TECENTRIQ

País: Israel

Idioma: inglés

Fuente: Ministry of Health

Ingredientes activos:

ATEZOLIZUMAB

Disponible desde:

ROCHE PHARMACEUTICALS (ISRAEL) LTD

formulario farmacéutico:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composición:

ATEZOLIZUMAB 60 MG/ML

Vía de administración:

I.V

tipo de receta:

Required

Fabricado por:

HOFFMANN LA ROCHE LTD, SWITZERLAND

indicaciones terapéuticas:

Urothelial Carcinoma• TECENTRIQ (atezolizumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumours have a PD-L1 expression ≥ 5%.• TECENTRIQ is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following any platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant chemotherapy.- Non-Small Cell Lung Cancer •TECENTRIQ, as a single agent, is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]), as determined by an approved test, with no EGFR or ALK genomic tumor aberrations.•TECENTRIQ, in combination with paclitaxel protein-bound and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.• 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 is indicated for the treatment of patients with metastatic NSCLC who are naïve to anti-PD-L1 or anti-PD-1 therapies and have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on approved therapy for NSCLC harboring these aberrations prior to receiving TECENTRIQ.• 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 NSCLC whose tumors have PD-L1 expression on ≥ 50% of tumor cells (TCs).- Locally Advanced or Metastatic Triple-Negative Breast Cancer Tecentriq, in combination with nab-paclitaxel, is indicated for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors have PD-L1 expression ≥1% and who have not received prior chemotherapy for metastatic disease.- 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)."- Hepatocellular CarcinomaTECENTRIQ, 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.- MelanomaTECENTRIQ, in combination with cobimetinib and vemurafenib, is indicated for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.- Alveolar Soft Part Sarcoma TECENTRIQ, as a single agent, is indicated for the treatment of adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft part sarcoma (ASPS).

Fecha de autorización:

2022-05-31

Información para el usuario

INFORMATION BOOKLET FOR PATIENTS
USING TECENTRIQ (ATEZOLIZUMAB)
60 MG/ML
The format and content of this booklet
were approved by the Ministry of Health in
DEAR PATIENT,
This booklet contains important safety information that you
must be aware of before and during treatment with Tecentriq
(atezolizumab).
The information in this booklet is not meant to replace your
doctor's discretion. For any additional questions, consult
your doctor.
For complete information about this medicine, refer to the
leaflet published in the Israeli Drug Registry on the Ministry
of Health website or on the Roche website, www.roche.co.il.
We wish you the best of health!
WHAT IS TECENTRIQ?
Tecentriq is a prescription drug used to treat certain types
of cancer.
HOW DOES TECENTRIQ WORK?
Tecentriq works by binding to a specific protein in the body,
called PD-L1. This protein suppresses the activity of the
immune system, thus preventing it from attacking cancer
cells. By binding to the PD-L1 protein, Tecentriq enables
the immune system to attack and destroy the cancer cells.
HOW IS TECENTRIQ ADMINISTERED?
Tecentriq can be administered in various doses and at
different intervals, according to your doctor's instructions.
Treatment is administered intravenously by the medical
team for 30 – 60 minutes.
IN VARIOUS DOSES
ADMINISTERED INTRAVENOUSLY
FOR 30 – 60 MINUTES
The format and content of this booklet
were approved by the Ministry of Health in
WHAT DO I NEED TO TELL MY DOCTOR BEFORE
RECEIVING TREATMENT WITH TECENTRIQ?
Before beginning treatment, you must provide your doctor
complete information on your medical background, including
illnesses you have or have had in the past, medicines you
take regularly, including prescription and non-prescription
medicines, vitamins, herbal supplements, as well as any
sensitivity to medicines.
This treatment is not suitable for everyone. Do not take
Tecentriq if you are sensitive to atezolizumab or to any of
the medicine's components
(glacial acetic acid, L-histidine, sucrose, polysorbate 20).
IT IS ALSO IMP

Ficha técnica

1
Tecentriq PI version 14
TECENTRIQ
®
 

ATEZOLIZUMAB
Concentrate for solution for infusion
NAME OF THE MEDICINAL PRODUCT
Tecentriq
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial of 20 mL of concentrate contains 1,200 mg atezolizumab.
After dilution_,_ the final concentration of the diluted solution
should be between 3.2 and 16.8
mg/mL.
One 14 mL vial of concentrate contains 840 mg of atezolizumab. After
dilution_,_ the final
concentration of the diluted solution should be between 3.2 and 16.8
mg/mL.
For dilution and other handling recommendations, see section 2.3.
For the full list of excipients, see section 11.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Clear, colourless to slightly yellowish liquid.
CLINICAL PARTICULARS
Patient safety information card and brochure
The marketing of TECENTRIQ is subject to a risk management plan (RMP)
including patient
safety information materials (patient information card and patient
brochure). These materials
emphasizes important safety information that the patient should be
aware of before and during
treatment. Please explain to the patient the need to review these
materials before starting
treatment.
1
INDICATIONS AND USAGE
1.1
UROTHELIAL CARCINOMA
●
TECENTRIQ (atezolizumab) is indicated for the treatment of patients
with locally advanced
or metastatic urothelial carcinoma who are not eligible for
cisplatin-containing
chemotherapy and whose tumours have a PD-L1 expression
≥
5%.
●
TECENTRIQ is indicated for the treatment of patients with locally
advanced or metastatic
urothelial carcinoma who have disease progression during or following
any platinum-
containing chemotherapy, or within 12 months of neoadjuvant or
adjuvant chemotherapy
1.2
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
2
with Stage II to IIIA NSCLC whose tumors have PD-L1 expression on
≥
50%