Tecentriq

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

atezolizumab

Saadav alates:

Roche Registration GmbH

ATC kood:

L01XC32

INN (Rahvusvaheline Nimetus):

atezolizumab

Terapeutiline rühm:

Antineoplastic agents

Terapeutiline ala:

Carcinoma, Transitional Cell; Carcinoma, Non-Small-Cell Lung; Urologic Neoplasms; Breast Neoplasms; Small Cell Lung Carcinoma

Näidustused:

Urothelial carcinomaTecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC):- after prior platinum containing chemotherapy, or - who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression ≥ 5% (see section 5.1).Non-small cell lung cancer Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non small cell lung cancer (NSCLC). In patients with EGFR mutant or ALK-positive NSCLC, Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section 5.1).Tecentriq, in combination with nab paclitaxel and carboplatin, is indicated for the first line treatment of adult patients with metastatic non-squamous NSCLC who do not have EGFR mutant or ALK positive NSCLC (see section 5.1).Tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a PD-L1 expression ≥ 50% tumour cells (TC) or ≥ 10% tumour-infiltrating immune cells (IC) and who do not have EGFR mutant or ALK-positive NSCLC (see section 5.1).Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC after prior chemotherapy. Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving Tecentriq (see section 5.1).Small cell lung cancerTecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) (see section 5.1).Hepatocellular carcinomaTecentriq, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy (see section 5.1).Urothelial carcinomaTecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC):- after prior platinum containing chemotherapy, or- who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression ≥ 5% (see section 5.1).Non-small cell lung cancerTecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a PD-L1 expression ≥ 50% tumour cells (TC) or ≥ 10% tumour-infiltrating immune cells (IC) and who do not have EGFR mutant or ALK-positive NSCLC (see section 5.1).Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC after prior chemotherapy. Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving Tecentriq (see section 5.1).Triple-negative breast cancerTecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.

Toote kokkuvõte:

Revision: 23

Volitamisolek:

Authorised

Loa andmise kuupäev:

2017-09-20

Infovoldik

151
B. PACKAGE LEAFLET
152 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TECENTRIQ 840 MG CONCENTRATE FOR SOLUTION FOR INFUSION
TECENTRIQ 1 200 MG CONCENTRATE FOR SOLUTION FOR INFUSION
atezolizumab
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 or nurse.
•
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Tecentriq is and what it is used for
2.
What you need to know before you are given Tecentriq
3.
How Tecentriq is given
4.
Possible side effects
5.
How to store Tecentriq
6.
Contents of the pack and other information
1.
WHAT TECENTRIQ IS AND WHAT IT IS USED FOR
WHAT TECENTRIQ IS
Tecentriq is an anti-cancer medicine that contains the active
substance atezolizumab.
•
It belongs to a group of medicines called monoclonal antibodies.
•
A monoclonal antibody is a type of protein designed to recognise and
attach to a specific target
in the body.
•
This antibody can help your immune system fight your cancer.
WHAT TECENTRIQ IS USED FOR
Tecentriq is used in adults to treat:
•
A kind of bladder cancer, called urothelial carcinoma
•
A kind of lung cancer, called non-small cell lung cancer
•
A kind of lung cancer, called small cell lung cancer
•
A kind of breast cancer, called triple negative breast cancer.
•
A kind of liver cancer, called hepatocellular carcinoma
Patients may get Tecentriq when their cancer has spread to other parts
of the body or has come back
after previous treatment.
Patients may get Tecentriq when their lung cancer has not spread to
other parts of the body and
treatment will be given after surgery and chemotherapy. Treatment
after surgery is called adjuvant
therapy.
Tecentriq may be given in combination with other anticancer medicines.
It is important that you also
read the package leaf

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Tecentriq 840 mg concentrate for solution for infusion
Tecentriq 1 200 mg concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tecentriq 840 mg concentrate for solution for infusion
One 14 mL vial of concentrate contains 840 mg of atezolizumab*
Tecentriq 1 200 mg concentrate for solution for infusion
One 20 mL vial of concentrate contains 1 200 mg atezolizumab*
After dilution (see section 6.6)
_, _
the final concentration of the diluted solution should be between 3.2
and 16.8 mg/mL
_. _
*Atezolizumab is an Fc-engineered, humanised IgG1 anti-programmed
death-ligand 1 (PD-L1)
monoclonal antibody produced in Chinese hamster ovary cells by
recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, colourless to slightly yellowish liquid. The solution has a pH
of 5.5 - 6.1 and an osmolality of
129 - 229 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Urothelial carcinoma (UC)
Tecentriq as monotherapy is indicated for the treatment of adult
patients with locally advanced or
metastatic UC:
•
after prior platinum-containing chemotherapy, or
•
who are considered cisplatin ineligible, and whose tumours have a
PD-L1 expression ≥ 5% (see
section 5.1).
Early-stage non-small cell lung cancer (NSCLC)
Tecentriq as monotherapy is indicated as adjuvant treatment following
complete resection and
platinum-based chemotherapy for adult patients with NSCLC with a high
risk of recurrence whose
tumours have PD-L1 expression on ≥ 50% of tumour cells (TC) and who
do not have EGFR mutant or
ALK
-positive NSCLC (see section 5.1 for selection criteria).
Metastatic NSCLC
Tecentriq, in combination with bevacizumab, paclitaxel and
carboplatin, is indicated for the first-line
treatment of adult patients with metastatic non-squamous NSCLC. In
patients with EGFR mutant or
3
ALK-positive NSCLC, Tecentriq, in combination with bevacizuma