CYRAMZA 10 MGML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

RAMUCIRUMAB

Available from:

ELI LILLY ISRAEL LTD, ISRAEL

ATC code:

L01XC21

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

RAMUCIRUMAB 10 MG/ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

ELI LILLY & COMPANY LTD., USA

Therapeutic area:

RAMUCIRUMAB

Therapeutic indications:

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 erlotinib is indicated for the first-line treatment of adult patients with metastatic non-small cell lung adenocarcinoma with activating epidermal growth factor receptor (EGFR) mutations.Cyramza 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.

Authorization date:

2021-04-30

Patient Information leaflet

I CYRAVL A 08
Page 1 of 10
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
This medicine is to be supplied by a physician’s prescription only
CYRAMZA 10 MG/ML
CONCENTRATE FOR SOLUTION FOR INFUSION
ACTIVE INGREDIENT AND ITS QUANTITY: each ml of the concentrate
contains 10 mg of
ramucirumab.
INACTIVE INGREDIENTS AND ALLERGENS IN THE PREPARATION: See chapter 2
section “important
information about some of the ingredients of this medicine” and
chapter 6 “Additional
information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine. If you have any
further questions, contact
your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may
harm them, even if it seems to you that their medical condition is
similar.
Cyramza is intended to treat adults (over the age of 18) only.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Cyramza is a medicine for the treatment of cancer:
-
Cyramza is given in combination with paclitaxel, for the treatment of
adults with advanced
gastric cancer (or cancer of the junction between the oesophagus and
the stomach) with
disease progression after prior treatment with chemotherapy (platinum
and
fluoropyrimidine).
-
Cyramza is given as a monotherapy for the treatment of adults with
advanced gastric
cancer (or cancer of the junction between the oesophagus and the
stomach) with disease
progression after prior treatment with chemotherapy (platinum or
fluoropyrimidine), for
whom treatment of Cyramza in combination with paclitaxel is not
appropriate.
-
Cyramza is given for the treatment of adults with metastatic
colorectal cancer with disease
progression, on or after prior therapy with oxaliplatin, bevacizumab,
and a
fluoropyrimidine. This treatment is administered in combination with
other medicines
called “FOLFIRI chemotherapy”, which include 5-fluorouracil,
folinic acid, and irinotecan.
-
Cyramza is given in combinati

Summary of Product characteristics

X CYRAVL A 08
Page 1 of 31
1.
NAME OF THE MEDICINAL PRODUCT
Cyramza 10 mg/ml
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.
The concentrate is a clear to slightly opalescent and colorless 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.
X CYRAVL A 08
Page 2 of 31
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 adenocarcinoma with activating
epidermal growth factor receptor
(EGFR) mutations (see section 5.1).
Cyramza in combination with docetaxel is indicated for the treatment
of