Tecentriq concentrate for solution for infusion

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

atezolizumab

Available from:

F. Hoffmann-La Roche Ltd. 4303 Kaiseraugst-secondary packager

ATC code:

L01XC32

INN (International Name):

atezolizumab

Dosage:

60mg/ml

Pharmaceutical form:

concentrate for solution for infusion

Units in package:

20ml glass vial

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-01-18

Patient Information leaflet

TECENTRIQ
®
Atezolizumab
1.
DESCRIPTION
1.1
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Anti-neoplastic agent, humanized immunoglobulin G1 (IgG1)
monoclonal antibody.
ATC code: not yet assigned
1.2
TYPE OF DOSAGE FORM
Concentrate for solution for infusion
1.3
ROUTE OF ADMINISTRATION
Intravenous (IV) infusion
1.4
STERILE / RADIOACTIVE STATEMENT
Sterile product
1.5
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient: _
atezolizumab
Tecentriq is supplied as a single-use vial containing 20 ml
preservative-free, colorless to slightly yellow solution, at a
concentration of 60 mg/ml. Each vial contains a total of 1200 mg
atezolizumab.
_Excipients:_
as registered locally
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATION
Tecentriq is indicated for the treatment of patients with locally
advanced or metastatic urothelial carcinoma after prior
chemotherapy or who are considered cisplatin ineligible.
Tecentriq is indicated for the treatment of patients with locally
advanced or metastatic non-small cell lung cancer (NSCLC) after
prior chemotherapy.
2.2
DOSAGE AND ADMINISTRATION
GENERAL
Tecentriq must be administered as an IV infusion under the
supervision of a qualified healthcare professional. Do not
administer as an IV push or bolus.
Substitution by any other biological medicinal product requires
the consent of the prescribing physician.
The recommended dose is 1200 mg administered by IV infusion
every three weeks. The initial dose of Tecentriq must be
administered over 60 minutes. If the first infusion is tolerated,
all subsequent infusions may be administered over 30 minutes.
DURATION OF TREATMENT
Patients are treated with Tecentriq until loss of clinical benefit
(see section 3.1.2 Clinical / Efficacy Studies) or unmanageable
toxicity.
DELAYED OR MISSED DOSES
If a planned dose of Tecentriq is missed, it should be administered
as soon as possible, do not wait until the next planned dose.
The schedule of administration should be adjusted to maintain a
3-week interval between doses.
_ _
DOSE MODIFICATIONS
No dose redu

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Tecentriq 1,200 mg concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 20 mL vial of concentrate contains 1,200 mg atezolizumab*.
After dilution (see section 6.6)_, _one mL of solution contains
approximately 4.4 mg of atezolizumab.
*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.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tecentriq 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).
Tecentriq as monotherapy is indicated for the treatment of adult
patients with locally advanced or
metastatic non-small cell lung cancer (NSCLC) after prior
chemotherapy. Patients with EGFR
activating mutations or ALK-positive tumour mutations should also have
received targeted therapy
before receiving Tecentriq (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Tecentriq must be initiated and supervised by physicians experienced
in the treatment of cancer._ _
PD-L1 testing for patients with UC
Patients with previously untreated UC should be selected for treatment
based on the tumour expression
of PD-L1 confirmed by a validated test (see section 5.1).
3
Posology
The recommended dose of Tecentriq is 1,200 mg administered
intr