Cyramza

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

Ramucirumab

Saatavilla:

Eli Lilly Nederland B.V.

ATC-koodi:

L01FX

INN (Kansainvälinen yleisnimi):

ramucirumab

Terapeuttinen ryhmä:

Antineoplastic agents

Terapeuttinen alue:

Stomach Neoplasms

Käyttöaiheet:

Gastric cancerCyramza 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.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.Colorectal cancerCyramza, 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 bevacizumab, oxaliplatin and a fluoropyrimidine.Non-small cell lung cancerCyramza in combination with docetaxel is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with disease progression after platinum-based chemotherapy.Hepatocellular carcinomaCyramza monotherapy is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma who have a serum alpha fetoprotein (AFP) of ≥ 400 ng/ml and who have been previously treated with sorafenib.

Tuoteyhteenveto:

Revision: 16

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2014-12-19

Pakkausseloste

44
B. PACKAGE LEAFLET
45
PACKAGE LEAFLET: INFORMATION FOR THE USER
CYRAMZA 10 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
ramucirumab
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 to treat advanced cancers of the colon or rectum
(parts of the large intestine) in
adults. It is given with other medicines called ‘FOLFIRI
chemotherapy’, including ‘5-fluorouracil’,
‘folinic acid

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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
Gastric cancer
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).
Colorectal cancer
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 bevacizumab, oxaliplatin and a
fluoropyrimidine.
3
Non-small cell lung cancer
Cyramza in combination with erlotinib is indicated for the first-line
treatment of adult patients with
metastatic non-small cell lung cancer with activating epidermal growth
factor receptor (EGFR)
mutations (see section 5.1).
Cyramza in combination