Cyramza 500mg50ml concentrate for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ramucirumab

Available from:

Eli Lilly and Company Ltd

ATC code:

L01XC21

INN (International Name):

Ramucirumab

Dosage:

10mg/1ml

Pharmaceutical form:

Solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08010500

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CYRAMZA
® 10 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
ramucirumab
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 ARE GIVEN 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 Cyramza is and what it is used for
2.
What you need to know before you are given Cyramza
3.
How you are given Cyramza
4.
Possible side effects
5.
How to store Cyramza
6.
Contents of the pack and other information
1.
WHAT CYRAMZA IS AND WHAT IT IS USED FOR
Cyramza is a cancer medicine that contains the active substance
ramucirumab, which is a monoclonal
antibody. This is a specialised protein that can recognise and attach
to another protein found on blood
vessels called ‘VEGF receptor 2’. This receptor is needed in the
development of new blood vessels.
To grow, cancer needs new blood vessels to develop. By attaching to
‘VEGF receptor 2’ and blocking
it the medicine cuts off the blood supply to the cancer cells.
Cyramza is given in combination with paclitaxel, another anti-cancer
medicine, for the treatment of
advanced stomach cancer (or cancer of the junction between the
oesophagus and the stomach) in
adults whose disease has worsened after treatment with medicines to
treat cancer.
Cyramza is used for the treatment of advanced stomach cancer (or
cancer of the junction between the
oesophagus and the stomach) in adults whose disease has worsened after
treatment with medicines to
treat cancer and for whom treatment of Cyramza in combination with
paclitaxel is not suitable.
Cyramza is used

Summary of Product characteristics

OBJECT 1
CYRAMZA 10 MG/ML CONCENTRATE FOR SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 16-Feb-2016 | Eli Lilly and
Company 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
Cyramza 10 mg/ml concentrate for solution for infusion
2. Qualitative and quantitative composition
One ml of concentrate for solution for infusion contains 10 mg
ramucirumab.
Each 10 ml vial contains 100 mg of ramucirumab.
Each 50 ml vial contains 500 mg of ramucirumab.
Ramucirumab is a human IgG1 monoclonal antibody produced in murine
(NS0) cells by recombinant
DNA technology.
Excipient with known effect:
Each 10 ml vial contains approximately 17 mg sodium.
Each 50 ml vial contains approximately 85 mg sodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Concentrate for solution for infusion (sterile concentrate).
The concentrate is a clear to slightly opalescent and colourless to
slightly yellow solution, pH 6.0.
4. Clinical particulars
4.1 Therapeutic indications
Cyramza in combination with paclitaxel is indicated for the treatment
of adult patients with advanced
gastric cancer or gastro-oesophageal junction adenocarcinoma with
disease progression after prior
platinum and fluoropyrimidine chemotherapy (see section 5.1).
Cyramza monotherapy is indicated for the treatment of adult patients
with advanced gastric cancer or
gastro-oesophageal junction adenocarcinoma with disease progression
after prior platinum or
fluoropyrimidine chemotherapy, for whom treatment in combination with
paclitaxel is not appropriate
(see section 5.1).
Cyramza, in combination with FOLFIRI (irinotecan, folinic acid, and
5-fluorouracil), is indicated for the
treatment of adult patients with metastatic colorectal cancer (mCRC)
with disease progression on or after
prior therapy with