OPDIVO 10 mg/mL concentrate for solution for infusion
Country: United Kingdom
Language: English
Source: myHealthbox
Patient Information leaflet
(PIL)
25-04-2024
Summary of Product characteristics
(SPC)
25-04-2024
Active ingredient:
Nivolumab
Available from:
Bristol-Myers Squibb Pharma EEIG
ATC code:
L01XC17
INN (International Name):
Nivolumab
Dosage:
10 mg/ml
Pharmaceutical form:
Concentrate for solution for infusion
Administration route:
Oral use
Units in package:
Pack size of 1 vial
Prescription type:
POM - Prescription Only Medicine
Manufactured by:
Bristol-Myers Squibb S.r.l.
Therapeutic group:
Antineoplastic agents, monoclonal antibodies
Therapeutic indications:
As monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults
Authorization status:
Authorised
Authorization date:
2015-06-19
Patient Information leaflet
1
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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.
- 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. 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 cells.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE OPDIVO
YOU SHOULD NOT BE GIVEN OPDIVO
if you are ALLERGIC
Read the complete document
Summary of Product characteristics
OPDIVO 10 mg/mL concentrate for solution for infusion
Summary of Product Characteristics Updated 22Jun2015 | BristolMyers Squibb Pharmaceutical 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.
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, colorless 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
OPDIVO as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.
4.2 Posology and method of administration
Treatment must be initiated and supervised by physicians experienced in the treatment of cancer.
Posology
The recommended dose of OPDIVO 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.
Dose escalation or reduction is not recommended. Dosing delay or discontinuation m
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