TECENTRIQ atezolizumab (rch) 840 mg/14 mL injection concentrated vial

देश: ऑस्ट्रेलिया

भाषा: अंग्रेज़ी

स्रोत: Department of Health (Therapeutic Goods Administration)

सक्रिय संघटक:

atezolizumab, Quantity: 840 mg

थमां उपलब्ध:

Roche Products Pty Ltd

फार्मास्यूटिकल फॉर्म:

Injection, concentrated

रचना:

Excipient Ingredients: histidine; glacial acetic acid; polysorbate 20; sucrose; water for injections

प्रशासन का मार्ग:

Intravenous

पैकेज में यूनिट:

1 vial

प्रिस्क्रिप्शन प्रकार:

(S4) Prescription Only Medicine

चिकित्सीय संकेत:

Early-stage non-small cell lung cancer,Tecentriq as monotherapy is indicated as adjuvant treatment following complete resection and no progression after platinum-based adjuvant chemotherapy for adult patients with stage II to IIIA (as per 7th edition of the UICC/AJCC staging system) NSCLC whose tumours have PD-L1 expression on greater than or equal to 50% of tumour cells.,Metastatic 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.,Tecentriq, in combination with nanoparticle albumin-bound paclitaxel (nab-paclitaxel) and carboplatin, is indicated for first-line treatment of patients with metastatic non-squamous NSCLC who do not have tumour EGFR or ALK genomic aberrations.,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.,Small cell lung cancer,Tecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).,Urothelial carcinoma,Tecentriq is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who,? are considered cisplatin ineligible and whose tumours express PD-L1 (PD-L1 stained tumour-infiltrating immune cells [IC] covering greater than or equal to 5% of the tumour area), as determined by a validated test, or,? are considered ineligible for any other platinum-containing chemotherapy regardless of the level of tumour PD-L1 expression.,This indication is approved based on overall response rate and duration of response in a single-arm study. Improvements in overall survival, progression-free survival, or health-related quality of life have not been established.,Hepatocellular carcinoma,Tecentriq, in combination with bevacizumab, is indicated for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

उत्पाद समीक्षा:

Visual Identification: Colourless to slightly yellow solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius

प्राधिकरण का दर्जा:

Registered

प्राधिकरण की तारीख:

2019-07-31

सूचना पत्रक

TECENTRIQ
®
_atezolizumab_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Tecentriq. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Tecentriq
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TECENTRIQ IS
USED FOR
Tecentriq contains the active
ingredient atezolizumab.
Tecentriq works by attaching to a
specific protein in your body called
'PD-L1'. This protein makes the
immune system in the body work less
well. By attaching to the protein,
Tecentriq helps your immune system
to fight your cancer.
Tecentriq is used to treat
•
a type of cancer that affects the
lungs, called non-small cell lung
cancer (NSCLC). Tecentriq is
used together with other
medicines (bevacizumab,
paclitaxel and carboplatin) when
the cancer has spread to other
parts of the body. Tecentriq can
also be used as a single treatment
(monotherapy) if the cancer has
come back after previous
treatment when the cancer is
advanced or spread to other parts
of the body.
•
a type of cancer that affects the
lungs, called small cell lung
cancer (SCLC) when the cancer
has spread within the lungs or to
other parts of the body. Tecentriq
is used together with the
chemotherapy medicines
etoposide and carboplatin.
•
a type of cancer that affects the
bladder and the urinary system,
called "urothelial carcinoma".
Tecentriq is used when the cancer
is advanced or spread to other
parts of the body.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS WHY TECENTRIQ HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor's prescription.
If you are being treated with
Tecentriq together with other
medicines, such as bevacizumab,
carbop

उत्पाद विशेषताएं

Tecentriq

191016
1
This medicinal product is subject to additional monitoring
IN AUSTRALIA
due to provisional approval
of an extension of indications. This will allow quick identification
of new safety information.
Healthcare professionals are asked to report any suspected adverse
events at
www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION – TECENTRIQ
® (ATEZOLIZUMAB)
1
NAME OF THE MEDICINE
Atezolizumab
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tecentriq 840 mg/14 mL concentrated injection
Each vial of 14 mL contains 840 mg of atezolizumab at a concentration
of 60 mg/mL.
Tecentriq 1200 mg/20 mL concentrated injection
Each vial of 20 mL contains 1200 mg of atezolizumab at a concentration
of 60 mg/mL.
For the full list of excipients, see section
_6.1 List of excipients_
.
3
PHARMACEUTICAL FORM
Concentrated injection for intravenous infusion. Tecentriq is supplied
as a single-use vial containing
either 14 mL or 20 mL preservative-free, colourless to slightly yellow
solution, at a concentration of
60 mg/mL.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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.
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.
SMALL CELL LUNG CANCER
Tecentriq, in combination with carboplatin and etoposide, is indicated
for the first-line treatment of
patients with extensive-stage small cell lung cancer (ES-SCLC).
UROTHELIAL CARCINOMA
Tecentriq is indicated for the treatment of patients with locally