-small cell
lung cancer after prior chemotherapy in adults.
Renal Cell Carcinoma (RCC)
OPDIVO as monotherapy is indicated for the treatment of advanced renal
cell carcinoma after prior
therapy in adults.
Classical Hodgkin Lympho