Product Information
Registration Status: ActiveSIN15425P
TECENTRIQ CONCENTRATE FOR SOLUTION FOR INFUSION 1200MG/ 20ML is approved to be sold in Singapore with effective from 2018-02-09. It is marketed by ROCHE SINGAPORE PTE LTD, with the registration number of SIN15425P.
This product contains Atezolizumab 1200 mg in the form of INFUSION, SOLUTION CONCENTRATE. It is approved for INTRAVENOUS use.
This product is manufactured by Roche Diagnostics GmbH in SWITZERLAND, andF. Hoffmann-La Roche Ltd in GERMANY.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}Description
Atezolizumab is an Fc-engineered, humanized, monoclonal antibody that binds to Programmed Death Ligand 1 (PD-L1) and blocks its interactions with the receptors B7.1 (also known as CD80) and Programmed Death 1 (PD-1). The binding of PD-L1 to PD-1 or B7.1 on activated T cells causes an inhibitory signal to suppress their production in the lymph nodes, thereby preventing immune responses to events such as pregnancy or autoimmune disease. This pathway is also utilized by cancer cells to evade the immune system through evasion of anti-tumor T-cell response. Furthermore, over-expression of PD-L1 and PD-1 has been linked to increased tumour aggressiveness and poorer prognosis. Currently the only antibody against PD-L1 and available as the product Tecentriq (FDA), atezolizumab is indicated for the treatment of locally advanced or metastatic urothelial carcinoma.
Indication
For the treatment of patients with locally advanced or metastatic urothelial carcinoma who: 1) have disease progression during or following platinum-containing chemotherapy, and 2) have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Mechanism of Action
Atezolizumab is a monoclonal antibody that binds to PD-L1 and blocks its interactions with both PD-1 and B7.1 receptors. This prevents PD-L1/PD-1 mediated inhibition of the immune response, including activation of the anti-tumor immune response without inducing antibody-dependent cellular cytotoxicity.
Pharmacokinetics
- Absorption
- The population PK analysis suggests steady state is obtained after 6 to 9 weeks (2 to 3 cycles) of repeated dosing. The systemic accumulation in area under the curve (AUC), maximum concentration (Cmax) and trough concentration (Cmin) was 1.91, 1.46 and 2.75-fold, respectively.
- Distribution
- 6.9 L
- Metabolism
- Elimination
Clearance
0.20 L/day
Toxicity
Most common adverse reactions (≥ 20% of patients) included: fatigue, decreased appetite, nausea, urinary tract infection, pyrexia, and constipation.
Active Ingredient/Synonyms
Atezolizumab | Atezolizumab |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.