Yervoy

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

Ipilimumab

MAH:

Bristol-Myers Squibb Pharma EEIG

ATC_code:

L01XC11

INN:

ipilimumab

therapeutic_group:

Antineoplastic agents

therapeutic_area:

Melanoma; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Mesothelioma, Malignant; Colorectal Neoplasms

therapeutic_indication:

MelanomaYERVOY as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.4). YERVOY in combination with nivolumab 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).Renal cell carcinoma (RCC)YERVOY in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5.1).Non-small cell lung cancer (NSCLC)YERVOY in combination with nivolumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation.Malignant pleural mesothelioma (MPM)YERVOY in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.Mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC)YERVOY in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy (see section 5.1).Oesophageal squamous cell carcinoma (OSCC)YERVOY in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%.

leaflet_short:

Revision: 53

authorization_status:

Authorised

authorization_date:

2011-07-13

PIL

75
B. PACKAGE LEAFLET
76
PACKAGE LEAFLET: INFORMATION FOR THE USER
YERVOY 5 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
ipilimumab
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 YERVOY is and what it is used for
2.
What you need to know before you use YERVOY
3.
How to use YERVOY
4.
Possible side effects
5.
How to store YERVOY
6.
Contents of the pack and other information
1.
WHAT YERVOY IS AND WHAT IT IS USED FOR
YERVOY contains the active substance ipilimumab, a protein which helps
your immune system to
attack and destroy cancer cells by your immune cells.
Ipilimumab alone is used to treat advanced melanoma (a type of skin
cancer) in adults and adolescents
12 years of age and older.
Ipilimumab in combination with nivolumab is used to treat

advanced melanoma (a type of skin cancer) in adults and adolescents 12
years of age and older

advanced renal cell carcinoma (advanced kidney cancer) in adults

malignant pleural mesothelioma (a type of cancer that affects the
lining of the lung) in adults

advanced colorectal cancer (colon or rectal cancer) in adults

advanced oesophageal cancer (gullet cancer) in adults.
Ipilimumab in combination with nivolumab and chemotherapy is used to
treat advanced non-small cell
lung cancer (a type of lung cancer) in adult.
As YERVOY may be given in combination with other anti-cancer
medicines, it is important that you
also read the package leaflet for these other medicines. If you have
any questions about these
medicines, please ask your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE YERVOY
YOU SHOULD NOT BE GIVEN YERVOY

if you are
ALLERGIC
to ipilimumab or any of the other ingredients of this medicine (listed
in
Sec

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
YERVOY 5 mg/ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate contains 5 mg ipilimumab.
One 10 ml vial contains 50 mg of ipilimumab.
One 40 ml vial contains 200 mg of ipilimumab.
Ipilimumab is a fully human anti-CTLA-4 monoclonal antibody (IgG1κ)
produced in Chinese hamster
ovary cells by recombinant DNA technology.
Excipients with known effect:
Each ml of concentrate contains 0.1 mmol sodium, which is 2.30 mg
sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Clear to slightly opalescent, colourless to pale yellow liquid that
may contain light (few) particulates
and has a pH of 7.0 and an osmolarity of 260-300 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Melanoma
YERVOY as monotherapy or in combination with nivolumab is indicated
for the treatment of
advanced (unresectable or metastatic) melanoma in adults and
adolescents 12 years of age and older
(see section 4.4).
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).
Renal cell carcinoma (RCC)
YERVOY in combination with nivolumab is indicated for the first-line
treatment of adult patients with
intermediate/poor-risk advanced renal cell carcinoma (see section
5.1).
Non-
small cell lung cancer (NSCLC)
YERVOY in combination with nivolumab and 2 cycles of platinum-based
chemotherapy is indicated
for the first-line treatment of metastatic non-small cell lung cancer
in adults whose tumours have no
sensitising EGFR mutation or ALK translocation.
3
Malignant pleural mesothelioma (MPM)
YERVOY in combination with nivolumab is indicated for the first-line
treatment of adult patients with
unresectable malignant pleural mesothelioma.
Misma