Product Information
Registration Status: ActiveIMFINZI CONCENTRATE FOR SOLUTION FOR INFUSION 50 MG/ML is approved to be sold in Singapore with effective from 2018-10-29. It is marketed by ASTRAZENECA SINGAPORE PTE LTD, with the registration number of SIN15569P.
This product contains Durvalumab 50 mg/ml in the form of INFUSION, SOLUTION CONCENTRATE. It is approved for INTRAVENOUS use.
This product is manufactured by Catalent Indiana in UNITED STATES, and LLC 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.
Description
Durvalumab is a a human monoclonal antibody that blocks programmed death ligand 1 (PD-L1), or CD 274. In May, 2017 it received FDA approval for previously treated patients with locally advanced or metastatic cancer in the urinary system (as Imfinzi). It is shown to be effective in patients with continued disease progression after the platinum-based chemotherapy. This drug has a relatively tolerable safety profile and its structural modification advantageously prevents the induction of antibody-dependent cytotoxicity (ADCC) or complement-dependent cytotoxicity (CDC) [L749].
Indication
Durvalumab is indicated for patients with urothelial carcinoma, such as urinary bladder, urethra or ureter cancer. Patients with prolonged disease progression due to failed platinum-based chemotherapy such as cisplatin and carboplatin are most likely to benefit from durvalumab treatment. Its clinical effectiveness is especially enhanced in PD-L1-positive patient groups [A19123].
Mechanism of Action
Durvalumab is a human immunoglobulin G1 kappa (IgGIk) monoclonal antibody that blocks PD-L1 binding to PD-1 and CD80. PD1 signalling pathway serves to physiologically limit the activity of T cells and autoimmune or inflammatory responses in the body however can be a mechanism of immunity resistance by tumor cells. Blockage of ligand-mediated PD1 pathway enhances further T cell activation, effector T cell proliferation, NK cell activity and cytokine production to minimize the growth of locally advancing or metastasizing solid tumors.
Clearance
Mean steady state clearance is approximately 8.24 mL/h (37.3% coefficient of variation).
Toxicity
Many toxic effects of durvalumab therapy are immune-mediated inflammation in various tissues including pneumonitis, hepatitis and colitis. Disturbances in endocrine system are possible adverse effects such as hypo/hyperthyroidism, type I diabetes mellitus and adrenal insufficiency. Cessation of therapy is recommended in case of any immune-mediated or infusion-related adverse reactions. Animal studies suggest a possibility of embryo-fetal toxicity.
Active Ingredient/Synonyms
Durvalumab | Durvalumab |
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.